European regulators have recommended expansion of the marketing authorization for Sotyktu (deucravacitinib, Bristol-Myers Squibb) to include treatment of active psoriatic arthritis in adults. 

The new indication, backed by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use, covers patients who experienced inadequate response or intolerance to prior disease-modifying antirheumatic drug therapy. The medication is approved for use alone or combined with methotrexate.

Sotyktu originally received European Union-wide marketing authorization on March 24, 2023, for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. 

Psoriatic arthritis is a chronic, immune-mediated inflammatory disease affecting the joints, entheses, and skin. Clinical manifestations include peripheral arthritis, dactylitis, enthesitis, and psoriatic involvement of the skin and nails. Approximately one third of patients with psoriasis develop psoriatic arthritis, which is associated with pain, fatigue, and impaired physical function. The disease can substantially impact quality of life and is linked to an increased risk for comorbidities.

Mechanism of Action and Administration 

Sotyktu is an oral selective tyrosine kinase 2 (TYK2) inhibitor that acts allosterically by binding to the regulatory domain of TYK2, a member of the Janus kinase (JAK) family. Selective inhibition of TYK2 disrupts signaling of key cytokines implicated in the pathogenesis of psoriatic disease, including interleukin (IL)-23, IL-12, and type I interferons. This results in reduced inflammatory signaling and improvement in clinical manifestations of plaque psoriasis and psoriatic arthritis.

Importantly, at physiologically relevant concentrations, Sotyktu demonstrates high selectivity for TYK2 and does not inhibit JAK1, JAK2, or JAK3 in vitro, differentiating it from broader JAK inhibitors. While the exact relationship between TYK2 inhibition and clinical efficacy is not fully understood, suppression of cytokine-driven inflammation is considered central to its therapeutic effect.

Sotyktu is available as tablets taken once daily. Treatment should be initiated by physicians experienced in diagnosing and treating these conditions, with regular evaluation of treatment effects.

Clinical Evidence and Efficacy

The regulatory decision builds on evidence from the phase 3 POETYK PSO-1 and PSO-2 trials, which demonstrated deucravacitinib’s superiority compared with placebo and apremilast in patients with moderate-to-severe plaque psoriasis. These multicenter studies randomized 1686 patients in a 1:2:1 ratio to receive placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily.

After 16 weeks of treatment, approximately 55% of patients treated with deucravacitinib achieved at least 75% reduction in their Psoriasis Area and Severity Index score compared with around 38% treated with apremilast and 11% receiving placebo. Additionally, about 51% of patients treated with deucravacitinib achieved a static Physician Global Assessment score of 0 or 1 with a reduction of 2 points or more, compared with 33% with apremilast and 8% with placebo. Patient-reported outcomes showed greater improvement in psoriasis symptoms and quality-of-life measures, with improvements maintained through 52 weeks of continuous treatment.

Safety Profile and Next Steps 

The most common side effect with Sotyktu is upper respiratory infection, which may affect more than 1 in 10 people. Side effects are generally mild to moderate and manageable. Patients with important or long-term infections, or recurring infections, must not take this medicine. The EMA determined that Sotyktu’s benefits outweigh its risks, providing an additional treatment option for patients who have not yet received systemic therapy and those who do not benefit from other systemic therapies.

Detailed recommendations for using this product will be described in the updated Summary of Product Characteristics, which will be published on the EMA website in all official European Union languages after the European Commission grants a decision on this marketing authorization change. 

The positive opinion represents a preliminary step. Commission decisions are normally issued 67 days from adoption of the opinion. As with all medicines, data on Sotyktu use will be continuously monitored, with suspected side effects carefully evaluated and necessary actions taken to protect patients.