At the 2024 Fall Clinical Dermatology Conference, Bristol Myers Squibb unveiled findings from the phase 3b/4 PSORIATYK SCALP trial, highlighting the effectiveness and safety of deucravacitinib (Sotyktu) in treating moderate to severe scalp psoriasis. The results, presented in a poster format, indicate significant clinical improvements among participants receiving the treatment compared to those on a placebo.
The PSORIATYK SCALP trial was a multicenter, randomized, double-blind, placebo-controlled study focused on adults aged 18 and older with moderate to severe scalp psoriasis. To qualify, participants were required to have a scalp-specific Physician Global Assessment (ss-PGA) score of 3 or higher, a Psoriasis Scalp Severity Index (PSSI) score of at least 12, and a body surface area involvement of 3% or more.
Participants were randomly assigned in a 1:2 ratio to receive either deucravacitinib 6 mg once daily or a placebo. After 16 weeks, all participants transitioned to an open-label phase, receiving deucravacitinib for an additional 36 weeks, which allowed for a thorough evaluation of the treatment’s long-term efficacy and safety.
The primary endpoint was the proportion of participants achieving an ss-PGA score of 0 or 1, signifying clear or almost clear scalp psoriasis. Key secondary endpoints included the attainment of a 90% improvement in the PSSI score and the evaluation of scalp-specific itch using a numeric rating scale.
At the 16-week mark, results showed that a significantly greater percentage of patients treated with deucravacitinib achieved an ss-PGA score of 0 or 1 compared to those receiving placebo. Additionally, improvements were noted in PSSI scores and reductions in scalp-specific itch, reinforcing the treatment’s effectiveness.
Safety evaluations indicated that deucravacitinib was generally well-tolerated, with adverse events occurring at rates similar to those observed in the placebo group. The most frequently reported adverse events included headache and upper respiratory infections, consistent with previous findings regarding TYK2 inhibitors.
“These results validate the efficacy and safety of once-daily oral deucravacitinib in patients with moderate to severe scalp psoriasis, including those with less extensive body psoriasis.”
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