FDA

FDA approves Sotyktu for active psoriatic arthritis in adults

March 13, 2026

On March 6, 2026, FDA approved Sotyktu (deucravacitinib), an oral tyrosine kinase 2 (TYK2) inhibitor, for the treatment of active psoriatic arthritis (PsA) in adults. Sotyktu was already approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Efficacy

Efficacy was assessed in two multicenter randomized, double-blind, placebo-controlled trials (PsA-1 and PsA-2), in which a total of 1,294 adults with active PsA (≥3 swollen joints, ≥3 tender joints, a C-reactive protein (CRP) level of ≥3 mg/L) and with active or a history of plaque psoriasis, were randomized to placebo or Sotyktu 6 mg once daily. In the PsA-1 trial, subjects also had presence of ≥1 bone erosion on X-ray of hands and/or feet. Trial PsA-2 included an active safety reference arm, in which 105 patients received apremilast 30 mg twice daily. After 16 weeks of treatment, all patients in both studies received active treatment with Sotyktu through 52 weeks.

Across the two trials, the mean age was 51 years, the mean weight was 84 kg, 49% of subjects were male, 23% were Hispanic or Latino, 78% were White, and 0.4% were Black and 11% were Asian. Subjects had a median duration of disease of 4.0 years and the majority of subjects had polyarthritis (76%) followed by oligoarthritis (14%). The majority of subjects in both trials were naïve to biologic treatment and had experienced an inadequate response, intolerance or loss of response to nonsteroidal anti-inflammatory drugs (NSAIDs), conventional synthetic DMARDs (csDMARDs), or apremilast. Trial PsA-2 also included anti-TNF alpha-experienced subjects. In the two trials, 56% of subjects were taking concomitant methotrexate; 10% were taking other concomitant csDMARDs, and 34% were not taking csDMARDs.

The primary endpoint in both trials was the percentage of subjects who achieved an American College of Rheumatology improvement of 20% (ACR20) response at week 16. In both trials, treatment with Sotyktu resulted in statistically significant improvement in disease activity, as measured by ACR20, compared to placebo at week 16. In the PsA-1 trial, ACR20 at week 16 was 54% in Sotyktu-treated patients vs. 34% in the placebo group-- a difference of 20% (95% confidence interval [CI], 13-27). In Trial PsA-2 , it was 54% vs 39%; difference, 15% (95% CI, 7-23). In both trials, ACR20 responses at week 16 were consistent regardless of concomitant DMARD use, age, gender, race, or baseline disease characteristics. In Trial PsA-2, similar ACR response rates were seen regardless of prior anti-TNF alpha therapy.

Safety

The overall safety profile of Sotyktu observed in patients with active psoriatic arthritis was generally consistent with the established safety profile in patients with plaque psoriasis. Most common adverse reactions (≥ 1%) are: upper respiratory infections, increased blood creatine phosphokinase (CPK), herpes simplex, mouth ulcers, folliculitis, and acne.

Recommended dose

Recommended Sotyktu dosage is 6 mg orally once daily.

Sotyktu is not recommended in patients with severe hepatic impairment (Child-Pugh C).

Sources:

Bristol Myers Squibb. (2026, March 6). U.S. FDA Approves Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis. [Press release]. https://news.bms.com/news/details/2026/U-S--FDA-Approves-Bristol-Myers-Squibbs-Sotyktu-deucravacitinib-for-the-Treatment-of-Adults-with-Active-Psoriatic-Arthritis/default.aspx

Sotyktu (deucravacitinib). [Package insert]. https://www.accessdata.fda.gov/drugsatfa_docs/label/2026/214958s002lbl.pdf Revised March 2026.