The European Commission has approved Bristol Myers Squibb’s Sotyktu (deucravacitinib) for adults with active psoriatic arthritis who had inadequate response or intolerance to prior DMARD therapy, making it the first TYK2 inhibitor authorized in the EU for PsA.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
The European Commission has approved Bristol Myers Squibb’s Sotyktu, alone or in combination with methotrexate, for adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to prior disease-modifying antirheumatic drug (DMARD) therapy. The decision makes Sotyktu the first tyrosine kinase 2 (TYK2) inhibitor authorized in the European Union for active PsA.
Sotyktu is a once-daily oral, selective TYK2 inhibitor designed to modulate signaling pathways linked to inflammatory diseases, including interleukin-23, interleukin-12, and type 1 interferons, offering a systemic oral option for both joint and skin manifestations of PsA.
The approval is based on results from the Phase 3 POETYK PsA-1 (NCT04908202) and POETYK PsA-2 (NCT04908189) trials, which evaluated Sotyktu 6 mg once daily in adults with active PsA. Across both studies, the drug achieved statistically significant improvements versus placebo in the primary endpoint of American College of Rheumatology 20 (ACR20) response and the key secondary endpoint of Minimal Disease Activity (MDA) at Week 16.
Together, the trials enrolled more than 1,200 patients, with PsA-1 focusing on biologic DMARD-naïve individuals and PsA-2 including both biologic-naïve patients and those previously treated with TNF-alpha inhibitors.
In POETYK PsA-1, 54.2% of Sotyktu-treated patients achieved ACR20 at Week 16 versus 34.1% with placebo. In PsA-2, ACR20 responses were 54.2% versus 39.4% for Sotyktu and placebo, respectively. MDA responses at Week 16 were 19.0% versus 10.2% in PsA-1 and 25.6% versus 14.7% in PsA-2 for Sotyktu and placebo, respectively. Additional efficacy measures, including ACR50 and ACR70 responses, also favored Sotyktu across both studies.
Health-related quality of life, measured by the SF-36 Physical Component Summary (PCS) score, improved at Week 16 and was sustained through Week 52, supporting durable symptom control. The safety profile in PsA patients was generally consistent with that observed in moderate-to-severe plaque psoriasis.
The most common adverse reactions included upper respiratory tract infections, increased blood creatine phosphokinase, herpes simplex infections, oral ulcers, acneiform rash, and folliculitis. Additional warnings included infections, including tuberculosis screening requirements, malignancies, major adverse cardiovascular events, venous thromboembolism, and pulmonary embolism.
Al Reba, senior vice president of Cardiovascular & Immunology Commercialization at Bristol Myers Squibb, said the approval addresses both joint- and skin-dominant disease manifestations in PsA and highlighted the company’s ongoing development efforts in other rheumatic conditions.
Frank Behrens, Professor of Rheumatology, Immunology, and Inflammation Medicine at Goethe-University Hospital, stated that the Phase 3 data demonstrated strong efficacy and a favorable safety and tolerability profile across diverse PsA manifestations.
Sotyktu was initially approved in the United States in 2022 and in the European Union in 2023 for moderate-to-severe plaque psoriasis. The drug also received U.S. FDA approval for active PsA in March 2026, ahead of the current EU authorization.
Psoriatic arthritis is a chronic immune-mediated disease affecting joints, tendons, skin, and nails. Up to 30% of patients with psoriasis may develop PsA, which is associated with pain, fatigue, functional impairment, and an increased risk of serious comorbidities.
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About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.