Efficacy of Deucravacitinib in Moderate to Severe Scalp Psoriasis: Analysis of Complete Clearance of Scalp Disease and Symptoms

Abstract

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Scalp psoriasis occurs in ~80% of patients; is associated with itching, flaking, pain, and bleeding; disproportionately reduces quality of life; and is challenging to treat with topical agents. PSORIATYK SCALP (NCT05478499), an ongoing, 52-week, phase 3b/4, multicenter, randomized, double-blinded, placebo-controlled trial, evaluated the efficacy and safety of deucravacitinib in patients with moderate to severe scalp psoriasis. This post hoc analysis compared the efficacy of deucravacitinib versus placebo in the achievement of complete clearance of scalp disease and symptoms.

Methods: Adults with moderate to severe scalp psoriasis (scalp-specific Physician Global Assessment [ss-PGA] score ≥3, scalp surface area involvement ≥20%, and Psoriasis Scalp Severity Index [PSSI] score ≥12 at baseline) and body surface area involvement ≥3% were randomized 1:2 to oral placebo (n=51) or deucravacitinib 6 mg once daily (n=103) through Week 16. Stratification factors included prior biologic use and body weight. At Week 16, all patients received open-label deucravacitinib treatment through Week 52. Outcomes included the proportions of patients who achieved an ss-PGA score of 0 (clear) (ss-PGA 0), 100% improvement from baseline in PSSI (PSSI 100), and scores of 0 (clear) in each of the scalp-specific numeric rating scales (ss-NRS) for itching, pain, and flaking. Nonresponder imputation was used for patients who had missing data. P values are nominal.

Results: Baseline disease characteristics, including ss-PGA, PSSI, and ss-NRS itching, pain, and flaking scores, were similar between the 2 groups. At Week 16, a significantly higher proportion of patients receiving deucravacitinib versus placebo achieved ss-PGA 0 (25.2% vs 3.9%, respectively; P=0.001) and PSSI 100 (27.2% vs 2.0%; P=0.0002). A significantly higher proportion of patients treated with deucravacitinib versus placebo achieved ss-NRS 0 for itching (16.0% vs 0.0%, respectively; P=0.003), pain (37.2% vs 13.3%; P=0.004), and flaking (22.5% vs 2.0%; P=0.001).

Conclusion: In this scalp-specific trial, deucravacitinib treatment was associated with greater complete clearance of scalp disease and symptoms at 16 weeks compared with placebo in patients with significant scalp disease.