Deucravacitinib for the treatment of plaque psoriasis receives approval by the European Commission

On March 24, 2023, the European Commission approved deucravacitinib, a first-in-class tyrosine kinase 2 inhibitor, for the treatment of moderate-to-severe plaque psoriasis.¹ This approval follows the European Medicines Agency recommendation in January.² Deucravacitinib, the first once-daily oral treatment option for this patient group, will be available for adult patients who are candidates for systemic therapy¹; it is also currently being investigated in systemic lupus erythematosus.³

In the phase 3 POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) trials, deucravacitinib had improved efficacy compared with placebo and apremilast, with improvements seen after Week 16 and maintained up to Week 52.² Overall, ~55% of patients treated with deucravacitinib achieved a 75% reduction in their Psoriasis Area and Severity Index score, compared with 11% of patients treated with placebo.² Also, significantly more deucravacitinib treated patients achieved a clear or almost clear Physician’s Global Assessment score at Week 16, compared with placebo treated patients.⁴ Results from the long term extension trial also supported this approval, with a consistent safety profile over 3 years of treatment; the most common adverse event being upper respiratory tract infection.⁴