FDA approves TYK2 inhibitor deucravacitinib for adults with active PsA

On March 6, 2026, the U.S. Food and Drug Administration (FDA) approved deucravacitinib, an oral selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with active psoriatic arthritis (PsA). Deucravacitinib is the first TYK2 inhibitor approved for this indication. 

The approval was based on results from the phase III, multicenter, randomized, double-blind, placebo-controlled POETYK PsA-1 (NCT04908202; N = 670) and POETYK PsA-2 (NCT04908189; N = 729) trials, which evaluated the safety and efficacy of 6 mg once daily deucravacitinib in adults with active PsA. POETYK PsA-1 enrolled patients not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD). POETYK PsA-2 enrolled patients who were bDMARD-naïve or had previously received tumor necrosis factor α (TNF-α) inhibitor treatment. Deucravacitinib 6 mg once daily was associated with significantly higher Week 16 American College of Rheumatology >20% improvement (ACR20) vs placebo in POETYK PsA-1 (54% vs 34%; multiplicity-controlled p < 0.0002) and POETYK PsA-2 (54% vs 39%; multiplicity-controlled p < 0.0002). Minimal disease activity response was also higher with deucravacitinib vs placebo in POETYK PsA-1 (19% vs 10%; p= 0.0012) and POETYK PsA-2 (26% vs 15%; p = 0.0007). The overall safety profile of deucravacitinib in PsA was generally consistent with that observed in patients with plaque psoriasis.