Synopsis
• In the phase 3 clinical trials POETYK PSO-1 and PSO-2, deucravacitinib was compared for effi cacy and safety 

with placebo and apremilast in the treatment of patients with moderate to severe plaque psoriasis1

 — Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved by the US 
Food and Drug Administration for the treatment of adults with moderate to severe plaque psoriasis 
who are candidates for systemic therapy or phototherapy

 — In each clinical trial, greater proportions of patients who received deucravacitinib achieved ≥75% 
reduction from baseline in the Psoriasis Area and Severity Index score (PASI 75)1 and static Physician’s 
Global Assessment scores of 0 or 1 (sPGA 0/1),1 and showed meaningful improvements on Psoriasis 
Symptoms and Signs Diary (PSSD) total scores (≥25 points)2 and Dermatology Life Quality Index (DLQI) 
total scores (≥4 points)3 compared with patients receiving placebo or apremilast

• In this post hoc analysis of data pooled from both trials, clinical and patient-reported outcomes (PROs) 
were found to be correlated 

• When analyzed by the deucravacitinib or placebo treatment arm, greater proportions of patients who 
received deucravacitinib reported symptom reduction and improved quality of life, both in patients 
who did and who did not achieve PASI 75 and sPGA 0/1 responses

Objective
• To explore the correlations between responses on clinical and PRO measures in pooled data from 

POETYK PSO-1 and PSO-2

Methods
• In POETYK PSO-1 (N = 666) and PSO-2 (N = 1020) adults (aged ≥18 years) with moderate to severe psoriasis 

were randomized 2:1:1 to deucravacitinib 6 mg once daily, placebo, or apremilast 30 mg twice daily

 — At Week 16 in each trial, patients who received placebo crossed over to deucravacitinib

• Using data pooled from both trials, we evaluated the correlation between responses measured by PASI 
and sPGA on one hand, and the PRO measures PSSD (≥25 points)2 and DLQI (≥4 points)3 on the other

 — The analysis populations for the PSSD and DLQI included all patients from the full analysis set who 
completed ≥1 item on the respective questionnaire at baseline and ≥1 post-baseline visit 
• At baseline, 1659 patients had a DLQI score recorded and 1553 had a PSSD score recorded

• Spearman correlation coeffi cients between clinical and PRO score changes from baseline to Week 16 were 
calculated with all treatment groups combined

• Mean PSSD and DLQI scores were determined within relative PASI and sPGA response levels

• The proportions of patients achieving meaningful improvement (ie, response) in PSSD total scores and 
on the DLQI were summarized by whether they did or did not achieve PASI 75 and sPGA 0/1, and were 
further analyzed by treatment arm

 — Results are reported for patients receiving deucravacitinib or placebo

Outcome measures
• PASI

 — Clinician evaluated

 — Range: 0–72, with higher scores indicating more severe disease

• sPGA

 — Clinician evaluated

 — Range: 0 (clear) to 4 (severe)

• PSSD

 — Patient rated

 — 5 skin symptoms (itch, tightness, burning, stinging, and pain) and 6 skin signs (dryness, cracking, 
scaling, shedding/fl aking, redness, and bleeding) associated with psoriasis were rated 0 (absent) to 
10 (worst imaginable); averages within each domain were multiplied by 10, then averaged across both 
domains to obtain a total score

 — Range: 0–100, with higher scores indicating heavier disease burden

• DLQI

 — Patient rated

 — 10 questions that assess the extent to which skin disease affects patients’ lives

 — Range: 0–30, with higher scores indicating more severe impact of disease 

Results
Correlations between clinical and PRO measures
• At Week 16, change from baseline in relative PASI score was correlated with changes in the PSSD total 

score (Spearman’s rank correlation coeffi cient [r
s
] = 0.536) and DLQI total score (r

s
 = 0.421) in the total 

study population

• At Week 16, change from baseline in sPGA score was correlated with changes in the PSSD total score 
(r

s
 = 0.496) and DLQI total score (r

s
 = 0.380) in the total study population

• Higher PASI or sPGA response was associated with greater PSSD and DLQI responses at Weeks 16, 24, and 
52 in the total study population (Figures 1–4)

Figure 1. PSSD total score change from baseline by PASI response group 
(treatment arms and trials pooled, n = 1536)

–50

–45

–40

–35

–30

–25

–20

–15

–10

–5

0

Week 16 Week 24 Week 52

P
SS

D
 c

h
an

ge
 f

ro
m

 b
as

e
li
n
e

a

PASI <50 PASI 50–74 PASI 75–89 PASI 90–99 PASI 100

aAt baseline, the mean PSSD total score (SD) was 54.4 (23.30) in the deucravacitinib arm, 53.1 (23.09) in the placebo arm, and 55.7 (22.90) in the apremilast arm. 
PASI 50–100, 50%–100% improvement from baseline in the Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary.

Figure 2. DLQI Change from baseline by PASI response group (treatment arms 
and trials pooled, n = 1643)

–14

–12

–10

–8

–6

–4

–2

0

Week 16 Week 24 Week 52

D
LQ

I 
ch

an
ge

 f
ro

m
 b

as
e
li
n
e

a

PASI <50 PASI 50–74 PASI 75–89 PASI 90–99 PASI 100

aThe mean baseline DLQI score (SD) among all patients in the study population was 12.0 (6.7).
DLQI, Dermatology Life Quality Index; PASI 50–100, 50%–100% improvement from baseline Psoriasis Area and Severity Index score.

Figure 3. PSSD change from baseline by sPGAa change group (treatment arms 
and trials pooled, n = 1536)

–50

–40

–30

–20

–10

0

10

20

Week 16 Week 24 Week 52

P
SS

D
 c

h
an

ge
 f

ro
m

 b
as

e
li
n
e

sPGA +1 sPGA 0 sPGA –1 sPGA –2 sPGA –3 or more

aAt baseline, 1345 patients in the total study population had an sPGA score of 3, and 340 had an sPGA score of 4. One patient had an sPGA score of 2; this patient was randomized but not treated. The mean 
baseline PSSD total score (SD) was 54.4 (23.30) in the deucravacitinib arm, 53.1 (23.09) in the placebo arm, and 55.7 (22.90) in the apremilast arm. 
PSSD, Psoriasis Symptoms and Signs Diary; sPGA, static Physician’s Global Assessment.

Figure 4. DLQI change from baseline by sPGAa change group (treatment arms 
and trials pooled, n = 1643)

Week 16 Week 24

–12

–10

–8

–6

–4

–2

0

2
Week 52

D
LQ

I 
ch

an
ge

 f
ro

m
 b

as
e
li
n
e

sPGA +1 sPGA 0 sPGA –1 sPGA –2 sPGA –3 or more

aAt baseline, 1345 patients in the total study population had an sPGA score of 3 and 340 had an sPGA score of 4. One patient had an sPGA score of 2; this patient was randomized but not treated. The mean 
baseline DLQI score (SD) among all patients in the study population was 12.0 (6.7).
DLQI, Dermatology Life Quality Index; sPGA, static Physician’s Global Assessment.

PSSD Response by Clinical Response
• At Week 16, PSSD total score response (≥25-point reduction from baseline) was reported by 64.8% and 65.3% of 

all patients across both trials who achieved PASI 75 (356/549) and/or sPGA 0/1 (330/505), respectively (Table 1)

 — Greater proportions of patients who received deucravacitinib and achieved clinical response reported 
PSSD total score response (68.6% of patients who achieved PASI 75 and 68.7% of patients who achieved 
sPGA 0/1) compared with patients who received placebo (31.3% of patients who achieved PASI 75 and 
37.0% of patients who achieved sPGA 0/1) (Table 1)

 — On the PSSD itch item, meaningful improvement (≥2 points) was reported by 80.8% of patients 
receiving deucravacitinib who achieved PASI 75 and 80.1% of deucravacitinib-treated patients who 
achieved sPGA 0/1, compared with 43.8% of patients receiving placebo who achieved PASI 75 and 
48.1% of placebo-treated patients who achieved sPGA 0/1 (Figure 5)

• At Week 16, 27.9% and 29.8% of all patients across both trials who did not achieve PASI 75 (188/674) 
and/or did not achieve sPGA 0/1 (214/718), respectively, nonetheless reported PSSD total score response

 — Greater proportions of patients who received deucravacitinib and did not achieve clinical response 
nonetheless reported PSSD total score response (41.8% of patients who did not achieve PASI 75 and 
44.1% of patients who did not achieve sPGA 0/1) compared with patients who received placebo 
(10.4% of patients who did not achieve PASI 75 and 10.3% who did not achieve sPGA 0/1)

 — On the PSSD itch item, meaningful improvement was reported by 54.9% of patients receiving 
deucravacitinib who did not achieve PASI 75 compared with 22.0% of patients receiving placebo who 
did not achieve PASI 75

Table 1. PSSD response at Week 16 in patients who achieved clinical response

PSSD Domain
Total patients

N = 1536
Deucravacitinib 

n = 765
Placebo 
n = 383

Total score (≥25-point reduction), n/Na (%)
PASI 75 356/549 (64.8)b 264/385 (68.6) 10/32 (31.3)
sPGA 0/1 330/505 (65.3)b 248/361 (68.7) 10/27 (37.0)

Symptom score (≥25-point reduction), n/Na (%)
PASI 75 323/549 (58.8)b 240/385 (62.3) 10/32 (31.3)
sPGA 0/1 296/505 (58.6)b 223/361 (61.8) 8/27 (29.6)

Sign score (≥25-point reduction), n/Na (%)
PASI 75 383/549 (69.8)b 284/385 (73.8) 10/32 (31.3)
sPGA 0/1 354/505 (70.1)b 267/361 (74.0) 10/27 (37.0)

aThe denominator represents the patients who achieved clinical response and who completed ≥1 PSSD item at baseline and ≥1 PSSD item at a post-baseline visit.
bTotal denominator includes patients who received apremilast. 
PASI 75, ≥75% improvement from baseline in Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

Figure 5. PSSD individual item response at Week 16 in patientsa who achieved 
clinical response

0

10

20

30

40

50

60

70

80

90

Deucravacitinib (n = 765) Placebo (n = 383)

P
at

ie
n
ts

, 
%

80.8 80.1 79.7 80.3

63.6 63.2

58.7 58.4

66.2 66.2

85.7 84.8

72.7 72.9

84.2 84.5
85.7 85.3

79.2 78.9

49.9
48.2

43.8

48.1 46.9

40.7

37.5 37.0

31.3

25.9

34.4

29.6

43.8

48.1 46.9 48.1 46.9

51.9

43.8

48.1

37.5

48.1

31.3
33.3

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

Itch
(≥2 points)

Tightness
(≥2 points)

Burning
(≥2 points)

Stinging
(≥2 points)

Pain
(≥2 points)

Dryness
(≥2 points)

Cracking
(≥2 points)

Scaling
(≥2 points)

Shedding/flaking
(≥2 points)

Redness
(≥2 points)

Bleeding
(≥2 points)

aDenominators include patients who achieved clinical response and completed ≥1 PSSD item at baseline and ≥1 PSSD item at a post-baseline visit.
PASI 75, 75% reduction from baseline in Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

DLQI Response by Clinical Response
• At Week 16, DLQI response (≥4-point reduction from baseline) was reported by 83.3% and 82.5% of all 

patients across both trials who achieved PASI 75 (553/664) and/or sPGA 0/1 (496/601), respectively 
(Table 2)

 — Greater proportions of patients who received deucravacitinib and achieved clinical response reported 
meaningful DLQI improvement (84.7% of patients who achieved PASI 75 and 83.3% of patients who 
achieved sPGA 0/1) compared with patients who received placebo (72.7% of patients who achieved 
PASI 75 and 70.6% of patients who achieved sPGA 0/1)

• At Week 16, 54.7% and 57.3% of all patients across both trials who did not achieve PASI 75 (444/811) 
and/or did not achieve sPGA 0/1 (501/874), respectively, nonetheless reported DLQI response

 — Greater proportions of patients who received deucravacitinib and did not achieve clinical response 
nonetheless reported meaningful DLQI improvement (67.1% of patients who did not achieve PASI 75 
and 70.8% of patients who did not achieve sPGA 0/1) compared with patients who received placebo 
(40.5% of patients who did not achieve PASI 75 and 41.7% who did not achieve sPGA 0/1)

Table 2. DLQI response at Week 16 in patients who achieved clinical response

DLQI ≥4-point reduction
Total patients  

N = 1643
Deucravacitinib 

n = 824
Placebo 
n = 409

PASI 75, n/Na (%) 553/664 (83.3)b 393/464 (84.7) 32/44 (72.7)

sPGA 0/1, n/Na (%) 496/601 (82.5)b 359/431 (83.3) 24/34 (70.6)
aThe denominator includes the patients who achieved clinical response and completed ≥1 DLQI item at baseline and ≥1 DLQI item at a post-baseline visit.
bTotal denominator includes patients who received apremilast. 
DLQI, Dermatology Life Quality Index; PASI 75, ≥75% improvement from baseline in Psoriasis Area and Severity Index score; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

Conclusions
• Psoriasis skin clearance, symptom reduction, and improved patient quality of life were 

correlated in the POETYK PSO-1 and PSO-2 trials

 — This correlation is consistent with that determined in other studies4-7

• Higher clinical response was associated with greater PRO measure response

• PRO measures capture patient-perceived treatment benefi ts that may not be ascertained by 
measuring rates of skin clearance with clinical assessments alone4

 — Psoriasis bears symptoms, such as pruritus, for which there are no validated objective 
measures,8 or which are best assessed by patients themselves9 in order to evaluate 
treatment effi cacy

 — Among patients who achieved PASI 75 at Week 16, 80.8% of patients who received 
deucravacitinib reported meaningful itch improvement on the PSSD compared with 
43.8% of patients who received placebo

• Among patients with and without clinical response, greater proportions of patients treated 
with deucravacitinib recorded improvement in their self-reported symptoms, signs, and quality 
of life compared with patients treated with placebo

References
1. Warren RB, et al. Ann Rheum Dis. 2022;81:1570-1571.

2. Papp KA, et al. [poster] Presented at the 30th Congress of the European Academy of Dermatology and Venereology (EADV); September 29–October 2, 2021; virtual meeting.
3. Augustin M, et al. [poster] Presented at the American Academy of Dermatology (AAD) Annual Meeting; March 25–29, 2022; Boston, MA.
4. Armstrong AW, et al. Am J Clin Dermatol. 2019;20:155-164.

5. Loft ND, et al. Acta Derm Venereol. 2019;99:1224-1230.

6. Schäfer I, et al. Eur J Dermatol. 2010;20:62-67.

7. Thaçi D, et al. Dermatol Ther (Heidelb). 2022;12:495-510.

8. Price A, Cohen DE. Dermatitis. 2014;225:334-344.

9. Armstrong AW, et al. J Dermatol Treat. 2019;30:27-34.

Acknowledgments
• This study was sponsored by Bristol Myers Squibb

• Medical writing and editorial assistance was provided by Eleanor Bush, MA, of Peloton Advantage, LLC, an OPEN Health company, and funded by Bristol Myers Squibb

Disclosures
• AWA: Grants and personal fees: AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Leo Pharma, and Novartis; Personal fees: Boehringer Ingelheim/Parexel, Celgene, 

Dermavant, Genentech, GlaxoSmithKline, Menlo Therapeutics, Merck, Modernizing Medicine, Ortho Dermatologics, Pfi zer, Regeneron, Sanofi  Genzyme, Science 37, 
Sun Pharma, and Valeant; Grants: Dermira, Kyowa Hakko Kirin, and UCB, outside the submitted work

• KAP: Speakers bureau: AbbVie, Amgen, Astellas, Celgene, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Leo Pharma, Merck Sharp & Dohme, Novartis, Pfi zer, and 
Valeant; Grant/research support: AbbVie, Akros, Allergan, Amgen, Anacor, Arcutis, AstraZeneca, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, 
Dermira, Dow Pharma, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, Leo Pharma, MedImmune, Meiji Seika Pharma, Merck Serono, 
Novartis, Pfi zer, Regeneron, Roche, Sanofi  Genzyme, Takeda, UCB, and Valeant; Consultant: AbbVie, Akros, Amgen, Arcutis, Astellas, AstraZeneca, Baxalta, Baxter, 
Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Forward Pharma, Galderma, Genentech, Janssen, Kyowa Hakko 
Kirin, Leo Pharma, Meiji Seika Pharma, Merck Serono, Merck Sharp & Dohme, Mitsubishi Pharma, Novartis, Pfi zer, Regeneron, Roche, Sanofi  Genzyme, Takeda, UCB, 
and Valeant; Honoraria: AbbVie, Akros, Amgen, Baxter, Boehringer Ingelheim, Celgene, Coherus, Eli Lilly, Forward Pharma, Galderma, GlaxoSmithKline, Janssen, Kyowa 
Hakko Kirin, Merck Sharp & Dohme, Merck Serono, Novartis, Pfi zer, Takeda, UCB, and Valeant; Scientifi c offi cer/steering committee/advisory board: AbbVie, Akros, 
Amgen, Anacor, Astellas, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dow Pharma, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Merck Serono, 
Merck Sharp & Dohme, Novartis, Pfi zer, Regeneron, Sanofi  Genzyme, and Valeant

• JZ, BB, YZ, RMK, and SB: Employees and shareholders of Bristol Myers Squibb

• JLB and MD: Employees of Clinical Outcomes Solutions, which has received consulting fees from Bristol Myers Squibb

• BS: Consultant (honoraria): AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Eli 
Lilly, Equillium, GlaxoSmithKline, Immunic Therapeutics, Janssen, Leo Pharma, Maruho, Meiji Seika Pharma, Mindera, Novartis, Ortho Dermatologics, Pfi zer, Regeneron, 
Sanofi  Genzyme, Sun Pharma, UCB, Ventyx Biosciences, and vTv Therapeutics; Speaker: AbbVie, Eli Lilly, Janssen, and Sanofi  Genzyme; Co-scientifi c director (consulting 
fee): CorEvitas’ (Corrona) Psoriasis Registry; Investigator: AbbVie, Cara, CorEvitas’ (Corrona) Psoriasis Registry, Dermavant, Dermira, and Novartis

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: correlations between patient-reported 
outcomes and clinical responses in the phase 3 clinical trials POETYK PSO-1 and POETYK PSO-2
April W. Armstrong,1 Kim A. Papp,2 Joe Zhuo,3 Brandon Becker,3 Yichen Zhong,3 Jennifer L. Beaumont,4 Michael DeRosa,4 Renata M. Kisa,3 Subhashis Banerjee,3 Bruce Strober5,6
1Keck School of Medicine, University of Southern California, Los Angeles, CA; 2Probity Medical Research, Waterloo, Ontario, Canada; 3Bristol Myers Squibb, Princeton, NJ; 4Clinical Outcomes Solutions, Chicago, IL; 5Yale University, New Haven, CT; 6Central Connecticut Dermatology, Cromwell, CT

Presented at the Fall Clinical Dermatology Conference; October 20–23, 2022; Las Vegas, NV This poster may not be reproduced without written permission from the authors.Email for April W. Armstrong, MD, MPH: aprilarmstrong@post.Harvard.edu

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Synopsis
• In the phase 3 clinical trials POETYK PSO-1 and PSO-2, deucravacitinib was compared for effi cacy and safety 

with placebo and apremilast in the treatment of patients with moderate to severe plaque psoriasis1

 — Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved by the US 
Food and Drug Administration for the treatment of adults with moderate to severe plaque psoriasis 
who are candidates for systemic therapy or phototherapy

 — In each clinical trial, greater proportions of patients who received deucravacitinib achieved ≥75% 
reduction from baseline in the Psoriasis Area and Severity Index score (PASI 75)1 and static Physician’s 
Global Assessment scores of 0 or 1 (sPGA 0/1),1 and showed meaningful improvements on Psoriasis 
Symptoms and Signs Diary (PSSD) total scores (≥25 points)2 and Dermatology Life Quality Index (DLQI) 
total scores (≥4 points)3 compared with patients receiving placebo or apremilast

• In this post hoc analysis of data pooled from both trials, clinical and patient-reported outcomes (PROs) 
were found to be correlated 

• When analyzed by the deucravacitinib or placebo treatment arm, greater proportions of patients who 
received deucravacitinib reported symptom reduction and improved quality of life, both in patients 
who did and who did not achieve PASI 75 and sPGA 0/1 responses

Objective
• To explore the correlations between responses on clinical and PRO measures in pooled data from 

POETYK PSO-1 and PSO-2

Methods
• In POETYK PSO-1 (N = 666) and PSO-2 (N = 1020) adults (aged ≥18 years) with moderate to severe psoriasis 

were randomized 2:1:1 to deucravacitinib 6 mg once daily, placebo, or apremilast 30 mg twice daily

 — At Week 16 in each trial, patients who received placebo crossed over to deucravacitinib

• Using data pooled from both trials, we evaluated the correlation between responses measured by PASI 
and sPGA on one hand, and the PRO measures PSSD (≥25 points)2 and DLQI (≥4 points)3 on the other

 — The analysis populations for the PSSD and DLQI included all patients from the full analysis set who 
completed ≥1 item on the respective questionnaire at baseline and ≥1 post-baseline visit 
• At baseline, 1659 patients had a DLQI score recorded and 1553 had a PSSD score recorded

• Spearman correlation coeffi cients between clinical and PRO score changes from baseline to Week 16 were 
calculated with all treatment groups combined

• Mean PSSD and DLQI scores were determined within relative PASI and sPGA response levels

• The proportions of patients achieving meaningful improvement (ie, response) in PSSD total scores and 
on the DLQI were summarized by whether they did or did not achieve PASI 75 and sPGA 0/1, and were 
further analyzed by treatment arm

 — Results are reported for patients receiving deucravacitinib or placebo

Outcome measures
• PASI

 — Clinician evaluated

 — Range: 0–72, with higher scores indicating more severe disease

• sPGA

 — Clinician evaluated

 — Range: 0 (clear) to 4 (severe)

• PSSD

 — Patient rated

 — 5 skin symptoms (itch, tightness, burning, stinging, and pain) and 6 skin signs (dryness, cracking, 
scaling, shedding/fl aking, redness, and bleeding) associated with psoriasis were rated 0 (absent) to 
10 (worst imaginable); averages within each domain were multiplied by 10, then averaged across both 
domains to obtain a total score

 — Range: 0–100, with higher scores indicating heavier disease burden

• DLQI

 — Patient rated

 — 10 questions that assess the extent to which skin disease affects patients’ lives

 — Range: 0–30, with higher scores indicating more severe impact of disease 

Results
Correlations between clinical and PRO measures
• At Week 16, change from baseline in relative PASI score was correlated with changes in the PSSD total 

score (Spearman’s rank correlation coeffi cient [r
s
] = 0.536) and DLQI total score (r

s
 = 0.421) in the total 

study population

• At Week 16, change from baseline in sPGA score was correlated with changes in the PSSD total score 
(r

s
 = 0.496) and DLQI total score (r

s
 = 0.380) in the total study population

• Higher PASI or sPGA response was associated with greater PSSD and DLQI responses at Weeks 16, 24, and 
52 in the total study population (Figures 1–4)

Figure 1. PSSD total score change from baseline by PASI response group 
(treatment arms and trials pooled, n = 1536)

–50

–45

–40

–35

–30

–25

–20

–15

–10

–5

0

Week 16 Week 24 Week 52

P
SS

D
 c

h
an

ge
 f

ro
m

 b
as

e
li
n
e

a

PASI <50 PASI 50–74 PASI 75–89 PASI 90–99 PASI 100

aAt baseline, the mean PSSD total score (SD) was 54.4 (23.30) in the deucravacitinib arm, 53.1 (23.09) in the placebo arm, and 55.7 (22.90) in the apremilast arm. 
PASI 50–100, 50%–100% improvement from baseline in the Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary.

Figure 2. DLQI Change from baseline by PASI response group (treatment arms 
and trials pooled, n = 1643)

–14

–12

–10

–8

–6

–4

–2

0

Week 16 Week 24 Week 52

D
LQ

I 
ch

an
ge

 f
ro

m
 b

as
e
li
n
e

a

PASI <50 PASI 50–74 PASI 75–89 PASI 90–99 PASI 100

aThe mean baseline DLQI score (SD) among all patients in the study population was 12.0 (6.7).
DLQI, Dermatology Life Quality Index; PASI 50–100, 50%–100% improvement from baseline Psoriasis Area and Severity Index score.

Figure 3. PSSD change from baseline by sPGAa change group (treatment arms 
and trials pooled, n = 1536)

–50

–40

–30

–20

–10

0

10

20

Week 16 Week 24 Week 52

P
SS

D
 c

h
an

ge
 f

ro
m

 b
as

e
li
n
e

sPGA +1 sPGA 0 sPGA –1 sPGA –2 sPGA –3 or more

aAt baseline, 1345 patients in the total study population had an sPGA score of 3, and 340 had an sPGA score of 4. One patient had an sPGA score of 2; this patient was randomized but not treated. The mean 
baseline PSSD total score (SD) was 54.4 (23.30) in the deucravacitinib arm, 53.1 (23.09) in the placebo arm, and 55.7 (22.90) in the apremilast arm. 
PSSD, Psoriasis Symptoms and Signs Diary; sPGA, static Physician’s Global Assessment.

Figure 4. DLQI change from baseline by sPGAa change group (treatment arms 
and trials pooled, n = 1643)

Week 16 Week 24

–12

–10

–8

–6

–4

–2

0

2
Week 52

D
LQ

I 
ch

an
ge

 f
ro

m
 b

as
e
li
n
e

sPGA +1 sPGA 0 sPGA –1 sPGA –2 sPGA –3 or more

aAt baseline, 1345 patients in the total study population had an sPGA score of 3 and 340 had an sPGA score of 4. One patient had an sPGA score of 2; this patient was randomized but not treated. The mean 
baseline DLQI score (SD) among all patients in the study population was 12.0 (6.7).
DLQI, Dermatology Life Quality Index; sPGA, static Physician’s Global Assessment.

PSSD Response by Clinical Response
• At Week 16, PSSD total score response (≥25-point reduction from baseline) was reported by 64.8% and 65.3% of 

all patients across both trials who achieved PASI 75 (356/549) and/or sPGA 0/1 (330/505), respectively (Table 1)

 — Greater proportions of patients who received deucravacitinib and achieved clinical response reported 
PSSD total score response (68.6% of patients who achieved PASI 75 and 68.7% of patients who achieved 
sPGA 0/1) compared with patients who received placebo (31.3% of patients who achieved PASI 75 and 
37.0% of patients who achieved sPGA 0/1) (Table 1)

 — On the PSSD itch item, meaningful improvement (≥2 points) was reported by 80.8% of patients 
receiving deucravacitinib who achieved PASI 75 and 80.1% of deucravacitinib-treated patients who 
achieved sPGA 0/1, compared with 43.8% of patients receiving placebo who achieved PASI 75 and 
48.1% of placebo-treated patients who achieved sPGA 0/1 (Figure 5)

• At Week 16, 27.9% and 29.8% of all patients across both trials who did not achieve PASI 75 (188/674) 
and/or did not achieve sPGA 0/1 (214/718), respectively, nonetheless reported PSSD total score response

 — Greater proportions of patients who received deucravacitinib and did not achieve clinical response 
nonetheless reported PSSD total score response (41.8% of patients who did not achieve PASI 75 and 
44.1% of patients who did not achieve sPGA 0/1) compared with patients who received placebo 
(10.4% of patients who did not achieve PASI 75 and 10.3% who did not achieve sPGA 0/1)

 — On the PSSD itch item, meaningful improvement was reported by 54.9% of patients receiving 
deucravacitinib who did not achieve PASI 75 compared with 22.0% of patients receiving placebo who 
did not achieve PASI 75

Table 1. PSSD response at Week 16 in patients who achieved clinical response

PSSD Domain
Total patients

N = 1536
Deucravacitinib 

n = 765
Placebo 
n = 383

Total score (≥25-point reduction), n/Na (%)
PASI 75 356/549 (64.8)b 264/385 (68.6) 10/32 (31.3)
sPGA 0/1 330/505 (65.3)b 248/361 (68.7) 10/27 (37.0)

Symptom score (≥25-point reduction), n/Na (%)
PASI 75 323/549 (58.8)b 240/385 (62.3) 10/32 (31.3)
sPGA 0/1 296/505 (58.6)b 223/361 (61.8) 8/27 (29.6)

Sign score (≥25-point reduction), n/Na (%)
PASI 75 383/549 (69.8)b 284/385 (73.8) 10/32 (31.3)
sPGA 0/1 354/505 (70.1)b 267/361 (74.0) 10/27 (37.0)

aThe denominator represents the patients who achieved clinical response and who completed ≥1 PSSD item at baseline and ≥1 PSSD item at a post-baseline visit.
bTotal denominator includes patients who received apremilast. 
PASI 75, ≥75% improvement from baseline in Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

Figure 5. PSSD individual item response at Week 16 in patientsa who achieved 
clinical response

0

10

20

30

40

50

60

70

80

90

Deucravacitinib (n = 765) Placebo (n = 383)

P
at

ie
n
ts

, 
%

80.8 80.1 79.7 80.3

63.6 63.2

58.7 58.4

66.2 66.2

85.7 84.8

72.7 72.9

84.2 84.5
85.7 85.3

79.2 78.9

49.9
48.2

43.8

48.1 46.9

40.7

37.5 37.0

31.3

25.9

34.4

29.6

43.8

48.1 46.9 48.1 46.9

51.9

43.8

48.1

37.5

48.1

31.3
33.3

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

Itch
(≥2 points)

Tightness
(≥2 points)

Burning
(≥2 points)

Stinging
(≥2 points)

Pain
(≥2 points)

Dryness
(≥2 points)

Cracking
(≥2 points)

Scaling
(≥2 points)

Shedding/flaking
(≥2 points)

Redness
(≥2 points)

Bleeding
(≥2 points)

aDenominators include patients who achieved clinical response and completed ≥1 PSSD item at baseline and ≥1 PSSD item at a post-baseline visit.
PASI 75, 75% reduction from baseline in Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

DLQI Response by Clinical Response
• At Week 16, DLQI response (≥4-point reduction from baseline) was reported by 83.3% and 82.5% of all 

patients across both trials who achieved PASI 75 (553/664) and/or sPGA 0/1 (496/601), respectively 
(Table 2)

 — Greater proportions of patients who received deucravacitinib and achieved clinical response reported 
meaningful DLQI improvement (84.7% of patients who achieved PASI 75 and 83.3% of patients who 
achieved sPGA 0/1) compared with patients who received placebo (72.7% of patients who achieved 
PASI 75 and 70.6% of patients who achieved sPGA 0/1)

• At Week 16, 54.7% and 57.3% of all patients across both trials who did not achieve PASI 75 (444/811) 
and/or did not achieve sPGA 0/1 (501/874), respectively, nonetheless reported DLQI response

 — Greater proportions of patients who received deucravacitinib and did not achieve clinical response 
nonetheless reported meaningful DLQI improvement (67.1% of patients who did not achieve PASI 75 
and 70.8% of patients who did not achieve sPGA 0/1) compared with patients who received placebo 
(40.5% of patients who did not achieve PASI 75 and 41.7% who did not achieve sPGA 0/1)

Table 2. DLQI response at Week 16 in patients who achieved clinical response

DLQI ≥4-point reduction
Total patients  

N = 1643
Deucravacitinib 

n = 824
Placebo 
n = 409

PASI 75, n/Na (%) 553/664 (83.3)b 393/464 (84.7) 32/44 (72.7)

sPGA 0/1, n/Na (%) 496/601 (82.5)b 359/431 (83.3) 24/34 (70.6)
aThe denominator includes the patients who achieved clinical response and completed ≥1 DLQI item at baseline and ≥1 DLQI item at a post-baseline visit.
bTotal denominator includes patients who received apremilast. 
DLQI, Dermatology Life Quality Index; PASI 75, ≥75% improvement from baseline in Psoriasis Area and Severity Index score; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

Conclusions
• Psoriasis skin clearance, symptom reduction, and improved patient quality of life were 

correlated in the POETYK PSO-1 and PSO-2 trials

 — This correlation is consistent with that determined in other studies4-7

• Higher clinical response was associated with greater PRO measure response

• PRO measures capture patient-perceived treatment benefi ts that may not be ascertained by 
measuring rates of skin clearance with clinical assessments alone4

 — Psoriasis bears symptoms, such as pruritus, for which there are no validated objective 
measures,8 or which are best assessed by patients themselves9 in order to evaluate 
treatment effi cacy

 — Among patients who achieved PASI 75 at Week 16, 80.8% of patients who received 
deucravacitinib reported meaningful itch improvement on the PSSD compared with 
43.8% of patients who received placebo

• Among patients with and without clinical response, greater proportions of patients treated 
with deucravacitinib recorded improvement in their self-reported symptoms, signs, and quality 
of life compared with patients treated with placebo

References
1. Warren RB, et al. Ann Rheum Dis. 2022;81:1570-1571.

2. Papp KA, et al. [poster] Presented at the 30th Congress of the European Academy of Dermatology and Venereology (EADV); September 29–October 2, 2021; virtual meeting.
3. Augustin M, et al. [poster] Presented at the American Academy of Dermatology (AAD) Annual Meeting; March 25–29, 2022; Boston, MA.
4. Armstrong AW, et al. Am J Clin Dermatol. 2019;20:155-164.

5. Loft ND, et al. Acta Derm Venereol. 2019;99:1224-1230.

6. Schäfer I, et al. Eur J Dermatol. 2010;20:62-67.

7. Thaçi D, et al. Dermatol Ther (Heidelb). 2022;12:495-510.

8. Price A, Cohen DE. Dermatitis. 2014;225:334-344.

9. Armstrong AW, et al. J Dermatol Treat. 2019;30:27-34.

Acknowledgments
• This study was sponsored by Bristol Myers Squibb

• Medical writing and editorial assistance was provided by Eleanor Bush, MA, of Peloton Advantage, LLC, an OPEN Health company, and funded by Bristol Myers Squibb

Disclosures
• AWA: Grants and personal fees: AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Leo Pharma, and Novartis; Personal fees: Boehringer Ingelheim/Parexel, Celgene, 

Dermavant, Genentech, GlaxoSmithKline, Menlo Therapeutics, Merck, Modernizing Medicine, Ortho Dermatologics, Pfi zer, Regeneron, Sanofi  Genzyme, Science 37, 
Sun Pharma, and Valeant; Grants: Dermira, Kyowa Hakko Kirin, and UCB, outside the submitted work

• KAP: Speakers bureau: AbbVie, Amgen, Astellas, Celgene, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Leo Pharma, Merck Sharp & Dohme, Novartis, Pfi zer, and 
Valeant; Grant/research support: AbbVie, Akros, Allergan, Amgen, Anacor, Arcutis, AstraZeneca, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, 
Dermira, Dow Pharma, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, Leo Pharma, MedImmune, Meiji Seika Pharma, Merck Serono, 
Novartis, Pfi zer, Regeneron, Roche, Sanofi  Genzyme, Takeda, UCB, and Valeant; Consultant: AbbVie, Akros, Amgen, Arcutis, Astellas, AstraZeneca, Baxalta, Baxter, 
Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Forward Pharma, Galderma, Genentech, Janssen, Kyowa Hakko 
Kirin, Leo Pharma, Meiji Seika Pharma, Merck Serono, Merck Sharp & Dohme, Mitsubishi Pharma, Novartis, Pfi zer, Regeneron, Roche, Sanofi  Genzyme, Takeda, UCB, 
and Valeant; Honoraria: AbbVie, Akros, Amgen, Baxter, Boehringer Ingelheim, Celgene, Coherus, Eli Lilly, Forward Pharma, Galderma, GlaxoSmithKline, Janssen, Kyowa 
Hakko Kirin, Merck Sharp & Dohme, Merck Serono, Novartis, Pfi zer, Takeda, UCB, and Valeant; Scientifi c offi cer/steering committee/advisory board: AbbVie, Akros, 
Amgen, Anacor, Astellas, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dow Pharma, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Merck Serono, 
Merck Sharp & Dohme, Novartis, Pfi zer, Regeneron, Sanofi  Genzyme, and Valeant

• JZ, BB, YZ, RMK, and SB: Employees and shareholders of Bristol Myers Squibb

• JLB and MD: Employees of Clinical Outcomes Solutions, which has received consulting fees from Bristol Myers Squibb

• BS: Consultant (honoraria): AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Eli 
Lilly, Equillium, GlaxoSmithKline, Immunic Therapeutics, Janssen, Leo Pharma, Maruho, Meiji Seika Pharma, Mindera, Novartis, Ortho Dermatologics, Pfi zer, Regeneron, 
Sanofi  Genzyme, Sun Pharma, UCB, Ventyx Biosciences, and vTv Therapeutics; Speaker: AbbVie, Eli Lilly, Janssen, and Sanofi  Genzyme; Co-scientifi c director (consulting 
fee): CorEvitas’ (Corrona) Psoriasis Registry; Investigator: AbbVie, Cara, CorEvitas’ (Corrona) Psoriasis Registry, Dermavant, Dermira, and Novartis

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: correlations between patient-reported 
outcomes and clinical responses in the phase 3 clinical trials POETYK PSO-1 and POETYK PSO-2
April W. Armstrong,1 Kim A. Papp,2 Joe Zhuo,3 Brandon Becker,3 Yichen Zhong,3 Jennifer L. Beaumont,4 Michael DeRosa,4 Renata M. Kisa,3 Subhashis Banerjee,3 Bruce Strober5,6
1Keck School of Medicine, University of Southern California, Los Angeles, CA; 2Probity Medical Research, Waterloo, Ontario, Canada; 3Bristol Myers Squibb, Princeton, NJ; 4Clinical Outcomes Solutions, Chicago, IL; 5Yale University, New Haven, CT; 6Central Connecticut Dermatology, Cromwell, CT

Presented at the Fall Clinical Dermatology Conference; October 20–23, 2022; Las Vegas, NV This poster may not be reproduced without written permission from the authors.Email for April W. Armstrong, MD, MPH: aprilarmstrong@post.Harvard.edu

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Synopsis
• In the phase 3 clinical trials POETYK PSO-1 and PSO-2, deucravacitinib was compared for effi cacy and safety 

with placebo and apremilast in the treatment of patients with moderate to severe plaque psoriasis1

 — Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved by the US 
Food and Drug Administration for the treatment of adults with moderate to severe plaque psoriasis 
who are candidates for systemic therapy or phototherapy

 — In each clinical trial, greater proportions of patients who received deucravacitinib achieved ≥75% 
reduction from baseline in the Psoriasis Area and Severity Index score (PASI 75)1 and static Physician’s 
Global Assessment scores of 0 or 1 (sPGA 0/1),1 and showed meaningful improvements on Psoriasis 
Symptoms and Signs Diary (PSSD) total scores (≥25 points)2 and Dermatology Life Quality Index (DLQI) 
total scores (≥4 points)3 compared with patients receiving placebo or apremilast

• In this post hoc analysis of data pooled from both trials, clinical and patient-reported outcomes (PROs) 
were found to be correlated 

• When analyzed by the deucravacitinib or placebo treatment arm, greater proportions of patients who 
received deucravacitinib reported symptom reduction and improved quality of life, both in patients 
who did and who did not achieve PASI 75 and sPGA 0/1 responses

Objective
• To explore the correlations between responses on clinical and PRO measures in pooled data from 

POETYK PSO-1 and PSO-2

Methods
• In POETYK PSO-1 (N = 666) and PSO-2 (N = 1020) adults (aged ≥18 years) with moderate to severe psoriasis 

were randomized 2:1:1 to deucravacitinib 6 mg once daily, placebo, or apremilast 30 mg twice daily

 — At Week 16 in each trial, patients who received placebo crossed over to deucravacitinib

• Using data pooled from both trials, we evaluated the correlation between responses measured by PASI 
and sPGA on one hand, and the PRO measures PSSD (≥25 points)2 and DLQI (≥4 points)3 on the other

 — The analysis populations for the PSSD and DLQI included all patients from the full analysis set who 
completed ≥1 item on the respective questionnaire at baseline and ≥1 post-baseline visit 
• At baseline, 1659 patients had a DLQI score recorded and 1553 had a PSSD score recorded

• Spearman correlation coeffi cients between clinical and PRO score changes from baseline to Week 16 were 
calculated with all treatment groups combined

• Mean PSSD and DLQI scores were determined within relative PASI and sPGA response levels

• The proportions of patients achieving meaningful improvement (ie, response) in PSSD total scores and 
on the DLQI were summarized by whether they did or did not achieve PASI 75 and sPGA 0/1, and were 
further analyzed by treatment arm

 — Results are reported for patients receiving deucravacitinib or placebo

Outcome measures
• PASI

 — Clinician evaluated

 — Range: 0–72, with higher scores indicating more severe disease

• sPGA

 — Clinician evaluated

 — Range: 0 (clear) to 4 (severe)

• PSSD

 — Patient rated

 — 5 skin symptoms (itch, tightness, burning, stinging, and pain) and 6 skin signs (dryness, cracking, 
scaling, shedding/fl aking, redness, and bleeding) associated with psoriasis were rated 0 (absent) to 
10 (worst imaginable); averages within each domain were multiplied by 10, then averaged across both 
domains to obtain a total score

 — Range: 0–100, with higher scores indicating heavier disease burden

• DLQI

 — Patient rated

 — 10 questions that assess the extent to which skin disease affects patients’ lives

 — Range: 0–30, with higher scores indicating more severe impact of disease 

Results
Correlations between clinical and PRO measures
• At Week 16, change from baseline in relative PASI score was correlated with changes in the PSSD total 

score (Spearman’s rank correlation coeffi cient [r
s
] = 0.536) and DLQI total score (r

s
 = 0.421) in the total 

study population

• At Week 16, change from baseline in sPGA score was correlated with changes in the PSSD total score 
(r

s
 = 0.496) and DLQI total score (r

s
 = 0.380) in the total study population

• Higher PASI or sPGA response was associated with greater PSSD and DLQI responses at Weeks 16, 24, and 
52 in the total study population (Figures 1–4)

Figure 1. PSSD total score change from baseline by PASI response group 
(treatment arms and trials pooled, n = 1536)

–50

–45

–40

–35

–30

–25

–20

–15

–10

–5

0

Week 16 Week 24 Week 52

P
SS

D
 c

h
an

ge
 f

ro
m

 b
as

e
li
n
e

a

PASI <50 PASI 50–74 PASI 75–89 PASI 90–99 PASI 100

aAt baseline, the mean PSSD total score (SD) was 54.4 (23.30) in the deucravacitinib arm, 53.1 (23.09) in the placebo arm, and 55.7 (22.90) in the apremilast arm. 
PASI 50–100, 50%–100% improvement from baseline in the Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary.

Figure 2. DLQI Change from baseline by PASI response group (treatment arms 
and trials pooled, n = 1643)

–14

–12

–10

–8

–6

–4

–2

0

Week 16 Week 24 Week 52

D
LQ

I 
ch

an
ge

 f
ro

m
 b

as
e
li
n
e

a

PASI <50 PASI 50–74 PASI 75–89 PASI 90–99 PASI 100

aThe mean baseline DLQI score (SD) among all patients in the study population was 12.0 (6.7).
DLQI, Dermatology Life Quality Index; PASI 50–100, 50%–100% improvement from baseline Psoriasis Area and Severity Index score.

Figure 3. PSSD change from baseline by sPGAa change group (treatment arms 
and trials pooled, n = 1536)

–50

–40

–30

–20

–10

0

10

20

Week 16 Week 24 Week 52

P
SS

D
 c

h
an

ge
 f

ro
m

 b
as

e
li
n
e

sPGA +1 sPGA 0 sPGA –1 sPGA –2 sPGA –3 or more

aAt baseline, 1345 patients in the total study population had an sPGA score of 3, and 340 had an sPGA score of 4. One patient had an sPGA score of 2; this patient was randomized but not treated. The mean 
baseline PSSD total score (SD) was 54.4 (23.30) in the deucravacitinib arm, 53.1 (23.09) in the placebo arm, and 55.7 (22.90) in the apremilast arm. 
PSSD, Psoriasis Symptoms and Signs Diary; sPGA, static Physician’s Global Assessment.

Figure 4. DLQI change from baseline by sPGAa change group (treatment arms 
and trials pooled, n = 1643)

Week 16 Week 24

–12

–10

–8

–6

–4

–2

0

2
Week 52

D
LQ

I 
ch

an
ge

 f
ro

m
 b

as
e
li
n
e

sPGA +1 sPGA 0 sPGA –1 sPGA –2 sPGA –3 or more

aAt baseline, 1345 patients in the total study population had an sPGA score of 3 and 340 had an sPGA score of 4. One patient had an sPGA score of 2; this patient was randomized but not treated. The mean 
baseline DLQI score (SD) among all patients in the study population was 12.0 (6.7).
DLQI, Dermatology Life Quality Index; sPGA, static Physician’s Global Assessment.

PSSD Response by Clinical Response
• At Week 16, PSSD total score response (≥25-point reduction from baseline) was reported by 64.8% and 65.3% of 

all patients across both trials who achieved PASI 75 (356/549) and/or sPGA 0/1 (330/505), respectively (Table 1)

 — Greater proportions of patients who received deucravacitinib and achieved clinical response reported 
PSSD total score response (68.6% of patients who achieved PASI 75 and 68.7% of patients who achieved 
sPGA 0/1) compared with patients who received placebo (31.3% of patients who achieved PASI 75 and 
37.0% of patients who achieved sPGA 0/1) (Table 1)

 — On the PSSD itch item, meaningful improvement (≥2 points) was reported by 80.8% of patients 
receiving deucravacitinib who achieved PASI 75 and 80.1% of deucravacitinib-treated patients who 
achieved sPGA 0/1, compared with 43.8% of patients receiving placebo who achieved PASI 75 and 
48.1% of placebo-treated patients who achieved sPGA 0/1 (Figure 5)

• At Week 16, 27.9% and 29.8% of all patients across both trials who did not achieve PASI 75 (188/674) 
and/or did not achieve sPGA 0/1 (214/718), respectively, nonetheless reported PSSD total score response

 — Greater proportions of patients who received deucravacitinib and did not achieve clinical response 
nonetheless reported PSSD total score response (41.8% of patients who did not achieve PASI 75 and 
44.1% of patients who did not achieve sPGA 0/1) compared with patients who received placebo 
(10.4% of patients who did not achieve PASI 75 and 10.3% who did not achieve sPGA 0/1)

 — On the PSSD itch item, meaningful improvement was reported by 54.9% of patients receiving 
deucravacitinib who did not achieve PASI 75 compared with 22.0% of patients receiving placebo who 
did not achieve PASI 75

Table 1. PSSD response at Week 16 in patients who achieved clinical response

PSSD Domain
Total patients

N = 1536
Deucravacitinib 

n = 765
Placebo 
n = 383

Total score (≥25-point reduction), n/Na (%)
PASI 75 356/549 (64.8)b 264/385 (68.6) 10/32 (31.3)
sPGA 0/1 330/505 (65.3)b 248/361 (68.7) 10/27 (37.0)

Symptom score (≥25-point reduction), n/Na (%)
PASI 75 323/549 (58.8)b 240/385 (62.3) 10/32 (31.3)
sPGA 0/1 296/505 (58.6)b 223/361 (61.8) 8/27 (29.6)

Sign score (≥25-point reduction), n/Na (%)
PASI 75 383/549 (69.8)b 284/385 (73.8) 10/32 (31.3)
sPGA 0/1 354/505 (70.1)b 267/361 (74.0) 10/27 (37.0)

aThe denominator represents the patients who achieved clinical response and who completed ≥1 PSSD item at baseline and ≥1 PSSD item at a post-baseline visit.
bTotal denominator includes patients who received apremilast. 
PASI 75, ≥75% improvement from baseline in Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

Figure 5. PSSD individual item response at Week 16 in patientsa who achieved 
clinical response

0

10

20

30

40

50

60

70

80

90

Deucravacitinib (n = 765) Placebo (n = 383)

P
at

ie
n
ts

, 
%

80.8 80.1 79.7 80.3

63.6 63.2

58.7 58.4

66.2 66.2

85.7 84.8

72.7 72.9

84.2 84.5
85.7 85.3

79.2 78.9

49.9
48.2

43.8

48.1 46.9

40.7

37.5 37.0

31.3

25.9

34.4

29.6

43.8

48.1 46.9 48.1 46.9

51.9

43.8

48.1

37.5

48.1

31.3
33.3

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

Itch
(≥2 points)

Tightness
(≥2 points)

Burning
(≥2 points)

Stinging
(≥2 points)

Pain
(≥2 points)

Dryness
(≥2 points)

Cracking
(≥2 points)

Scaling
(≥2 points)

Shedding/flaking
(≥2 points)

Redness
(≥2 points)

Bleeding
(≥2 points)

aDenominators include patients who achieved clinical response and completed ≥1 PSSD item at baseline and ≥1 PSSD item at a post-baseline visit.
PASI 75, 75% reduction from baseline in Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

DLQI Response by Clinical Response
• At Week 16, DLQI response (≥4-point reduction from baseline) was reported by 83.3% and 82.5% of all 

patients across both trials who achieved PASI 75 (553/664) and/or sPGA 0/1 (496/601), respectively 
(Table 2)

 — Greater proportions of patients who received deucravacitinib and achieved clinical response reported 
meaningful DLQI improvement (84.7% of patients who achieved PASI 75 and 83.3% of patients who 
achieved sPGA 0/1) compared with patients who received placebo (72.7% of patients who achieved 
PASI 75 and 70.6% of patients who achieved sPGA 0/1)

• At Week 16, 54.7% and 57.3% of all patients across both trials who did not achieve PASI 75 (444/811) 
and/or did not achieve sPGA 0/1 (501/874), respectively, nonetheless reported DLQI response

 — Greater proportions of patients who received deucravacitinib and did not achieve clinical response 
nonetheless reported meaningful DLQI improvement (67.1% of patients who did not achieve PASI 75 
and 70.8% of patients who did not achieve sPGA 0/1) compared with patients who received placebo 
(40.5% of patients who did not achieve PASI 75 and 41.7% who did not achieve sPGA 0/1)

Table 2. DLQI response at Week 16 in patients who achieved clinical response

DLQI ≥4-point reduction
Total patients  

N = 1643
Deucravacitinib 

n = 824
Placebo 
n = 409

PASI 75, n/Na (%) 553/664 (83.3)b 393/464 (84.7) 32/44 (72.7)

sPGA 0/1, n/Na (%) 496/601 (82.5)b 359/431 (83.3) 24/34 (70.6)
aThe denominator includes the patients who achieved clinical response and completed ≥1 DLQI item at baseline and ≥1 DLQI item at a post-baseline visit.
bTotal denominator includes patients who received apremilast. 
DLQI, Dermatology Life Quality Index; PASI 75, ≥75% improvement from baseline in Psoriasis Area and Severity Index score; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

Conclusions
• Psoriasis skin clearance, symptom reduction, and improved patient quality of life were 

correlated in the POETYK PSO-1 and PSO-2 trials

 — This correlation is consistent with that determined in other studies4-7

• Higher clinical response was associated with greater PRO measure response

• PRO measures capture patient-perceived treatment benefi ts that may not be ascertained by 
measuring rates of skin clearance with clinical assessments alone4

 — Psoriasis bears symptoms, such as pruritus, for which there are no validated objective 
measures,8 or which are best assessed by patients themselves9 in order to evaluate 
treatment effi cacy

 — Among patients who achieved PASI 75 at Week 16, 80.8% of patients who received 
deucravacitinib reported meaningful itch improvement on the PSSD compared with 
43.8% of patients who received placebo

• Among patients with and without clinical response, greater proportions of patients treated 
with deucravacitinib recorded improvement in their self-reported symptoms, signs, and quality 
of life compared with patients treated with placebo

References
1. Warren RB, et al. Ann Rheum Dis. 2022;81:1570-1571.

2. Papp KA, et al. [poster] Presented at the 30th Congress of the European Academy of Dermatology and Venereology (EADV); September 29–October 2, 2021; virtual meeting.
3. Augustin M, et al. [poster] Presented at the American Academy of Dermatology (AAD) Annual Meeting; March 25–29, 2022; Boston, MA.
4. Armstrong AW, et al. Am J Clin Dermatol. 2019;20:155-164.

5. Loft ND, et al. Acta Derm Venereol. 2019;99:1224-1230.

6. Schäfer I, et al. Eur J Dermatol. 2010;20:62-67.

7. Thaçi D, et al. Dermatol Ther (Heidelb). 2022;12:495-510.

8. Price A, Cohen DE. Dermatitis. 2014;225:334-344.

9. Armstrong AW, et al. J Dermatol Treat. 2019;30:27-34.

Acknowledgments
• This study was sponsored by Bristol Myers Squibb

• Medical writing and editorial assistance was provided by Eleanor Bush, MA, of Peloton Advantage, LLC, an OPEN Health company, and funded by Bristol Myers Squibb

Disclosures
• AWA: Grants and personal fees: AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Leo Pharma, and Novartis; Personal fees: Boehringer Ingelheim/Parexel, Celgene, 

Dermavant, Genentech, GlaxoSmithKline, Menlo Therapeutics, Merck, Modernizing Medicine, Ortho Dermatologics, Pfi zer, Regeneron, Sanofi  Genzyme, Science 37, 
Sun Pharma, and Valeant; Grants: Dermira, Kyowa Hakko Kirin, and UCB, outside the submitted work

• KAP: Speakers bureau: AbbVie, Amgen, Astellas, Celgene, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Leo Pharma, Merck Sharp & Dohme, Novartis, Pfi zer, and 
Valeant; Grant/research support: AbbVie, Akros, Allergan, Amgen, Anacor, Arcutis, AstraZeneca, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, 
Dermira, Dow Pharma, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, Leo Pharma, MedImmune, Meiji Seika Pharma, Merck Serono, 
Novartis, Pfi zer, Regeneron, Roche, Sanofi  Genzyme, Takeda, UCB, and Valeant; Consultant: AbbVie, Akros, Amgen, Arcutis, Astellas, AstraZeneca, Baxalta, Baxter, 
Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Forward Pharma, Galderma, Genentech, Janssen, Kyowa Hakko 
Kirin, Leo Pharma, Meiji Seika Pharma, Merck Serono, Merck Sharp & Dohme, Mitsubishi Pharma, Novartis, Pfi zer, Regeneron, Roche, Sanofi  Genzyme, Takeda, UCB, 
and Valeant; Honoraria: AbbVie, Akros, Amgen, Baxter, Boehringer Ingelheim, Celgene, Coherus, Eli Lilly, Forward Pharma, Galderma, GlaxoSmithKline, Janssen, Kyowa 
Hakko Kirin, Merck Sharp & Dohme, Merck Serono, Novartis, Pfi zer, Takeda, UCB, and Valeant; Scientifi c offi cer/steering committee/advisory board: AbbVie, Akros, 
Amgen, Anacor, Astellas, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dow Pharma, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Merck Serono, 
Merck Sharp & Dohme, Novartis, Pfi zer, Regeneron, Sanofi  Genzyme, and Valeant

• JZ, BB, YZ, RMK, and SB: Employees and shareholders of Bristol Myers Squibb

• JLB and MD: Employees of Clinical Outcomes Solutions, which has received consulting fees from Bristol Myers Squibb

• BS: Consultant (honoraria): AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Eli 
Lilly, Equillium, GlaxoSmithKline, Immunic Therapeutics, Janssen, Leo Pharma, Maruho, Meiji Seika Pharma, Mindera, Novartis, Ortho Dermatologics, Pfi zer, Regeneron, 
Sanofi  Genzyme, Sun Pharma, UCB, Ventyx Biosciences, and vTv Therapeutics; Speaker: AbbVie, Eli Lilly, Janssen, and Sanofi  Genzyme; Co-scientifi c director (consulting 
fee): CorEvitas’ (Corrona) Psoriasis Registry; Investigator: AbbVie, Cara, CorEvitas’ (Corrona) Psoriasis Registry, Dermavant, Dermira, and Novartis

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: correlations between patient-reported 
outcomes and clinical responses in the phase 3 clinical trials POETYK PSO-1 and POETYK PSO-2
April W. Armstrong,1 Kim A. Papp,2 Joe Zhuo,3 Brandon Becker,3 Yichen Zhong,3 Jennifer L. Beaumont,4 Michael DeRosa,4 Renata M. Kisa,3 Subhashis Banerjee,3 Bruce Strober5,6
1Keck School of Medicine, University of Southern California, Los Angeles, CA; 2Probity Medical Research, Waterloo, Ontario, Canada; 3Bristol Myers Squibb, Princeton, NJ; 4Clinical Outcomes Solutions, Chicago, IL; 5Yale University, New Haven, CT; 6Central Connecticut Dermatology, Cromwell, CT

Presented at the Fall Clinical Dermatology Conference; October 20–23, 2022; Las Vegas, NV This poster may not be reproduced without written permission from the authors.Email for April W. Armstrong, MD, MPH: aprilarmstrong@post.Harvard.edu

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Synopsis
• In the phase 3 clinical trials POETYK PSO-1 and PSO-2, deucravacitinib was compared for effi cacy and safety 

with placebo and apremilast in the treatment of patients with moderate to severe plaque psoriasis1

 — Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved by the US 
Food and Drug Administration for the treatment of adults with moderate to severe plaque psoriasis 
who are candidates for systemic therapy or phototherapy

 — In each clinical trial, greater proportions of patients who received deucravacitinib achieved ≥75% 
reduction from baseline in the Psoriasis Area and Severity Index score (PASI 75)1 and static Physician’s 
Global Assessment scores of 0 or 1 (sPGA 0/1),1 and showed meaningful improvements on Psoriasis 
Symptoms and Signs Diary (PSSD) total scores (≥25 points)2 and Dermatology Life Quality Index (DLQI) 
total scores (≥4 points)3 compared with patients receiving placebo or apremilast

• In this post hoc analysis of data pooled from both trials, clinical and patient-reported outcomes (PROs) 
were found to be correlated 

• When analyzed by the deucravacitinib or placebo treatment arm, greater proportions of patients who 
received deucravacitinib reported symptom reduction and improved quality of life, both in patients 
who did and who did not achieve PASI 75 and sPGA 0/1 responses

Objective
• To explore the correlations between responses on clinical and PRO measures in pooled data from 

POETYK PSO-1 and PSO-2

Methods
• In POETYK PSO-1 (N = 666) and PSO-2 (N = 1020) adults (aged ≥18 years) with moderate to severe psoriasis 

were randomized 2:1:1 to deucravacitinib 6 mg once daily, placebo, or apremilast 30 mg twice daily

 — At Week 16 in each trial, patients who received placebo crossed over to deucravacitinib

• Using data pooled from both trials, we evaluated the correlation between responses measured by PASI 
and sPGA on one hand, and the PRO measures PSSD (≥25 points)2 and DLQI (≥4 points)3 on the other

 — The analysis populations for the PSSD and DLQI included all patients from the full analysis set who 
completed ≥1 item on the respective questionnaire at baseline and ≥1 post-baseline visit 
• At baseline, 1659 patients had a DLQI score recorded and 1553 had a PSSD score recorded

• Spearman correlation coeffi cients between clinical and PRO score changes from baseline to Week 16 were 
calculated with all treatment groups combined

• Mean PSSD and DLQI scores were determined within relative PASI and sPGA response levels

• The proportions of patients achieving meaningful improvement (ie, response) in PSSD total scores and 
on the DLQI were summarized by whether they did or did not achieve PASI 75 and sPGA 0/1, and were 
further analyzed by treatment arm

 — Results are reported for patients receiving deucravacitinib or placebo

Outcome measures
• PASI

 — Clinician evaluated

 — Range: 0–72, with higher scores indicating more severe disease

• sPGA

 — Clinician evaluated

 — Range: 0 (clear) to 4 (severe)

• PSSD

 — Patient rated

 — 5 skin symptoms (itch, tightness, burning, stinging, and pain) and 6 skin signs (dryness, cracking, 
scaling, shedding/fl aking, redness, and bleeding) associated with psoriasis were rated 0 (absent) to 
10 (worst imaginable); averages within each domain were multiplied by 10, then averaged across both 
domains to obtain a total score

 — Range: 0–100, with higher scores indicating heavier disease burden

• DLQI

 — Patient rated

 — 10 questions that assess the extent to which skin disease affects patients’ lives

 — Range: 0–30, with higher scores indicating more severe impact of disease 

Results
Correlations between clinical and PRO measures
• At Week 16, change from baseline in relative PASI score was correlated with changes in the PSSD total 

score (Spearman’s rank correlation coeffi cient [r
s
] = 0.536) and DLQI total score (r

s
 = 0.421) in the total 

study population

• At Week 16, change from baseline in sPGA score was correlated with changes in the PSSD total score 
(r

s
 = 0.496) and DLQI total score (r

s
 = 0.380) in the total study population

• Higher PASI or sPGA response was associated with greater PSSD and DLQI responses at Weeks 16, 24, and 
52 in the total study population (Figures 1–4)

Figure 1. PSSD total score change from baseline by PASI response group 
(treatment arms and trials pooled, n = 1536)

–50

–45

–40

–35

–30

–25

–20

–15

–10

–5

0

Week 16 Week 24 Week 52

P
SS

D
 c

h
an

ge
 f

ro
m

 b
as

e
li
n
e

a

PASI <50 PASI 50–74 PASI 75–89 PASI 90–99 PASI 100

aAt baseline, the mean PSSD total score (SD) was 54.4 (23.30) in the deucravacitinib arm, 53.1 (23.09) in the placebo arm, and 55.7 (22.90) in the apremilast arm. 
PASI 50–100, 50%–100% improvement from baseline in the Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary.

Figure 2. DLQI Change from baseline by PASI response group (treatment arms 
and trials pooled, n = 1643)

–14

–12

–10

–8

–6

–4

–2

0

Week 16 Week 24 Week 52

D
LQ

I 
ch

an
ge

 f
ro

m
 b

as
e
li
n
e

a

PASI <50 PASI 50–74 PASI 75–89 PASI 90–99 PASI 100

aThe mean baseline DLQI score (SD) among all patients in the study population was 12.0 (6.7).
DLQI, Dermatology Life Quality Index; PASI 50–100, 50%–100% improvement from baseline Psoriasis Area and Severity Index score.

Figure 3. PSSD change from baseline by sPGAa change group (treatment arms 
and trials pooled, n = 1536)

–50

–40

–30

–20

–10

0

10

20

Week 16 Week 24 Week 52

P
SS

D
 c

h
an

ge
 f

ro
m

 b
as

e
li
n
e

sPGA +1 sPGA 0 sPGA –1 sPGA –2 sPGA –3 or more

aAt baseline, 1345 patients in the total study population had an sPGA score of 3, and 340 had an sPGA score of 4. One patient had an sPGA score of 2; this patient was randomized but not treated. The mean 
baseline PSSD total score (SD) was 54.4 (23.30) in the deucravacitinib arm, 53.1 (23.09) in the placebo arm, and 55.7 (22.90) in the apremilast arm. 
PSSD, Psoriasis Symptoms and Signs Diary; sPGA, static Physician’s Global Assessment.

Figure 4. DLQI change from baseline by sPGAa change group (treatment arms 
and trials pooled, n = 1643)

Week 16 Week 24

–12

–10

–8

–6

–4

–2

0

2
Week 52

D
LQ

I 
ch

an
ge

 f
ro

m
 b

as
e
li
n
e

sPGA +1 sPGA 0 sPGA –1 sPGA –2 sPGA –3 or more

aAt baseline, 1345 patients in the total study population had an sPGA score of 3 and 340 had an sPGA score of 4. One patient had an sPGA score of 2; this patient was randomized but not treated. The mean 
baseline DLQI score (SD) among all patients in the study population was 12.0 (6.7).
DLQI, Dermatology Life Quality Index; sPGA, static Physician’s Global Assessment.

PSSD Response by Clinical Response
• At Week 16, PSSD total score response (≥25-point reduction from baseline) was reported by 64.8% and 65.3% of 

all patients across both trials who achieved PASI 75 (356/549) and/or sPGA 0/1 (330/505), respectively (Table 1)

 — Greater proportions of patients who received deucravacitinib and achieved clinical response reported 
PSSD total score response (68.6% of patients who achieved PASI 75 and 68.7% of patients who achieved 
sPGA 0/1) compared with patients who received placebo (31.3% of patients who achieved PASI 75 and 
37.0% of patients who achieved sPGA 0/1) (Table 1)

 — On the PSSD itch item, meaningful improvement (≥2 points) was reported by 80.8% of patients 
receiving deucravacitinib who achieved PASI 75 and 80.1% of deucravacitinib-treated patients who 
achieved sPGA 0/1, compared with 43.8% of patients receiving placebo who achieved PASI 75 and 
48.1% of placebo-treated patients who achieved sPGA 0/1 (Figure 5)

• At Week 16, 27.9% and 29.8% of all patients across both trials who did not achieve PASI 75 (188/674) 
and/or did not achieve sPGA 0/1 (214/718), respectively, nonetheless reported PSSD total score response

 — Greater proportions of patients who received deucravacitinib and did not achieve clinical response 
nonetheless reported PSSD total score response (41.8% of patients who did not achieve PASI 75 and 
44.1% of patients who did not achieve sPGA 0/1) compared with patients who received placebo 
(10.4% of patients who did not achieve PASI 75 and 10.3% who did not achieve sPGA 0/1)

 — On the PSSD itch item, meaningful improvement was reported by 54.9% of patients receiving 
deucravacitinib who did not achieve PASI 75 compared with 22.0% of patients receiving placebo who 
did not achieve PASI 75

Table 1. PSSD response at Week 16 in patients who achieved clinical response

PSSD Domain
Total patients

N = 1536
Deucravacitinib 

n = 765
Placebo 
n = 383

Total score (≥25-point reduction), n/Na (%)
PASI 75 356/549 (64.8)b 264/385 (68.6) 10/32 (31.3)
sPGA 0/1 330/505 (65.3)b 248/361 (68.7) 10/27 (37.0)

Symptom score (≥25-point reduction), n/Na (%)
PASI 75 323/549 (58.8)b 240/385 (62.3) 10/32 (31.3)
sPGA 0/1 296/505 (58.6)b 223/361 (61.8) 8/27 (29.6)

Sign score (≥25-point reduction), n/Na (%)
PASI 75 383/549 (69.8)b 284/385 (73.8) 10/32 (31.3)
sPGA 0/1 354/505 (70.1)b 267/361 (74.0) 10/27 (37.0)

aThe denominator represents the patients who achieved clinical response and who completed ≥1 PSSD item at baseline and ≥1 PSSD item at a post-baseline visit.
bTotal denominator includes patients who received apremilast. 
PASI 75, ≥75% improvement from baseline in Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

Figure 5. PSSD individual item response at Week 16 in patientsa who achieved 
clinical response

0

10

20

30

40

50

60

70

80

90

Deucravacitinib (n = 765) Placebo (n = 383)

P
at

ie
n
ts

, 
%

80.8 80.1 79.7 80.3

63.6 63.2

58.7 58.4

66.2 66.2

85.7 84.8

72.7 72.9

84.2 84.5
85.7 85.3

79.2 78.9

49.9
48.2

43.8

48.1 46.9

40.7

37.5 37.0

31.3

25.9

34.4

29.6

43.8

48.1 46.9 48.1 46.9

51.9

43.8

48.1

37.5

48.1

31.3
33.3

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

Itch
(≥2 points)

Tightness
(≥2 points)

Burning
(≥2 points)

Stinging
(≥2 points)

Pain
(≥2 points)

Dryness
(≥2 points)

Cracking
(≥2 points)

Scaling
(≥2 points)

Shedding/flaking
(≥2 points)

Redness
(≥2 points)

Bleeding
(≥2 points)

aDenominators include patients who achieved clinical response and completed ≥1 PSSD item at baseline and ≥1 PSSD item at a post-baseline visit.
PASI 75, 75% reduction from baseline in Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

DLQI Response by Clinical Response
• At Week 16, DLQI response (≥4-point reduction from baseline) was reported by 83.3% and 82.5% of all 

patients across both trials who achieved PASI 75 (553/664) and/or sPGA 0/1 (496/601), respectively 
(Table 2)

 — Greater proportions of patients who received deucravacitinib and achieved clinical response reported 
meaningful DLQI improvement (84.7% of patients who achieved PASI 75 and 83.3% of patients who 
achieved sPGA 0/1) compared with patients who received placebo (72.7% of patients who achieved 
PASI 75 and 70.6% of patients who achieved sPGA 0/1)

• At Week 16, 54.7% and 57.3% of all patients across both trials who did not achieve PASI 75 (444/811) 
and/or did not achieve sPGA 0/1 (501/874), respectively, nonetheless reported DLQI response

 — Greater proportions of patients who received deucravacitinib and did not achieve clinical response 
nonetheless reported meaningful DLQI improvement (67.1% of patients who did not achieve PASI 75 
and 70.8% of patients who did not achieve sPGA 0/1) compared with patients who received placebo 
(40.5% of patients who did not achieve PASI 75 and 41.7% who did not achieve sPGA 0/1)

Table 2. DLQI response at Week 16 in patients who achieved clinical response

DLQI ≥4-point reduction
Total patients  

N = 1643
Deucravacitinib 

n = 824
Placebo 
n = 409

PASI 75, n/Na (%) 553/664 (83.3)b 393/464 (84.7) 32/44 (72.7)

sPGA 0/1, n/Na (%) 496/601 (82.5)b 359/431 (83.3) 24/34 (70.6)
aThe denominator includes the patients who achieved clinical response and completed ≥1 DLQI item at baseline and ≥1 DLQI item at a post-baseline visit.
bTotal denominator includes patients who received apremilast. 
DLQI, Dermatology Life Quality Index; PASI 75, ≥75% improvement from baseline in Psoriasis Area and Severity Index score; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

Conclusions
• Psoriasis skin clearance, symptom reduction, and improved patient quality of life were 

correlated in the POETYK PSO-1 and PSO-2 trials

 — This correlation is consistent with that determined in other studies4-7

• Higher clinical response was associated with greater PRO measure response

• PRO measures capture patient-perceived treatment benefi ts that may not be ascertained by 
measuring rates of skin clearance with clinical assessments alone4

 — Psoriasis bears symptoms, such as pruritus, for which there are no validated objective 
measures,8 or which are best assessed by patients themselves9 in order to evaluate 
treatment effi cacy

 — Among patients who achieved PASI 75 at Week 16, 80.8% of patients who received 
deucravacitinib reported meaningful itch improvement on the PSSD compared with 
43.8% of patients who received placebo

• Among patients with and without clinical response, greater proportions of patients treated 
with deucravacitinib recorded improvement in their self-reported symptoms, signs, and quality 
of life compared with patients treated with placebo

References
1. Warren RB, et al. Ann Rheum Dis. 2022;81:1570-1571.

2. Papp KA, et al. [poster] Presented at the 30th Congress of the European Academy of Dermatology and Venereology (EADV); September 29–October 2, 2021; virtual meeting.
3. Augustin M, et al. [poster] Presented at the American Academy of Dermatology (AAD) Annual Meeting; March 25–29, 2022; Boston, MA.
4. Armstrong AW, et al. Am J Clin Dermatol. 2019;20:155-164.

5. Loft ND, et al. Acta Derm Venereol. 2019;99:1224-1230.

6. Schäfer I, et al. Eur J Dermatol. 2010;20:62-67.

7. Thaçi D, et al. Dermatol Ther (Heidelb). 2022;12:495-510.

8. Price A, Cohen DE. Dermatitis. 2014;225:334-344.

9. Armstrong AW, et al. J Dermatol Treat. 2019;30:27-34.

Acknowledgments
• This study was sponsored by Bristol Myers Squibb

• Medical writing and editorial assistance was provided by Eleanor Bush, MA, of Peloton Advantage, LLC, an OPEN Health company, and funded by Bristol Myers Squibb

Disclosures
• AWA: Grants and personal fees: AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Leo Pharma, and Novartis; Personal fees: Boehringer Ingelheim/Parexel, Celgene, 

Dermavant, Genentech, GlaxoSmithKline, Menlo Therapeutics, Merck, Modernizing Medicine, Ortho Dermatologics, Pfi zer, Regeneron, Sanofi  Genzyme, Science 37, 
Sun Pharma, and Valeant; Grants: Dermira, Kyowa Hakko Kirin, and UCB, outside the submitted work

• KAP: Speakers bureau: AbbVie, Amgen, Astellas, Celgene, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Leo Pharma, Merck Sharp & Dohme, Novartis, Pfi zer, and 
Valeant; Grant/research support: AbbVie, Akros, Allergan, Amgen, Anacor, Arcutis, AstraZeneca, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, 
Dermira, Dow Pharma, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, Leo Pharma, MedImmune, Meiji Seika Pharma, Merck Serono, 
Novartis, Pfi zer, Regeneron, Roche, Sanofi  Genzyme, Takeda, UCB, and Valeant; Consultant: AbbVie, Akros, Amgen, Arcutis, Astellas, AstraZeneca, Baxalta, Baxter, 
Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Forward Pharma, Galderma, Genentech, Janssen, Kyowa Hakko 
Kirin, Leo Pharma, Meiji Seika Pharma, Merck Serono, Merck Sharp & Dohme, Mitsubishi Pharma, Novartis, Pfi zer, Regeneron, Roche, Sanofi  Genzyme, Takeda, UCB, 
and Valeant; Honoraria: AbbVie, Akros, Amgen, Baxter, Boehringer Ingelheim, Celgene, Coherus, Eli Lilly, Forward Pharma, Galderma, GlaxoSmithKline, Janssen, Kyowa 
Hakko Kirin, Merck Sharp & Dohme, Merck Serono, Novartis, Pfi zer, Takeda, UCB, and Valeant; Scientifi c offi cer/steering committee/advisory board: AbbVie, Akros, 
Amgen, Anacor, Astellas, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dow Pharma, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Merck Serono, 
Merck Sharp & Dohme, Novartis, Pfi zer, Regeneron, Sanofi  Genzyme, and Valeant

• JZ, BB, YZ, RMK, and SB: Employees and shareholders of Bristol Myers Squibb

• JLB and MD: Employees of Clinical Outcomes Solutions, which has received consulting fees from Bristol Myers Squibb

• BS: Consultant (honoraria): AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Eli 
Lilly, Equillium, GlaxoSmithKline, Immunic Therapeutics, Janssen, Leo Pharma, Maruho, Meiji Seika Pharma, Mindera, Novartis, Ortho Dermatologics, Pfi zer, Regeneron, 
Sanofi  Genzyme, Sun Pharma, UCB, Ventyx Biosciences, and vTv Therapeutics; Speaker: AbbVie, Eli Lilly, Janssen, and Sanofi  Genzyme; Co-scientifi c director (consulting 
fee): CorEvitas’ (Corrona) Psoriasis Registry; Investigator: AbbVie, Cara, CorEvitas’ (Corrona) Psoriasis Registry, Dermavant, Dermira, and Novartis

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: correlations between patient-reported 
outcomes and clinical responses in the phase 3 clinical trials POETYK PSO-1 and POETYK PSO-2
April W. Armstrong,1 Kim A. Papp,2 Joe Zhuo,3 Brandon Becker,3 Yichen Zhong,3 Jennifer L. Beaumont,4 Michael DeRosa,4 Renata M. Kisa,3 Subhashis Banerjee,3 Bruce Strober5,6
1Keck School of Medicine, University of Southern California, Los Angeles, CA; 2Probity Medical Research, Waterloo, Ontario, Canada; 3Bristol Myers Squibb, Princeton, NJ; 4Clinical Outcomes Solutions, Chicago, IL; 5Yale University, New Haven, CT; 6Central Connecticut Dermatology, Cromwell, CT

Presented at the Fall Clinical Dermatology Conference; October 20–23, 2022; Las Vegas, NV This poster may not be reproduced without written permission from the authors.Email for April W. Armstrong, MD, MPH: aprilarmstrong@post.Harvard.edu

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Synopsis
• In the phase 3 clinical trials POETYK PSO-1 and PSO-2, deucravacitinib was compared for effi cacy and safety 

with placebo and apremilast in the treatment of patients with moderate to severe plaque psoriasis1

 — Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved by the US 
Food and Drug Administration for the treatment of adults with moderate to severe plaque psoriasis 
who are candidates for systemic therapy or phototherapy

 — In each clinical trial, greater proportions of patients who received deucravacitinib achieved ≥75% 
reduction from baseline in the Psoriasis Area and Severity Index score (PASI 75)1 and static Physician’s 
Global Assessment scores of 0 or 1 (sPGA 0/1),1 and showed meaningful improvements on Psoriasis 
Symptoms and Signs Diary (PSSD) total scores (≥25 points)2 and Dermatology Life Quality Index (DLQI) 
total scores (≥4 points)3 compared with patients receiving placebo or apremilast

• In this post hoc analysis of data pooled from both trials, clinical and patient-reported outcomes (PROs) 
were found to be correlated 

• When analyzed by the deucravacitinib or placebo treatment arm, greater proportions of patients who 
received deucravacitinib reported symptom reduction and improved quality of life, both in patients 
who did and who did not achieve PASI 75 and sPGA 0/1 responses

Objective
• To explore the correlations between responses on clinical and PRO measures in pooled data from 

POETYK PSO-1 and PSO-2

Methods
• In POETYK PSO-1 (N = 666) and PSO-2 (N = 1020) adults (aged ≥18 years) with moderate to severe psoriasis 

were randomized 2:1:1 to deucravacitinib 6 mg once daily, placebo, or apremilast 30 mg twice daily

 — At Week 16 in each trial, patients who received placebo crossed over to deucravacitinib

• Using data pooled from both trials, we evaluated the correlation between responses measured by PASI 
and sPGA on one hand, and the PRO measures PSSD (≥25 points)2 and DLQI (≥4 points)3 on the other

 — The analysis populations for the PSSD and DLQI included all patients from the full analysis set who 
completed ≥1 item on the respective questionnaire at baseline and ≥1 post-baseline visit 
• At baseline, 1659 patients had a DLQI score recorded and 1553 had a PSSD score recorded

• Spearman correlation coeffi cients between clinical and PRO score changes from baseline to Week 16 were 
calculated with all treatment groups combined

• Mean PSSD and DLQI scores were determined within relative PASI and sPGA response levels

• The proportions of patients achieving meaningful improvement (ie, response) in PSSD total scores and 
on the DLQI were summarized by whether they did or did not achieve PASI 75 and sPGA 0/1, and were 
further analyzed by treatment arm

 — Results are reported for patients receiving deucravacitinib or placebo

Outcome measures
• PASI

 — Clinician evaluated

 — Range: 0–72, with higher scores indicating more severe disease

• sPGA

 — Clinician evaluated

 — Range: 0 (clear) to 4 (severe)

• PSSD

 — Patient rated

 — 5 skin symptoms (itch, tightness, burning, stinging, and pain) and 6 skin signs (dryness, cracking, 
scaling, shedding/fl aking, redness, and bleeding) associated with psoriasis were rated 0 (absent) to 
10 (worst imaginable); averages within each domain were multiplied by 10, then averaged across both 
domains to obtain a total score

 — Range: 0–100, with higher scores indicating heavier disease burden

• DLQI

 — Patient rated

 — 10 questions that assess the extent to which skin disease affects patients’ lives

 — Range: 0–30, with higher scores indicating more severe impact of disease 

Results
Correlations between clinical and PRO measures
• At Week 16, change from baseline in relative PASI score was correlated with changes in the PSSD total 

score (Spearman’s rank correlation coeffi cient [r
s
] = 0.536) and DLQI total score (r

s
 = 0.421) in the total 

study population

• At Week 16, change from baseline in sPGA score was correlated with changes in the PSSD total score 
(r

s
 = 0.496) and DLQI total score (r

s
 = 0.380) in the total study population

• Higher PASI or sPGA response was associated with greater PSSD and DLQI responses at Weeks 16, 24, and 
52 in the total study population (Figures 1–4)

Figure 1. PSSD total score change from baseline by PASI response group 
(treatment arms and trials pooled, n = 1536)

–50

–45

–40

–35

–30

–25

–20

–15

–10

–5

0

Week 16 Week 24 Week 52

P
SS

D
 c

h
an

ge
 f

ro
m

 b
as

e
li
n
e

a

PASI <50 PASI 50–74 PASI 75–89 PASI 90–99 PASI 100

aAt baseline, the mean PSSD total score (SD) was 54.4 (23.30) in the deucravacitinib arm, 53.1 (23.09) in the placebo arm, and 55.7 (22.90) in the apremilast arm. 
PASI 50–100, 50%–100% improvement from baseline in the Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary.

Figure 2. DLQI Change from baseline by PASI response group (treatment arms 
and trials pooled, n = 1643)

–14

–12

–10

–8

–6

–4

–2

0

Week 16 Week 24 Week 52

D
LQ

I 
ch

an
ge

 f
ro

m
 b

as
e
li
n
e

a

PASI <50 PASI 50–74 PASI 75–89 PASI 90–99 PASI 100

aThe mean baseline DLQI score (SD) among all patients in the study population was 12.0 (6.7).
DLQI, Dermatology Life Quality Index; PASI 50–100, 50%–100% improvement from baseline Psoriasis Area and Severity Index score.

Figure 3. PSSD change from baseline by sPGAa change group (treatment arms 
and trials pooled, n = 1536)

–50

–40

–30

–20

–10

0

10

20

Week 16 Week 24 Week 52

P
SS

D
 c

h
an

ge
 f

ro
m

 b
as

e
li
n
e

sPGA +1 sPGA 0 sPGA –1 sPGA –2 sPGA –3 or more

aAt baseline, 1345 patients in the total study population had an sPGA score of 3, and 340 had an sPGA score of 4. One patient had an sPGA score of 2; this patient was randomized but not treated. The mean 
baseline PSSD total score (SD) was 54.4 (23.30) in the deucravacitinib arm, 53.1 (23.09) in the placebo arm, and 55.7 (22.90) in the apremilast arm. 
PSSD, Psoriasis Symptoms and Signs Diary; sPGA, static Physician’s Global Assessment.

Figure 4. DLQI change from baseline by sPGAa change group (treatment arms 
and trials pooled, n = 1643)

Week 16 Week 24

–12

–10

–8

–6

–4

–2

0

2
Week 52

D
LQ

I 
ch

an
ge

 f
ro

m
 b

as
e
li
n
e

sPGA +1 sPGA 0 sPGA –1 sPGA –2 sPGA –3 or more

aAt baseline, 1345 patients in the total study population had an sPGA score of 3 and 340 had an sPGA score of 4. One patient had an sPGA score of 2; this patient was randomized but not treated. The mean 
baseline DLQI score (SD) among all patients in the study population was 12.0 (6.7).
DLQI, Dermatology Life Quality Index; sPGA, static Physician’s Global Assessment.

PSSD Response by Clinical Response
• At Week 16, PSSD total score response (≥25-point reduction from baseline) was reported by 64.8% and 65.3% of 

all patients across both trials who achieved PASI 75 (356/549) and/or sPGA 0/1 (330/505), respectively (Table 1)

 — Greater proportions of patients who received deucravacitinib and achieved clinical response reported 
PSSD total score response (68.6% of patients who achieved PASI 75 and 68.7% of patients who achieved 
sPGA 0/1) compared with patients who received placebo (31.3% of patients who achieved PASI 75 and 
37.0% of patients who achieved sPGA 0/1) (Table 1)

 — On the PSSD itch item, meaningful improvement (≥2 points) was reported by 80.8% of patients 
receiving deucravacitinib who achieved PASI 75 and 80.1% of deucravacitinib-treated patients who 
achieved sPGA 0/1, compared with 43.8% of patients receiving placebo who achieved PASI 75 and 
48.1% of placebo-treated patients who achieved sPGA 0/1 (Figure 5)

• At Week 16, 27.9% and 29.8% of all patients across both trials who did not achieve PASI 75 (188/674) 
and/or did not achieve sPGA 0/1 (214/718), respectively, nonetheless reported PSSD total score response

 — Greater proportions of patients who received deucravacitinib and did not achieve clinical response 
nonetheless reported PSSD total score response (41.8% of patients who did not achieve PASI 75 and 
44.1% of patients who did not achieve sPGA 0/1) compared with patients who received placebo 
(10.4% of patients who did not achieve PASI 75 and 10.3% who did not achieve sPGA 0/1)

 — On the PSSD itch item, meaningful improvement was reported by 54.9% of patients receiving 
deucravacitinib who did not achieve PASI 75 compared with 22.0% of patients receiving placebo who 
did not achieve PASI 75

Table 1. PSSD response at Week 16 in patients who achieved clinical response

PSSD Domain
Total patients

N = 1536
Deucravacitinib 

n = 765
Placebo 
n = 383

Total score (≥25-point reduction), n/Na (%)
PASI 75 356/549 (64.8)b 264/385 (68.6) 10/32 (31.3)
sPGA 0/1 330/505 (65.3)b 248/361 (68.7) 10/27 (37.0)

Symptom score (≥25-point reduction), n/Na (%)
PASI 75 323/549 (58.8)b 240/385 (62.3) 10/32 (31.3)
sPGA 0/1 296/505 (58.6)b 223/361 (61.8) 8/27 (29.6)

Sign score (≥25-point reduction), n/Na (%)
PASI 75 383/549 (69.8)b 284/385 (73.8) 10/32 (31.3)
sPGA 0/1 354/505 (70.1)b 267/361 (74.0) 10/27 (37.0)

aThe denominator represents the patients who achieved clinical response and who completed ≥1 PSSD item at baseline and ≥1 PSSD item at a post-baseline visit.
bTotal denominator includes patients who received apremilast. 
PASI 75, ≥75% improvement from baseline in Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

Figure 5. PSSD individual item response at Week 16 in patientsa who achieved 
clinical response

0

10

20

30

40

50

60

70

80

90

Deucravacitinib (n = 765) Placebo (n = 383)

P
at

ie
n
ts

, 
%

80.8 80.1 79.7 80.3

63.6 63.2

58.7 58.4

66.2 66.2

85.7 84.8

72.7 72.9

84.2 84.5
85.7 85.3

79.2 78.9

49.9
48.2

43.8

48.1 46.9

40.7

37.5 37.0

31.3

25.9

34.4

29.6

43.8

48.1 46.9 48.1 46.9

51.9

43.8

48.1

37.5

48.1

31.3
33.3

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

Itch
(≥2 points)

Tightness
(≥2 points)

Burning
(≥2 points)

Stinging
(≥2 points)

Pain
(≥2 points)

Dryness
(≥2 points)

Cracking
(≥2 points)

Scaling
(≥2 points)

Shedding/flaking
(≥2 points)

Redness
(≥2 points)

Bleeding
(≥2 points)

aDenominators include patients who achieved clinical response and completed ≥1 PSSD item at baseline and ≥1 PSSD item at a post-baseline visit.
PASI 75, 75% reduction from baseline in Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

DLQI Response by Clinical Response
• At Week 16, DLQI response (≥4-point reduction from baseline) was reported by 83.3% and 82.5% of all 

patients across both trials who achieved PASI 75 (553/664) and/or sPGA 0/1 (496/601), respectively 
(Table 2)

 — Greater proportions of patients who received deucravacitinib and achieved clinical response reported 
meaningful DLQI improvement (84.7% of patients who achieved PASI 75 and 83.3% of patients who 
achieved sPGA 0/1) compared with patients who received placebo (72.7% of patients who achieved 
PASI 75 and 70.6% of patients who achieved sPGA 0/1)

• At Week 16, 54.7% and 57.3% of all patients across both trials who did not achieve PASI 75 (444/811) 
and/or did not achieve sPGA 0/1 (501/874), respectively, nonetheless reported DLQI response

 — Greater proportions of patients who received deucravacitinib and did not achieve clinical response 
nonetheless reported meaningful DLQI improvement (67.1% of patients who did not achieve PASI 75 
and 70.8% of patients who did not achieve sPGA 0/1) compared with patients who received placebo 
(40.5% of patients who did not achieve PASI 75 and 41.7% who did not achieve sPGA 0/1)

Table 2. DLQI response at Week 16 in patients who achieved clinical response

DLQI ≥4-point reduction
Total patients  

N = 1643
Deucravacitinib 

n = 824
Placebo 
n = 409

PASI 75, n/Na (%) 553/664 (83.3)b 393/464 (84.7) 32/44 (72.7)

sPGA 0/1, n/Na (%) 496/601 (82.5)b 359/431 (83.3) 24/34 (70.6)
aThe denominator includes the patients who achieved clinical response and completed ≥1 DLQI item at baseline and ≥1 DLQI item at a post-baseline visit.
bTotal denominator includes patients who received apremilast. 
DLQI, Dermatology Life Quality Index; PASI 75, ≥75% improvement from baseline in Psoriasis Area and Severity Index score; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

Conclusions
• Psoriasis skin clearance, symptom reduction, and improved patient quality of life were 

correlated in the POETYK PSO-1 and PSO-2 trials

 — This correlation is consistent with that determined in other studies4-7

• Higher clinical response was associated with greater PRO measure response

• PRO measures capture patient-perceived treatment benefi ts that may not be ascertained by 
measuring rates of skin clearance with clinical assessments alone4

 — Psoriasis bears symptoms, such as pruritus, for which there are no validated objective 
measures,8 or which are best assessed by patients themselves9 in order to evaluate 
treatment effi cacy

 — Among patients who achieved PASI 75 at Week 16, 80.8% of patients who received 
deucravacitinib reported meaningful itch improvement on the PSSD compared with 
43.8% of patients who received placebo

• Among patients with and without clinical response, greater proportions of patients treated 
with deucravacitinib recorded improvement in their self-reported symptoms, signs, and quality 
of life compared with patients treated with placebo

References
1. Warren RB, et al. Ann Rheum Dis. 2022;81:1570-1571.

2. Papp KA, et al. [poster] Presented at the 30th Congress of the European Academy of Dermatology and Venereology (EADV); September 29–October 2, 2021; virtual meeting.
3. Augustin M, et al. [poster] Presented at the American Academy of Dermatology (AAD) Annual Meeting; March 25–29, 2022; Boston, MA.
4. Armstrong AW, et al. Am J Clin Dermatol. 2019;20:155-164.

5. Loft ND, et al. Acta Derm Venereol. 2019;99:1224-1230.

6. Schäfer I, et al. Eur J Dermatol. 2010;20:62-67.

7. Thaçi D, et al. Dermatol Ther (Heidelb). 2022;12:495-510.

8. Price A, Cohen DE. Dermatitis. 2014;225:334-344.

9. Armstrong AW, et al. J Dermatol Treat. 2019;30:27-34.

Acknowledgments
• This study was sponsored by Bristol Myers Squibb

• Medical writing and editorial assistance was provided by Eleanor Bush, MA, of Peloton Advantage, LLC, an OPEN Health company, and funded by Bristol Myers Squibb

Disclosures
• AWA: Grants and personal fees: AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Leo Pharma, and Novartis; Personal fees: Boehringer Ingelheim/Parexel, Celgene, 

Dermavant, Genentech, GlaxoSmithKline, Menlo Therapeutics, Merck, Modernizing Medicine, Ortho Dermatologics, Pfi zer, Regeneron, Sanofi  Genzyme, Science 37, 
Sun Pharma, and Valeant; Grants: Dermira, Kyowa Hakko Kirin, and UCB, outside the submitted work

• KAP: Speakers bureau: AbbVie, Amgen, Astellas, Celgene, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Leo Pharma, Merck Sharp & Dohme, Novartis, Pfi zer, and 
Valeant; Grant/research support: AbbVie, Akros, Allergan, Amgen, Anacor, Arcutis, AstraZeneca, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, 
Dermira, Dow Pharma, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, Leo Pharma, MedImmune, Meiji Seika Pharma, Merck Serono, 
Novartis, Pfi zer, Regeneron, Roche, Sanofi  Genzyme, Takeda, UCB, and Valeant; Consultant: AbbVie, Akros, Amgen, Arcutis, Astellas, AstraZeneca, Baxalta, Baxter, 
Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Forward Pharma, Galderma, Genentech, Janssen, Kyowa Hakko 
Kirin, Leo Pharma, Meiji Seika Pharma, Merck Serono, Merck Sharp & Dohme, Mitsubishi Pharma, Novartis, Pfi zer, Regeneron, Roche, Sanofi  Genzyme, Takeda, UCB, 
and Valeant; Honoraria: AbbVie, Akros, Amgen, Baxter, Boehringer Ingelheim, Celgene, Coherus, Eli Lilly, Forward Pharma, Galderma, GlaxoSmithKline, Janssen, Kyowa 
Hakko Kirin, Merck Sharp & Dohme, Merck Serono, Novartis, Pfi zer, Takeda, UCB, and Valeant; Scientifi c offi cer/steering committee/advisory board: AbbVie, Akros, 
Amgen, Anacor, Astellas, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dow Pharma, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Merck Serono, 
Merck Sharp & Dohme, Novartis, Pfi zer, Regeneron, Sanofi  Genzyme, and Valeant

• JZ, BB, YZ, RMK, and SB: Employees and shareholders of Bristol Myers Squibb

• JLB and MD: Employees of Clinical Outcomes Solutions, which has received consulting fees from Bristol Myers Squibb

• BS: Consultant (honoraria): AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Eli 
Lilly, Equillium, GlaxoSmithKline, Immunic Therapeutics, Janssen, Leo Pharma, Maruho, Meiji Seika Pharma, Mindera, Novartis, Ortho Dermatologics, Pfi zer, Regeneron, 
Sanofi  Genzyme, Sun Pharma, UCB, Ventyx Biosciences, and vTv Therapeutics; Speaker: AbbVie, Eli Lilly, Janssen, and Sanofi  Genzyme; Co-scientifi c director (consulting 
fee): CorEvitas’ (Corrona) Psoriasis Registry; Investigator: AbbVie, Cara, CorEvitas’ (Corrona) Psoriasis Registry, Dermavant, Dermira, and Novartis

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: correlations between patient-reported 
outcomes and clinical responses in the phase 3 clinical trials POETYK PSO-1 and POETYK PSO-2
April W. Armstrong,1 Kim A. Papp,2 Joe Zhuo,3 Brandon Becker,3 Yichen Zhong,3 Jennifer L. Beaumont,4 Michael DeRosa,4 Renata M. Kisa,3 Subhashis Banerjee,3 Bruce Strober5,6
1Keck School of Medicine, University of Southern California, Los Angeles, CA; 2Probity Medical Research, Waterloo, Ontario, Canada; 3Bristol Myers Squibb, Princeton, NJ; 4Clinical Outcomes Solutions, Chicago, IL; 5Yale University, New Haven, CT; 6Central Connecticut Dermatology, Cromwell, CT

Presented at the Fall Clinical Dermatology Conference; October 20–23, 2022; Las Vegas, NV This poster may not be reproduced without written permission from the authors.Email for April W. Armstrong, MD, MPH: aprilarmstrong@post.Harvard.edu

Scientifi c Content on Demand
To request a copy of this poster:

Scan QR code via a barcode 
reader application

QR codes are valid for 30 days after 
the congress presentation date.



Synopsis
• In the phase 3 clinical trials POETYK PSO-1 and PSO-2, deucravacitinib was compared for effi cacy and safety 

with placebo and apremilast in the treatment of patients with moderate to severe plaque psoriasis1

 — Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved by the US 
Food and Drug Administration for the treatment of adults with moderate to severe plaque psoriasis 
who are candidates for systemic therapy or phototherapy

 — In each clinical trial, greater proportions of patients who received deucravacitinib achieved ≥75% 
reduction from baseline in the Psoriasis Area and Severity Index score (PASI 75)1 and static Physician’s 
Global Assessment scores of 0 or 1 (sPGA 0/1),1 and showed meaningful improvements on Psoriasis 
Symptoms and Signs Diary (PSSD) total scores (≥25 points)2 and Dermatology Life Quality Index (DLQI) 
total scores (≥4 points)3 compared with patients receiving placebo or apremilast

• In this post hoc analysis of data pooled from both trials, clinical and patient-reported outcomes (PROs) 
were found to be correlated 

• When analyzed by the deucravacitinib or placebo treatment arm, greater proportions of patients who 
received deucravacitinib reported symptom reduction and improved quality of life, both in patients 
who did and who did not achieve PASI 75 and sPGA 0/1 responses

Objective
• To explore the correlations between responses on clinical and PRO measures in pooled data from 

POETYK PSO-1 and PSO-2

Methods
• In POETYK PSO-1 (N = 666) and PSO-2 (N = 1020) adults (aged ≥18 years) with moderate to severe psoriasis 

were randomized 2:1:1 to deucravacitinib 6 mg once daily, placebo, or apremilast 30 mg twice daily

 — At Week 16 in each trial, patients who received placebo crossed over to deucravacitinib

• Using data pooled from both trials, we evaluated the correlation between responses measured by PASI 
and sPGA on one hand, and the PRO measures PSSD (≥25 points)2 and DLQI (≥4 points)3 on the other

 — The analysis populations for the PSSD and DLQI included all patients from the full analysis set who 
completed ≥1 item on the respective questionnaire at baseline and ≥1 post-baseline visit 
• At baseline, 1659 patients had a DLQI score recorded and 1553 had a PSSD score recorded

• Spearman correlation coeffi cients between clinical and PRO score changes from baseline to Week 16 were 
calculated with all treatment groups combined

• Mean PSSD and DLQI scores were determined within relative PASI and sPGA response levels

• The proportions of patients achieving meaningful improvement (ie, response) in PSSD total scores and 
on the DLQI were summarized by whether they did or did not achieve PASI 75 and sPGA 0/1, and were 
further analyzed by treatment arm

 — Results are reported for patients receiving deucravacitinib or placebo

Outcome measures
• PASI

 — Clinician evaluated

 — Range: 0–72, with higher scores indicating more severe disease

• sPGA

 — Clinician evaluated

 — Range: 0 (clear) to 4 (severe)

• PSSD

 — Patient rated

 — 5 skin symptoms (itch, tightness, burning, stinging, and pain) and 6 skin signs (dryness, cracking, 
scaling, shedding/fl aking, redness, and bleeding) associated with psoriasis were rated 0 (absent) to 
10 (worst imaginable); averages within each domain were multiplied by 10, then averaged across both 
domains to obtain a total score

 — Range: 0–100, with higher scores indicating heavier disease burden

• DLQI

 — Patient rated

 — 10 questions that assess the extent to which skin disease affects patients’ lives

 — Range: 0–30, with higher scores indicating more severe impact of disease 

Results
Correlations between clinical and PRO measures
• At Week 16, change from baseline in relative PASI score was correlated with changes in the PSSD total 

score (Spearman’s rank correlation coeffi cient [r
s
] = 0.536) and DLQI total score (r

s
 = 0.421) in the total 

study population

• At Week 16, change from baseline in sPGA score was correlated with changes in the PSSD total score 
(r

s
 = 0.496) and DLQI total score (r

s
 = 0.380) in the total study population

• Higher PASI or sPGA response was associated with greater PSSD and DLQI responses at Weeks 16, 24, and 
52 in the total study population (Figures 1–4)

Figure 1. PSSD total score change from baseline by PASI response group 
(treatment arms and trials pooled, n = 1536)

–50

–45

–40

–35

–30

–25

–20

–15

–10

–5

0

Week 16 Week 24 Week 52

P
SS

D
 c

h
an

ge
 f

ro
m

 b
as

e
li
n
e

a

PASI <50 PASI 50–74 PASI 75–89 PASI 90–99 PASI 100

aAt baseline, the mean PSSD total score (SD) was 54.4 (23.30) in the deucravacitinib arm, 53.1 (23.09) in the placebo arm, and 55.7 (22.90) in the apremilast arm. 
PASI 50–100, 50%–100% improvement from baseline in the Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary.

Figure 2. DLQI Change from baseline by PASI response group (treatment arms 
and trials pooled, n = 1643)

–14

–12

–10

–8

–6

–4

–2

0

Week 16 Week 24 Week 52

D
LQ

I 
ch

an
ge

 f
ro

m
 b

as
e
li
n
e

a

PASI <50 PASI 50–74 PASI 75–89 PASI 90–99 PASI 100

aThe mean baseline DLQI score (SD) among all patients in the study population was 12.0 (6.7).
DLQI, Dermatology Life Quality Index; PASI 50–100, 50%–100% improvement from baseline Psoriasis Area and Severity Index score.

Figure 3. PSSD change from baseline by sPGAa change group (treatment arms 
and trials pooled, n = 1536)

–50

–40

–30

–20

–10

0

10

20

Week 16 Week 24 Week 52

P
SS

D
 c

h
an

ge
 f

ro
m

 b
as

e
li
n
e

sPGA +1 sPGA 0 sPGA –1 sPGA –2 sPGA –3 or more

aAt baseline, 1345 patients in the total study population had an sPGA score of 3, and 340 had an sPGA score of 4. One patient had an sPGA score of 2; this patient was randomized but not treated. The mean 
baseline PSSD total score (SD) was 54.4 (23.30) in the deucravacitinib arm, 53.1 (23.09) in the placebo arm, and 55.7 (22.90) in the apremilast arm. 
PSSD, Psoriasis Symptoms and Signs Diary; sPGA, static Physician’s Global Assessment.

Figure 4. DLQI change from baseline by sPGAa change group (treatment arms 
and trials pooled, n = 1643)

Week 16 Week 24

–12

–10

–8

–6

–4

–2

0

2
Week 52

D
LQ

I 
ch

an
ge

 f
ro

m
 b

as
e
li
n
e

sPGA +1 sPGA 0 sPGA –1 sPGA –2 sPGA –3 or more

aAt baseline, 1345 patients in the total study population had an sPGA score of 3 and 340 had an sPGA score of 4. One patient had an sPGA score of 2; this patient was randomized but not treated. The mean 
baseline DLQI score (SD) among all patients in the study population was 12.0 (6.7).
DLQI, Dermatology Life Quality Index; sPGA, static Physician’s Global Assessment.

PSSD Response by Clinical Response
• At Week 16, PSSD total score response (≥25-point reduction from baseline) was reported by 64.8% and 65.3% of 

all patients across both trials who achieved PASI 75 (356/549) and/or sPGA 0/1 (330/505), respectively (Table 1)

 — Greater proportions of patients who received deucravacitinib and achieved clinical response reported 
PSSD total score response (68.6% of patients who achieved PASI 75 and 68.7% of patients who achieved 
sPGA 0/1) compared with patients who received placebo (31.3% of patients who achieved PASI 75 and 
37.0% of patients who achieved sPGA 0/1) (Table 1)

 — On the PSSD itch item, meaningful improvement (≥2 points) was reported by 80.8% of patients 
receiving deucravacitinib who achieved PASI 75 and 80.1% of deucravacitinib-treated patients who 
achieved sPGA 0/1, compared with 43.8% of patients receiving placebo who achieved PASI 75 and 
48.1% of placebo-treated patients who achieved sPGA 0/1 (Figure 5)

• At Week 16, 27.9% and 29.8% of all patients across both trials who did not achieve PASI 75 (188/674) 
and/or did not achieve sPGA 0/1 (214/718), respectively, nonetheless reported PSSD total score response

 — Greater proportions of patients who received deucravacitinib and did not achieve clinical response 
nonetheless reported PSSD total score response (41.8% of patients who did not achieve PASI 75 and 
44.1% of patients who did not achieve sPGA 0/1) compared with patients who received placebo 
(10.4% of patients who did not achieve PASI 75 and 10.3% who did not achieve sPGA 0/1)

 — On the PSSD itch item, meaningful improvement was reported by 54.9% of patients receiving 
deucravacitinib who did not achieve PASI 75 compared with 22.0% of patients receiving placebo who 
did not achieve PASI 75

Table 1. PSSD response at Week 16 in patients who achieved clinical response

PSSD Domain
Total patients

N = 1536
Deucravacitinib 

n = 765
Placebo 
n = 383

Total score (≥25-point reduction), n/Na (%)
PASI 75 356/549 (64.8)b 264/385 (68.6) 10/32 (31.3)
sPGA 0/1 330/505 (65.3)b 248/361 (68.7) 10/27 (37.0)

Symptom score (≥25-point reduction), n/Na (%)
PASI 75 323/549 (58.8)b 240/385 (62.3) 10/32 (31.3)
sPGA 0/1 296/505 (58.6)b 223/361 (61.8) 8/27 (29.6)

Sign score (≥25-point reduction), n/Na (%)
PASI 75 383/549 (69.8)b 284/385 (73.8) 10/32 (31.3)
sPGA 0/1 354/505 (70.1)b 267/361 (74.0) 10/27 (37.0)

aThe denominator represents the patients who achieved clinical response and who completed ≥1 PSSD item at baseline and ≥1 PSSD item at a post-baseline visit.
bTotal denominator includes patients who received apremilast. 
PASI 75, ≥75% improvement from baseline in Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

Figure 5. PSSD individual item response at Week 16 in patientsa who achieved 
clinical response

0

10

20

30

40

50

60

70

80

90

Deucravacitinib (n = 765) Placebo (n = 383)

P
at

ie
n
ts

, 
%

80.8 80.1 79.7 80.3

63.6 63.2

58.7 58.4

66.2 66.2

85.7 84.8

72.7 72.9

84.2 84.5
85.7 85.3

79.2 78.9

49.9
48.2

43.8

48.1 46.9

40.7

37.5 37.0

31.3

25.9

34.4

29.6

43.8

48.1 46.9 48.1 46.9

51.9

43.8

48.1

37.5

48.1

31.3
33.3

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

Itch
(≥2 points)

Tightness
(≥2 points)

Burning
(≥2 points)

Stinging
(≥2 points)

Pain
(≥2 points)

Dryness
(≥2 points)

Cracking
(≥2 points)

Scaling
(≥2 points)

Shedding/flaking
(≥2 points)

Redness
(≥2 points)

Bleeding
(≥2 points)

aDenominators include patients who achieved clinical response and completed ≥1 PSSD item at baseline and ≥1 PSSD item at a post-baseline visit.
PASI 75, 75% reduction from baseline in Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

DLQI Response by Clinical Response
• At Week 16, DLQI response (≥4-point reduction from baseline) was reported by 83.3% and 82.5% of all 

patients across both trials who achieved PASI 75 (553/664) and/or sPGA 0/1 (496/601), respectively 
(Table 2)

 — Greater proportions of patients who received deucravacitinib and achieved clinical response reported 
meaningful DLQI improvement (84.7% of patients who achieved PASI 75 and 83.3% of patients who 
achieved sPGA 0/1) compared with patients who received placebo (72.7% of patients who achieved 
PASI 75 and 70.6% of patients who achieved sPGA 0/1)

• At Week 16, 54.7% and 57.3% of all patients across both trials who did not achieve PASI 75 (444/811) 
and/or did not achieve sPGA 0/1 (501/874), respectively, nonetheless reported DLQI response

 — Greater proportions of patients who received deucravacitinib and did not achieve clinical response 
nonetheless reported meaningful DLQI improvement (67.1% of patients who did not achieve PASI 75 
and 70.8% of patients who did not achieve sPGA 0/1) compared with patients who received placebo 
(40.5% of patients who did not achieve PASI 75 and 41.7% who did not achieve sPGA 0/1)

Table 2. DLQI response at Week 16 in patients who achieved clinical response

DLQI ≥4-point reduction
Total patients  

N = 1643
Deucravacitinib 

n = 824
Placebo 
n = 409

PASI 75, n/Na (%) 553/664 (83.3)b 393/464 (84.7) 32/44 (72.7)

sPGA 0/1, n/Na (%) 496/601 (82.5)b 359/431 (83.3) 24/34 (70.6)
aThe denominator includes the patients who achieved clinical response and completed ≥1 DLQI item at baseline and ≥1 DLQI item at a post-baseline visit.
bTotal denominator includes patients who received apremilast. 
DLQI, Dermatology Life Quality Index; PASI 75, ≥75% improvement from baseline in Psoriasis Area and Severity Index score; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

Conclusions
• Psoriasis skin clearance, symptom reduction, and improved patient quality of life were 

correlated in the POETYK PSO-1 and PSO-2 trials

 — This correlation is consistent with that determined in other studies4-7

• Higher clinical response was associated with greater PRO measure response

• PRO measures capture patient-perceived treatment benefi ts that may not be ascertained by 
measuring rates of skin clearance with clinical assessments alone4

 — Psoriasis bears symptoms, such as pruritus, for which there are no validated objective 
measures,8 or which are best assessed by patients themselves9 in order to evaluate 
treatment effi cacy

 — Among patients who achieved PASI 75 at Week 16, 80.8% of patients who received 
deucravacitinib reported meaningful itch improvement on the PSSD compared with 
43.8% of patients who received placebo

• Among patients with and without clinical response, greater proportions of patients treated 
with deucravacitinib recorded improvement in their self-reported symptoms, signs, and quality 
of life compared with patients treated with placebo

References
1. Warren RB, et al. Ann Rheum Dis. 2022;81:1570-1571.

2. Papp KA, et al. [poster] Presented at the 30th Congress of the European Academy of Dermatology and Venereology (EADV); September 29–October 2, 2021; virtual meeting.
3. Augustin M, et al. [poster] Presented at the American Academy of Dermatology (AAD) Annual Meeting; March 25–29, 2022; Boston, MA.
4. Armstrong AW, et al. Am J Clin Dermatol. 2019;20:155-164.

5. Loft ND, et al. Acta Derm Venereol. 2019;99:1224-1230.

6. Schäfer I, et al. Eur J Dermatol. 2010;20:62-67.

7. Thaçi D, et al. Dermatol Ther (Heidelb). 2022;12:495-510.

8. Price A, Cohen DE. Dermatitis. 2014;225:334-344.

9. Armstrong AW, et al. J Dermatol Treat. 2019;30:27-34.

Acknowledgments
• This study was sponsored by Bristol Myers Squibb

• Medical writing and editorial assistance was provided by Eleanor Bush, MA, of Peloton Advantage, LLC, an OPEN Health company, and funded by Bristol Myers Squibb

Disclosures
• AWA: Grants and personal fees: AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Leo Pharma, and Novartis; Personal fees: Boehringer Ingelheim/Parexel, Celgene, 

Dermavant, Genentech, GlaxoSmithKline, Menlo Therapeutics, Merck, Modernizing Medicine, Ortho Dermatologics, Pfi zer, Regeneron, Sanofi  Genzyme, Science 37, 
Sun Pharma, and Valeant; Grants: Dermira, Kyowa Hakko Kirin, and UCB, outside the submitted work

• KAP: Speakers bureau: AbbVie, Amgen, Astellas, Celgene, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Leo Pharma, Merck Sharp & Dohme, Novartis, Pfi zer, and 
Valeant; Grant/research support: AbbVie, Akros, Allergan, Amgen, Anacor, Arcutis, AstraZeneca, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, 
Dermira, Dow Pharma, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, Leo Pharma, MedImmune, Meiji Seika Pharma, Merck Serono, 
Novartis, Pfi zer, Regeneron, Roche, Sanofi  Genzyme, Takeda, UCB, and Valeant; Consultant: AbbVie, Akros, Amgen, Arcutis, Astellas, AstraZeneca, Baxalta, Baxter, 
Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Forward Pharma, Galderma, Genentech, Janssen, Kyowa Hakko 
Kirin, Leo Pharma, Meiji Seika Pharma, Merck Serono, Merck Sharp & Dohme, Mitsubishi Pharma, Novartis, Pfi zer, Regeneron, Roche, Sanofi  Genzyme, Takeda, UCB, 
and Valeant; Honoraria: AbbVie, Akros, Amgen, Baxter, Boehringer Ingelheim, Celgene, Coherus, Eli Lilly, Forward Pharma, Galderma, GlaxoSmithKline, Janssen, Kyowa 
Hakko Kirin, Merck Sharp & Dohme, Merck Serono, Novartis, Pfi zer, Takeda, UCB, and Valeant; Scientifi c offi cer/steering committee/advisory board: AbbVie, Akros, 
Amgen, Anacor, Astellas, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dow Pharma, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Merck Serono, 
Merck Sharp & Dohme, Novartis, Pfi zer, Regeneron, Sanofi  Genzyme, and Valeant

• JZ, BB, YZ, RMK, and SB: Employees and shareholders of Bristol Myers Squibb

• JLB and MD: Employees of Clinical Outcomes Solutions, which has received consulting fees from Bristol Myers Squibb

• BS: Consultant (honoraria): AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Eli 
Lilly, Equillium, GlaxoSmithKline, Immunic Therapeutics, Janssen, Leo Pharma, Maruho, Meiji Seika Pharma, Mindera, Novartis, Ortho Dermatologics, Pfi zer, Regeneron, 
Sanofi  Genzyme, Sun Pharma, UCB, Ventyx Biosciences, and vTv Therapeutics; Speaker: AbbVie, Eli Lilly, Janssen, and Sanofi  Genzyme; Co-scientifi c director (consulting 
fee): CorEvitas’ (Corrona) Psoriasis Registry; Investigator: AbbVie, Cara, CorEvitas’ (Corrona) Psoriasis Registry, Dermavant, Dermira, and Novartis

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: correlations between patient-reported 
outcomes and clinical responses in the phase 3 clinical trials POETYK PSO-1 and POETYK PSO-2
April W. Armstrong,1 Kim A. Papp,2 Joe Zhuo,3 Brandon Becker,3 Yichen Zhong,3 Jennifer L. Beaumont,4 Michael DeRosa,4 Renata M. Kisa,3 Subhashis Banerjee,3 Bruce Strober5,6
1Keck School of Medicine, University of Southern California, Los Angeles, CA; 2Probity Medical Research, Waterloo, Ontario, Canada; 3Bristol Myers Squibb, Princeton, NJ; 4Clinical Outcomes Solutions, Chicago, IL; 5Yale University, New Haven, CT; 6Central Connecticut Dermatology, Cromwell, CT

Presented at the Fall Clinical Dermatology Conference; October 20–23, 2022; Las Vegas, NV This poster may not be reproduced without written permission from the authors.Email for April W. Armstrong, MD, MPH: aprilarmstrong@post.Harvard.edu

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Synopsis
• In the phase 3 clinical trials POETYK PSO-1 and PSO-2, deucravacitinib was compared for effi cacy and safety 

with placebo and apremilast in the treatment of patients with moderate to severe plaque psoriasis1

 — Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved by the US 
Food and Drug Administration for the treatment of adults with moderate to severe plaque psoriasis 
who are candidates for systemic therapy or phototherapy

 — In each clinical trial, greater proportions of patients who received deucravacitinib achieved ≥75% 
reduction from baseline in the Psoriasis Area and Severity Index score (PASI 75)1 and static Physician’s 
Global Assessment scores of 0 or 1 (sPGA 0/1),1 and showed meaningful improvements on Psoriasis 
Symptoms and Signs Diary (PSSD) total scores (≥25 points)2 and Dermatology Life Quality Index (DLQI) 
total scores (≥4 points)3 compared with patients receiving placebo or apremilast

• In this post hoc analysis of data pooled from both trials, clinical and patient-reported outcomes (PROs) 
were found to be correlated 

• When analyzed by the deucravacitinib or placebo treatment arm, greater proportions of patients who 
received deucravacitinib reported symptom reduction and improved quality of life, both in patients 
who did and who did not achieve PASI 75 and sPGA 0/1 responses

Objective
• To explore the correlations between responses on clinical and PRO measures in pooled data from 

POETYK PSO-1 and PSO-2

Methods
• In POETYK PSO-1 (N = 666) and PSO-2 (N = 1020) adults (aged ≥18 years) with moderate to severe psoriasis 

were randomized 2:1:1 to deucravacitinib 6 mg once daily, placebo, or apremilast 30 mg twice daily

 — At Week 16 in each trial, patients who received placebo crossed over to deucravacitinib

• Using data pooled from both trials, we evaluated the correlation between responses measured by PASI 
and sPGA on one hand, and the PRO measures PSSD (≥25 points)2 and DLQI (≥4 points)3 on the other

 — The analysis populations for the PSSD and DLQI included all patients from the full analysis set who 
completed ≥1 item on the respective questionnaire at baseline and ≥1 post-baseline visit 
• At baseline, 1659 patients had a DLQI score recorded and 1553 had a PSSD score recorded

• Spearman correlation coeffi cients between clinical and PRO score changes from baseline to Week 16 were 
calculated with all treatment groups combined

• Mean PSSD and DLQI scores were determined within relative PASI and sPGA response levels

• The proportions of patients achieving meaningful improvement (ie, response) in PSSD total scores and 
on the DLQI were summarized by whether they did or did not achieve PASI 75 and sPGA 0/1, and were 
further analyzed by treatment arm

 — Results are reported for patients receiving deucravacitinib or placebo

Outcome measures
• PASI

 — Clinician evaluated

 — Range: 0–72, with higher scores indicating more severe disease

• sPGA

 — Clinician evaluated

 — Range: 0 (clear) to 4 (severe)

• PSSD

 — Patient rated

 — 5 skin symptoms (itch, tightness, burning, stinging, and pain) and 6 skin signs (dryness, cracking, 
scaling, shedding/fl aking, redness, and bleeding) associated with psoriasis were rated 0 (absent) to 
10 (worst imaginable); averages within each domain were multiplied by 10, then averaged across both 
domains to obtain a total score

 — Range: 0–100, with higher scores indicating heavier disease burden

• DLQI

 — Patient rated

 — 10 questions that assess the extent to which skin disease affects patients’ lives

 — Range: 0–30, with higher scores indicating more severe impact of disease 

Results
Correlations between clinical and PRO measures
• At Week 16, change from baseline in relative PASI score was correlated with changes in the PSSD total 

score (Spearman’s rank correlation coeffi cient [r
s
] = 0.536) and DLQI total score (r

s
 = 0.421) in the total 

study population

• At Week 16, change from baseline in sPGA score was correlated with changes in the PSSD total score 
(r

s
 = 0.496) and DLQI total score (r

s
 = 0.380) in the total study population

• Higher PASI or sPGA response was associated with greater PSSD and DLQI responses at Weeks 16, 24, and 
52 in the total study population (Figures 1–4)

Figure 1. PSSD total score change from baseline by PASI response group 
(treatment arms and trials pooled, n = 1536)

–50

–45

–40

–35

–30

–25

–20

–15

–10

–5

0

Week 16 Week 24 Week 52

P
SS

D
 c

h
an

ge
 f

ro
m

 b
as

e
li
n
e

a

PASI <50 PASI 50–74 PASI 75–89 PASI 90–99 PASI 100

aAt baseline, the mean PSSD total score (SD) was 54.4 (23.30) in the deucravacitinib arm, 53.1 (23.09) in the placebo arm, and 55.7 (22.90) in the apremilast arm. 
PASI 50–100, 50%–100% improvement from baseline in the Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary.

Figure 2. DLQI Change from baseline by PASI response group (treatment arms 
and trials pooled, n = 1643)

–14

–12

–10

–8

–6

–4

–2

0

Week 16 Week 24 Week 52

D
LQ

I 
ch

an
ge

 f
ro

m
 b

as
e
li
n
e

a

PASI <50 PASI 50–74 PASI 75–89 PASI 90–99 PASI 100

aThe mean baseline DLQI score (SD) among all patients in the study population was 12.0 (6.7).
DLQI, Dermatology Life Quality Index; PASI 50–100, 50%–100% improvement from baseline Psoriasis Area and Severity Index score.

Figure 3. PSSD change from baseline by sPGAa change group (treatment arms 
and trials pooled, n = 1536)

–50

–40

–30

–20

–10

0

10

20

Week 16 Week 24 Week 52

P
SS

D
 c

h
an

ge
 f

ro
m

 b
as

e
li
n
e

sPGA +1 sPGA 0 sPGA –1 sPGA –2 sPGA –3 or more

aAt baseline, 1345 patients in the total study population had an sPGA score of 3, and 340 had an sPGA score of 4. One patient had an sPGA score of 2; this patient was randomized but not treated. The mean 
baseline PSSD total score (SD) was 54.4 (23.30) in the deucravacitinib arm, 53.1 (23.09) in the placebo arm, and 55.7 (22.90) in the apremilast arm. 
PSSD, Psoriasis Symptoms and Signs Diary; sPGA, static Physician’s Global Assessment.

Figure 4. DLQI change from baseline by sPGAa change group (treatment arms 
and trials pooled, n = 1643)

Week 16 Week 24

–12

–10

–8

–6

–4

–2

0

2
Week 52

D
LQ

I 
ch

an
ge

 f
ro

m
 b

as
e
li
n
e

sPGA +1 sPGA 0 sPGA –1 sPGA –2 sPGA –3 or more

aAt baseline, 1345 patients in the total study population had an sPGA score of 3 and 340 had an sPGA score of 4. One patient had an sPGA score of 2; this patient was randomized but not treated. The mean 
baseline DLQI score (SD) among all patients in the study population was 12.0 (6.7).
DLQI, Dermatology Life Quality Index; sPGA, static Physician’s Global Assessment.

PSSD Response by Clinical Response
• At Week 16, PSSD total score response (≥25-point reduction from baseline) was reported by 64.8% and 65.3% of 

all patients across both trials who achieved PASI 75 (356/549) and/or sPGA 0/1 (330/505), respectively (Table 1)

 — Greater proportions of patients who received deucravacitinib and achieved clinical response reported 
PSSD total score response (68.6% of patients who achieved PASI 75 and 68.7% of patients who achieved 
sPGA 0/1) compared with patients who received placebo (31.3% of patients who achieved PASI 75 and 
37.0% of patients who achieved sPGA 0/1) (Table 1)

 — On the PSSD itch item, meaningful improvement (≥2 points) was reported by 80.8% of patients 
receiving deucravacitinib who achieved PASI 75 and 80.1% of deucravacitinib-treated patients who 
achieved sPGA 0/1, compared with 43.8% of patients receiving placebo who achieved PASI 75 and 
48.1% of placebo-treated patients who achieved sPGA 0/1 (Figure 5)

• At Week 16, 27.9% and 29.8% of all patients across both trials who did not achieve PASI 75 (188/674) 
and/or did not achieve sPGA 0/1 (214/718), respectively, nonetheless reported PSSD total score response

 — Greater proportions of patients who received deucravacitinib and did not achieve clinical response 
nonetheless reported PSSD total score response (41.8% of patients who did not achieve PASI 75 and 
44.1% of patients who did not achieve sPGA 0/1) compared with patients who received placebo 
(10.4% of patients who did not achieve PASI 75 and 10.3% who did not achieve sPGA 0/1)

 — On the PSSD itch item, meaningful improvement was reported by 54.9% of patients receiving 
deucravacitinib who did not achieve PASI 75 compared with 22.0% of patients receiving placebo who 
did not achieve PASI 75

Table 1. PSSD response at Week 16 in patients who achieved clinical response

PSSD Domain
Total patients

N = 1536
Deucravacitinib 

n = 765
Placebo 
n = 383

Total score (≥25-point reduction), n/Na (%)
PASI 75 356/549 (64.8)b 264/385 (68.6) 10/32 (31.3)
sPGA 0/1 330/505 (65.3)b 248/361 (68.7) 10/27 (37.0)

Symptom score (≥25-point reduction), n/Na (%)
PASI 75 323/549 (58.8)b 240/385 (62.3) 10/32 (31.3)
sPGA 0/1 296/505 (58.6)b 223/361 (61.8) 8/27 (29.6)

Sign score (≥25-point reduction), n/Na (%)
PASI 75 383/549 (69.8)b 284/385 (73.8) 10/32 (31.3)
sPGA 0/1 354/505 (70.1)b 267/361 (74.0) 10/27 (37.0)

aThe denominator represents the patients who achieved clinical response and who completed ≥1 PSSD item at baseline and ≥1 PSSD item at a post-baseline visit.
bTotal denominator includes patients who received apremilast. 
PASI 75, ≥75% improvement from baseline in Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

Figure 5. PSSD individual item response at Week 16 in patientsa who achieved 
clinical response

0

10

20

30

40

50

60

70

80

90

Deucravacitinib (n = 765) Placebo (n = 383)

P
at

ie
n
ts

, 
%

80.8 80.1 79.7 80.3

63.6 63.2

58.7 58.4

66.2 66.2

85.7 84.8

72.7 72.9

84.2 84.5
85.7 85.3

79.2 78.9

49.9
48.2

43.8

48.1 46.9

40.7

37.5 37.0

31.3

25.9

34.4

29.6

43.8

48.1 46.9 48.1 46.9

51.9

43.8

48.1

37.5

48.1

31.3
33.3

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

PASI
75

sPGA
0/1

Itch
(≥2 points)

Tightness
(≥2 points)

Burning
(≥2 points)

Stinging
(≥2 points)

Pain
(≥2 points)

Dryness
(≥2 points)

Cracking
(≥2 points)

Scaling
(≥2 points)

Shedding/flaking
(≥2 points)

Redness
(≥2 points)

Bleeding
(≥2 points)

aDenominators include patients who achieved clinical response and completed ≥1 PSSD item at baseline and ≥1 PSSD item at a post-baseline visit.
PASI 75, 75% reduction from baseline in Psoriasis Area and Severity Index score; PSSD, Psoriasis Symptoms and Signs Diary; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

DLQI Response by Clinical Response
• At Week 16, DLQI response (≥4-point reduction from baseline) was reported by 83.3% and 82.5% of all 

patients across both trials who achieved PASI 75 (553/664) and/or sPGA 0/1 (496/601), respectively 
(Table 2)

 — Greater proportions of patients who received deucravacitinib and achieved clinical response reported 
meaningful DLQI improvement (84.7% of patients who achieved PASI 75 and 83.3% of patients who 
achieved sPGA 0/1) compared with patients who received placebo (72.7% of patients who achieved 
PASI 75 and 70.6% of patients who achieved sPGA 0/1)

• At Week 16, 54.7% and 57.3% of all patients across both trials who did not achieve PASI 75 (444/811) 
and/or did not achieve sPGA 0/1 (501/874), respectively, nonetheless reported DLQI response

 — Greater proportions of patients who received deucravacitinib and did not achieve clinical response 
nonetheless reported meaningful DLQI improvement (67.1% of patients who did not achieve PASI 75 
and 70.8% of patients who did not achieve sPGA 0/1) compared with patients who received placebo 
(40.5% of patients who did not achieve PASI 75 and 41.7% who did not achieve sPGA 0/1)

Table 2. DLQI response at Week 16 in patients who achieved clinical response

DLQI ≥4-point reduction
Total patients  

N = 1643
Deucravacitinib 

n = 824
Placebo 
n = 409

PASI 75, n/Na (%) 553/664 (83.3)b 393/464 (84.7) 32/44 (72.7)

sPGA 0/1, n/Na (%) 496/601 (82.5)b 359/431 (83.3) 24/34 (70.6)
aThe denominator includes the patients who achieved clinical response and completed ≥1 DLQI item at baseline and ≥1 DLQI item at a post-baseline visit.
bTotal denominator includes patients who received apremilast. 
DLQI, Dermatology Life Quality Index; PASI 75, ≥75% improvement from baseline in Psoriasis Area and Severity Index score; sPGA 0/1, static Physician’s Global Assessment score of 0 or 1.

Conclusions
• Psoriasis skin clearance, symptom reduction, and improved patient quality of life were 

correlated in the POETYK PSO-1 and PSO-2 trials

 — This correlation is consistent with that determined in other studies4-7

• Higher clinical response was associated with greater PRO measure response

• PRO measures capture patient-perceived treatment benefi ts that may not be ascertained by 
measuring rates of skin clearance with clinical assessments alone4

 — Psoriasis bears symptoms, such as pruritus, for which there are no validated objective 
measures,8 or which are best assessed by patients themselves9 in order to evaluate 
treatment effi cacy

 — Among patients who achieved PASI 75 at Week 16, 80.8% of patients who received 
deucravacitinib reported meaningful itch improvement on the PSSD compared with 
43.8% of patients who received placebo

• Among patients with and without clinical response, greater proportions of patients treated 
with deucravacitinib recorded improvement in their self-reported symptoms, signs, and quality 
of life compared with patients treated with placebo

References
1. Warren RB, et al. Ann Rheum Dis. 2022;81:1570-1571.

2. Papp KA, et al. [poster] Presented at the 30th Congress of the European Academy of Dermatology and Venereology (EADV); September 29–October 2, 2021; virtual meeting.
3. Augustin M, et al. [poster] Presented at the American Academy of Dermatology (AAD) Annual Meeting; March 25–29, 2022; Boston, MA.
4. Armstrong AW, et al. Am J Clin Dermatol. 2019;20:155-164.

5. Loft ND, et al. Acta Derm Venereol. 2019;99:1224-1230.

6. Schäfer I, et al. Eur J Dermatol. 2010;20:62-67.

7. Thaçi D, et al. Dermatol Ther (Heidelb). 2022;12:495-510.

8. Price A, Cohen DE. Dermatitis. 2014;225:334-344.

9. Armstrong AW, et al. J Dermatol Treat. 2019;30:27-34.

Acknowledgments
• This study was sponsored by Bristol Myers Squibb

• Medical writing and editorial assistance was provided by Eleanor Bush, MA, of Peloton Advantage, LLC, an OPEN Health company, and funded by Bristol Myers Squibb

Disclosures
• AWA: Grants and personal fees: AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Leo Pharma, and Novartis; Personal fees: Boehringer Ingelheim/Parexel, Celgene, 

Dermavant, Genentech, GlaxoSmithKline, Menlo Therapeutics, Merck, Modernizing Medicine, Ortho Dermatologics, Pfi zer, Regeneron, Sanofi  Genzyme, Science 37, 
Sun Pharma, and Valeant; Grants: Dermira, Kyowa Hakko Kirin, and UCB, outside the submitted work

• KAP: Speakers bureau: AbbVie, Amgen, Astellas, Celgene, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Leo Pharma, Merck Sharp & Dohme, Novartis, Pfi zer, and 
Valeant; Grant/research support: AbbVie, Akros, Allergan, Amgen, Anacor, Arcutis, AstraZeneca, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, 
Dermira, Dow Pharma, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, Leo Pharma, MedImmune, Meiji Seika Pharma, Merck Serono, 
Novartis, Pfi zer, Regeneron, Roche, Sanofi  Genzyme, Takeda, UCB, and Valeant; Consultant: AbbVie, Akros, Amgen, Arcutis, Astellas, AstraZeneca, Baxalta, Baxter, 
Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Forward Pharma, Galderma, Genentech, Janssen, Kyowa Hakko 
Kirin, Leo Pharma, Meiji Seika Pharma, Merck Serono, Merck Sharp & Dohme, Mitsubishi Pharma, Novartis, Pfi zer, Regeneron, Roche, Sanofi  Genzyme, Takeda, UCB, 
and Valeant; Honoraria: AbbVie, Akros, Amgen, Baxter, Boehringer Ingelheim, Celgene, Coherus, Eli Lilly, Forward Pharma, Galderma, GlaxoSmithKline, Janssen, Kyowa 
Hakko Kirin, Merck Sharp & Dohme, Merck Serono, Novartis, Pfi zer, Takeda, UCB, and Valeant; Scientifi c offi cer/steering committee/advisory board: AbbVie, Akros, 
Amgen, Anacor, Astellas, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dow Pharma, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Merck Serono, 
Merck Sharp & Dohme, Novartis, Pfi zer, Regeneron, Sanofi  Genzyme, and Valeant

• JZ, BB, YZ, RMK, and SB: Employees and shareholders of Bristol Myers Squibb

• JLB and MD: Employees of Clinical Outcomes Solutions, which has received consulting fees from Bristol Myers Squibb

• BS: Consultant (honoraria): AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Eli 
Lilly, Equillium, GlaxoSmithKline, Immunic Therapeutics, Janssen, Leo Pharma, Maruho, Meiji Seika Pharma, Mindera, Novartis, Ortho Dermatologics, Pfi zer, Regeneron, 
Sanofi  Genzyme, Sun Pharma, UCB, Ventyx Biosciences, and vTv Therapeutics; Speaker: AbbVie, Eli Lilly, Janssen, and Sanofi  Genzyme; Co-scientifi c director (consulting 
fee): CorEvitas’ (Corrona) Psoriasis Registry; Investigator: AbbVie, Cara, CorEvitas’ (Corrona) Psoriasis Registry, Dermavant, Dermira, and Novartis

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: correlations between patient-reported 
outcomes and clinical responses in the phase 3 clinical trials POETYK PSO-1 and POETYK PSO-2
April W. Armstrong,1 Kim A. Papp,2 Joe Zhuo,3 Brandon Becker,3 Yichen Zhong,3 Jennifer L. Beaumont,4 Michael DeRosa,4 Renata M. Kisa,3 Subhashis Banerjee,3 Bruce Strober5,6
1Keck School of Medicine, University of Southern California, Los Angeles, CA; 2Probity Medical Research, Waterloo, Ontario, Canada; 3Bristol Myers Squibb, Princeton, NJ; 4Clinical Outcomes Solutions, Chicago, IL; 5Yale University, New Haven, CT; 6Central Connecticut Dermatology, Cromwell, CT

Presented at the Fall Clinical Dermatology Conference; October 20–23, 2022; Las Vegas, NV This poster may not be reproduced without written permission from the authors.Email for April W. Armstrong, MD, MPH: aprilarmstrong@post.Harvard.edu

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