Deucravacitinib long-term efficacy and safety in plaque psoriasis: 2-year results from the phase 3 POETYK PSO program
Richard B Warren,1 Howard Sofen,2 Shinichi Imafuku,3 Jacek C Szepietowski,4 Andrew Blauvelt,5 Lynda Spelman,6 Jessica Toms,7 Alex Buck,7,8 Subhashis Banerjee,7 Alan Menter9
1Dermatology Centre, Salford Royal NHS Foundation Trust, NIHR Manchester Biomedical Research Centre, The University of Manchester, Manchester, UK; 2UCLA School of Medicine and Dermatology Research Associates, Los Angeles, CA, USA; 3Fukuoka University Hospital, Fukuoka, Japan; 4Wroclaw Medical University, Wroclaw, Poland; 5Oregon Medical Research Center, Portland, OR, USA;  
6Veracity Clinical Research, Brisbane, QLD, Australia; 7Bristol Myers Squibb, Princeton, NJ, USA; 8Cytel Inc, Cambridge, MA, USA; 9Baylor University Medical Center, Dallas, TX, USA

Presented at the 2022 Fall Clinical Dermatology Conference; October 20—23, 2022; Las Vegas, NV
This is an encore of the 2022 EADV Spring Symposium poster

This poster may not be reproduced without written permission from the authors.Email for Richard B Warren, BSc, MBChB, MRCP, PhD: richard.warren@manchester.ac.uk

Synopsis
• Tyrosine kinase 2 (TYK2) is an intracellular enzyme that mediates signaling of cytokines 

(interleukin [IL]-23 and Type I interferons) involved in psoriasis pathogenesis1

• Deucravacitinib, an oral, selective, allosteric 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 phototherapy2

 — Uniquely binds to the regulatory domain rather than to the more conserved catalytic domain 
where Janus kinase (JAK) 1/2/3 inhibitors bind (Supplemental Material)1

• Findings from the phase 3 POETYK PSO-1 and PSO-2 trials in patients with moderate to severe 
plaque psoriasis showed that deucravacitinib was significantly more efficacious than placebo and 
apremilast based on the coprimary endpoints of ≥75% reduction from baseline in Psoriasis Area 
and Severity Index (PASI 75) and achievement of a static Physician’s Global Assessment score of  
0 (clear) or 1 (almost clear) with a ≥2-point improvement from baseline (sPGA 0/1) at Week 16 
and was well tolerated3,4

• Clinical responses were maintained through 52 weeks in patients who received continuous 
deucravacitinib treatment and were improved in patients who switched from placebo to 
deucravacitinib at Week 165

• Patients completing the POETYK PSO-1 and PSO-2 trials could enroll in the POETYK long-term 
extension (LTE) trial and receive open-label deucravacitinib 6 mg once daily

Objectives
• The primary objective of this analysis was to characterize the safety and tolerability of long-term 

deucravacitinib use in patients with moderate to severe plaque psoriasis

• The secondary objective was to characterize the maintenance of efficacy responses 

Methods
Study designs
• The study designs for POETYK PSO-1, PSO-2, and the LTE are summarized in Figure 1

• Patients meeting the following key criteria were eligible to enroll in one of the parent studies:
 — Age ≥18 years
 — Diagnosis of moderate to severe plaque psoriasis

 x  Baseline PASI ≥12, sPGA ≥3, and body surface area (BSA) involvement ≥10%
• Patient randomization in POETYK PSO-1 and PSO-2 was stratified by geographic region, body 

weight, and prior biologic use

• All patients were eligible to enter the POETYK LTE after 52 weeks

Figure 1. POETYK PSO-1, PSO-2, and LTE study designs

100

POETYK PSO-1 and PSO-2

Deucravacitinib 6 mg QDPlacebo (n = 166)

Deucravacitinib 6 mg QD<PASI 50

Apremilast 30 mg BID≥PASI 50

Titrate*

P
O

E
T

Y
K

 P
SO

-1
1
:2

:1
 r

an
d
o
m

iz
at

io
n

Deucravacitinib 6 mg QD (n = 332)

Apremilast 30 mg BIDa (n = 168)

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 

≥PASI 75

Apremilast 30 mg BIDa (n = 254)

≥PASI 75

P
O

E
T

Y
K

 P
SO

-2
1
:2

:1
 r

an
d
o
m

iz
at

io
n

Cumulative
exposure
(weeks)

16 24 520

1
:1

Deucravacitinib 6 mg QDPlacebob

Deucravacitinib 6 mg QDPlacebob

Primary
endpoint

B
LI

N
D

E
D

 S
W

IT
C

H
 T

O
 O

P
E
N

-L
A

B
E
L 

D
E
U

C
R

A
V

A
C

IT
IN

IB

Open-label deucravacitinib 6 mg QD 
(N = 1221)

POETYK LTE

14856 60 68 76 88 112 124 1364 8 12 20 28 32 36 40 44 48

480 964 8 16 24 36 60 72 84Exposure 
relative to 

LTE (weeks)

1 year

2 yearsc

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; due to a programming error, however, these patients continued on placebo until Week 52. 
cData were reported through the cutoff date of October 1, 2021.  
BID, twice daily; LTE, long-term extension; 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.

Outcome measures
• Safety outcomes included total adverse events (AEs) and select AEs of interest, including infections, 

herpes zoster, major adverse cardiovascular events (MACE), venous thromboembolism (VTE) events, 
and malignancies through the cutoff date of October 1, 2021

 —  To account for variable periods of treatment exposure, safety events are reported both as 
frequencies and as exposure-adjusted incidence rates (EAIRs) per 100 person-years (PY)

• Efficacy endpoints included PASI 75, ≥90% reduction from baseline in PASI (PASI 90), and sPGA 0/1 
responses through the cutoff date of October 1, 2021

• Consistent with methodologies for assessing long-term outcomes in clinical trials of psoriasis 
therapies, 2 methods of imputation were used for sensitivity analyses6

 —  Treatment failure rule (TFR): Patients who discontinued treatment or the study due to worsening of 
psoriasis or lack of efficacy were imputed as nonresponders

 —  Modified nonresponder imputation (mNRI): Multiple imputation was used for patients with 
missing data, and patients who discontinued due to worsening of psoriasis were imputed as 
nonresponders; only patients who discontinued or reached Week 60 by October 1, 2021,  
were included  

Results
Patients 
• A total of 1519 patients received ≥1 dose of deucravacitinib across the parent trials and the POETYK LTE, 

including 1364 patients in POETYK PSO-1/PSO-2 and 1221 patients in the POETYK LTE 

• Enrollment in the POETYK LTE coincided with the peak of the COVID-19 pandemic 

• Baseline patient demographics and disease characteristics for the overall population are 
presented in Table 1 

Exposure 
• The median exposure to deucravacitinib was 682 days 

• Exposure data at 1 year and 2 years are presented in Table 2 
 —  Exposure during Weeks 0―52 of POETYK PSO-1/PSO-2 was 969.0 PY, with an additional  

1513.0 PY of exposure during the POETYK LTE 
 —  1179 patients had ≥1 year (52 weeks) of continuous exposure and 584 had ≥2 years (104 weeks) 

of continuous exposure 

Table 1. Baseline patient demographics and disease characteristics in the parent trials

Parameter
Total 

(N = 1519)

Age, mean (SD), y 46.6 (13.4)

Weight, mean (SD), kg 90.6 (21.6)

Female, n (%) 493 (32.5)

Race, n (%)

White 1325 (87.2)

Asian 153 (10.1)

Black or African American 23 (1.5)

Other 18 (1.2)

Age at disease onset, mean (SD), y 28.8 (14.9)

Disease duration, mean (SD), y 18.7 (12.7)

PASI, mean (SD) 21.1 (8.1)

sPGA, n (%)

3 (moderate) 1211 (79.7)

4 (severe) 308 (20.3)

BSA involvement, mean (SD), % 26.2 (15.8)
BSA, body surface area; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment.

Table 2. Extent of exposure to deucravacitinib

Continuous exposure, n (%)

At 1 yeara At 2 yearsb

Deucravacitinib 6 mg QD 
(N = 1364) 

Total PY = 969.0

Deucravacitinib 6 mg QD 
(N = 1519) 

Total PY = 2482.0

≥52 weeks 503 (36.9) 1179 (77.6)

≥104 weeks — 584 (38.4)

Total exposure, n (%)

≥52 weeks — 1200 (79.0)

≥104 weeks — 606 (39.9)
aThis represents the pooled patient population of POETYK PSO-1 and PSO-2 (Weeks 0―52). Not all patients were receiving deucravacitinib 6 mg QD continuously 
throughout this period. bThis represents the pooled POETYK PSO-1 and PSO-2 population enrolled in the POETYK LTE through the 120-day cutoff date of October 1, 2021. 
LTE, long-term extension; PY, person-years; QD, once daily.

Overall safety
• A summary of overall safety with deucravacitinib, including the most common AEs at 1 year and  

2 years, is presented in Table 3
 —  2-year safety outcomes should be considered in the context of COVID-19, as the timing of the 

POETYK LTE coincided with the peak of the pandemic

• A consistent AE profile was observed across POETYK PSO-1, PSO-2, and the LTE, aside from 
COVID-19 (Table 3)

• AEs were predominantly mild or moderate in severity

• An additional 8 deaths were reported in the POETYK LTE up to the cutoff date
 —  6 of these deaths were due to COVID-19, 1 was attributed to a ruptured thoracic aortic 

aneurysm (not drug related), and 1 was due to an unknown cause
 —  Mortality due to COVID-19 was not higher than expected since the mortality rate was 

comparable to rates in the general population and a reference population (placebo arm of the 
Johnson & Johnson/Janssen COVID-19 vaccine trial) during the pandemic7

Table 3. Overall safety summary at 1 year vs at 2 years (as-treated population)

 

At 1 yeara 
(POETYK PSO-1 + PSO-2)

At 2 yearsb  
(POETYK PSO-1 + PSO-2 + LTE)

Deucravacitinib 6 mg QD 
(N = 1364) 

Total PY = 969.0

Deucravacitinib 6 mg QD 
(N = 1519) 

Total PY = 2482.0

AE category n (%) EAIR/100 PY n (%) EAIR/100 PY

AEs 995 (72.9) 229.2 1214 (79.9) 154.4

SAEs 55 (4.0) 5.7 145 (9.5) 6.1

Discontinued treatment due to AEs 43 (3.2) 4.4 69 (4.5) 2.8

Deaths 2 (0.1) 0.2 10 (0.7) 0.4

Most common AEs (≥5% of patients) n (%) EAIR/100 PY n (%) EAIR/100 PY

Nasopharyngitis 229 (16.8) 26.1 271 (17.8) 12.9

Upper respiratory tract infection 124 (9.1) 13.4 150 (9.9) 6.5

COVID-19 5 (0.4) 0.5 124 (8.2) 5.1

Headache 80 (5.9) 8.5 99 (6.5) 4.2

Arthralgia 55 (4.0) 5.7 85 (5.6) 3.5

Diarrhea 69 (5.1) 7.3 84 (5.5) 3.5
aThis represents the pooled patient population of POETYK PSO-1 and PSO-2 (Weeks 0―52). Not all patients were receiving deucravacitinib 6 mg QD continuously 
throughout this period. bThis represents the pooled POETYK PSO-1 and PSO-2 population enrolled in the POETYK LTE through the 120-day cutoff date of  
October 1, 2021. 
AE, adverse event; EAIR, exposure-adjusted incidence rate; LTE, long-term extension; PY, person-years; QD, once daily; SAEs, serious adverse events.

AEs of interest 
• The incidence rates for AEs of interest were generally consistent with findings from clinical trials 

of other agents targeting similar pathways in patients with moderate to severe plaque psoriasis, 
after accounting for the different methodologies and time frames of those studies; rates were 
also comparable to real-world registry data (Figure 2)8-23

• The incidence rates were similar at 1 year and 2 years, except for events related to COVID-19 
infection (Table 4) 

• Most COVID-19 cases were not severe or serious and did not lead to treatment discontinuation 
 —  A total of 6 COVID-19―related deaths were reported at 2 years, corresponding to an EAIR of 

0.2/100 PY (Table 4) 
 x  This is comparable to the incidence of deaths in the placebo group (N = 19,544) of the 

Johnson & Johnson/Janssen global vaccine study (0.23/100 PY)7 
 —  The majority of patients who experienced a COVID-19―related serious AE (SAE) had known 

or potential risk factors for severe illness from COVID-19 (eg, diabetes mellitus, obesity, 
cardiovascular disease, lung disease, smoking) 

• The incidence rates for MACE, VTEs, and malignancies were low and in line with observations in 
POETYK PSO-1 and PSO-2 (Table 4) 

• Descriptions of VTE events occurring during the study period are included in the Supplemental 
Material 

 — None of these events were considered drug related 

• The ratio of basal cell cancer to squamous cell cancer remained close to 2:1

• The incidence rates for non–nonmelanoma skin cancers (non-NMSCs) were not higher than 
expected in the psoriasis population or clinical trial safety data with approved agents24

 —  Descriptions of the lymphoma cases are included in the Supplemental Material; all 3 patients 
with lymphoma had multiple confounding factors that made it difficult to attribute these 
events to treatment24

 —  Other non-NMSCs occurring at 2 years were not clustered to any particular malignancy type24

Figure 2. EAIRs for serious infections, malignancies (excluding NMSC), and MACE at 2 yearsa 
compared with long-term safety data, real-world data, or registry studies of other systemic 
psoriasis therapies

Serious infections

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

E
A

IR
/1

0
0
 P

Y
 (

9
5
%

 C
I)

2.6
(+COVID-19)

0.9
(-COVID-19)

Deucravacitinib (PSO-1 &
 PSO-2, LTE) 

excluding COVID-19

Deucravacitinib (PSO-1 &
 PSO-2, LTE) 

w
ith COVID-19

Psoriasis
background rate 

in registry
Clinical
trials

Clinical trial
long-term

safety studies

Ustekinum
ab

Guselkum
ab

Risankizum
ab

Secukinum
ab

Optum
Labs – IL-17 inhibitor

Optum
Labs – IL-12/23 inhibitor

Optum
 – IL-17 inhibitor

Optum
 – IL-12/23 inhibitor

Optum
 – aprem

ilast
M
arketScan – aprem

ilast

M
arketScan – ustekinum

ab

BADBIR – ustekinum
ab

PSOLAR – ustekinum
ab

PsoBest – ustekinum
ab

Tofacitinib – psoriasis
Tofacitinib – PsA
Tofacitinib – RA

Psoriasis background rate in real-world data

Malignancies (excluding NMSC)

E
A

IR
/1

0
0
 P

Y
 (

9
5
%

 C
I)

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

0.5

D
e
u
cravacitin

ib
E
A

IR
/1

0
0
 P

Y

Deucravacitinib (PSO-1 &
 PSO-2, LTE)

Psoriasis
background 

rate in 
registry

Clinical trial
long-term

safety studies

Ustekinum
ab

Guselkum
ab

Risankizum
ab

Optum
 – IL-17 inhibitor

Optum
 – IL-12/23 inhibitor

Optum
 – aprem

ilast
M
arketScan – all psoriasis

M
arketScan – adalim

um
ab

M
arketScan – etanercept

M
arketScan – general population

PSO
LAR – ustekinum

ab
PsoBest – ustekinum

ab
US SEER database
Tofacitinib – psoriasis
Tofacitinib – PsA
Tofacitinib – RA

Psoriasis background rate in real-world data
Clinical
trials

E
A

IR
/1

0
0
 P

Y
 (

9
5
%

 C
I)

0.0

0.5

1.0

1.5

2.0

2.5

3.0

0.4
D

e
u
cravacitin

ib
E
A

IR
/1

0
0
 P

Y

MACE

Deucravacitinib (PSO-1 &
 PSO-2, LTE)

Ustekinum
ab

Guselkum
ab

Risankizum
ab

Secukinum
ab

Optum
 – IL-17 inhibitor (7)

Optum
 – IL-12/23 inhibitor (7)

Optum
 – aprem

ilast (7)
PSO

LAR – ustekinum
ab

PsoBest – ustekinum
ab

Tofacitinib – psoriasis
Tofacitinib – PsA

Tofacitinib – RA

Psoriasis
background 

rate in registry
Clinical trial

long-term safety studies
Psoriasis background rate 

in real-world data (claims data)
Clinical
trials

aThis represents the pooled POETYK PSO-1 and PSO-2 population enrolled in the POETYK LTE through the 120-day cutoff date of October 1, 2021. 
BADBIR, British Association of Dermatologists Biologic and Immunomodulators Register; EAIR, exposure-adjusted incidence rate; IL, interleukin; LTE, long-term 
extension; MACE, major adverse cardiovascular event; NMSC, nonmelanoma skin cancer; PsA, psoriatic arthritis; PsoBest, German Psoriasis Registry; PSOLAR, 
PSOriasis Longitudinal Assessment and Registry; PY, person-years; RA, rheumatoid arthritis; SEER, Surveillance, Epidemiology, and End Results Program.

Table 4. AEs of interest at 1 year vs at 2 years (as-treated population)
At 1 yeara 

(POETYK PSO-1 + PSO-2)
At 2 yearsb  

(POETYK PSO-1 + PSO-2 + LTE)

Deucravacitinib 6 mg QD 
(N = 1364) 

Total PY = 969.0

Deucravacitinib 6 mg QD 
(N = 1519) 

Total PY = 2482.0

AE category n (%) EAIR/100 PY n (%) EAIR/100 PY

Serious infections 17 (1.2) 1.7 64 (4.2) 2.6

Herpes zoster infection 9 (0.7) 0.9 18 (1.2) 0.7

Total COVID-19 infection 5 (0.4) 0.5 124 (8.2) 5.1

Serious COVID-19 infection 2 (0.1) 0.2 30 (2.0) 1.2

COVID-19 pneumonia 0 (0) 0.0 13 (0.9) 0.5

COVID-19—related deaths 0 (0) 0.0 6 (0.4) 0.2

MACEc 3 (0.2) 0.3 9 (0.6) 0.4

VTEd 2 (0.1) 0.2 3 (0.2) 0.1

Total malignancies 10 (0.7) 1.0 22 (1.4) 0.9

NMSC 7 (0.5) 0.7 11 (0.7) 0.4

Malignancies excluding NMSC 3 (0.2) 0.3 12 (0.8) 0.5

Lymphoma 1 (0.1) 0.1 3 (0.2) 0.1
aThis represents the pooled patient population of POETYK PSO-1 and PSO-2 (Weeks 0―52). Not all patients were on deucravacitinib 6 mg QD continuously 
throughout this period. bThis represents the pooled POETYK PSO-1 and PSO-2 population enrolled in the POETYK LTE through the 120-day cutoff date of  
October 1, 2021. cMACE is defined as cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. dVTE is defined as pulmonary embolism and 
deep vein thrombosis.  
AE, adverse event; EAIR, exposure-adjusted incidence rate; MACE, major adverse cardiovascular event; NMSC, nonmelanoma skin cancer; PY, person-years;  
QD, once daily; VTE, venous thromboembolism.

Efficacy
• Over 60 weeks of follow-up in the POETYK LTE, the proportions of patients who achieved PASI 75, 

PASI 90, and sPGA 0/1 were similar regardless of which treatment they were receiving at Week 52 
in the parent study (Table 5)

• Sensitivity analyses demonstrated the robustness of these results, with comparable response rates 
observed using the TFR, as-observed, or mNRI method (Table 5; Figure 3) 

Figure 3. Clinical efficacy responses during POETYK LTE Weeks 0—60 in patients who 
were receiving deucravacitinib at Week 52 in the parent study (sensitivity analysis):  
PASI 75a, PASI 90b, and sPGA 0/1c

77.7%
79.4%

75.7%

0

10

20

30

40

50

60

70

80

90

100

0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60

R
e
sp

o
n
se

 r
at

e
, 

%
 o

f 
p
at

ie
n
ts

Weeks

PASI 75

0

10

20

30

40

50

60

70

80

90

100

R
e
sp

o
n
se

 r
at

e
, 

%
 o

f 
p
at

ie
n
ts

28

Weeks

43.6%

49.6%

43.6%

70.8%
70.8%

50.7%

44.5%

71.3%

TFR As observed mNRIImputation method:

47.3%

0 4 8 12 16 20 24 32 36 40 44 48 52 56 60

PASI 90
TFR As observed mNRIImputation method:

0

10

20

30

40

50

60

70

80

90

100

R
e
sp

o
n
se

 r
at

e
, 

%
 o

f 
p
at

ie
n
ts

28

Weeks

0 4 8 12 16 20 24 32 36 40 44 48 52 56 60

sPGA 0/1
TFR As observed mNRIImputation method:

56.0%

58.7%

56.0%

60.0%

56.3%

57.1%

Patients, n

944TFR

805mNRI

920

805

920

805

908

805

908

805

882

805

839

805

705

805

944As observed 919 920 905 903 875 829 690

aPASI 75 responder defined as at least a 75% improvement from the parent study baseline in the PASI score. bPASI 90 responder defined as at least a 90% 
improvement from the parent study baseline in the PASI score. csPGA 0/1 responder defined as an sPGA score of 0 or 1 with at least a 2-point improvement from 
parent study baseline. mNRI: Multiple imputation was used for patients with missing data, and patients who discontinued due to worsening of psoriasis only were 
imputed as nonresponders; includes patients who reached Week 60 or discontinued by October 1, 2021. TFR: NRI was implemented for patients who discontinued 
treatment or study due to worsening of psoriasis or lack of efficacy.  
mNRI, modified nonresponder imputation; PASI 75, ≥75% reduction from baseline in Psoriasis Area and Severity Index; PASI 90, ≥90% reduction from baseline  
in PASI; sPGA 0/1, static Physician’s Global Assessment score of 0 (clear) or 1 (almost clear) with a ≥2-point improvement from baseline; TFR, treatment  
failure rule.

Acknowledgments
• This study was 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
• The authors also acknowledge Julie Scotto, BS, MPH, for her contributions to this analysis

Conclusions
• Overall, the 2-year safety profile of deucravacitinib was consistent with Weeks 0―52 of the 

POETYK PSO-1 and PSO-2 trials, and there were no emerging safety signals

 —  The severity of AEs continued to be predominantly mild or moderate, and the incidence 
of SAEs and AEs leading to discontinuation remained low

 —  The most common AEs (≥5% of patients) included nasopharyngitis, upper respiratory 
tract infection, diarrhea, arthralgia, and headache

 —  An increase in serious infections was observed, which is attributable to COVID-19 
infections due to the ongoing pandemic

 —  No cases of herpes zoster were disseminated, serious, or led to treatment discontinuation

 —  The overall malignancy incidence rate was largely in line with POETYK PSO-1 and PSO-2 
and rates seen in other clinical trials and in real-world populations

 —  There was a low incidence rate of cardiovascular events (eg, MACE) that was 
comparable to long-term safety data from clinical trials with anti-IL-12/23 or anti-IL-23 
agents and in real-world populations

• Unlike most other previous phase 3 trials, the POETYK studies were conducted in the 
context of the global COVID-19 pandemic, and COVID-19 rates increased from Year 1 to  
Year 2

 —  The overall incidence rates for COVID-19 infection and COVID-19―related hospitalization 
and death were consistent with background epidemiologic rates

• Clinical efficacy was maintained for up to 2 years with deucravacitinib treatment, 
regardless of which treatment was received at Week 52 in the parent study  

 —  Response rates at the start of the LTE for PASI 75, PASI 90, and sPGA 0/1 were 
maintained at LTE Week 60

 —  Consistent results were observed across tested imputation methods, including TFR, 
mNRI, and as-observed data

• These findings further support the use of deucravacitinib, a once-daily oral drug, as an 
effective and well-tolerated treatment for moderate to severe plaque psoriasis

References and Supplemental Material

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Disclosures
RBW: Research grants: AbbVie, Almirall, Amgen, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, and UCB; Consulting 
fees: AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, DiCE, Eli Lilly, Janssen, Leo Pharma, Novartis, 
Pfizer, Sanofi, UCB, and UNION. HS: Clinical investigator: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli 
Lilly, Janssen, Leo Pharma, Novartis, and Sun Pharma. SI: Grants and personal fees: AbbVie, Eisai, Janssen, Kyowa Kirin, 
Leo Pharma, Maruho, Sun Pharma, Taiho Yakuhin, Tanabe Mitsubishi, and Torii Yakuhin; Personal fees: Amgen (Celgene), 
Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Novartis, and UCB. JCS: Advisory board member/
consultant: AbbVie, Leo Pharma, Novartis, Pierre-Fabre, Sanofi Genzyme, and Trevi; Speaker: AbbVie, Eli Lilly, Janssen-Cilag, 
Leo Pharma, Novartis, and Sanofi Genzyme; Investigator: AbbVie, Amgen, Bristol Myers Squibb, Galapagos, Galderma, Incyte, 
InfraRX, Janssen-Cilag, Manlo Therapeutics, Merck, Novartis, Pfizer, Regeneron, Trevi, and UCB. AB: Scientific adviser and/or 
clinical study investigator: AbbVie, Abcentra, Aligos, Almirall, Amgen, Arcutis, Arena, Aslan, Athenex, Boehringer Ingelheim, 
Bristol Myers Squibb, Dermavant, EcoR1, Eli Lilly, Evommune, Forte Biosciences, Galderma, Incyte, Janssen, Landos, 
Leo Pharma, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, and Vibliome. LS: Consultant, paid 
investigator, and/or speaker: AbbVie, Amgen, Anacor, Ascend, Astellas, AstraZeneca, Blaze Bioscience, Boehringer Ingelheim, 
Botanix, Bristol Myers Squibb, Celgene, Dermira, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Hexima, Janssen, Leo 
Pharma, Mayne Pharma, MedImmune, Merck, Merck-Serono, Novartis, Otsuka, Pfizer, Phosphagenics, Photon MD, Regeneron, 
Roche, Samumed, Sanofi Genzyme, SHR, Sun Pharma ANZ, Trius, UCB, and Zai Lab. JT and SB: Employees and shareholders: 
Bristol Myers Squibb. AB: Contractor (through functional service provider Cytel): Bristol Myers Squibb. AM: Advisory board: 
Abbott Labs, Amgen, Boehringer Ingelheim, Janssen Biotech, and Leo Pharma; Consultant: Abbott Labs, Amgen, Eli Lilly, 
Janssen Biotech, Leo Pharma, Novartis, Sun Pharma, and UCB; Honoraria: Abbott Labs, Amgen, Boehringer Ingelheim, Eli 
Lilly, Janssen Biotech, Leo Pharma, Novartis, Sun Pharma, and UCB; Investigator: Abbott Labs, Amgen, Boehringer Ingelheim, 
Celgene, Eli Lilly, Janssen Biotech, Leo Pharma, Merck, Novartis, Sun Pharma, and UCB; Research grants: Abbott Labs, 
Amgen, Boehringer Ingelheim, Celgene, Janssen Biotech, Leo Pharma, Merck, and Sun Pharma; Speaker: Abbott Labs, Amgen, 
Janssen Biotech, Leo Pharma, Sun Pharma, and UCB.

Table 5. Efficacy results at Week 60 by imputation analysis  
Deucravacitinib — deucravacitinib Placebo — deucravacitinib Apremilast — deucravacitinib Total

Week 0 Week 60 Week 0 Week 60 Week 0 Week 60 Week 0 Week 60

Type of sensitivity  
analysis n

Mean 
response  
rate (%) n

Mean 
response  
rate (%) n

Mean 
response  
rate (%) n

Mean 
response 
rate (%) n

Mean 
response  
rate (%) n

Mean 
response  
rate (%) n

Mean 
response  
rate (%) n

Mean 
response  
rate (%)

PASI 75  

TFR 944 70.8 705 77.7 197 34.5 127 87.4 80 73.8 70 87.1 1221 65.1 902 79.8

mNRI 805 71.3 805 75.7 138 37.0 138 87.4 79 74.7 79 84.8 1022 66.9 1022 78.1

As observed 944 70.8 690 79.4 197 34.5 124 89.5 80 73.8 70 87.1 1221 65.1 884 81.4

PASI 90  

TFR 944 43.6 705 49.6 197 15.7 127 53.5 80 40.0 70 62.9 1221 38.9 902 51.2

mNRI 805 44.5 805 47.3 138 17.4 138 54.2 79 40.5 79 60.1 1022 40.5 1022 49.3

As observed 944 43.6 690 50.7 197 15.7 124 54.8 80 40.0 70 62.9 1221 38.9 884 52.3

sPGA 0/1  

TFR 944 56.0 705 58.7 197 25.4 126 65.1 80 53.8 70 72.9 1221 50.9 901 60.7

mNRI 805 56.3 805 57.1 138 27.5 138 65.0 79 54.4 79 70.7 1022 52.3 1022 59.2

As observed 944 56.0 690 60.0 197 25.4 123 66.7 80 53.8 70 72.9 1221 50.9 883 61.9

TFR: NRI was implemented for patients who discontinued treatment or study due to worsening of psoriasis or lack of efficacy. mNRI: Multiple imputation was used for patients with missing data, and patients who discontinued due to worsening of psoriasis only were imputed as nonresponders; includes patients who reached 
Week 60 or discontinued by October 1, 2021.  
mNRI, modified nonresponder imputation; PASI 75, ≥75% reduction from baseline in Psoriasis Area and Severity Index; PASI 90, ≥90% reduction from baseline in PASI; sPGA 0/1, static Physician’s Global Assessment score of 0 (clear) or 1 (almost clear) with a ≥2% improvement from baseline; TFR, treatment failure rule.