PRINCETON, N.J., May 11, 2026
Bristol Myers Squibb announced that the European Commission has approved Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis (PsA) who previously showed inadequate response or intolerance to disease-modifying antirheumatic drugs (DMARDs). The approval marks a major regulatory milestone for the company’s immunology portfolio and positions Sotyktu as the first and only TYK2 inhibitor approved in the European Union for active psoriatic arthritis.
The once-daily oral therapy can be used either alone or in combination with methotrexate and expands Bristol Myers Squibb’s presence in chronic immune-mediated inflammatory diseases beyond plaque psoriasis. The decision was supported by positive data from the pivotal Phase 3 POETYK PsA clinical trial program, where Sotyktu demonstrated statistically significant improvements in both joint and skin manifestations associated with psoriatic arthritis. The approval also reinforces growing industry confidence in selective TYK2 inhibition as a differentiated immunology treatment mechanism capable of delivering efficacy while maintaining a favorable safety profile compared with broader JAK inhibition approaches.
Phase 3 POETYK Trials Demonstrated Significant Clinical Benefit
The European approval was primarily based on results from the POETYK PsA-1 and POETYK PsA-2 Phase 3 trials, which evaluated Sotyktu 6 mg once daily in adults with active psoriatic arthritis. Across both studies, patients treated with Sotyktu achieved significantly higher rates of ACR20 response, the primary endpoint measuring improvement in disease activity, compared with placebo at Week 16. The trials also demonstrated improvement in the key secondary endpoint of Minimal Disease Activity (MDA), highlighting benefits across both musculoskeletal inflammation and skin disease burden.
In POETYK PsA-1, 54.2% of patients receiving Sotyktu achieved ACR20 response versus 34.1% with placebo, while POETYK PsA-2 showed a similar 54.2% response rate compared with 39.4% for placebo-treated patients. Additional analyses revealed improvements in higher response thresholds including ACR50 and ACR70, further supporting the therapy’s broad clinical activity. Researchers also reported meaningful gains in patient-reported outcomes and physical functioning, including improvements measured using the SF-36 Physical Component Summary score, an important indicator of health-related quality of life for patients living with chronic inflammatory disease.
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First Approved TYK2 Inhibitor Expands Immunology Treatment Options
Sotyktu represents a major advancement in immunology because it is the first approved selective TYK2 inhibitor designed to target signaling pathways involved in inflammatory diseases while avoiding broader inhibition of JAK1, JAK2, or JAK3 pathways. The therapy works by selectively binding to the regulatory domain of TYK2, modulating cytokines including IL-23, IL-12, and Type 1 interferons, which are known contributors to psoriatic arthritis and plaque psoriasis pathogenesis. Bristol Myers Squibb emphasized that the differentiated mechanism may help provide durable efficacy with a manageable safety profile.
Clinical safety findings in psoriatic arthritis patients were generally consistent with previous studies conducted in plaque psoriasis populations. The most common adverse events included upper respiratory infections, elevated creatine phosphokinase levels, herpes simplex infections, oral ulcers, acneiform rash, and folliculitis. Regulatory labeling also includes warnings regarding infections, tuberculosis screening, cardiovascular risks, thrombosis, and malignancy monitoring. Industry experts view the approval as strategically important because psoriatic arthritis remains a highly heterogeneous disease involving joint pain, swelling, enthesitis, skin lesions, fatigue, and significant quality-of-life impairment that often requires long-term immune modulation.
Bristol Myers Squibb Continues Global Expansion of Sotyktu Franchise
The new European Commission approval significantly expands the commercial opportunity for Sotyktu, which was first approved by the U.S. FDA in 2022 for moderate-to-severe plaque psoriasis and later received U.S. approval in March 2026 for active psoriatic arthritis. Bristol Myers Squibb continues advancing the therapy across additional immune-mediated diseases as part of its broader immunology strategy focused on rheumatology, dermatology, and inflammatory disorders. Company executives stated that the approval reflects the growing importance of precision immunomodulation approaches capable of addressing chronic inflammatory disease while improving long-term patient quality of life.
The company also highlighted five years of accumulated clinical efficacy and safety data supporting Sotyktu’s expanding global use in plaque psoriasis. Analysts expect the TYK2 inhibitor market to become increasingly competitive over the coming years as additional companies pursue selective kinase inhibition strategies for autoimmune and inflammatory diseases. With this latest European approval, Bristol Myers Squibb strengthens its position within the rapidly growing immunology therapeutics sector while expanding treatment options for patients living with debilitating psoriatic arthritis.
Source: Bristol Myers Squibb press release
