Promising Phase 3 Data for Oral Deucravacitinib from Bristol Myers Squibb in Psoriasis

In two pivotal Phase 3 trials evaluating deucravacitinib 6mg once daily for the treatment of patients with moderate to severe plaque psoriasis, significantly more patients met both co-primary endpoints—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 versus placebo.

Deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor in development by Bristol Myers Squibb, was well tolerated with a low rate of discontinuation due to adverse events (AEs). Results, from the POETYK PSO-1 and POETYK PSO-2 trials were presented at the AAD 2021 VMX.

Deucravacitinib demonstrated a robust efficacy profile, including superiority to placebo for the co-primary endpoints and to Otezla® (apremilast) for key secondary endpoints. 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.

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

“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,” says April Armstrong, M., MPH, 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.”

Deucravacitinib was well-tolerated and had a similar safety profile in both trials. The most common AEs (≥5%) with deucravacitinib treatment at Week 16 were nasopharyngitis and upper respiratory tract infection with low rates of headache, diarrhea and nausea.