Deucravacitinib Improves Psoriasis Symptoms and Signs Diary Domain Scores in Patients With Moderate 
to Severe Plaque Psoriasis: Results From the Phase 3 POETYK PSO-1 and POETYK PSO-2 Studies 
April W Armstrong,1 Bruce Strober,2 Kenneth B Gordon,3 Joe Zhuo,4 Brandon Becker,4 Renata M Kisa,4 John Throup,4 Jonghyeon Kim,4 Kim Papp5
1Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; 2Yale University, New Haven, CT, and Central Connecticut Dermatology, Cromwell, CT, USA; 3Medical College of Wisconsin, Milwaukee, WI, USA; 4Bristol Myers Squibb, Princeton, NJ, USA;  
5Probity Medical Research, Waterloo, ON, Canada

Introduction
• Tyrosine kinase 2 (TYK2) is an intracellular kinase that mediates signaling 

of key cytokines (interleukin [IL]-23, IL-12, and Type I interferons [IFNs]) 
involved in psoriasis pathogenesis1

• Deucravacitinib is a novel, oral, and selective inhibitor that binds to 
the regulatory domain of TYK2, and thereby via an allosteric mechanism 
inhibits signaling of IL-23, IL-12, and Type I IFN1 

• In the Phase 3 POETYK PSO-1 and PSO-2 trials, deucravacitinib 
demonstrated superiority compared with placebo and apremilast for 
multiple endpoints, including clinical and patient-reported outcomes2

 — Results from the Psoriasis Symptoms and Signs Diary (PSSD) focusing 
on patient-reported symptoms were previously described at the 2021 
American Academy of Dermatology annual meeting2

Objective
• To compare the effect of deucravacitinib vs placebo and vs apremilast on 

item-level changes over time for patient-reported psoriasis symptoms and 
signs measured by the PSSD, and to further evaluate the contribution of 
individual subdomains on symptom and sign scores in POETYK PSO-1 and 
PSO-2

Methods
Study designs
• POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) were 52-week, 

Phase 3, double-blind trials that randomized patients with moderate 
to severe plaque psoriasis (body surface area [BSA] involvement ≥10%, 
Psoriasis Area and Severity Index [PASI] score ≥12, static Physician’s Global 
Assessment [sPGA] score ≥3) 2:1:1 to deucravacitinib 6 mg once daily, 
placebo, or apremilast 30 mg twice daily2

• Patients recorded psoriasis symptoms and signs daily (24-h recall) using 
the PSSD

 — The PSSD is a patient-reported instrument that assesses the severity  
of 5 symptoms (burning, itch, pain, skin tightness, stinging) and 6 signs 
(bleeding, cracking, dryness, redness, scaling, shedding or flaking) on  
a numerical scale ranging from 0 (absent) to 10 (worst imaginable)3,4

 — Psoriasis symptom and sign summary scores (0–100) were derived based 
on average scores for the individual symptom and sign domains

Results
Baseline disease characteristics
• A total of 666 and 1020 patients were randomized in PSO-1 and PSO-2, 

respectively2

• In both trials, PSSD total and symptom and sign summary scores were 
similar across groups at baseline (Table 1)

Table 1. Baseline PSSD total and summary scores

POETYK PSO-1 POETYK PSO-2

Mean  
PSSD score  
(min, max)

Placebo
(n=166)

Deucravacitinib
(n=332)

Apremilast
(n=168)

Placebo
(n=255)

Deucravacitinib
(n=511)

Apremilast
(n=254)

Total 
53.4  

(6.1, 100.0)
53.5  

(0.0, 100.0)
57.4  

(1.0, 100.0)
52.9  

(0.0, 100.0)
55.0  

(5.9, 100.0)
54.5  

(8.2, 100.0)

Symptom
51.4  

(0.3, 100.0)
51.7  

(0.0, 100.0)
56.2  

(2.0, 100.0)
50.1  

(0.0, 100.0)
52.3  

(1.0, 100.0)
51.9  

(0.0, 100.0)

Sign
55.5  

(9.4, 100.0)
55.3  

(0.0, 100.0)
58.6  

(0.0, 100.0)
55.7  

(0.0, 100.0)
57.7  

(5.7, 100.0)
57.2  

(11.7, 100.0)

max, maximum; min, minimum; PSSD, Psoriasis Symptoms and Signs Diary.

• PSSD symptom and sign domain scores were also similar across groups at 
baseline (data not shown)

PSSD scores
• Deucravacitinib-treated patients experienced significantly greater 

improvements in mean change from baseline in PSSD total scores, 
symptom summary scores, and sign summary scores compared with those 
receiving placebo or apremilast at Week 16 and Week 24 (Figure 1)

Figure 1. Mean change from baseline in PSSD total scores, symptom 
summary scores, and sign summary scores at Week 16 and Week 24

–36.3†

–25.0

–35.0†

–24.2

–37.6†

–25.8

–34.9†

–27.0

–33.0†

–25.2

–36.9†

–28.9

–7.0 –6.3 –7.7

–33.2*† –32.0*
†

–34.3*†

–24.5 –23.7 –25.4

-50

-40

-30

-20

-10

0
PSSD total score PSSD symptom score PSSD sign score

M
e
an

 c
h
an

ge
 f

ro
m

 b
as

e
li
n
e

Week 16
POETYK PSO-1 POETYK PSO-2

Week 24

Deucravacitinib 6 mg QDPlacebo Apremilast 30 mg BID

–4.8 –3.2 –6.3

–33.1*† –31.3*
†

–35.0*†

–24.7 –23.0 –26.5

-50

-40

-30

-20

-10

0
PSSD total score PSSD symptom score PSSD sign score

M
e
an

 c
h
an

ge
 f

ro
m

 b
as

e
li
n
e

POETYK PSO-1

-50

-40

-30

-20

-10

0
PSSD total score PSSD symptom score PSSD sign score

POETYK PSO-2

-50

-40

-30

-20

-10

0
PSSD total score PSSD symptom score PSSD sign score

*P<0.0001 vs placebo. †P<0.0001 vs apremilast. 
Modified baseline observation carried forward was used to impute missing data. 
BID, twice daily; PSSD, Psoriasis Symptoms and Signs Diary; QD, once daily.

• Significantly greater improvements from baseline were observed in all 
individual symptom and sign domain scores at Week 16 for patients 
treated with deucravacitinib compared with placebo or apremilast and 
were consistent between PSO-1 and PSO-2 (Figure 2)

 — The greatest improvements in psoriasis symptoms were observed for 
itch, skin tightness, and pain in both studies

 — The greatest improvements in psoriasis signs were observed for 
dryness, scaling, and shedding or flaking

Figure 2. Mean change from baseline in PSSD symptom domain 
scores and PSSD sign domain scores at Week 16

-5

-4

-3

-2

-1

0

M
e
an

 c
h
an

ge
 f

ro
m

 b
as

e
li
n
e

POETYK PSO-1 PSSD symptom domain scores POETYK PSO-2 PSSD symptom domain scores

Deucravacitinib 6 mg QDPlacebo Apremilast 30 mg BID

-5

-4

-3

-2

-1

0

M
e
an

 c
h
an

ge
 f

ro
m

 b
as

e
li
n
e

POETYK PSO-1 PSSD sign domain scores

-5

-4

-3

-2

-1

0

POETYK PSO-2 PSSD sign domain scores

-5

-4

-3

-2

-1

0

–0.6 –0.7 –0.6 –0.8
–0.5

–3.1*†

–3.6*†
–3.1*†

–3.4*†
–2.8*†

–2.3
–2.7

–2.1

–2.7

–2.1

Burning Itch Pain Skin tightness Stinging

–0.3
–0.5

–0.2
–0.5

–0.1

–2.9*†

–3.6*†

–2.9*†

–3.5*†

–2.7*†

–2.1

–2.7
–2.3

–2.6

–1.8

Burning Itch Pain Skin tightness Stinging

–0.6 –0.6 –0.7 –0.6 –0.6 –0.7

–2.2*†

–3.4*†

–3.9*†
–3.5*†

–3.9*† –4.0*†

–1.6

–2.6
–2.9

–2.6

–3.0 –3.1

Bleeding Cracking Dryness Redness Scaling
Shedding
 or flaking

–0.6
–0.9 –0.8

–0.7 –0.9 –0.8

–2.3*†

–3.5*†
–3.8*†

–3.6*† –3.6*†
–3.8*†

–1.8

–2.6
–2.9

–2.6 –2.7 –2.7

Bleeding Cracking Dryness Redness Scaling
Shedding 
or flaking

*P<0.0001 vs placebo. †P<0.01 vs apremilast. 
Modified baseline observation carried forward was used to impute missing data. 
BID, twice daily; PSSD, Psoriasis Symptoms and Signs Diary; QD, once daily.

• Benefits favoring deucravacitinib increased or were maintained through 
Week 24 and were consistent between PSO-1 and PSO-2 (Figure 3)

Figure 3. Mean change from baseline in PSSD symptom domain 
scores and PSSD sign domain scores at Week 24

-5

-4

-3

-2

-1

0

M
e
an

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h
an

ge
 f

ro
m

 b
as

e
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n
e

POETYK PSO-1 PSSD symptom domain scores POETYK PSO-2 PSSD symptom domain scores

-5

-4

-3

-2

-1

0

M
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h
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ge
 f

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 b
as

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n
e

POETYK PSO-1 PSSD sign domain scores

-5

-4

-3

-2

-1

0

POETYK PSO-2 PSSD sign domain scores

-5

-4

-3

-2

-1

0

Burning Itch Pain Skin tightness Stinging Burning Itch Pain Skin tightness Stinging

Bleeding Cracking Dryness Redness Scaling
Shedding
or flakingBleeding Cracking Dryness Redness Scaling

Shedding
or flaking

–3.4†

–4.0†

–3.3†

–3.9†

–3.1†

–2.3
–2.7

–2.2
–2.6

–2.2

–3.1†

–3.9†

–3.0†

–3.8†

–2.8†
–2.3

–3.0
–2.5 –2.7

–2.1

–2.4†

–3.8†
–4.2†

–3.9†
–4.1† –4.2†

–1.8

–2.7 –2.9
–2.6 –2.7 –2.8

–2.3†

–3.6†

–4.2†
–3.8†

–4.1†
–4.3

–1.8

–2.9
–3.2

–2.9
–3.2 –3.3

Deucravacitinib 6 mg QD Apremilast 30 mg BID

†P<0.01 vs apremilast. 
Modified baseline observation carried forward was used to impute missing data. 
BID, twice daily; PSSD, Psoriasis Symptoms and Signs Diary; QD, once daily.

Conclusions
• In this post hoc analysis, deucravacitinib treatment was significantly 

superior to placebo and apremilast in improving individual patient-
reported psoriasis symptoms and signs at Week 16 in patients with 
moderate to severe plaque psoriasis 

 — Benefits favoring deucravacitinib were maintained at Week 24

• The greatest symptom improvement was consistently observed for the 
itch domain

 — This may prove particularly meaningful to patients given the 
prevalence and burden of itch, a symptom that affects the vast 
majority of patients with psoriasis5

• Improvements in the patient-reported psoriasis symptoms and 
signs burden are consistent with the higher clinical response rates 
previously reported in deucravacitinib-treated patients in PSO-1  
and PSO-22

References
1. Burke JR et al. Sci Transl Med 2019;11:1-16. 2. Armstrong A et al. Presented at the Annual Meeting of the 
American Academy of Dermatology; April 23-25, 2021. 3. Feldman SR et al. J Dermatol Trans Surg 2016;20:19-26.  
4. Mathias SD et al. J Dermatol Treat 2016;27:322-327. 5. Komiya E et al. Int J Mol Sci 2020;21:8406.

Acknowledgments
• We would like to thank the patients and investigators who participated in these clinical trials.

• These clinical trials were sponsored by Bristol Myers Squibb. Professional medical writing from Lisa Feder, PhD, 
and editorial assistance were provided by Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, 
USA, and were funded by Bristol Myers Squibb.

Relationships and Activities
•   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, Pfizer, Regeneron, Sanofi Genzyme, Science 
37, Sun Pharma, and Valeant; Grants: Dermira, Kyowa Hakko Kirin, and UCB, outside the submitted work

•   BS: Honoraria or consultation fees: 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, 
Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, and Ventyxbio; Speaker: AbbVie, Eli Lilly, Janssen, and 
Sanofi Genzyme; Scientific co-director (consulting fee): CorEvitas’ Psoriasis Registry; Investigator: AbbVie, Cara, 
CorEvitas’ Psoriasis Registry, Dermavant, Eli Lilly/Dermira, and Novartis

•   KBG: Grant support and consulting fees: AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, 
Janssen, Novartis, and UCB; Consulting fees: Amgen, Almirall, Dermira, Leo Pharma, Pfizer, and Sun Pharma

•   JZ, BB, RMK, JT, and JK: Employees and shareholders: Bristol Myers Squibb

•   KP: Speakers bureau: AbbVie, Amgen, Astellas, Celgene, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Leo 
Pharma, Merck Sharp & Dohme, Novartis, Pfizer, 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, Pfizer, Regeneron, Roche, Sanofi Genzyme, 
Takeda, UCB, and Valeant; Consultant: AbbVie, Akros, Amgen, Arcutis, Astellas, AstraZeneca, Baxalta, Baxter, 
Boehringer Ingelheim, Bristol Myers Squibb, CanFite, 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, Pfizer, 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 Serono, Merck Sharp & 
Dohme, Novartis, Pfizer, Takeda, UCB, and Valeant; Scientific officer/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, Pfizer, 
Regeneron, Sanofi Genzyme, and Valeant

Presented at the Fall Clinical Dermatology Conference®; October 21—24, 2021; Las Vegas, NV, and Virtual
This is an encore of the 2021 EADV 30th Congress poster

This poster may not be reproduced without written permission from the authors.Email for April W Armstrong, MD, MPH: April.Armstrong@med.usc.edu