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Bristol Myers Squibb Presents Positive Data from Two Pivotal Phase 3 Psoriasis Studies Demonstrating Superiority of Deucravacitinib Compared to Placebo and Otezla® (apremilast)

Published: 2021-04-23 14:00:00 ET
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Significantly more patients treated with deucravacitinib achieved PASI 75 and sPGA 0/1 compared to patients treated with placebo and Otezla at Week 16, with an increased benefit versus Otezla at Week 24 and maintained through Week 52

Deucravacitinib was well tolerated with a low rate of discontinuation due to adverse events

Deucravacitinib is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action

Results presented as late-breaking research at the 2021 American Academy of Dermatology Virtual Meeting Experience

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced positive results from two pivotal Phase 3 trials evaluating deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. The POETYK PSO-1 and POETYK PSO-2 trials, which evaluated deucravacitinib 6 mg once daily, met both co-primary endpoints versus placebo, with significantly more patients achieving Psoriasis Area and Severity Index (PASI) 75 response and a static Physician's Global Assessment score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment with deucravacitinib. Deucravacitinib was well tolerated with a low rate of discontinuation due to adverse events (AEs).

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(Graphic: Business Wire)

(Graphic: Business Wire)

Deucravacitinib demonstrated superior skin clearance compared with Otezla® (apremilast) for key secondary endpoints in both studies, as measured by PASI 75 and sPGA 0/1 responses at Week 16 and Week 24. Findings include:

PASI 75 Response in POETYK PSO-1 and POETYK PSO-2:

  • 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.

sPGA 0/1 Response in POETYK PSO-1 and POETYK PSO-2:

  • 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.

“In both pivotal studies, deucravacitinib was superior to Otezla across multiple endpoints, including measures of durability and maintenance of response, suggesting that deucravacitinib has the potential to become a new oral standard of care for patients who require systemic therapy and need a better oral option for their moderate to severe plaque psoriasis,” said April Armstrong, M.D., M.P.H., Associate Dean and Professor of Dermatology at the University of Southern California. “As many patients with moderate to severe plaque psoriasis remain undertreated or even untreated, it is also highly encouraging to see that deucravacitinib improved patient symptoms and outcomes to a greater extent than Otezla.”

Superiority of Deucravacitinib Versus Placebo and Otezla

Deucravacitinib demonstrated a robust efficacy profile, including superiority to placebo for the co-primary endpoints and to Otezla for key secondary endpoints. In addition to PASI 75 and sPGA 0/1 measures, deucravacitinib was superior to Otezla across both studies in multiple other secondary endpoints, demonstrating significant and clinically meaningful efficacy improvements in symptom burden and quality of life measures.

POETYK PSO-1 and POETYK PSO-2 Results at Week 16 and Week 24

Endpoint

POETYK PSO-1 (n=666)

POETYK PSO-2 (n=1,020)

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

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