Deucravacitinib Shows Significant Efficacy and Safety in Phase 3b/4 Trial for Moderate to Severe Scalp Psoriasis

Image Credit: © Ilia

Bristol Myers Squibb presented the results of the phase 3b/4 PSORIATYK SCALP trial at the 2024 Fall Clinical Dermatology Conference. The data, showcased in a poster, highlighted the efficacy and safety of deucravacitinib (Sotyktu) in patients with moderate to severe scalp psoriasis, demonstrating significant improvements in clinical outcomes compared to placebo.

The PSORIATYK SCALP trial was a multicenter, randomized, double-blinded, placebo-controlled study designed to evaluate the efficacy and safety of deucravacitinib in adults aged 18 years and older with moderate to severe scalp psoriasis.

The trial enrolled participants who presented with a scalp-specific Physician Global Assessment (ss-PGA) score of 3 or higher, Psoriasis Scalp Severity Index (PSSI) score of at least 12, and body surface area involvement of 3% or more.

Participants were randomized in a 1:2 ratio to receive either deucravacitinib 6 mg once daily or a placebo. After 16 weeks, all participants were switched to open-label deucravacitinib for an additional 36 weeks, allowing for a comprehensive assessment of long-term efficacy and safety.

The primary endpoint of the study was the proportion of participants achieving an ss-PGA score of 0 or 1, indicating clear or almost clear scalp psoriasis. Key secondary endpoints included the achievement of a 90% improvement in the PSSI score and the assessment of scalp-specific itch using a numeric rating scale.

At the primary endpoint assessment at 16 weeks, a significantly higher percentage of patients receiving deucravacitinib achieved an ss-PGA score of 0 or 1 compared to those on placebo. Additionally, improvements in the PSSI score and reductions in scalp-specific itch were observed, underscoring the treatment's efficacy.

Safety assessments revealed that deucravacitinib was generally well-tolerated, with adverse events comparable to those seen in placebo-treated patients. The most common adverse events included headache and upper respiratory infections, which were consistent with findings from previous studies of TYK2 inhibitors.

"These results support the efficacy and safety of once-daily oral deucravacitinib in patients with moderate to severe scalp psoriasis, including those with less extensive overall body psoriasis," according to poster authors Callis Duffin et al.

For more news from Fall Clinical, subscribe to receive our eNewsletter.

Reference

1. Callis Duffin K, Egeberg A, Nascimento A, et al. Efficacy and safety of deucravacitinib in patients with moderate to severe scalp psoriasis: results from the PSORIATYK SCALP trial. Presented at: Fall Clinical 2024; October 24-27, 2024; Las Vegas, Nevada.