Bristol Myers Squibb has received European Commission approval for Sotyktu (deucravacitinib) to treat adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to at least one disease‑modifying antirheumatic drug (DMARD). The decision makes Sotyktu, a once‑daily oral, selective tyrosine kinase 2 (TYK2) inhibitor, the first medicine in its class cleared in the European Union for this indication.
The EU approval is based on data from the pivotal Phase 3 POETYK PsA‑1 and POETYK PsA‑2 studies, which evaluated Sotyktu 6 mg once daily, alone or in combination with methotrexate, in adults with active PsA. In both trials, Sotyktu met the primary endpoint, delivering significantly higher American College of Rheumatology 20 (ACR20) response rates at Week 16 versus placebo, and achieved key secondary endpoints such as Minimal Disease Activity (MDA) and improvements in quality‑of‑life measures. Health‑related quality of life, assessed by the SF‑36 Physical Component Summary score, improved at Week 16 compared with placebo and was maintained through Week 52 in both studies.
BMS positioned the approval as an important advance for patients living with a chronic immune‑mediated disease that often involves both joint inflammation and difficult‑to‑manage skin symptoms. “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 at Bristol Myers Squibb, in the company’s statement. The company said it plans to continue developing deucravacitinib across additional rheumatologic indications as part of a broader immunology strategy.
Investigators highlighted the drug’s efficacy and safety profile in the Phase 3 program. According to Frank Behrens, MD, Professor of Rheumatology, Immunology and Inflammation Medicine at Goethe‑University Hospital, the POETYK PsA data demonstrate that Sotyktu can provide “comprehensive relief” across musculoskeletal and skin domains for adults with PsA. The overall safety profile in psoriatic arthritis was generally consistent with that seen in patients with plaque psoriasis treated with Sotyktu, with the most common adverse reactions (≥1%) including upper respiratory infections, increased blood creatine phosphokinase, herpes simplex infections, oral ulcers, acneiform rash and folliculitis.
The European label includes special warnings and precautions related to infections, tuberculosis screening, malignancies, major adverse cardiovascular events, venous thromboembolism, immunizations and certain excipients. Treatment is not recommended in combination with other potent immunosuppressants, reflecting broader class concerns around immunomodulatory therapies. Sotyktu was first approved in the EU in 2023 for adults with moderate‑to‑severe plaque psoriasis who are candidates for systemic therapy, and the new PsA indication further broadens its use in immune‑mediated inflammatory disease.
The updated European Summary of Product Characteristics reflecting the psoriatic arthritis indication will be published on the European Medicines Agency website following the Commission’s decision. BMS said the expanded label underscores its commitment to immunology and adds another oral option in a PsA treatment landscape still dominated by injectable biologics.
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