PRINCETON, N.J. — September 17, 2026
Bristol Myers Squibb announced positive two-year results from the Phase 3 POETYK PsA-2 study, including its open-label extension, showing durable efficacy and a consistent safety profile for Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). The data, being presented at the Congress of Clinical Rheumatology-West, showed that clinical responses continued to improve through Week 52 and were maintained through Week 104 among patients receiving Sotyktu. In patients who received continuous Sotyktu treatment from the start of the Phase 3 study, Week 104 ACR20/50/70 response rates were 76.2%, 52.6% and 34.6%, respectively, based on observed analysis, while Minimal Disease Activity (MDA) was achieved by 51.2%. The findings add longer-term evidence to Sotyktu’s clinical development program following its approval for adults with active PsA earlier in 2026.
Sotyktu Maintains Responses Across Key PsA Measures
Durable improvements were observed across ACR20, ACR50, ACR70 and MDA endpoints, including among patients who initially received placebo before switching to Sotyktu at Week 16. In the continuous-treatment group, nonresponder-imputation analyses at Week 104 showed ACR20, ACR50 and ACR70 responses of 65.3%, 44.9% and 29.4%, respectively, with MDA achieved by 43.7% of patients. Among participants who switched from placebo to Sotyktu at Week 16, observed Week 104 ACR20/50/70 responses reached 76.9%, 54.6% and 37.7%, while MDA was achieved by 48.7%. The data were generated from the 729-patient POETYK PsA-2 trial, which included biologic-naïve patients and patients previously treated with TNFα inhibitors. These longer-term findings expand the evidence base for Sotyktu across multiple manifestations of PsA, a chronic immune-mediated disease affecting joints, skin and other musculoskeletal structures.
Two-Year Safety Profile Remains Consistent
Sotyktu was generally well tolerated through Week 104, with no new safety signals identified, according to Bristol Myers Squibb. Safety outcomes remained consistent with previously reported results through 52 weeks and with the established long-term safety profile observed in the company’s psoriasis clinical program. Among patients with any Sotyktu exposure during the cumulative two-year period, adverse events occurred in 86.6% of 604 patients, serious adverse events in 12.6%, and adverse events leading to discontinuation in 7.6%. The most frequently reported adverse events included upper respiratory tract infection, nasopharyngitis and COVID-19. Sotyktu is an oral selective TYK2 inhibitor designed to selectively inhibit signaling involving IL-23, IL-12 and Type 1 interferons. Its continued evaluation in PsA is focused on demonstrating sustained disease control while expanding understanding of its longer-term use across immune-mediated diseases.
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Bristol Myers Squibb Expands Sotyktu Immunology Strategy
The two-year POETYK PsA-2 findings strengthen Bristol Myers Squibb’s broader development strategy for Sotyktu in immune-mediated diseases, while adding long-term evidence following its PsA approval. The Phase 3 PsA program consists of POETYK PsA-1 and POETYK PsA-2, with both studies evaluating adults with active PsA through placebo-controlled and longer-term treatment periods. Patients completing 52 weeks could enter open-label extensions receiving Sotyktu 6 mg once daily through Week 156, providing an opportunity to generate additional durability and safety data. Bristol Myers Squibb is continuing to build its immunology portfolio across rheumatology, dermatology and pulmonology, with Sotyktu representing an important oral targeted therapy within that strategy. The Week 104 results provide additional clinical evidence for sustained Sotyktu treatment in PsA and support continued evaluation of the therapy across chronic immune-mediated conditions.
Source: Bristol Myers Squibb, press release
