US FDA Approves First and Only TYK2 Inhibitor for the Treatment of Psoriatic Arthritis

The US Food and Drug Administration (FDA) today approved deucravacitinib (Sotyktu, Bristol Myers Squibb) for the treatment of adults with active psoriatic arthritis (PsA).¹

“Today’s announcement marks the introduction of a new, differentiated option to treat adults with active psoriatic arthritis,” Al Reba, senior vice president, Cardiovascular & Immunology Commercialization, Bristol Myers Squibb. “This latest approval of Sotyktu confirms its important role in managing both skin and joint symptoms of psoriatic disease and is a key milestone as we continue to explore its development in diseases that have limited or no treatment options.”

The approval is 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.^2,3

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).⁴

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.⁵

“The psoriatic disease community has been waiting for an additional oral treatment to address the debilitating joint and skin symptoms of this disease,” Steven Taylor, President & Chief Executive Officer of the Arthritis Foundation, said in a press release. “We welcome this new treatment option for people living with psoriatic arthritis.”¹

References:

1. U.S. FDA Approves Bristol Myers Squibb’s Sotyktu® (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis. Bristol Myers Squibb. News release. March 7, 2026. Accessed March 7, 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
2. A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs. ClinicalTrials.gov. Updated September 27, 2024. Accessed March 5, 2026. https://clinicaltrials.gov/study/NCT04908202
3. A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment. ClinicalTrials.gov. Updated June 11, 2025. Accessed June 12, 2025. https://www.clinicaltrials.gov/study/NCT04908189
4. van der Heijde D, Mease P, Paul C, et al. Efficacy and Safety of Deucravacitinib up to Week 52: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study in Patients With Active Psoriatic Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs. Presented at: ACR Convergence 2025; October 24-29; Chicago, Illinois. Abstract #LB20
5. Bristol Myers Squibb Presents Late-Breaking Data from Phase 3 POETYK PsA-2 Trial Demonstrating Superiority of Sotyktu (deucravacitinib) Compared with Placebo in Adults with Psoriatic Arthritis. News release. Bristol Myers Squibb. March 8, 2025. Accessed March 5, 2026. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-Late-Breaking-Data-from-Phase-3-POETYK-PsA-2-Trial-Demonstrating-Superiority-of-Sotyktu-deucravacitinib-Compared-with-Placebo-in-Adults-with-Psoriatic-Arthritis/default.aspx