Human medicines European public assessment report (EPAR): Sotyktu, deucravacitinib, Date of authorisation: 24/03/2023, Revision: 1, Status: Authorised
Two main studies involving 1,686 patients with moderate to severe plaque psoriasis compared Sotyktu with placebo (a dummy treatment) and apremilast, another systemic therapy for plaque psoriasis. The studies looked at an improvement of patients’ symptoms after 16 weeks of treatment.
Around 55% of patients treated with Sotyktu had a reduction of at least 75% in their PASI score (a measure of the severity and extent of skin lesions) compared with around 38% of those treated with apremilast and around 11% of those who received placebo.
Additionally, around 51% of patients treated with Sotyktu achieved a sPGA score (a measure of the severity and extent of skin lesions) of 0 or 1 (where 0 and 1 refer to skin clear or almost clear, respectively) and had a reduction of 2 points or more in their sPGA score. Around 33% of those treated with apremilast and around 8% in those who received placebo had these results.
Improvement of symptoms were maintained after 52 weeks of treatment with Sotyktu.
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