FDA Approves Sotyktu for the Treatment of Adults with Active Psoriatic Arthritis
On March 6, 2026, the US Food and Drug Administration (FDA) approved Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis (PsA). Deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, is the first TYK2 inhibitor approved for PsA and is taken once daily at a 6 mg dose.
The approval is based on data from the phase 3 POETYK PsA-1 and POETYK PsA-2 trials, which enrolled 670 and 624 adults with active PsA, respectively. Participants met CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria and had at least 3 swollen and 3 tender joints, along with active or documented plaque psoriasis. Both trials evaluated deucravacitinib 6 mg once daily vs placebo, with the primary endpoint defined as achievement of an American College of Rheumatology 20 (ACR20) response at week 16. In both studies, deucravacitinib demonstrated significant improvement in ACR20 and Minimal Disease Activity responses compared with placebo.
Health-related quality of life was also assessed using the 36-Item Short Form Health Survey (SF-36). “Patients treated with Sotyktu showed improvements in SF-36 Physical Component Summary score at week 16 compared to placebo,” said Philip J. Mease, MD, noting gains in physical functioning, bodily pain, and general health domains.
The overall safety profile in PsA was generally consistent with prior psoriasis studies. The most common adverse reactions (≥1% in deucravacitinib and greater than placebo) included upper respiratory infections, increased creatine phosphokinase, herpes simplex, mouth ulcers, folliculitis, and acne. Warnings and precautions include hypersensitivity reactions, infections, tuberculosis, malignancy including lymphomas, rhabdomyolysis, laboratory abnormalities, immunizations, and potential risks related to Janus kinase inhibition.
Reference
U.S. FDA Approves Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis. News release. March 6, 2026. Accessed March 10, 2026. https://www.businesswire.com/news/home/20260306816774/en/U.S.-FDA-Approves-Bristol-Myers-Squibbs-Sotyktu-deucravacitinib-for-the-Treatment-of-Adults-with-Active-Psoriatic-Arthritis
