FDA Approves Deucravacitinib for Active Psoriatic Arthritis

The FDA has approved deucravacitinib (Sotyktu; Bristol Myers Squibb) for the treatment of adults with active psoriatic arthritis (PsA), making it the first and only tyrosine kinase 2 (TYK2) inhibitor approved for this indication.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 and immunology commercialization, Bristol Myers Squibb, said in a news release. “This latest approval of [deucravacitinib] 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.”¹

PsA is a chronic, immune-mediated, heterogeneous disease with manifestations spanning the musculoskeletal and cutaneous systems, including inflammatory arthritis, enthesitis, dactylitis, and psoriatic skin and nail lesions. Up to 30% of patients with psoriasis go on to develop PsA.¹

"PsA is a chronic, progressive autoimmune condition that often involves both the joints and skin. Patients often have trouble moving and staying active and can experience pain in the joints, tendons, or ligaments," Philip J. Mease, MD, director of rheumatology research, Providence Swedish Medical Center, and clinical professor, University of Washington School of Medicine, Seattle, said. "New oral, effective first-line treatments are needed.”¹

Evidence Supporting Approval

The approval is supported by data from the phase 3 POETYK PsA-1 (NCT04908202) and POETYK PsA-2 (NCT04908189) trials, which evaluated deucravacitinib 6 mg once daily in adults with active PsA. Both trials met their primary end point: a significantly greater proportion of deucravacitinib-treated patients achieved an American College of Rheumatology 20% improvement response at week 16 compared with placebo (POETYK PsA-1: 54.2% vs 34.1%; P < .0001; POETYK PsA-2: 54.2% vs 39.4%; P =.0002).^2-4 Minimal disease activity response was a key secondary end point also met in both trials.¹ Data from POETYK PsA-2 further demonstrated that clinical response improved and was maintained from week 16 through week 52.²

“In clinical trials, health-related quality of life was assessed by the 36-Item Short Form Health Survey (SF-36). Patients treated with [deucravacitinib] showed improvements in SF-36 Physical Component Summary (PCS) score at week 16 compared to placebo (key secondary end point). There were also improvements in all 4 SF-36 PCS domain scale scores: physical functioning, role-physical, bodily pain, and general health. By aiding in symptom management, [deucravacitinib] could make a meaningful difference for patients,” Mease said.¹

Deucravacitinib binds selectively to the regulatory domain of TYK2, inducing allosteric inhibition and downstream modulation of IL-23, IL-12, and type 1 interferons.¹ The overall safety profile in patients with PsA was consistent with that observed in plaque psoriasis. The most common adverse events included upper respiratory infections, elevated creatine kinase, herpes simplex, mouth ulcers, folliculitis, and acne.¹

The FDA first approved deucravacitinib in 2022 for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.¹

“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 and CEO of the Arthritis Foundation, said in the news release. “We welcome this new treatment option for people living with PsA.”¹

REFERENCES

1. U.S. FDA approves Bristol Myers Squibb's Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis. News release. Bristol Myers Squibb. March 6, 2026. Accessed March 9, 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. Bristol Myers Squibb presents late-breaking data from pivotal phase 3 POETYK PsA-1 trial demonstrating superiority of Sotyktu (deucravacitinib) compared with placebo in adults with psoriatic arthritis. News release. Bristol Myers Squibb. June 11, 2025. Accessed March 9, 2026. https://news.bms.com/news/details/2025/Bristol-Myers-Squibb-Presents-Late-Breaking-Data-from-Pivotal-Phase-3-POETYK-PsA-1-Trial-Demonstrating-Superiority-of-Sotyktu-deucravacitinib-Compared-with-Placebo-in-Adults-with-Psoriatic-Arthritis/default.aspx

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. ClinicalTrials.gov. Updated October 24, 2025. Accessed March 9, 2025. https://clinicaltrials.gov/study/NCT04908202

4. 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 13, 2025. Accessed March 9, 2026. https://clinicaltrials.gov/study/NCT04908189