Bristol Myers Squibb announced that the European Commission has approved Sotyktu for the treatment of adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to prior disease-modifying antirheumatic drug (DMARD) therapy.
The approval allows Sotyktu to be used either alone or in combination with methotrexate and marks the first approval of a tyrosine kinase 2 (TYK2) inhibitor for active psoriatic arthritis in the European Union. The once-daily oral therapy represents a new treatment option for patients living with the chronic inflammatory disease, which affects both the joints and skin and can significantly impair quality of life.
According to Bristol Myers Squibb, the approval was supported by results from the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials. The studies evaluated the efficacy and safety of Sotyktu 6 mg once daily in adults with active psoriatic arthritis.
In both trials, patients treated with Sotyktu achieved statistically significant improvements in disease activity compared with placebo. The primary endpoint measured was the American College of Rheumatology 20 (ACR20) response criteria, a standard assessment that evaluates improvement in joint symptoms. Researchers also reported positive outcomes for Minimal Disease Activity (MDA), a key secondary endpoint reflecting broader disease control.
Al Reba, Senior Vice President of Cardiovascular and Immunology Commercialization at Bristol Myers Squibb, said the approval represents an important advancement in addressing both skin and joint symptoms associated with psoriatic arthritis.
He noted that the approval introduces a new therapeutic approach for patients with the chronic immune-mediated condition and added that the company plans to continue evaluating Sotyktu in additional rheumatic diseases.
Frank Behrens, Professor of Rheumatology, Immunology and Inflammation Medicine at Goethe-University Hospital, said psoriatic arthritis manifests differently among patients and often combines widespread musculoskeletal inflammation with difficult-to-manage skin symptoms.
Behrens added that the safety and efficacy profile demonstrated in the POETYK PsA studies supports Sotyktu’s potential to provide comprehensive symptom relief for adults living with the disease.
In addition to improvements in joint and skin symptoms, patients receiving Sotyktu also showed gains in health-related quality of life measures. Clinical trials assessed quality of life using the 36-Item Short Form Health Survey (SF-36), where treated patients experienced improvements in Physical Component Summary scores by Week 16 compared with placebo. These benefits were maintained through Week 52 in both studies.
The overall safety profile observed in patients with active psoriatic arthritis was generally consistent with previous findings in plaque psoriasis studies. The most commonly reported adverse reactions included upper respiratory infections, elevated blood creatine phosphokinase levels, herpes simplex infections, oral ulcers, acneiform rash, and folliculitis.
The therapy also carries warnings regarding infections, tuberculosis screening before treatment, malignancies, major adverse cardiovascular events, deep vein thrombosis, pulmonary embolism, and immunizations.
Sotyktu received approval from the U.S. Food and Drug Administration in March 2026 for adults with active psoriatic arthritis. The drug was first approved in 2022 for moderate-to-severe plaque psoriasis in adults eligible for systemic therapy or phototherapy. In 2023, the European Commission approved Sotyktu for plaque psoriasis, followed by additional approvals in multiple international markets.
Bristol Myers Squibb said the therapy now has five years of clinical efficacy and safety data in moderate-to-severe plaque psoriasis and thanked patients and investigators involved in the POETYK PsA clinical development program.