FDA Approves First TYK2 Inhibitor for Adults With Active Psoriatic Arthritis

This past Friday, the FDA approved deucravacitinib (Sotyktu; Bristol Myers Squibb), an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for adults with active psoriatic arthritis (PsA), the first in its drug class to receive this indication.¹

The agency first approved deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.² Taken as a 6-mg tablet, deucravacitinib selectively targets TYK2, interfering with the signaling of IL-23, IL-12, and type 1 interferons, all key cytokines involved in the pathogenesis of both plaque psoriasis and PsA.¹

“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,” Al Reba, vice president of cardiovascular and immunology commercialization at Bristol Myers Squibb, said in a news release.¹

Friday’s approval was based on positive results from the pivotal phase 3 POETYK PsA-1 (NCT04908202) and POETYK PsA-2 (NCT04908189) trials, which evaluated the efficacy and safety of deucravacitinib 6 mg once daily in adults with active PsA. Findings presented at the EULAR 2025 Congress this past summer demonstrated deucravacitinib’s potential as a new treatment option for patients who are biologic naive or have had prior therapy, with clinical responses maintained through 52 weeks.³

Specifically, in the POETYK PsA-1 trial, patients treated with deucravacitinib experienced statistically significant improvements in American College of Rheumatology 20 (ACR20), ACR50, and ACR70 responses compared with placebo, along with substantial skin clearance, as shown by Psoriasis Area and Severity Index (PASI) 75 responses (51.9% vs 7.1%) by week 16.

Key secondary patient-reported end points were also achieved, including reductions in the Health Assessment Questionnaire-Disability Index (HAQ-DI) and improvements in both the Physical Component Summary (SF-36 PCS) and Functional Assessment of Chronic Illness Therapy-Fatigue scores. The researchers also observed improvements in composite measures such as Minimal Disease Activity (MDA).

Although the prespecified analysis of radiographic progression did not reach statistical significance, post hoc analysis showed a larger proportion of patients on deucravacitinib had no progression at week 16.

Similarly, in the POETYK PsA-2 trial, deucravacitinib demonstrated sustained and continued improvement in clinical responses through week 52 in patients with active PsA. At week 16, significantly more patients receiving deucravacitinib achieved an ACR20 response than placebo (54.2% vs 39.4%; P = .0002). ACR20 rates increased to 62.2% for patients on continuous deucravacitinib and 67.3% for those who switched from placebo by week 52.

Improvements in ACR50, ACR70, PASI 75, HAQ-DI, MDA response, and SF-36 PCS were maintained or enhanced through week 52. Lastly, the overall safety profile of deucravacitinib observed in patients with active PsA was consistent with that seen in those with plaque psoriasis.¹ The most common adverse reactions include upper respiratory infections, mouth ulcers, folliculitis, and acne.

Still, the PsA community welcomes this approval with open arms.

“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.”

References

1. US 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://news.bms.com/news/corporate-financial/2026/U-S--FDA-Approves-Bristol-Myers-Squibbs-Sotyktu-deucravacitinib-for-the-Treatment-of-Adults-with-Active-Psoriatic-Arthritis/default.aspx
2. PT staff. FDA approves deucravacitinib for adults with moderate-to-severe plaque psoriasis. Pharmacy Times. Updated September 15, 2022. Accessed March 9, 2026. https://www.pharmacytimes.com/view/fda-approves-deucravacitinib-for-adults-with-moderate-to-severe-plaque-psoriasis
3. Steinzor P. Deucravacitinib shows superiority in psoriatic arthritis phase 3 trial. AJMC. Updated June 13, 2025. Accessed March 9, 2026. https://www.ajmc.com/view/deucravacitinib-shows-superiority-in-psoriatic-arthritis-phase-3-trial