FDA Approves First, Only TYK2 Inhibitor for the Treatment of Psoriatic Arthritis: Daily Dose

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On March 7, 2026, we reported on the FDA approval of deucravacitinib (Sotyktu, Bristol Myers Squibb) for the treatment of adults with active psoriatic arthritis (PsA).

The approval

The approval was based on results from the randomized, double-blind phase 3 POETYK PsA-1 (NCT04908202) and POETYK PsA-2 (NCT04908189) clinical trials. POETYK PsA-1 evaluated the efficacy and safety of deucravacitinib in approximately 670 persons with active PsA not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD), while POETYK PsA-2 included approximately 730 individuals with active PsA who were bDMARD naïve or who had prior tumor necrosis factor alpha inhibitor treatment.

Results of POETYK PsA-1 (n = 670) showed that deucravacitinib 6 mg once daily demonstrated statistically significant and durable efficacy in biologic-naïve patients with active PsA, with a safety profile consistent with prior psoriasis studies. The trial met its primary endpoint, with deucravacitinib achieving a significantly higher ACR20 (≥ 20% improvement in joint counts and key disease activity measures) response rate than placebo at week 16 (54.2% vs 34.1%; P < .0001). Clinical responses continued to improve beyond week 16 and were maintained through week 52, including sustained ACR50 and ACR70 responses (≥50% and ≥70% improvement, respectively).

Results of POETYK PsA-2 (n = 729) showed that deucravacitinib demonstrated significantly greater efficacy than placebo across key musculoskeletal, dermatologic, disease activity, and quality-of-life endpoints at week 16, with responses maintained through week 52. At week 16, ACR20 was achieved by 54.2% of patients receiving deucravacitinib versus 39.4% with placebo (P = .0002). Higher response rates were also observed for ACR50 (28.8% vs 16.3%) and ACR70 (10.6% vs 5.4%). Skin responses favored deucravacitinib, with PASI75 (≥ 75% improvement from baseline in the Psoriasis Area and Severity Index) achieved in 40.9% versus 15.4% of placebo-treated patients (P < .0001). Minimal disease activity was achieved by 25.6% of patients receiving deucravacitinib compared with 14.7% with placebo (P = .0007). Deucravacitinib was associated with greater improvements in physical function and health-related quality of life, and improvements were observed in disease activity measures.

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