Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in scalp, nail, and palmoplantar psoriasis: subgroup analyses 
of the phase 3 POETYK PSO-1 and PSO-2 trials
Andrew Blauvelt,1 Phoebe Rich,2 Howard Sofen,3 Jo Lambert,4 Joseph F Merola,5 Mark Lebwohl,6 Thomas Scharnitz,7 Kim Hoyt,7 Renata M Kisa,7 Subhashis Banerjee7
1Oregon Medical Research Center, Portland, OR, USA; 2Oregon Dermatology and Research Center, Portland, OR, USA; 3UCLA School of Medicine, Los Angeles, CA, USA; 4Ghent University, Ghent, Belgium; 5Brigham and Women’s Hospital, Brigham Dermatology Associates, and Harvard Medical School, Boston, MA, USA; 6Icahn School of Medicine at Mount Sinai, New York, NY, USA; 7Bristol Myers Squibb, Princeton, NJ, USA

Presented at the 2022 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 Andrew Blauvelt, MD, MBA: ABlauvelt@oregonmedicalresearch.com 

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Introduction
• Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is 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 phototherapy1

 — Uniquely binds to the regulatory domain instead of the catalytic domain of TYK22

 x ≥100-fold greater selectivity for TYK2 vs Janus kinase (JAK) 1/3 and ≥2000-fold greater selectivity for 
TYK2 vs JAK 2 in cells2,3

 — Inhibits TYK2-mediated cytokine signaling involved in psoriasis pathogenesis (eg, interleukin-23, Type I 
interferons)2

• Two 52-week, phase 3 psoriasis trials (POETYK PSO-1 and POETYK PSO-2) previously demonstrated that 
deucravacitinib was superior to placebo and apremilast at Week 16 based on the coprimary endpoints4,5:

 — ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75)
 — Static Physician’s Global Assessment score of 0 (clear) or 1 (almost clear) with a ≥2-point improvement from 

baseline (sPGA 0/1)

• Clinical efficacy and overall safety and tolerability were maintained for up to 2 years6

Objective
• Evaluate the efficacy of deucravacitinib treatment in patients with moderate to severe scalp, fingernail, and 

palmoplantar psoriasis 

Methods
Study designs
• POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) enrolled adults with moderate to severe plaque 

psoriasis (PASI ≥12, sPGA ≥3, body surface area involvement ≥10%) (Figure 1)

Figure 1. Study designs

POETYK PSO-1
(N = 666)

POETYK PSO-2
(N = 1020)

Deucravacitinib 6 mg QDPlacebo (n = 166)

Deucravacitinib 6 mg QD<PASI 50

Apremilast 30 mg BID≥PASI 50

Titrate*

1
:2

:1
 R

an
d
om

iz
at

io
n

Weeks 16 24 520

Deucravacitinib 6 mg QDPlacebo (n = 255)

Deucravacitinib 6 mg QD (n = 511)

Deucravacitinib 6 mg QD<PASI 75

Deucravacitinib 6 mg QD<PASI 75

Deucravacitinib 6 mg QD

Deucravacitinib 6 mg QD

Placebob

Apremilast 30 mg BIDa (n = 254)

≥PASI 75

1
:2

:1
 R

an
d
om

iz
at

io
n

Weeks 16 24 520

1:1

Deucravacitinib 6 mg QDPlacebob

Deucravacitinib 6 mg QD (n = 332)

Primary
endpoint

Primary
endpoint

Apremilast 30 mg BIDa (n = 168)

≥PASI 75

aApremilast was titrated from 10 mg QD to 30 mg BID over the first 5 days of dosing. 
bUpon relapse (≥50% loss of Week 24 PASI percentage improvement from baseline), patients were to be switched to deucravacitinib 6 mg QD. 
BID, twice daily; PASI, Psoriasis Area and Severity Index; PASI 50, ≥50% reduction from baseline in PASI; PASI 75, ≥75% reduction from baseline in PASI; QD, once daily.

Outcomes
• This analysis looked at scalp-, fingernail-, and palmoplantar-specific outcomes in pooled patients from POETYK 

PSO-1 and PSO-2, including:
 — Scalp-specific PGA score of 0 or 1 (ss-PGA 0/1) and ≥90% reduction from baseline in Psoriasis Scalp Severity 

Index (PSSI 90) in patients with moderate to severe scalp psoriasis (ss-PGA ≥3) at baseline
 — PGA-Fingernails score of 0 or 1 (PGA-F 0/1) in patients with moderate to severe fingernail psoriasis  

(PGA-F ≥3) at baseline
 — Palmoplantar PGA score of 0 or 1 (pp-PGA 0/1) and palmoplantar PASI (pp-PASI) response in patients with 

moderate to severe palmoplantar psoriasis (pp-PGA ≥3) at baseline
• Outcomes in patients randomized to deucravacitinib vs placebo are reported through Week 16, and efficacy in 

deucravacitinib-treated patients is reported through Week 24

• Outcomes in patients who crossed over from placebo to deucravacitinib at Week 16 are reported from  
Weeks 16 —52

Statistical analysis
• None of the statistical comparisons of deucravacitinib vs placebo were multiplicity controlled

Results
Baseline patient demographics and disease characteristics
• In the pooled POETYK PSO-1 and PSO-2 population (N = 1264; Table 1):

 — 63.9% (n = 808) had moderate to severe scalp psoriasis
 — 14.6% (n = 184) had moderate to severe fingernail psoriasis
 — 6.5% (n = 82) had moderate to severe palmoplantar psoriasis

• Presence of moderate to severe disease in these special areas was balanced overall in the deucravacitinib 
group vs the placebo group 

Table 1. Baseline patient demographics and disease characteristics
POETYK PSO-1 and PSO-2

Placebo Deucravacitinib 
Parameter (n = 421) (n = 843)
Age, mean (SD), y 47.5 (13.7) 46.5 (13.5)
Weight, mean (SD), kg 90.6 (21.1) 90.6 (21.9)
Female, n (%) 127 (30.2) 277 (32.9)
Race, n (%)

White 360 (85.5) 741 (87.9)
Asian 42 (10.0) 83 (9.8)
Other 19 (4.5) 19 (2.3)

Disease duration, mean (SD), y 18.9 (12.9) 18.6 (12.7)
Prior systemic treatment use, n (%)

Yes 248 (58.9) 474 (56.2)
Nonbiologic (± biologic) 183 (43.5) 326 (38.7)
Biologic 146 (34.7) 295 (35.0)

No 173 (41.1) 369 (43.8)
sPGA, n (%)

3 = moderate 345 (81.9) 665 (78.9)
4 = severe 75 (17.8) 178 (21.1)

PASI, mean (SD) 20.9 (8.6) 21.1 (8.0)
BSA, mean (SD), % 25.3 (16.1) 26.4 (15.8)
ss-PGA ≥3, n (%) 294 (69.8) 514 (61.0)
PGA-F ≥3, n (%) 72 (17.1) 112 (13.3)
pp-PGA ≥3, n (%) 25 (5.9) 57 (6.8)
PSSD symptom score, mean (SD) 50.6 (25.6) 52.1 (25.9)
DLQI, mean (SD) 11.6 (6.7) 11.9 (6.6)

BSA, body surface area; DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PGA-F, Physician’s Global Assessment-Fingernails; pp-PGA, palmoplantar Physician’s Global 
Assessment; PSSD, Psoriasis Symptoms and Signs Diary; sPGA, static Physician’s Global Assessment; ss-PGA, scalp-specific Physician’s Global Assessment.

Scalp psoriasis
• Significantly more patients receiving deucravacitinib vs placebo achieved ss-PGA 0/1 at Week 16 (Figure 2)

 — Efficacy was significantly greater with deucravacitinib vs placebo by Week 1 
 — ss-PGA 0/1 responses at Week 16 were maintained through Week 24 in deucravacitinib-treated patients

Figure 2. ss-PGA 0/1a responses through Week 24 (pooled POETYK PSO-1 and PSO-2; NRI)

0

10

20

30

40

50

ss
-P

G
A

 0
/1

 r
es

po
n
se

 r
at

e,
%

 o
f 

pa
ti

en
ts

60

70

80

90

100

0 4 8 12

Weeks
16 20 24

64.0%† 64.4%

1 2

17.3%

*

†

†

†

†

Primary endpoint

Placebo (n = 294) Deucravacitinib 6 mg QD (n = 514)

aIncluded patients with a baseline ss-PGA score ≥3. 
*P < 0.05 vs placebo. †P < 0.0001 vs placebo. Missing data were imputed with NRI.
NRI, nonresponder imputation; QD, once daily; ss-PGA 0/1, scalp-specific Physician’s Global Assessment score of 0 or 1.

• Significantly more patients receiving deucravacitinib vs placebo achieved PSSI 90 at Week 16 (Figure 3)
 — Efficacy was significantly greater with deucravacitinib vs placebo by Week 1
 — PSSI 90 responses at Week 16 were maintained through Week 24 in deucravacitinib-treated patients

Figure 3. PSSI 90a responses through Week 24 (pooled POETYK PSO-1 and PSO-2; NRI)

0

10

20

30

40

50

P
SS

I 9
0 

re
sp

on
se

 r
at

e,
%

 o
f 

pa
ti

en
ts

60

70

80

90

100

0 4 8 12

Weeks
16 20 241 2

Primary endpoint

Placebo (n = 294) Deucravacitinib 6 mg QD (n = 514)

†

†

†

*

50.6%†

10.5%

53.5%

*

aIncluded patients with a baseline ss-PGA score ≥3. 
*P < 0.05 vs placebo. †P < 0.0001 vs placebo. Missing data were imputed with NRI.
NRI, nonresponder imputation; PSSI 90, ≥90% reduction from baseline in Psoriasis Scalp Severity Index; QD, once daily; ss-PGA, scalp-specific Physician’s Global Assessment.

• In patients who crossed over from placebo to deucravacitinib at Week 16, 67.5% achieved ss-PGA 0/1 at  
Week 52 (Figure 4) and 62.3% achieved PSSI 90 at Week 52

 — These rates were comparable to Week 24 findings in patients who received continuous deucravacitinib  
from Day 1

Figure 4. ss-PGA 0/1a responses through Week 52 in placebo crossovers (pooled POETYK PSO-1 and 
PSO-2; NRI) 

1 2

67.5%

0

10

20

30

40

50

ss
-P

G
A

 0
/1

 r
es

po
n
se

 r
at

e,
%

 o
f 

pa
ti

en
ts

60

70

80

90

100

0 4 8 12 16 20 24 28 32 36 40 44 48 52

Weeks

Primary endpoint

Placebo (n = 294) Placebo–deucravacitinib (n = 252)
aIncluded patients with a baseline ss-PGA score ≥3. 
Missing data were imputed with NRI.
NRI, nonresponder imputation; ss-PGA 0/1, scalp-specific Physician’s Global Assessment score of 0 or 1.

Fingernail psoriasis
• Significantly more patients receiving deucravacitinib vs placebo achieved PGA-F 0/1 at Week 16 (Figure 5) 

 — PGA-F 0/1 responses at Week 16 increased through Week 24 in deucravacitinib-treated patients
• In patients who crossed over from placebo to deucravacitinib at Week 16, 51.6% achieved PGA-F 0/1 at  

Week 52 (Figure 6)

Figure 5. PGA-F 0/1a responses through Week 24 (pooled POETYK PSO-1 and PSO-2; NRI)

32.1%

8.3%

20.5%*

0

10

20

30

40

50

P
G

A
-F

 0
/1

 r
es

po
n
se

 r
at

e,
%

 o
f 

pa
ti

en
ts

60

70

80

90

100

0 4 8 12 16 20 24

Weeks

Primary endpoint

Placebo (n = 112) Deucravacitinib 6 mg QD (n = 72)

aIncluded patients with a baseline PGA-F score ≥3.
*P = 0.0272 vs placebo. Missing data were imputed with NRI.
NRI, nonresponder imputation; PGA-F 0/1, Physician’s Global Assessment-Fingernails score of 0 or 1; QD, once daily.

Figure 6. PGA-F 0/1a responses through Week 52 in placebo crossovers (pooled POETYK PSO-1 and 
PSO-2; NRI)

51.6%

0

10

20

30

40

50

P
G

A
-F

 0
/1

 r
es

po
n
se

 r
at

e,
%

 o
f 

pa
ti

en
ts

60

70

80

90

100

0 4 8 12 16 20 24 28 32 36 40 44 48 52

Weeks

Primary endpoint

Placebo (n = 72) Placebo–deucravacitinib (n = 62)
aIncluded patients with a baseline PGA-F score ≥3.
Missing data were imputed with NRI.
NRI, nonresponder imputation; PGA-F 0/1, Physician’s Global Assessment-Fingernails score of 0 or 1.

Palmoplantar psoriasis
• Significantly more patients receiving deucravacitinib vs placebo achieved pp-PGA 0/1 at Week 16 (Figure 7)

 — pp-PGA 0/1 responses at Week 16 were increased at Week 24 in deucravacitinib-treated patients
• In patients who crossed over from placebo to deucravacitinib at Week 16, 41.2% achieved pp-PGA 0/1 at Week 52

Figure 7. pp-PGA 0/1a responses through Week 24 (pooled POETYK PSO-1 and PSO-2; NRI)

56.1%

16.0%

49.1%*

0

10

20

30

40

50

pp
-P

G
A

 0
/1

 r
es

po
n
se

 r
at

e,
%

 o
f 

pa
ti

en
ts

60

70

80

90

100

0 4 8 12

Weeks
16 20 241 2

Primary endpoint

Placebo (n = 25) Deucravacitinib 6 mg QD (n = 57)

aIncluded patients with a baseline pp-PGA score ≥3. 
*P = 0.0052 vs placebo. Missing data were imputed with NRI.
NRI, nonresponder imputation; QD, once daily; pp-PGA 0/1, palmoplantar Physician’s Global Assessment score of 0 or 1.

• Mean change from baseline in pp-PASI, adjusted for baseline covariates, was significantly greater with 
deucravacitinib vs placebo at Week 16 (Figure 8)

 — Greater efficacy with deucravacitinib vs placebo was observed as early as Week 4
 — pp-PASI responses at Week 16 were maintained through Week 24 in deucravacitinib-treated patients

Figure 8. Change from baseline in pp-PASIa through Week 24 (pooled POETYK PSO-1 and PSO-2; mBOCF)

-4.2b

-10.7

-13.3*

-20

-10

M
ea

n
 C

FB
 in

 p
p-

P
A

SI

Baseline pp-PASI, mean (SD)

Placebo
(n = 25)

Deucravacitinib
(n = 57)

17.5 (12.5) 15.9 (10.9)

0

0 4 8 12

Weeks

16 20 241 2

Placebo (n = 25) Deucravacitinib 6 mg QD (n = 57)

*

*
*

aIncluded patients with a baseline pp-PGA score ≥3.
bData in placebo crossover patients through Week 52 are currently unavailable.
*P ≤ 0.0097 vs placebo. Missing data were imputed with the mBOCF method.
CFB, change from baseline; mBOCF, modified baseline observation carried forward; pp-PASI, palmoplantar Psoriasis Area and Severity Index; pp-PGA, palmoplantar Physician’s Global Assessment; QD, once daily.

Conclusions
• In POETYK PSO-1 and PSO-2 patients with moderate to severe scalp, fingernail, or palmoplantar psoriasis at 

baseline, deucravacitinib was significantly more efficacious than placebo in improving disease burden in these 
special high impact areas through Week 16, with additional improvements observed in deucravacitinib-treated 
patients through Week 24

• Patients who crossed over from placebo to deucravacitinib at Week 16 achieved comparable responses at 
Week 52 to those observed at Week 24 in patients who had received continuous deucravacitinib treatment 
from baseline

• These findings support the use of deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, in patients with 
moderate to severe scalp, fingernail, or palmoplantar psoriasis

References
1. SOTYKTU™ (deucravacitinib) [package insert]. Princeton, NJ, USA: Bristol-Myers Squibb Company; September 2022.
2. Burke JR, et al. Sci Transl Med. 2019;11:eaaw1736.
3. Wrobleski ST, et al. J Med Chem. 2019;62:8973-8995. 
4. Armstrong AW, et al. J Am Acad Dermatol. 2022;S0190-9622(22)02256-3. doi: 10.1016/j.jaad.2022.07.002. Online ahead of print.
5. Strober B, et al. J Am Acad Dermatol. 2022;S0190-9622(22)02643-3. doi: 10.1016/j.jaad.2022.08.061. Online ahead of print.
6. Warren RB, et al. Presented at the European Academy of Dermatology and Venereology (EADV) Spring Symposium; 12—14 May 2022; 

Ljubljana, Slovenia.

Acknowledgments
• These clinical trials were sponsored by Bristol Myers Squibb

• Writing and editorial assistance was provided by Liz Rockstein, PhD, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, 
USA, funded by Bristol Myers Squibb

Disclosures
• AB: Speaker (received honoraria): AbbVie, Arcutis, Bristol Myers Squibb, Eli Lilly, Pfizer, Regeneron, Sanofi, and UCB; Scientific adviser 

(received honoraria): AbbVie, Abcentra, Affibody, Aligos, Almirall, Alumis, Amgen, AnaptysBio, Arcutis, Arena, Aslan, Athenex, Bluefin 
Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, EcoR1, Eli Lilly, Escient, Evelo, Evommune, Forte 
Bioscience, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo Pharma, Merck, Novartis, Pfizer, Rapt, Regeneron, 
Sanofi Genzyme, Spherix Global Insights, Sun Pharma, TLL Pharmaceutical, TrialSpark, UCB, Vibliome, and Xencor; Clinical study 
investigator (institution has received clinical study funds): AbbVie, Acelyrin, Almirall, Amgen, Arcutis, Athenex, Boehringer Ingelheim, 
Bristol Myers Squibb, Concert, Dermavant, Eli Lilly, Evelo, Evommune, Galderma, Incyte, Janssen, Leo Pharma, Merck, Novartis, Pfizer, 
Regeneron, Sun Pharma, and UCB

• PR: Research (principal investigator on pharmaceutical trials): AbbVie, Arcutis, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, 
Novartis, Sun Pharma, and UCB

• HS: Clinical investigator: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen, Leo Pharma, Novartis, and  
Sun Pharma

• JL: Unrestricted grants: AbbVie, Almirall, Celgene, Eli Lilly, Janssen-Cilag, Leo Pharma, Novartis, and UCB; Speaker: AbbVie, Almirall, 
Bristol Myers Squibb, Janssen-Cilag, Pfizer, and UCB; Consultant: AbbVie, BMS, Celgene, Eli Lilly, Janssen-Cilag, Leo Pharma, Novartis,  
and UCB

• JFM: Consultant and/or investigator: Amgen, AbbVie, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Leo Pharma, Novartis, 
Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB

• ML: Research funds on behalf of Mount Sinai: AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Dermavant, Eli Lilly, Incyte, 
Janssen, Ortho Dermatologics, Regeneron, and UCB; Consultant: Aditum Bio, Almirall, AltruBio AnaptysBio, Arcutis, Arena, Aristea, Arrive 
Technologies, Avotres, BiomX, Boehringer Ingelheim, Brickell Biotech, Bristol Myers Squibb, Cara, Castle Biosciences, CorEvitas’ (Corrona) 
Psoriasis Registry, Dermavant, Dr Reddy’s Laboratories, Evelo Biosciences, Evommune, Forte Biosciences, Helsinn Therapeutics, Hexima, 
Leo Pharma, Meiji Seika Pharma, Mindera, Pfizer, Seanergy, and Verrica

• TS, RMK, and SB: Employees and shareholders: Bristol Myers Squibb
• KH: Contractor: Bristol Myers Squibb via Syneos Health