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 and the 2021 NPF Research Symposium poster

 This poster may not be reproduced without written permission from the authors.Email for Diamant Thaçi, MD: diamant.thaci@uksh.de 

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Compared With Placebo and Apremilast in Moderate to Severe Psoriasis:  
Integrated Laboratory Parameter Results From the Phase 3 POETYK PSO-1 and POETYK PSO-2 Trials
Diamant Thaçi,1 Kenneth Gordon,2 Melinda Gooderham,3 Bruce Strober,4 Neil J Korman,5 Subhashis Banerjee,6 Elizabeth Colston,6 Jonghyeon Kim,6 John Throup,6 Akimichi Morita7 
1University of Lübeck, Lübeck, Germany; 2Medical College of Wisconsin, Milwaukee, WI, USA; 3Probity Medical Research, Waterloo, ON, Canada; 4Yale University, New Haven, CT, and Central Connecticut Dermatology, Cromwell, CT, USA;  
5Case Western Reserve University and University Hospitals, Cleveland, OH, USA; 6Bristol Myers Squibb, Princeton, NJ, USA; 7Nagoya City University, Graduate School of Medical Sciences, Nagoya, Japan

Introduction
• Tyrosine kinase 2 (TYK2) is an intracellular enzyme that mediates signaling of key cytokines (interleukin [IL]-23, 

IL-12, and Type I interferons) involved in psoriasis pathogenesis1,2

• Deucravacitinib is a novel oral agent that selectively inhibits TYK2 via an allosteric mechanism by uniquely 
binding to the regulatory domain2

• In the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials, deucravacitinib was significantly more efficacious than 
placebo and apremilast and was well tolerated in patients with moderate to severe plaque psoriasis3

Objective
• The present analyses assessed the effects of deucravacitinib on hematologic, lipid, and chemistry parameters 

in blood in the POETYK trials

Methods
Study designs
• POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) were Phase 3, 52-week, double-blind, randomized, 

placebo- and active comparator (apremilast)-controlled trials conducted globally (Figure 1)2 
 — Enrolled patients with moderate to severe plaque psoriasis (BSA, ≥10%; PASI, ≥12; sPGA, ≥3) were 

randomized 1:2:1 to receive oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice 
daily during Weeks 0−16

 — Blinded treatment switches occurred at Week 16 and Week 24

• Patients receiving placebo were switched to deucravacitinib at Week 16
• Patients receiving apremilast who failed to meet trial-specific efficacy thresholds (PASI 50 in PSO-1; 

PASI 75 in PSO-2) were switched to deucravacitinib at Week 24

Figure 1. POETYK PSO-1 and PSO-2 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 BIDPASI 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

PASI 75

Apremilast 30 mg BIDa (n=254)

PASI 751
: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)

Coprimary endpoints: PASI 75, sPGA 0/1 for deucravacitinib vs placebo at Week 16

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 50, ≥50% reduction from baseline in Psoriasis Area and Severity Index; PASI 75, ≥75% reduction from baseline in PASI; QD, once 
daily; sPGA 0/1, static Physician’s Global Assessment score of 0/1.

Laboratory assessments over Weeks 0−16
• Pooled data from POETYK PSO-1 and PSO-2 are presented
• Standard laboratory parameters in blood were evaluated

 — Hematologic parameters: lymphocytes, neutrophils, platelets, and hemoglobin

 — Lipid parameters: total cholesterol and triglycerides

 — Chemistry parameters: creatine phosphokinase (CPK), creatinine, ALT, and AST

• Toxicity Grades 3—4 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0), shifts in toxicity 
grade, and discontinuations due to laboratory abnormalities were also assessed 

Laboratory assessments over Weeks 0−52
• Standard laboratory parameters in blood were evaluated in patients enrolled in PSO-1 who received 

continuous deucravacitinib treatment from baseline to Week 52

Results
Patient population
• 666 and 1020 patients were randomized in PSO-1 and PSO-2, respectively, and were included in this analysis

Laboratory assessments over Weeks 0−16
• Overall, no clinically relevant trends were observed over Weeks 0−16 in the levels of any of the assessed 

laboratory parameters (Figure 2 and Figure 3)
• Laboratory parameters remained within normal ranges for most patients throughout both trials

Figure 2. Hematologic parameters, Weeks 0−16

Placebo Apremilast 30 mg BIDDeucravacitinib 6 mg QD

0

1

2

3

4

5

Lymphocytes

LLN

ULN

M
e
an

 ±
SD

, 
1
0

9 /
L

1 2 4 8 12 160

Weeks
n=    419                        393                         369                          368                          355 

842                        792                         775                          750                          739
421                        398                         379                          368                          365

12

13

14

15

16

Hemoglobin

LLN

ULN

M
e
an

 ±
SD

, 
g/

d
L

1 2 4 8 12 160

Weeks
n=    419                        393                         371                          368                          356 

842                        797                         779                          753                          747
421                        401                         381                          369                          366

0

2

4

6

8

Neutrophils

M
e
an

 ±
SD

, 
1
09

/L

LLN

ULN

1 2 4 8 12 160

Weeks
n=    419                        393                         369                          368                          355 

842                        792                         775                          750                          739
421                        398                         379                          368                          365

100

150

200

250

300

350

400

450

500

Platelets

M
e
an

 ±
SD

, 
1
0

9 /
L

LLN

ULN

1 2 4 8 12 160

Weeks
n=    418                        388                         367                          364                          355 

842                        784                         769                          747                          742
421                        398                         377                          368                          365

POETYK PSO-1 and PSO-2 pooled data; Weeks 0−16. 
BID, twice daily; LLN, lower limit of normal; QD, once daily; ULN, upper limit of normal.

Figure 3. Lipid and chemistry parameters, Weeks 0−16

Creatinine

0.5

0.8

1.0

1.3

1.5 ULN

LLNM
e
an

 ±
 S

D
, 

m
g/

d
L

M
e
an

 ±
 S

D
, 

m
g/

d
L

M
e
an

 ±
 S

D
, 

m
g/

d
L

1 2 4 8 12 160
Weeks

n=    419 394 382 368 358
842 803 793 765 758
422 402 385 377 369

0

200

400

Triglycerides

LLN

ULN

8 160
Weeks

100

150

200

250

300

ULN

Total cholesterol

LLN

8 160
Weeks

n=    419 380 357
842 790 755
422 384 369

n=    419 380 357
842 790 755
422 384 369

0

250

500

750

1000

CPK

LLN

ULN

1 2 4 8 12 160
Weeks

n=    419 393 382 368 357
842 802 793 764 757
422 402 384 377 369

0

20

40

60
AST

ULN

LLN

M
e
an

 ±
 S

D
, 

U
/L

M
e
an

 ±
 S

D
, 

U
/L

M
e
an

 ±
 S

D
, 

U
/L

1 2 4 8 12 160
Weeks

n=    419 392 382 368 357
842 802 793 764 757
422 402 384 377 369

0

20

40

60

ALT

ULN

LLN

1 2 4 8 12 160
Weeks

n=    419  391 382 368 357
842 802 793 764 757
422  402 384 377 369

Placebo Apremilast 30 mg BIDDeucravacitinib 6 mg QD

POETYK PSO-1 and PSO-2 pooled data; Weeks 0−16. 
No Grade 4 CPK elevations were observed during consecutive study visits. 
BID, twice daily; CPK, creatine phosphokinase; LLN, lower limit of normal; QD, once daily; ULN, upper limit of normal.

Laboratory parameter grades and shifts (CTCAE version 5.0)
• Grade ≥3 laboratory abnormalities occurred at low frequencies and were comparable across treatment groups 

(Table 1)
 — Triglyceride and CPK elevations were the most common Grade ≥3 laboratory abnormalities and occurred 

at a similar incidence in each group

• Shifts of ≥2 CTCAE grades (increases) from baseline were balanced overall and infrequent for all treatment 
groups 

 — Triglyceride shifts from Grade ≤2 to Grade ≥3 occurred at a low frequency and were comparable across 
groups: placebo, 1.3%; deucravacitinib, 1.7%; apremilast, 1.7%
• There were patients with Grade 3/4 elevations in triglyceride levels at baseline (placebo, 0.7%; 

deucravacitinib, 0.6%; apremilast, 0.7%), reflecting the comorbidity of metabolic syndrome associated 
with psoriasis

 — CPK shifts from Grade ≤2 to Grade ≥3 occurred at a low frequency and were comparable across groups: 
placebo, 0.7%; deucravacitinib, 1.3%; apremilast, 0.5%
• CPK elevations from baseline to Grade ≥1 postbaseline: placebo, 14.8%; deucravacitinib, 16.6%; 

apremilast, 11.0% 
• All CPK elevations were asymptomatic, nonserious, and resolved without treatment
• Most Grade 3/4 CPK elevations were associated with increased recent physical activity during treatment 

Table 1. Grade ≥3 laboratory abnormalities, Weeks 0−16

Placebo 
(n=419) 

n (%) 

Deucravacitinib 
(n=842) 

n (%)

Apremilast 
(n=422) 

n (%)

Parameter Grade Baseline Week 16 Baseline Week 16 Baseline Week 16

Lymphocyte count decreased
3
4

0
0

1 (0.2)
0

0 
0

1 (0.1)
0

0
0

0
0

Neutrophil count decreased
3
4

0
0

1 (0.2)
0

1 (0.1)
0

1 (0.1)
0

0
0

0
0

Platelet count decreased
3
4

0
0

0
0

0
0

0
0

0
0

0
0

Anemia
3
4

0
N/A

0
N/A

0
N/A

0
N/A

0
N/A

1 (0.2)
N/A

Total cholesterol increased
3
4

0
0

0
0

0
0

0
0

0
0

0
0

Triglycerides increased
3
4

2 (0.5)
1 (0.2)

6 (1.5)
0

4 (0.5)
1 (0.1)

13 (1.6)
2 (0.2)

3 (0.7)
0

8 (2.0)
0

CPK increased
3
4

1 (0.2)
0

3 (0.7)
1 (0.2)

1 (0.1)
0

5 (0.6)
6 (0.7)

1 (0.2)
0

2 (0.5)
1 (0.2)

Creatinine increased
3
4

0
0

0 
0

0
0

0
0

0
0

0
0

ALT increased
3
4

0
0

0
0

0
0

0
0

0
0

0
0

AST increased
3
4

0
0

0
0

0
0

1 (0.1)
0

0
0

1 (0.2)
0

POETYK PSO-1 and PSO-2 pooled data; Weeks 0−16. 
CPK, creatine phosphokinase; N/A, not applicable because there is no hemoglobin value for CTCAE Grade 4 (life-threatening consequences; urgent 
intervention indicated).

Laboratory abnormality adverse events leading to discontinuation, Weeks 0−16
• Discontinuations due to laboratory abnormalities were low and balanced across treatment groups (Table 2)

Table 2. Laboratory abnormality adverse events leading to discontinuation, Weeks 0−16

Adverse event  
(preferred term)

Placebo
(n=419)

n (%) 

Deucravacitinib
(n=842)

n (%)

Apremilast
(n=422)

n (%)

Lymphopenia 0 1 (0.1)a 0

Blood CPK increased 0 1 (0.1)b 1 (0.2)

Hepatic function abnormal 0 1 (0.1)c 0

Liver function test abnormal 1 (0.2) 0 0

AST increased 0 0 1 (0.2)

POETYK PSO-1 and PSO-2 pooled data; Weeks 0−16. 
CPK, creatine phosphokinase. 
aPatient had Grade 1 lymphocyte count decreased at baseline and Grade 3 at Week 4; treatment was discontinued and lymphocyte count returned to 
Grade 2; there were no associated infection adverse events. 
bPatient had elevated CPK at screening (1796 U/L) and baseline (932 U/L). 
cPatient had a medical history of fatty liver disease and recent alcohol use (increased alcohol consumption due to ankle injury [2x usual]).

Laboratory assessments over Weeks 0−52
• No clinically relevant cumulative trends were observed in any assessed laboratory parameters in PSO-1 patients 

who were randomized to deucravacitinib at baseline and who continued to receive treatment until Week 52 
(Figure 4 and Figure 5) 

• Discontinuation rates due to laboratory abnormalities were not increased between Weeks 16−52 vs Weeks 0−16  

Figure 4. Hematologic parameters in patients receiving deucravacitinib (PSO-1), Weeks 0−52

Deucravacitinib 6 mg QD

0

1

2

3

4

5

Weeks
1 2 4 8 12 160 20 24 28 32 36 40 44 48 52

LLN

ULN

Lymphocytes

n= 332 317 312 303 295 298 283 286 280 270 257 259 255 254 n=  332 317 312 303 295 298 283 286 280 270 257 259 255 254

0

2

4

6

8

Weeks
1 2 4 8 12 160 20 24 28 32 36 40 44 48 52

LLN

ULN

Neutrophils

Hemoglobin

12

13

14

15

16

17

Weeks
1 2 4 8 12 160 20 24 28 32 36 40 44 48 52

LLN

ULN

n= 332 318 313 305 297 299 285 291 283 272 260 261 258 257n= 332 314 311 303 295 298 285 287  282 270 260 257 256 254

100

150

200

250

300

350

400

450

500

Weeks
1 2 4 8 12 160 20 24 28 32 36 40 44 48 52

LLN

ULN

Platelets

M
e
an

 ±
 S

D
, 

1
0

9
/L

M
e
an

 ±
 S

D
, 

g/
d
L

M
e
an

 ±
 S

D
, 

1
0

9
/L

M
e
an

 ±
 S

D
, 

1
0

9
/L

Graphs display as observed data for patients randomized to deucravacitinib at baseline in PSO-1 who continued treatment until Week 52. 
LLN, lower limit of normal; QD, once daily; ULN, upper limit of normal. 

Figure 5. Lipid and chemistry parameters in patients receiving deucravacitinib (PSO-1),  
Weeks 0−52

Deucravacitinib 6 mg QD

0.5

1

1.5

Weeks
1 2 4 8 12 160 20 24 28 32 36 40 44 48 52

LLN

ULN

Creatinine

n= 332 322 319 308 303 304 295 293 288 278 268 265 266 266

0

250

500

750

1000

1250

1500

Weeks
1 2 4 8 12 160 20 24 28 32 36 40 44 48 52

LLN

ULN

CPK

n= 332 322 319 308 302 304 293 292 288 278 267 266 266 263

0

20

40

60

Weeks
1 2 4 8 12 160 20 24 28 32 36 40 44 48 52

LLN

ULN

ALT

n= 332 322 319 308 302 304 292 292 287 277 267 265 266 263

100

150

200

250

Weeks
8 160 24 52

Total cholesterol
ULN

LLN

n=  332 317 301 294 262

M
e
an

 ±
 S

D
, 

m
g/

d
L

M
e
an

 ±
 S

D
, 

m
g/

d
L

M
e
an

 ±
 S

D
, 

U
/L

M
e
an

 ±
 S

D
, 

U
/L

Graphs display as observed data for patients randomized to deucravacitinib at baseline in PSO-1 who continued treatment until Week 52. 
CPK, creatine phosphokinase; LLN, lower limit of normal; QD, once daily; ULN, upper limit of normal. 

Conclusions
• Patients receiving deucravacitinib treatment showed no meaningful changes in multiple hematologic, 

chemistry, and lipid parameters in the blood over Weeks 0−16 in 2 large Phase 3 trials in psoriasis 
(POETYK PSO-1 and PSO-2)

 — Discontinuations due to laboratory abnormalities were rare and balanced across treatment 
groups

• No trends were evident for any laboratory parameter with continued deucravacitinib treatment over 
52 weeks

• These results suggest that routine laboratory monitoring is not warranted during deucravacitinib 
treatment 

References
1. Nogueira M et al. Drugs 2020;80:341-351. 

2. Burke JR et al. Sci Transl Med 2019;11:1-16. 

3. Armstrong A et al. Presented at the Annual Meeting of the American Academy of Dermatology; 2021. 

Acknowledgments
• We would like to thank the patients and investigators who participated in these 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
• DT: Advisory board, principal investigator, and lecture fees: AbbVie, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, Bristol Myers 

Squibb, Celgene, DS Pharma, Eli Lilly, Galapagos, Galderma, Janssen-Cilag, Leo Pharma, Novartis, Pfizer, Regeneron, Roche-Posay, 
Samsung, Sandoz-Hexal, Sanofi, and UCB

• KG: 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

• MG: Advisory board, principal investigator, and lecture fees: AbbVie, Galderma, Leo Pharma, Pfizer, and Regeneron; Advisory board and 
lecture fees: Actelion Pharmaceuticals; Principal investigator and consulting fees: Akros Pharma; Advisory board, principal investigator, 
lecture fees, and consulting fees: Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Sanofi Genzyme, and Valeant; 
Principal investigator: Arcutis, Bristol Myers Squibb, Dermira, GlaxoSmithKline, MedImmune, Merck, Roche Laboratories, and UCB; Principal 
investigator and lecture fees: Glenmark

• 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, 
Janssen, Lilly, Sanofi Genzyme; Scientific co-director (consulting fee): CorEvitas’ Psoriasis Registry; Investigator: AbbVie, Cara, CorEvitas’ 
Psoriasis Registry, Dermavant, Eli Lilly/Dermira, and Novartis

• NJK: Advisory board, consulting fees: AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, 
Principia, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB; Grant support/Principal investigator: AbbVie, Amgen, Argenx, Bristol Myers 
Squibb, Celgene, Chemocentryx, Eli Lilly, Galderma, Kyowa Hakko Kirin, Leo Pharma, Menlo, Principia, Prothena, Rhizen, Syntimmune, 
Trevi, and Xbiotech; Speaker: AbbVie, Eli Lilly, Janssen, Novartis, Regeneron, and Sanofi Genzyme

• SB, EC, JK, and JT: Employees and shareholders: Bristol Myers Squibb

• AM: Grant/research support, consultant, speakers bureau: AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eisai, Eli Lilly, 
Janssen, Kyowa Hakko Kirin, Leo Pharma, Maruho, Mitsubishi Tanabe, Nichi-Iko, Nippon Kayaku, Novartis, Pfizer, Sun Pharma, Taiho 
Pharmaceutical, Torii Pharmaceutical, UCB, and Ushio