As reported in a recent article by Pharmaceutical Technology, Bristol Myers Squibb (BMS) has secured US Food and Drug Administration (FDA) approval for Sotyktu (deucravacitinib) as a treatment for adults with active psoriatic arthritis (PsA), expanding the drug’s role beyond dermatology into rheumatologic disease. The decision makes Sotyktu the first selective tyrosine kinase 2 (TYK2) inhibitor authorized in the US specifically for psoriatic arthritis.
The approval is supported by results from two pivotal Phase III trials, POETYK PsA‑I and POETYK PsA‑II, which evaluated the safety and efficacy of once-daily oral deucravacitinib 6 mg in adults with active disease. Both studies were multicentre, randomized, double-blind, and placebo-controlled, with treatment periods extending to 52 weeks.
POETYK PsA‑I enrolled 670 patients who had not previously received biologic disease-modifying antirheumatic drugs, while POETYK PsA‑II included 624 patients who were either biologic-naïve or had prior exposure to tumour necrosis factor (TNF) inhibitors. In both trials, the primary endpoint was the proportion of patients achieving an ACR20 response at week 16, a commonly used measure of improvement in signs and symptoms of psoriatic arthritis. Key secondary outcomes included rates of minimal disease activity, as well as more stringent ACR50 and ACR70 responses.
Across both studies, deucravacitinib demonstrated statistically and clinically meaningful improvements in joint and disease activity compared with placebo. The safety profile observed in patients with psoriatic arthritis was consistent with prior experience in plaque psoriasis. The most frequently reported adverse events included acne, folliculitis, elevated blood creatine phosphokinase levels, herpes simplex infections, oral ulcers, and upper respiratory tract infections.
Sotyktu was first approved by the FDA in 2022 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Since that time, the drug has gained approvals in multiple global markets for this dermatologic indication and has accumulated approximately five years of clinical safety and efficacy data in psoriasis populations.
Commenting on the latest approval, Al Reba, senior vice-president for cardiovascular and immunology commercialisation at BMS, said the decision introduces a new, differentiated oral option for people living with psoriatic arthritis, reinforcing Sotyktu’s potential to address both skin and joint manifestations of psoriatic disease. He added that the milestone supports BMS’s broader strategy of developing therapies for immune-mediated conditions with unmet treatment needs.
The regulatory win comes as BMS reported full-year 2025 revenues of $48.2 billion, broadly in line with the $48.3 billion posted in 2024, underscoring a stable financial backdrop as the company expands Sotyktu’s clinical footprint.
