The US FDA has approved Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis, Bristol Myers Squibb announced on 6 March 2026. The oral, once-daily selective tyrosine kinase 2 (TYK2) inhibitor is the first drug of its mechanistic class to receive approval for this indication. Sotyktu was first approved in 2022 for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, and the psoriatic arthritis indication represents the second US approval for the molecule.
The approval covers adults with active psoriatic arthritis at a dose of 6 mg once daily. Sotyktu achieves selectivity for TYK2 by binding to the enzyme's regulatory domain, resulting in allosteric inhibition that mediates signaling through interleukin-23, interleukin-12, and type I interferons. The drug has not been shown to inhibit JAK1, JAK2, or JAK3 in in vitro assays at physiologically relevant concentrations, though the label carries a precautionary statement noting that it is not known whether TYK2 inhibition may be associated with adverse reactions observed with JAK inhibitors. Sotyktu is not recommended for use with other potent immunosuppressants.
The approval was supported by results from two Phase 3, randomized, double-blind, placebo-controlled trials. POETYK PsA-1 enrolled 670 patients naïve to biologic disease-modifying antirheumatic drugs, while POETYK PsA-2 enrolled 624 patients who were either biologic-naïve or had prior TNFα inhibitor exposure. In both studies, the primary endpoint was the proportion of patients achieving an ACR20 response at Week 16. In POETYK PsA-1, 54% of patients receiving Sotyktu achieved ACR20 compared with 34% on placebo (difference 20 percentage points; 95% CI 12–27; p<0.0002). In POETYK PsA-2, ACR20 rates were 54% versus 39% (difference 15 percentage points; 95% CI 7–23; p<0.0002). Minimal disease activity, a key secondary endpoint, was also met in both trials: 19% versus 10% in PsA-1 (p=0.0012) and 26% versus 15% in PsA-2 (p=0.0007). The safety profile observed in the psoriatic arthritis trials was generally consistent with that established in plaque psoriasis. The most common adverse reactions at 1% or greater included upper respiratory infections, elevated creatine phosphokinase, herpes simplex, mouth ulcers, folliculitis, and acne.
The approval arrives in a psoriatic arthritis treatment landscape that has expanded considerably in recent years, with multiple biologic and targeted oral therapies now available. Injectable options include TNFα inhibitors, IL-17 inhibitors such as secukinumab and ixekizumab, the dual IL-17A/F inhibitor bimekizumab (approved for psoriatic arthritis in 2024), and IL-23 inhibitors guselkumab and risankizumab. Among oral targeted therapies, apremilast offers a PDE4-based mechanism with a more modest efficacy profile, while the JAK inhibitors tofacitinib and upadacitinib carry boxed warnings regarding cardiovascular events, thrombosis, malignancy, and mortality derived from postmarketing data in rheumatoid arthritis. The addition of deucravacitinib introduces a mechanistically distinct oral option that does not carry those same boxed warnings, though its label does reference potential risks related to JAK inhibition as a class consideration. Up to 30% of patients with psoriasis develop psoriatic arthritis, a chronic condition that can cause progressive joint damage and disability. The disease remains heterogeneous, and many patients do not achieve minimal disease activity or remission on existing therapies. The company said it continues to explore deucravacitinib's development in diseases with limited or no treatment options.
Spot something wrong? Report an issue with this article