Sotyktu (deucravacitinib) Awaits FDA Decision by March 6 for Adults with Active Psoriatic Arthritis

The U.S. Food and Drug Administration approved Sotyktu (deucravacitinib) on March 6, 2026, for adults with active psoriatic arthritis, Bristol Myers Squibb announced March 7. The approval was based on phase 3 clinical trials showing significant improvement in joint symptoms and physical function without new safety concerns, officials said.

Sotyktu (deucravacitinib) is the first selective oral tyrosine kinase 2 (TYK2) inhibitor approved for the treatment of adults with active psoriatic arthritis (PsA), Bristol Myers Squibb officials said in a March 7 announcement. The U.S. Food and Drug Administration’s approval on March 6, 2026, followed the agency’s review of supplemental New Drug Application (sNDA) data from two pivotal phase 3 clinical trials, POETYK PsA-1 and POETYK PsA-2, which collectively enrolled nearly 1,400 patients with active PsA and a history of plaque psoriasis, according to company records and clinical trial registries.

In POETYK PsA-1, 54.2% of patients receiving deucravacitinib 6 mg once daily achieved ACR20 at week 16 compared with 34.1% on placebo (P < 0.0001), according to company data.

The POETYK PsA-1 trial (NCT04908202) included 670 biologic-naïve patients, while POETYK PsA-2 enrolled 729 patients with prior tumor necrosis factor (TNF) inhibitor experience, Bristol Myers Squibb reported. Both studies were randomized, double-blind, placebo-controlled trials with a 16-week placebo-controlled period followed by active treatment for up to 52 weeks. The primary endpoint in both trials was the American College of Rheumatology 20 (ACR20) response at week 16.

The trial also demonstrated statistically significant improvements in minimal disease activity (19.0% vs. 10.2%, P < 0.0001), physical function measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI), fatigue assessed by the FACIT-Fatigue scale, and quality of life as measured by the SF-36 Physical Component Summary (PCS). Radiographic progression of joint damage was inhibited at week 16 and this benefit was maintained through week 52. Patients who crossed over from placebo to active treatment at week 16 showed comparable reductions in progression by week 52, officials said.

In POETYK PsA-2, deucravacitinib also met its primary endpoint with an ACR20 response rate of 54.2% versus 39.4% for placebo at week 16 (P = 0.0002). The trial showed greater efficacy across musculoskeletal, dermatologic, disease activity, and quality-of-life measures. Deeper clinical responses, including ACR50 and ACR70, were achieved more frequently with deucravacitinib than placebo, and these responses were durable through 52 weeks, sources confirmed.

The safety profile of deucravacitinib in these PsA trials was consistent with prior studies in moderate-to-severe plaque psoriasis, with no new safety signals observed, according to Bristol Myers Squibb. Notably, the drug does not carry a boxed warning like conventional Janus kinase (JAK) inhibitors, reflecting its selective mechanism of action. Sotyktu selectively inhibits TYK2, a protein that regulates cytokines interleukin (IL)-23, IL-12, and type 1 interferons involved in inflammatory pathways, without affecting JAK1, JAK2, or JAK3, company literature states.

The FDA accepted the sNDA for Sotyktu with a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026. Regulatory milestones include acceptance of supplemental applications in China by the National Medical Products Administration and in Japan by the Ministry of Health, Labour and Welfare, as well as validation of a Type II variation by the European Medicines Agency to expand the indication to psoriatic arthritis, according to Bristol Myers Squibb regulatory filings.

Before approval, approximately one in three rheumatologists surveyed considered Sotyktu a substantial advance for PsA treatment, company officials noted. The approval was supported by 52-week data from both trials, including open-label extension studies, demonstrating durable efficacy in joint symptoms, skin manifestations, and physical function.

Sotyktu had previously received FDA approval for moderate-to-severe plaque psoriasis, making this the first time the selective TYK2 inhibitor was authorized for psoriatic arthritis, according to regulatory records. The drug is administered orally at a dose of 6 mg once daily.