FDA Approves Sotyktu for Adults With Active Psoriatic Arthritis

WEDNESDAY, March 11, 2026 (HealthDay News) -- The U.S. Food and Drug Administration has approved Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis.Sotyktu is an oral, selective tyrosine kinase 2 inhibitor and is the first such inhibitor to be approved for psoriatic arthritis.The approval is based on results from the POETYK PsA-1 and POETYK PsA-2 trials, which involved 670 and 624 participants, respectively. Compared with placebo, Sotyktu resulted in significant improvement in disease activity, as measured by American College of Rheumatology ≥20 percent improvement, which was achieved by 54 percent of 336 patients and 54 percent of 312 assigned to Sotyktu in the two trials, compared with 34 percent of 334 and 39 percent of 312 assigned to placebo. The secondary end point of minimal disease activity response was seen in 19 and 26 percent assigned to Sotyktu versus 10 and 15 percent receiving placebo. The safety profile was consistent with that seen in patients with plaque psoriasis."Patients treated with Sotyktu showed improvements in 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS) score at week 16 compared to placebo," Philip J. Mease, M.D., from the University of Washington in Seattle, said in a statement. "There were also improvements in all four SF-36 PCS domain scale scores: physical functioning, role-physical, bodily-pain, and general health. By aiding in symptom management, Sotyktu could make a meaningful difference for patients."Approval of Sotyktu was granted to Bristol Myers Squibb.More Information.Sign up for our weekly HealthDay newsletter

FDA Approves Sotyktu for Adults With Active Psoriatic Arthritis

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