FDA Grants Second Approval to Sotyktu in the US; approved for Adults with Active Psoriatic Arthritis

The U.S. Food and Drug Administration (FDA) has granted approval for Sotyktu (deucravacitinib), an oral, selective inhibitor of tyrosine kinase 2 (TYK2), for use in adult patients with active psoriatic arthritis (PsA). This marks the first approval of a TYK2 inhibitor for this condition in the United States.

The decision was supported by positive outcomes from two pivotal Phase 3 clinical studies, POETYK PsA-1 and POETYK PsA-2, which evaluated the efficacy and safety of deucravacitinib at a dosage of 6 mg taken once daily. Both trials demonstrated that patients receiving deucravacitinib experienced a significant reduction in disease activity compared with placebo, based on American College of Rheumatology 20% improvement (ACR20) scores at Week 16, the primary efficacy measure. Clinically meaningful improvements were also observed in secondary endpoints, including the proportion of participants achieving Minimal Disease Activity (MDA).

Key Clinical Findings of POETYK PsA Clinical Program

In both Phase 3 trials, deucravacitinib treatment resulted in higher response rates compared with placebo across major clinical endpoints:

Endpoint	Trial	Sotyktu (%)	Placebo (%)	Difference
ACR20 response	PsA-1	54	34	+20
ACR20 response	PsA-2	54	39	+15
ACR50 response	PsA-1	24	14	+11
ACR50 response	PsA-2	29	16	+13
ACR70 response	PsA-1	12	5	+6
ACR70 response	PsA-2	10	5	+5
Minimal Disease Activity	PsA-1	19	10	+9
Minimal Disease Activity	PsA-2	26	15	+11

About the POETYK PsA Clinical Program

The Phase 3 POETYK PsA development program consists of two multicenter, randomized, double-blind, placebo-controlled trials: POETYK PsA-1 and POETYK PsA-2. Both studies enrolled adults aged 18 years and older with active psoriatic arthritis.

• POETYK PsA-1 involved 670 participants who had not previously received biologic disease-modifying antirheumatic drugs (bDMARDs).

• POETYK PsA-2 included 624 patients who were either bDMARD-naïve or had been treated previously with tumor necrosis factor (TNF) inhibitors.

Participants met the Classification Criteria for Psoriatic Arthritis (CASPAR), having at least three swollen and three tender joints, along with current or historical evidence of plaque psoriasis.

Each trial featured a 52-week study period. The first 16 weeks compared deucravacitinib with placebo, after which all participants transitioned to active treatment through Week 52. The second study (PsA-2) additionally included a comparison arm for apremilast to assess safety.

The main goal in both studies was to determine the percentage of participants achieving ACR20 improvement by Week 16, with several secondary measures evaluating overall disease control and symptom relief.

Participants completing 52 weeks of therapy were offered the opportunity to continue into an open-label extension phase lasting up to three years.