Bristol-Myers Squibb announced on September 9, 2022, that the U.S. Food and Drug Administration (FDA) has approved Sotyktu (deucravacitinib) for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. This is an oral, highly selective, first-in-class tyrosine kinase 2 (TYK2) allosteric inhibitor. Sotyktu is not recommended for use in combination with other potent immunosuppressants.
This approval is based on results from two Phase 3, global, multicenter, double-blind, randomized clinical trials, POETYK PSO-1 (n=664) and POETYK PSO-2 (n=1020), which evaluated the efficacy and safety of Sotyktu compared to apremilast and placebo in adult patients with moderate to severe plaque psoriasis.
The co-primary endpoint was the proportion of patients with a greater than 75% improvement in the Psoriasis Area and Severity Index (PASI) score and sPGA 0/1 (static physician overall assessment of complete/near-complete clearance of skin symptoms) at week 16. PS: PASI 75 was defined as a PASI score improvement of at least 75% from baseline.
The efficacy of Sotyktu was demonstrated at weeks 16 and 24, with a duration of response up to week 52. Sotyktu demonstrated a good safety and tolerability profile.
Week 16: PASI 75 rates: 58.7% and 53.6% in the Sotyktu group, 12.7% and 9.4% in the placebo group, and 35.1% and 40.2% in the Aprepitant group; sPGA 0/1 rates: 53.6% and 50.3% in the Sotyktu group, 7.2% and 8.6% in the placebo group, and 32.1% and 34.3% in the Aprepitant group.
Week 24: PASI 75 rates: 69.0% and 59.3% in the Sotyktu group, and 38.1% and 37.8% in the Aprepitant group; sPGA 0/1 rates: 58.4% and 50.4% in the Sotyktu group, and 31.0% and 29.5% in the Aprepitant group.
In the POETYK PSO trial, at week 16, the most common adverse reactions (≥1%) in Sotyktu patients were upper respiratory tract infection (19.2%), elevated serum creatine phosphokinase (2.7%), herpes simplex (2.0%), oral ulcers (1.9%), folliculitis (1.7%), and acne (1.4%).
Psoriasis is a chronic, systemic, immune-mediated disease. Sotyktu is the first approved oral treatment in nearly a decade, a once-daily tablet systemic treatment regimen for psoriasis, meaning that unlike topical treatments applied directly to the skin, this drug minimizes systemic inflammation. Its action differs from existing systemic medications, including other oral therapies requiring injection and biologics.
