Influence of baseline demographics/disease characteristics on efficacy of  
an oral selective TYK2 inhibitor, BMS-986165, in patients with moderate to  

severe plaque psoriasis: Phase 2, randomized, placebo-controlled trial

Fall Clinical Dermatology Conference • October 17–20, 2019 • Las Vegas, NV, USA

K Gordon,1 K Papp,2 M Gooderham,3 D Thaçi,4 P Foley,5 A Morita,6 S Kundu,7 R Kisa,7 A Napoli,7 S Banerjee7
1Medical College of Wisconsin, Milwaukee, WI, USA; 2K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada; 3SKiN Centre for Dermatology, Queen’s University and Probity Medical Research, Peterborough, ON, Canada;  

4University of Lübeck, Lübeck, Germany; 5The University of Melbourne, St Vincent’s Hospital Melbourne & Probity Medical Research, Skin & Cancer Foundation Inc, Melbourne, Victoria, Australia;  
6Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; 7Bristol-Myers Squibb, Princeton, NJ, USA

• Psoriasis is a chronic, immune-mediated disorder characterized 
by symptoms that are associated with reduced health-related 
quality of life and decreased work productivity.1

• BMS-986165 is an oral, selective inhibitor of tyrosine kinase 2 
(TYK2),2,3 an enzyme that activates signal transducer and 
activator of transcription (STAT)-dependent cytokine signaling 
pathways involved in psoriasis pathophysiology.4,5 

• In a 12-week, Phase 2 trial of BMS-986165 in patients with 
moderate to severe plaque psoriasis6: 

 ○ Psoriasis Area and Severity Index (PASI) 75 responses  
were highest at doses from 3 mg twice daily (BID) up to  
12 mg once daily (QD; 67–75%) vs placebo at Week 12  
(7%; P0.001; primary endpoint) (Table 1). 

 ○ Adverse events were generally mild to moderate and 
resulted in drug discontinuation in 4% of placebo patients 
and 2–7% of patients across the active doses.

INTRODUCTION

• To report the influence of baseline demographics and disease 
characteristics on Week 12 efficacy for the 3 most effective 
doses of BMS-986165 (3 mg BID, 6 mg BID, and 12 mg QD).

OBJECTIVE

Study design
• Adults with moderate to severe plaque psoriasis  

(body surface area [BSA] 10%, PASI score 12, static 
Physician Global Assessment [sPGA] score 3) were 
randomized equally to BMS-986165 (3 mg every other day,  
3 mg QD, 3 mg BID, 6 mg BID, 12 mg QD) or placebo.

• The treatment period was 12 weeks, with an additional 30-day 
off-treatment follow-up period for safety assessment, with 
efficacy measures collected post-treatment.

Subgroup analyses
• Subgroup analyses of efficacy endpoints were performed for 

the following baseline characteristics; randomization was not 
stratified by these characteristics. 

Baseline demographics

• Weight (90 kg, 90 kg and 100 kg, 100 kg). 

• Body mass index (BMI; 25 kg/m2 [underweight/normal],  
25–30 kg/m2 [overweight], 30 kg/m2  [obese]). 

• Age (18–45 years, 45 years). 

Baseline disease

• Age of psoriasis onset (18 years, 18–45 years, 45 years, 
based on pediatric onset, and 2 peaks of psoriasis onset in adults). 

• Dermatology Life Quality Index (DLQI) score (10, 10–20, 
20, corresponding approximately to the following categories 
of effect on the patient’s life: small to moderate, moderate to 
large, extremely large7). 

METHODS

Patients
• In total, 267 patients were randomized and treated in the study.

• Patient demographics and disease characteristics were similar 
across treatment groups (Table 2).

Subgroup analyses of efficacy endpoints
• Subgroup analyses are reported for patients treated with 

BMS-986165 at doses shown to have the highest levels of 
efficacy (3 mg BID and above [n=134]). 

 ○  There was a slight imbalance in the number of patients per 
treatment in each subgroup, as no stratification by subgroup 
was performed at randomization.

Baseline demographics
• At Week 12, the proportions of patients achieving PASI 75, 

PASI 90, or sPGA 0/1 were consistent across baseline 
demographic subgroups.

 ○ By weight (90 kg vs 90 kg; Figure 1A): 

 ∙ Although PASI 90 response rates were generally lower in 
the 90 kg versus the 90 kg subgroup (22–38% vs 
48–59%), the 95% CIs overlapped between subgroups in 
each treatment group; differences among subgroups do 
not appear to be clinically meaningful. 

 ∙ Similar consistency in response rates was seen  
when a baseline weight cut-off of 100 kg was used  
(data not shown). 

 ○  By BMI (25 kg/m2; 25–30 kg/m2; 30 kg/m2; Table 3): 

 ∙ Although PASI 75 and PASI 90 response rates were 
numerically higher in the underweight/normal (25 kg/m2) 
BMI subgroup than in the overweight (25–30 kg/m2) or 
obese (30 kg/m2) subgroups, the 95% CIs mostly 
overlapped across these subgroups; differences among 
the subgroups do not appear to be clinically meaningful. 

 ∙ Response rates for sPGA 0/1 were generally similar 
between BMI subgroups. 

 ○ By age (18–45 years vs 45 years; Figure 1B): 

 ∙ Although PASI 75, PASI 90, and sPGA 0/1 response 
rates were generally higher for the younger versus the 
older subgroup, the 95% CIs all overlapped between the  
2 subgroups; differences between the 2 subgroups do 
not appear to be clinically meaningful.

RESULTS

References
1. Korman NJ et al. Dermatol Online J. 2015;21:pii:13030/qt1x16v3dg.

2. Tokarski JS et al. J Biol Chem. 2015;290:11061-11074.

3. Gillooly K et al. Arthritis Rheumatol. 2016;68(suppl 10):abstract 11L.

4. Shaw MH et al. Proc Natl Acad Sci U S A. 2003;100:11594-11599.

5. Harden JL et al. J Autoimmun. 2015;64:66-73.

6. Papp K et al. N Engl J Med. 2018;379:1313-1321.

7. Hongbo Y et al. J Investig Dermatol. 2005;125:659-664.

8. European Medicines Agency. Guideline on clinical investigation of medicinal products indicated for the 
treatment of psoriasis. 2004. https://www.ema.europa.eu/documents/scientific-guideline/
guideline-clinical-investigation-medicinal-products-indicated-treatment-psoriasis_en.pdf. Accessed December 
17, 2018.

Acknowledgments
The authors wish to acknowledge all investigators and patients involved in this study. This study was funded by 

Bristol-Myers Squibb. Professional medical writing and editorial assistance was provided by Joanna Wright, DPhil, 

at Caudex and was funded by Bristol-Myers Squibb.

Disclosures
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. 

KP: grant support, consulting fees, advisory board, and speakers bureau: Amgen, AbbVie, Boehringer Ingelheim, 

Eli Lilly, Janssen, Kyowa Hakko Kirin, Leo Pharma, Novartis, Pfizer, UCB, and Valeant; grant support, consulting 

fees, and Scientific Officer: Akros; consulting fees: Can-Fite; grant support, consulting fees, advisory board, 

speakers bureau, and travel support: Celgene; grant support, consulting fees, and advisory board: Merck Sharp & 

Dohme, PRCL, and Takeda; grant support: Anacor, GlaxoSmithKline, and Meiji Seika Pharma; and grant support 

and consulting fees: Coherus and Dermira. MG: advisory board, principal investigator, and lecture fees: AbbVie, 

Galderma SA, Leo Pharma, Pfizer, and Regeneron Pharmaceuticals; 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 Corporation, Eli Lilly, Janssen, Novartis 

Pharmaceuticals, Sanofi Genzyme, and Valeant Pharmaceuticals; principal investigator: Arcutis Pharmaceuticals, 

Bristol-Myers Squibb, Dermira, GlaxoSmithKline, MedImmune, Merck and Co., Roche Laboratories, and UCB; and 

principal investigator and lecture fees: Glenmark. DT: grant support, lecture fees, consulting fees, and advisory 

board: AbbVie; lecture fees, consulting fees, and advisory board: Almirall, Pfizer, Regeneron, Sandoz-Hexal, 

Sanofi, and UCB; consulting fees and advisory board: Boehringer Ingelheim; grant support, lecture fees, 

consulting fees, advisory board, and writing assistance: Celgene and Novartis; and lecture fees, consulting fees, 

advisory board, and writing assistance: Eli Lilly, Leo Pharma, and Janssen-Cilag. PF: grant support,  

advisory board, speakers bureau, and travel support: AbbVie, Celgene, CSL Limited, Galderma, iNova, Janssen, 

Leo Pharma, Eli Lilly, Novartis, Pfizer, and Sanofi; grant support and advisory board: Amgen and Sun Pharma;  

grant support: Boehringer Ingelheim, Celtaxsys, Cutanea, Dermira, Genentech, and Regeneron; grant support, 

advisory board, and speakers bureau: GlaxoSmithKline; grant support and consulting fees: Bristol-Myers Squibb; 

grant support, speakers bureau, and travel support: Roche. AM: grant support and lecture fees: AbbVie, Eisai, 

Kyowa Hakko Kirin, Leo Pharma, Maruho, Mitsubishi-Tanabe Pharm, Novartis, and Torii Pharmaceutical; and 

lecture fees: Celgene, Eli Lilly Japan, and Janssen Pharmaceutical K.K. SK, RK, AN, and SB: employees and 

shareholders: Bristol-Myers Squibb.

Previously presented at the Caribbean Dermatology Symposium, held January 15–19, 2019.

Table 1: Efficacy of BMS-986165 at Week 12 (NRI).

Placebo
(n=45)

BMS-986165

3 mg 
QOD 

(n=44)

3 mg  
QD

(n=44)

3 mg  
BID

(n=45)

6 mg  
BID

(n=45)

12 mg  
QD

(n=44)

Primary endpoint: PASI 75

Patients, n (%) 3 (7) 4 (9) 17 (39) 31 (69) 30 (67) 33 (75)

P value vs placebo - 0.49 0.001 0.001 0.001 0.001

Secondary endpoints

PASI 90

Patients, n (%) 1 (2) 3 (7) 7 (16) 20 (44) 20 (44) 19 (43)

Difference vs 
placebo, % (95% CI) -

5  
(–16 to 25)

14  
(–7 to 33)

42  
(21–60)

42  
(21–60)

41  
(20–58) 

PASI 100

Patients, n (%) 0 (0) 1 (2) 0 (0) 4 (9) 8 (18) 11 (25)

Difference vs 
placebo, % (95% CI) -

2  
(–18 to 23) -

9  
(–13 to 30)

18  
(–4 to 38)

25  
(4–44)

sPGA 0/1

Patients, n (%) 3 (7) 9 (20) 17 (39) 34 (76) 29 (64) 33 (75)

Difference vs 
placebo, % (95% CI) -

14  
(–7 to 33)

32  
(11–50)

69  
(51–83)

58  
(38–74)

68  
(50–82)

DLQI 0/1

Patients, n (%) 2 (4) 7 (16) 7 (16) 19 (42) 27 (60) 28 (64)

Difference vs 
placebo, % (95% CI) -

12  
(–2 to 26)

12  
(–2 to 26)

38  
(20–54) 

56  
(38–71)

59  
(41–74)

Data have been rounded to the nearest integer. For patients who discontinued early or who had a missing value 
at any time point, data were imputed as a non-response at that time point, regardless of the status of response at 
the time of discontinuation. The numbers of patients with NRI in each group were as follows: for PASI endpoints: 
placebo n=11, 3 mg QOD n=6, 3 mg QD n=3, 3 mg BID n=1, 6 mg BID n=5, and 12 mg QD n=1; for sPGA 0/1: 
placebo n=11, 3 mg QOD n=6, 3 mg QD n=6, 3 mg BID n=1, 6 mg BID n=6, and 12 mg QD n=1; for DLQI 0/1: 
placebo n=11, 3 mg QOD n=6, 3 mg QD n=3, 3 mg BID n=2, 6 mg BID n=5, and 12 mg QD n=1. P values for 
endpoints other than the primary endpoint are not reported because these values have not been adjusted for 
multiple comparisons; 95% CIs are unadjusted. 
From N Engl J Med, Papp KA et al, Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in Psoriasis, Vol 
379, pages 1313–1321. Copyright © 2018 Massachusetts Medical Society. Reprinted with permission from 
Massachusetts Medical Society. 
BID=twice daily; CI=confidence interval; DLQI 0/1=Dermatology Life Quality Index score of 0 or 1 (scores on the 
DLQI range from 0 to 30, with higher scores indicating worse quality of life); NRI=non-responder imputation;  
PASI 75=75% improvement in Psoriasis Area and Severity Index score; PASI 90=90% improvement in 
Psoriasis Area and Severity Index score; PASI 100=100% improvement in Psoriasis Area and Severity Index 
score; QD=once daily; QOD=every other day; sPGA 0/1=static Physician Global Assessment score of 0 or 1 
(scores on the sPGA range from 0 to 5, with higher scores indicating greater disease severity).

Table 2: Demographic and clinical characteristics of patients at 
baseline.

Characteristic
Total

(N=267)
Placebo 
(n=45)

BMS-986165

3 mg 
QOD 

(n=44)

3 mg 
QD 

(n=44)

3 mg 
BID 

(n=45)

6 mg 
BID 

(n=45)

12 mg 
QD 

(n=44)

Demographic characteristics

Age, years 45±13 46±12 41±12 45±14 46±15 43±13 47±12

Sex, male, n (%) 194 (73) 37 (82) 36 (82) 30 (68) 26 (58) 35 (78) 30 (68)

Race, n (%)*

White 225 (84) 40 (89) 35 (80) 39 (89) 39 (87) 35 (78) 37 (84)

Asian 36 (13) 5 (11) 6 (14) 5 (11) 5 (11) 9 (20) 6 (14)

Other 6 (2) 0 (0) 3 (7) 0 (0) 1 (2) 1 (2) 1 (2)

Body weight, kg 88±20 96±21 90±18 87±22 84±18 84±19 88±24

BMI, kg/m2 29±5 30±6 29±6 29±5 28±5 27±5 29±5

Clinical characteristics

Median (range)  
duration of 
disease, years

15  
(1–61)

18  
(2–48)

18  
(1–52)

13  
(2–60)

13  
(1–61)

15  
(1–55)

20  
(1–47)

Previous use of  
biologic agent, 
n (%)

115 (43) 20 (44) 19 (43) 19 (43) 19 (42) 20 (44) 18 (41)

PASI score† 18±6 19±6 17±4 18±6 19±8 18±6 18±5

DLQI score‡ 12±7 13±7 12±8 12±7 13±5 11±6 13±7

BSA, %§ 23±13 24±13 20±8 23±17 24±15 25±13 21±12

Plus-minus values are mean ± SD. Formal statistical analysis was not performed to evaluate between-group 
differences. Data have been rounded to the nearest integer. Percentages may not total 100 because of rounding. 
*Race was reported by the patients on a questionnaire at screening or baseline. 
†PASI scores range from 0 to 72, with higher scores indicating greater severity of psoriasis. 
‡DLQI scores range from 0 to 30, with higher scores indicating worse quality of life. 
§Percentage of BSA affected by psoriasis.
Adapted from N Engl J Med, Papp KA et al, Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in Psoriasis, 
Vol 379, pages 1313–1321. Copyright © 2018 Massachusetts Medical Society. Reprinted with permission from 
Massachusetts Medical Society. 
BID=twice daily; BMI=body mass index; BSA=body surface area; DLQI=Dermatology Life Quality Index; 
PASI=Psoriasis Area and Severity Index; QD=once daily; QOD=every other day; SD=standard deviation.

Baseline disease
• At Week 12, the proportions of patients achieving PASI 75, 

PASI 90, or sPGA 0/1 were generally consistent across 
baseline disease subgroups. 

 ○  By age of onset (18 years, 18–45 years, 45 years; 
Figure 2A): 

 ∙ Although some variability in PASI 75 and PASI 90 response 
rates between subgroups was seen, the 95% CIs all 
overlapped between subgroups within each treatment 
group; differences among subgroups within each treatment 
arm do not appear to be clinically meaningful. 

 ∙ Response rates for sPGA 0/1 were generally similar 
across age of onset subgroups.

 ○  By PASI score (20, 20; Figure 2B): 

 ∙ Response rates for the subgroup of patients with  
PASI scores 20 were similar to those for patients with 
PASI scores 20.

 ○ A general consistency in responses was seen regardless of 
BMI, disease duration, or previous biologic use (Table 3), or 
musculoskeletal symptoms, sPGA score, DLQI, or BSA 
(Table 4).

• BSA (20%, 20%, to indicate less/more severe disease8).

• PASI score (20, 20, to indicate less/more severe disease8).

• Disease duration (15 years, 15 years, based on median 
duration of disease in the overall trial population6).

• Musculoskeletal symptoms (no, yes) such as joint pain, heel 
pain, or back pain. 

• sPGA score (3 [moderate], 4–5 [severe]). 

• Previous biologic use (no, yes). 

Statistical analysis
• Response rates and 95% confidence intervals (CIs) are 

presented in the bar charts. 

• Missing data were imputed using non-responder imputation; 
patients who discontinued early or who had a missing value at any 
time point had data imputed as a non-response at that time point, 
regardless of the status of response at the time of discontinuation.

90 kg

45 years18–45 years

90 kg

A

B

PASI 75

Placebo
Weight 90 kg (n=16): 18.8% (95% CI: 4.0–45.6)
Weight 90 kg (n=29): 0% (95% CI: 0.0–11.9)

29n = 16
3 mg BID

27 18 25 19 81 53

72.4 62.5
74.1

55.6

76.0 73.7
74.1

64.2
90

100

80

70

60

50

40

30

20

10

0

6 mg BID 12 mg QD Combined*

R
es

po
nd

er
s 

at
 W

ee
k 

12
 (%

)

48.3 37.5

59.3

22.2

48.0
36.8 51.9

32.1

PASI 90

90

100

80

70

60

50

40

30

20

10

0

Placebo
Weight 90 kg (n=16): 6.3% (95% CI: 0.2–30.2)
Weight 90 kg (n=29): 0% (95% CI: 0.0–11.9)

29n = 16 27 18 25 19 81 53
3 mg BID 6 mg BID 12 mg QD Combined*

R
es

po
nd

er
s 

at
 W

ee
k 

12
 (%

) 72.4
81.3

63.0
66.7

80.0
68.4

71.6 71.7

sPGA 0/1

90

100

80

70

60

50

40

30

20

10

0

Placebo
Weight 90 kg (n=16): 12.5% (95% CI: 1.6–38.3)
Weight 90 kg (n=29): 3.4% (95% CI: 0.1–17.8)

29n = 16 27 18 25 19 81 53
3 mg BID 6 mg BID 12 mg QD Combined*

22n = 23
3 mg BID

24 21 20 24 66 68
6 mg BID 12 mg QD Combined*

22n = 23 24 21 20 24 66 68
3 mg BID 6 mg BID 12 mg QD Combined*

22n = 23 24 21 20 24 66 68
3 mg BID 6 mg BID 12 mg QD Combined*

R
es

po
nd

er
s 

at
 W

ee
k 

12
 (%

)

PASI 75

Placebo
18–45 years (n=20): 5.0% (95% CI: 0.1–24.9)
45 years (n=25): 8.0% (95% CI: 1.0–26.0)

77.3

60.9
66.7 66.7

80.0
70.8 74.2

66.2
90

100

80
70
60
50
40
30
20
10
0

R
es

po
nd

er
s 

at
 W

ee
k 

12
 (%

)

PASI 90

90
100

80
70
60
50
40
30
20
10
0

Placebo
18–45 years (n=20): 0% (95% CI: 0.0–16.8)
45 years (n=25): 4.0% (95% CI: 0.1–20.4)

54.5

34.8

58.3

28.6

45.0
41.7 53.0

35.3

R
es

po
nd

er
s 

at
 W

ee
k 

12
 (%

)

sPGA 0/1

90
100

80
70
60
50
40
30
20
10
0

Placebo
18–45 years (n=20): 5.0% (95% CI: 0.1–24.9)
45 years (n=25): 8.0% (95% CI: 1.0–26.0)

77.3 73.9 70.8

57.1

85.0

66.7 77.3

66.2

R
es

po
nd

er
s 

at
 W

ee
k 

12
 (%

)

Figure 1: Efficacy of BMS-986165: endpoints at Week 12 by baseline demographic characteristics: A) weight and B) age.

Error bars are 95% exact CIs; data labels above each bar are the response rates.
*BMS-986165 3 mg BID, 6 mg BID, and 12 mg QD combined.
BID=twice daily; CI=confidence interval; PASI 75=75% improvement in Psoriasis Area and Severity Index score; PASI 90=90% improvement in Psoriasis Area and Severity Index score; QD=once daily; sPGA 0/1=static Physician Global 
Assessment score of 0 or 1.

A

18 years 18–45 years 45 years

PASI 20 PASI 20

50.0

45.8 39.5
33.348.537.548.3

41.2

69.0
68.8 72.7

50.0

80.0

71.9 65.8
73.5

PASI 75B

Placebo
20 (n=31): 0% (95% CI: 0.0–11.2)
20 (n=14): 21.4% (95% CI: 4.7–50.8)

R
es

po
nd

er
s 

at
 W

ee
k 

12
 (%

)

29n = 16 33 12 34 10 96 38

90
100

80
70
60
50
40
30
20
10

0

90
100

80
70
60
50
40
30
20
10

0

90
100

80
70
60
50
40
30
20
10

0

PASI 90

Placebo
20 (n=31): 0% (95% CI: 0.0–11.2)
20 (n=14): 7.1% (95% CI: 0.2–33.9)

R
es

po
nd

er
s 

at
 W

ee
k 

12
 (%

)

29n = 16 33 12 34 10 96 38

80.0

75.0
63.2

41.7

72.768.8
79.3

73.5

sPGA 0/1

Placebo
20 (n=31): 3.2% (95% CI: 0.1–16.7)
20 (n=14): 14.3% (95% CI: 1.8–42.8)

R
es

po
nd

er
s 

at
 W

ee
k 

12
 (%

)

29n = 16 33 12 34 10 96 38

R
es

po
nd

er
s 

at
 W

ee
k 

12
 (%

)

PASI 75

13 21
3 mg BID 6 mg BID 12 mg QD Combined*

11 16 26 3 9 29 6 38 76 20n =

76.9
71.4

54.5
50.0

76.9
66.7 77.8

75.9
66.7

65.8
75.0 60.0

90
100

80
70
60
50
40
30
20
10
0

Placebo
18 years (n=14): 0% (95% CI: 0.0–23.2)
18–45 years (n=27): 11.1% (95% CI: 2.4–29.2)
45 years (n=4): 0% (95% CI: 0.0–60.2)

PASI 90

3 mg BID 6 mg BID 12 mg QD Combined*
13 21 11 16 26 3 9 29 6 38 76 20n =

53.8

42.9 36.4

18.8

61.5

33.3

44.4

48.3 16.7

36.8
51.3

30.0

90
100

80
70
60
50
40
30
20
10
0R

es
po

nd
er

s 
at

 W
ee

k 
12

 (%
)

Placebo
18 years (n=14): 0% (95% CI: 0.0–23.2)
18–45 years (n=27): 3.7% (95% CI: 0.1–19.0)
45 years (n=4): 0% (95% CI: 0.0–60.2)

sPGA 0/1

3 mg BID 6 mg BID 12 mg QD Combined*
13n = 21 11 16 26 3 9 29 6 38 76 20

84.6
71.4

72.7

56.3
69.2

66.7 77.8
75.9

66.7

71.1 72.4
70.090

100

80
70
60
50
40
30
20
10
0R

es
po

nd
er

s 
at

 W
ee

k 
12

 (%
)

Placebo
18 years (n=14): 0% (95% CI: 0.0–23.2)
18–45 years (n=27): 11.1% (95% CI: 2.4–29.2)
45 years (n=4): 0% (95% CI: 0.0–60.2)

3 mg BID 6 mg BID 12 mg QD Combined* 3 mg BID 6 mg BID 12 mg QD Combined* 3 mg BID 6 mg BID 12 mg QD Combined*

Figure 2: Efficacy of BMS-986165: endpoints at Week 12 by baseline disease characteristics: A) age at onset of psoriasis and B) PASI score.

Error bars are 95% exact CIs; data labels above each bar are the response rates.
*BMS-986165 3 mg BID, 6 mg BID, and 12 mg QD combined.
BID=twice daily; CI=confidence interval; PASI=Psoriasis Area and Severity Index; PASI 75=75% improvement in Psoriasis Area and Severity Index score; PASI 90=90% improvement in Psoriasis Area and Severity Index score; QD=once daily;  
sPGA 0/1=static Physician Global Assessment score of 0 or 1.

• In patients with moderate to severe plaque 
psoriasis, BMS-986165 demonstrated 
consistent efficacy at oral doses 3 mg BID 
regardless of baseline weight, BMI, or age; 
age at onset; baseline disease severity (PASI, 
musculoskeletal symptoms, sPGA, DLQI, 
BSA) or duration; or previous biologic use. 

 ○ Although variation in response was seen 
among some subgroups, the 95% CIs 
mostly overlapped between 
complementary subgroups within 
treatment groups and the differences did 
not appear to be clinically meaningful. 

 ○ Small patient numbers may underlie the 
fluctuations observed. 

• Two global, randomized, placebo-controlled 
and active-comparator Phase 3 trials in 
psoriasis are underway to confirm these 
findings (POETYK PSO program; 
ClinicalTrials.gov identifiers: NCT03624127 
and NCT03611751).

CONCLUSIONS

Table 4: Efficacy of BMS-986165: endpoints at Week 12 by disease characteristics at baseline.

Endpoint Dose
Musculoskeletal symptoms sPGA score DLQI BSA

No Yes 3 (moderate)
4–5 

(severe) <10 10–<20 20 20% 20%

PASI 75

3 mg BID n=3464.7 (46.5–80.3)
n=11

81.8 (48.2–97.7)
n=29

65.5 (45.7–82.1)
n=16

75.0 (47.6–92.7)
n=14

57.1 (28.9–82.3)
n=26

73.1 (52.2–88.4)
n=5

80.0 (28.4–99.5)
n=26

69.2 (48.2–85.7)
n=19

68.4 (43.4–87.4)

6 mg BID n=3467.6 (49.5–82.6)
n=11

63.6 (30.8–89.1)
n=32

65.6 (46.8–81.4)
n=12

75.0 (42.8–94.5)
n=19

84.2 (60.4–96.6)
n=22

50.0 (28.2–71.8)
n=4

75.0 (19.4–99.4)
n=19

84.2 (60.4–96.6)
n=26

53.8 (33.4–73.4)

12 mg QD n=2975.9 (56.5–89.7)
n=15

73.3 (44.9–92.2)
n=28 

71.4 (51.3–86.8)
n=16

81.3 (54.4–96.0)
n=19

78.9 (54.4–93.9)
n=14

78.6 (49.2–95.3)
n=11

63.6 (30.8–89.1)
n=28

75.0 (55.1–89.3)
n=16

75.0 (47.6–92.7)

Combined* n=9769.1 (58.9–78.1)
n=37

73.0 (55.9–86.2)
n=89

67.4 (56.7–77.0)
n=44

77.3 (62.2–88.5)
n=52

75.0 (61.1–86.0)
n=62

66.1 (53.0–77.7)
n=20 

70.0 (45.7–88.1)
n=73

75.3 (63.9–84.7)
n=61

63.9 (50.6–75.8)

PASI 90

3 mg BID n=3447.1 (29.8–64.9)
n=11

36.4 (10.9–69.2)
n=29

37.9 (20.7–57.7)
n=16

56.3 (29.9–80.2)
n=14

35.7 (12.8–64.9)
n=26

50.0 (29.9–70.1)
n=5

40.0 (5.3–85.3)
n=26

50.0 (29.9–70.1)
n=19

36.8 (16.3–61.6)

6 mg BID n=3444.1 (27.2–62.1)
n=11

45.5 (16.7–76.6)
n=32

43.8 (26.4–62.3)
n=12

50.0 (21.1–78.9)
n=19

68.4 (43.4–87.4)
n=22 

22.7 (7.8–45.4)
n=4 

50.0 (6.8–93.2)
n=19

57.9 (33.5–79.7)
n=26 

34.6 (17.2–55.7)

12 mg QD n=2944.8 (26.4–64.3)
n=15

40.0 (16.3–67.7)
n=28

42.9 (24.5–62.8)
n=16

43.8 (19.8–70.1)
n=19

42.1 (20.3–66.5)
n=14

42.9 (17.7–71.1)
n=11

45.5 (16.7–76.6)
n=28

35.7 (18.6–55.9)
n=16

56.3 (29.9–80.2)

Combined* n=9745.4 (35.2–55.8)
n=37

40.5 (24.8–57.9)
n=89

41.6 (31.2–52.5)
n=44

50.0 (34.6–65.4)
n=52 

50.0 (35.8–64.2)
n=62

38.7 (26.6–51.9)
n=20

45.0 (23.1–68.5)
n=73

46.6 (34.8–58.6)
n=61

41.0 (28.6–54.3)

sPGA 0/1

3 mg BID n=3470.6 (52.5–84.9)
n=11

90.9 (58.7–99.8)
n=29

75.9 (56.5–89.7)
n=16

75.0 (47.6–92.7)
n=14

64.3 (35.1–87.2)
n=26

80.8 (60.6–93.4)
n=5

80.0 (28.4–99.5)
n=26

80.8 (60.6–93.4)
n=19

68.4 (43.4–87.4)

6 mg BID n=3467.6 (49.5–82.6)
n=11

54.5 (23.4–83.3)
n=32

62.5 (43.7–78.9)
n=12

75.0 (42.8–94.5)
n=19

78.9 (54.4–93.9)
n=22 

50.0 (28.2–71.8)
n=4

75.0 (19.4–99.4)
n=19

78.9 (54.4–93.9)
n=26

53.8 (33.4–73.4)

12 mg QD n=2975.9 (56.5–89.7)
n=15

73.3 (44.9–92.2)
n=28

75.0 (55.1–89.3)
n=16

75.0 (47.6–92.7)
n=19

73.7 (48.8–90.9)
n=14

85.7 (57.2–98.2)
n=11

63.6 (30.8–89.1)
n=28

75.0 (55.1–89.3)
n=16

75.0 (47.6–92.7)

Combined* n=9771.1 (61.0–79.9)
n=37

73.0 (55.9–86.2)
n=89

70.8 (60.2–79.9)
n=44

75.0 (59.7–86.8)
n=52

73.1 (59.0–84.4)
n=62

71.0 (58.1–81.8)
n=20 

70.0 (45.7–88.1)
n=73

78.1 (66.9–86.9)
n=61

63.9 (50.6–75.8)
Data are shown as response rate, % (95% exact CI).
Data for the placebo arm are as follows: 
Musculoskeletal symptoms: no (n=24): PASI 75, 12.5 (2.7–32.4); PASI 90, 4.2 (0.1–21.1); sPGA 0/1, 12.5 (2.7–32.4); yes (n=21): PASI 75, 0.0 (0.0–16.1); PASI 90, 0.0 (0.0–16.1); sPGA 0/1, 0.0 (0.0–16.1).
sPGA score: 3 (n=29): PASI 75, 3.4 (0.1–17.8); PASI 90, 0.0 (0.0–11.9); sPGA 0/1, 6.9 (0.8–22.8); 4–5 (n=16): PASI 75, 12.5 (1.6–38.3); PASI 90, 6.3 (0.2–30.2); sPGA 0/1, 6.3 (0.2–30.2).
DLQI: <10 (n=14): PASI 75, 0.0 (0.0–23.2); PASI 90, 0.0 (0.0–23.2); sPGA 0/1, 7.1 (0.2–33.9); 10–<20 (n=23): PASI 75, 8.7 (1.1–28.0); PASI 90, 0.0 (0.0–14.8); sPGA 0/1, 8.7 (1.1–28.0); 20 (n=8): PASI 75, 12.5 (0.3–52.7);  
PASI 90, 12.5 (0.3–52.7); sPGA 0/1, 0.0 (0.0–36.9).
BSA: 20% (n=19): PASI 75, 0.0 (0.0–17.6); PASI 90, 0.0 (0.0–17.6); sPGA 0/1, 5.3 (0.1–26.0); 20% (n=26): PASI 75, 11.5 (2.4–30.2); PASI 90, 3.8 (0.1–19.6); sPGA 0/1, 7.7 (0.9–25.1).
*BMS-986165 3 mg BID, 6 mg BID, and 12 mg QD combined.
BID=twice daily; BSA=body surface area; CI=confidence interval; DLQI=Dermatology Life Quality Index; PASI 75=75% improvement in Psoriasis Area and Severity Index score; PASI 90=90% improvement in Psoriasis Area and Severity  
Index score; QD=once daily; sPGA 0/1=static Physician Global Assessment score of 0 or 1.

Table 3: Efficacy of BMS-986165: endpoints at Week 12 by baseline BMI and disease duration, and previous biologic use.

Endpoint Dose
BMI Disease duration, years Previous biologic use per IWRS

25 kg/m2 25–30 kg/m2 30 kg/m2 15 15 No Yes

PASI 75

3 mg BID n=1384.6 (54.6–98.1)
n=16

56.3 (29.9–80.2)
n=16

68.8 (41.3–89.0)
n=25

72.0 (50.6–87.9)
n=20

65.0 (40.8–84.6)
n=26

65.4 (44.3–82.8)
n=19

73.7 (48.8–90.9)

6 mg BID n=1973.7 (48.8–90.9)
n=11

63.6 (30.8–89.1)
n=15

60.0 (32.3–83.7)
n=22 

68.2 (45.1–86.1)
n=23

65.2 (42.7–83.6)
n=25

80.0 (59.3–93.2)
n=20

50.0 (27.2–72.8)

12 mg QD n=988.9 (51.8–99.7)
n=19

73.7 (48.8–90.9)
n=16

68.8 (41.3–89.0)
n=13 

61.5 (31.6–86.1)
n=31

80.6 (62.5–92.5)
n=26

80.8 (60.6–93.4)
n=18

66.7 (41.0–86.7)

Combined* n=4180.5 (65.1–91.2)
n=46

65.2 (49.8–78.6)
n=47 

66.0 (50.7–79.1)
n=60

68.3 (55.0–79.7)
n=74

71.6 (59.9–81.5)
n=77

75.3 (64.2–84.4)
n=57

63.2 (49.3–75.6)

PASI 90

3 mg BID n=1376.9 (46.2–95.0)
n=16

18.8 (4.0–45.6)
n=16

43.8 (19.8–70.1)
n=25

48.0 (27.8–68.7)
n=20

40.0 (19.1–63.9)
n=26

50.0 (29.9–70.1)
n=19

36.8 (16.3–61.6)

6 mg BID n=19 57.9 (33.5–79.7)
n=11

54.5 (23.4–83.3)
n=15

20.0 (4.3–48.1)
n=22

54.5 (32.2–75.6)
n=23

34.8 (16.4–57.3)
n=25

60.0 (38.7–78.9)
n=20

25.0 (8.7–49.1)

12 mg QD n=9 66.7 (29.9–92.5)
n=19

36.8 (16.3–61.6)
n=16

37.5 (15.2–64.6)
n=13

23.1 (5.0–53.8)
n=31

51.6 (33.1–69.8)
n=26

42.3 (23.4–63.1)
n=18

44.4 (21.5–69.2)

Combined* n=41 65.9 (49.4–79.9)
n=46

34.8 (21.4–50.2)
n=47

34.0 (20.9–49.3)
n=60

45.0 (32.1–58.4)
n=74

43.2 (31.8–55.3)
n=77

50.6 (39.0–62.2)
n=57

35.1 (22.9–48.9)

sPGA 0/1

3 mg BID n=1376.9 (46.2–95.0)
n=16

68.8 (41.3–89.0)
n=16

81.3 (54.4–96.0)
n=25

68.0 (46.5–85.1)
n=20

85.0 (62.1–96.8)
n=26

61.5 (40.6–79.8)
n=19

94.7 (74.0–99.9)

6 mg BID n=1963.2 (38.4–83.7)
n=11

63.6 (30.8–89.1)
n=15

66.7 (38.4–88.2)
n=22

63.6 (40.7–82.8)
n=23

65.2 (42.7–83.6)
n=25

72.0 (50.6–87.9)
n=20

55.0 (31.5–76.9)

12 mg QD n=988.9 (51.8–99.7)
n=19

78.9 (54.4–93.9)
n=16

62.5 (35.4–84.8)
n=13

53.8 (25.1–80.8)
n=31

83.9 (66.3–94.5)
n=26

80.8 (60.6–93.4)
n=18

66.7 (41.0–86.7)

Combined* n=4173.2 (57.1–85.8)
n=46

71.7 (56.5–84.0)
n=47

70.2 (55.1–82.7)
n=60

63.3 (49.9–75.4)
n=74

78.4 (67.3–87.1)
n=77

71.4 (60.0–81.2)
n=57

71.9 (58.5–83.0)
Data are shown as response rate, % (95% exact CI).
Data for the placebo arm are as follows: 
BMI: 25 kg/m2 (n=6): PASI 75, 0.0 (0.0–45.9); PASI 90, 0.0 (0.0–45.9); sPGA 0/1, 0.0 (0.0–45.9); 25–30 kg/m2 (n=14): PASI 75, 7.1 (0.2–33.9); PASI 90, 0.0 (0.0–23.2); sPGA 0/1, 7.1 (0.2–33.9); 30 kg/m2 (n=25): PASI 75, 8.0 (1.0–26.0);  
PASI 90, 4.0 (0.1–20.4); sPGA 0/1, 8.0 (1.0–26.0).
Disease duration: 15 years (n=16): PASI 75, 6.3 (0.2–30.2); PASI 90, 0.0 (0.0–20.6); sPGA 0/1, 12.5 (1.6–38.3); 15 years (n=29): PASI 75, 6.9 (0.8–22.8); PASI 90, 3.4 (0.1–17.8); sPGA 0/1, 3.4 (0.1–17.8). 
Previous biologic use per IWRS: no (n=25): PASI 75, 4.0 (0.1–20.4); PASI 90, 0.0 (0.0–13.7); sPGA 0/1, 8.0 (1.0–26.0); yes (n=20): PASI 75, 10.0 (1.2–31.7); PASI 90, 5.0 (0.1–24.9); sPGA 0/1, 5.0 (0.1–24.9).
*BMS-986165 3 mg BID, 6 mg BID, and 12 mg QD combined.
BID=twice daily; BMI=body mass index; CI=confidence interval; IWRS=Interactive Web Response System; PASI 75=75% improvement in Psoriasis Area and Severity Index score; PASI 90=90% improvement in Psoriasis Area and Severity  
Index score; QD=once daily; sPGA 0/1=static Physician Global Assessment score of 0 or 1.

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