FDA Approves Deucravacitinib (Sotyktu) for Adults with Active Psoriatic Arthritis

The FDA has approved deucravacitinib (Sotyktu) for adults with active psoriatic arthritis (PsA). It's the first oral therapy in its class approved for this condition.

The report says the decision was supported by phase 3 POETYK PsA-1 and POETYK PsA-2 randomized clinical trials, which evaluated deucravacitinib 6 mg once daily in adults with active PsA.

The report attributes the pivotal efficacy evidence to POETYK PsA-1 and POETYK PsA-2 and identifies the primary endpoint as an American College of Rheumatology 20 (ACR20) response at Week 16. In POETYK PsA-1, ACR20 responses were observed in 54% of patients receiving deucravacitinib versus 34% with placebo, a 20–percentage-point difference (95% CI, 12–27). In POETYK PsA-2, ACR20 responses were reported in 54% of treated patients compared with 39% of those receiving placebo, a 15–percentage-point difference (95% CI, 7–23). Overall, the report describes higher Week 16 ACR20 response rates with deucravacitinib than with placebo in both phase 3 trials.

Beyond the primary endpoint, the report lists ACR50 and ACR70 responses and minimal disease activity (MDA) among additional endpoints. It notes that multiplicity adjustments were not applied to some secondary analyses. The report also states that, across both studies, deucravacitinib was associated with improvements in health-related quality of life, including increases in the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS) score at Week 16 compared with placebo. These outcomes are presented alongside the stated analytical caution for select secondary comparisons.

On safety, the report states that the safety profile in patients with PsA was consistent with prior studies in plaque psoriasis. It lists the most common adverse reactions as those occurring in at least 1% of treated patients and more frequently than placebo: upper respiratory infections, increased creatine phosphokinase levels, herpes simplex, mouth ulcers, folliculitis, and acne. The safety section frames these as common reactions observed more often with deucravacitinib than with placebo within the PsA trial dataset, without detailing event rates.

Key Takeaways:

• The report states the FDA approved deucravacitinib (Sotyktu) for adults with active psoriatic arthritis, supported by phase 3 POETYK PsA-1 and PsA-2 trials evaluating 6 mg once daily.
• Across both POETYK PsA trials, the article reports higher Week 16 ACR20 response rates with deucravacitinib than with placebo.
• The report describes the PsA safety profile as consistent with prior plaque psoriasis studies and lists common adverse reactions (≥1% and more frequent than placebo) including upper respiratory infections, increased creatine phosphokinase, herpes simplex, mouth ulcers, folliculitis, and acne.