By: IPP Bureau
Last updated : May 11, 2026 11:25 am
The once-daily oral therapy is the first and only tyrosine kinase 2 (TYK2) inhibitor approved in the European Union for this indication, marking a significant expansion of its immunology portfolio
Bristol Myers Squibb has secured a major regulatory win, announcing that the European Commission has approved Sotyktu (deucravacitinib) for the treatment of active psoriatic arthritis (PsA) in adults.
The drug may be used alone or in combination with methotrexate in patients who have had an inadequate response or intolerance to prior disease-modifying antirheumatic drugs (DMARDs).
The once-daily oral therapy is the first and only tyrosine kinase 2 (TYK2) inhibitor approved in the European Union for this indication, marking a significant expansion of its immunology portfolio.
“The European approval of Sotyktu for active psoriatic arthritis represents an important advancement in addressing both the skin and joint symptoms of this chronic immune-mediated disease,” said Al Reba, senior vice president, Cardiovascular & Immunology Commercialization, Bristol Myers Squibb.
“This milestone marks a new approach to treating psoriatic arthritis, and we look forward to continuing the development of Sotyktu for other serious rheumatic conditions as part of our commitment to addressing the life-altering impact of these diseases.”
The approval is backed by data from the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 trials, which showed Sotyktu outperformed placebo at Week 16 across key endpoints, including American College of Rheumatology (ACR) 20 response rates and Minimal Disease Activity (MDA).
Improvements extended across both joint and skin symptoms, with sustained benefits observed through Week 52 in select measures.
“The impressive safety and the efficacy profile observed in the pivotal POETYK PsA trials demonstrate the ability of Sotyktu, the first approved TYK2 inhibitor, to provide comprehensive relief for adults living with this chronic, immune-mediated inflammatory disease,” said Frank Behrens, Professor of Rheumatology, Immunology, and Inflammation Medicine, Goethe-University Hospital, Frankfurt.
Quality-of-life gains were also recorded using the SF-36 survey, with patients on Sotyktu showing meaningful improvement in physical health scores compared with placebo.
Safety findings were consistent with prior studies in plaque psoriasis, with common adverse events including upper respiratory infections, elevated creatine phosphokinase, herpes simplex infections, oral ulcers, acneiform rash, and folliculitis.
The label includes warnings for infections, malignancy risk, cardiovascular events, thrombosis, and laboratory abnormalities.
Already approved in the United States for active PsA and previously for moderate-to-severe plaque psoriasis, Sotyktu continues its global rollout across multiple indications.
Psoriatic arthritis affects up to 30% of people with psoriasis and is characterized by inflammatory joint disease, enthesitis, dactylitis, and skin and nail involvement—often with a profound impact on quality of life.
With this latest approval, Bristol Myers Squibb strengthens its position in immunology, betting on targeted TYK2 inhibition as a next-generation approach to treating chronic inflammatory disease.