Bristol Myers Squibb Presents Positive Data from Two Pivotal Phase 3 Psoriasis Studies Demonstrating Superiority of Deucravacitinib Compared to Placebo and Otezla? (apremilast)
- At Week 16, 58.7% and 53.6% of patients receiving deucravacitinib achieved PASI 75 response, respectively, versus 12.7% and 9.4% receiving placebo and 35.1% and 40.2% receiving Otezla.
- At Week 24, 69.0% and 59.3% of patients receiving deucravacitinib achieved PASI 75 response, respectively, versus 38.1% and 37.8% receiving Otezla.
- Among patients who achieved PASI 75 response at Week 24 with deucravacitinib and continued treatment with deucravacitinib, 82.5% and 81.4%, respectively, maintained PASI 75 response at Week 52.
- At Week 16, 53.6% and 50.3% of patients receiving deucravacitinib achieved sPGA 0/1 response, respectively, versus 7.2% and 8.6% receiving placebo and 32.1% and 34.3% receiving Otezla.
- At Week 24, 58.4% and 50.4% of patients receiving deucravacitinib achieved sPGA 0/1 response, respectively, versus 31.0% and 29.5% receiving Otezla.
POETYK PSO-1 and POETYK PSO-2 Results at Week 16 and Week 24 |
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Endpoint |
POETYK PSO-1 (n=666) |
POETYK PSO-2 (n=1,020) |
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Deucravacitinib 6 mg (n=332) |
Otezla 30 mg (n=168) |
Placebo (n=166) |
Deucravacitinib 6 mg (n=511) |
Otezla 30 mg (n=254) |
Placebo (n=255) |
|
PASI 75*a |
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Week 16 |
58.7%*? |
35.1% |
12.7% |
53.6%*? |
40.2% |
9.4% |
Week 24 |
69.0%? |
38.1% |
- |
59.3%? |
37.8% |
- |
sPGA 0/1*b |
||||||
Week 16 |
53.6%*? |
32.1% |
7.2% |
50.3%*? |
34.3% |
8.6% |
Week 24 |
58.4%? |
31.0% |
- |
50.4%? |
29.5% |
- |
(Scalp) ss-PGA 0/1c |
||||||
Week 16 |
70.8%*? |
39.1% |
17.4% |
60.3%*? |
37.3% |
17.3% |
Week 24 |
71.8%? |
42.7% |
- |
59.7%? |
41.6% |
- |
PSSD-Symptoms CFBd |
||||||
Week 16 |
-26.7*? |
-17.8 |
-3.6 |
-28.3*? |
-21.1 |
-4.7 |
Week 24 |
-31.9? |
-20.7 |
- |
-29.1? |
-21.4 |
- |
DLQI 0/1e |
||||||
Week 16 |
40.7%*? |
28.6% |
10.6% |
38.0%*? |
23.1% |
9.8% |
Week 24 |
47.8%? |
24.2% |
- |
41.8%? |
21.5% |
- |
*Co-primary endpoints for POETYK PSO-1 and POETYK PSO-2 were PASI 75 and sPGA 0/1 for deucravacitinib vs placebo at Week 16. |
a. PASI 75 is defined as at least a 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores. *p<0.0001 vs placebo. ?p<0.0001 vs Otezla. ?p=0.0003 vs Otezla. |
b. sPGA 0/1 is defined as a static Physician?s Global Assessment (sPGA) score of clear or almost clear. *p<0.0001 vs placebo. ?p<0.0001 vs Otezla. |
c. ss-PGA 0/1 is defined as a scalp-specific Physician?s Global Assessment (ss-PGA) score of clear or almost clear in those with ss-PGA of at least 3 (moderate) at baseline. POETYK PSO-1: *p<0.0001 vs placebo. ?p<0.0001 vs Otezla. POETYK PSO-2: *p<0.0001 vs placebo. ?p<0.0001 vs Otezla. ?p=0.0002 vs Otezla. |
d. Change from baseline (CFB) in Psoriasis Symptoms and Signs Diary (PSSD) captures improvement in symptoms of itch, pain, stinging, burning and skin tightness in patient eDiaries. *p<0.0001 vs placebo. ?p<0.0001 vs Otezla. |
e. Dermatology Life Quality Index (DLQI) 0/1 scores reflect no effect at all on patient?s life in patients with a baseline DLQI score of =2. POETYK PSO-1: *p<0.0001 vs placebo. ?p=0.0106 vs Otezla. ?p<0.0001 vs Otezla. POETYK PSO-2: *p<0.0001 vs placebo. ?p<0.0001 vs Otezla. |