Bristol‑Myers Squibb reported that 63.1% of patients receiving continuous Sotyktu (deucravacitinib) achieved an ACR20 response at week 52 in the POETYK PsA‑1 trial, compared with 54.2% at week 16. Patients who switched from placebo to Sotyktu at week 16 reached a 60.8% ACR20 rate at week 52. Radiographic analysis confirmed inhibition of joint‑damage progression, and the safety profile remained consistent with earlier data, with upper respiratory infection the most frequently reported adverse event.
Integrated analyses of the PAISLEY‑SLE and PAISLEY LTE studies showed sustained efficacy and consistent safety of Sotyktu for up to four years in patients with moderate‑to‑severe systemic lupus erythematosus. Phase 3 trials for lupus are ongoing, and the long‑term data reinforce the drug’s durability in this indication.
Sotyktu is already approved in multiple countries for moderate‑to‑severe plaque psoriasis. Regulatory applications for psoriatic arthritis are under review in the United States, European Union, Japan, and China, with the FDA assigning a PDUFA goal date of March 6 2026. The company also presented Phase 1 data for a CD19‑targeted CAR T cell therapy (BMS‑986353) in severe, refractory SLE, systemic sclerosis, and idiopathic inflammatory myopathies, highlighting its broader autoimmune pipeline.
The positive 52‑week results strengthen Bristol‑Myers Squibb’s autoimmune portfolio and support potential label expansion, offering a moderate benefit to the company’s long‑term growth prospects.
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