CO144 Improvements in Scalp Outcomes With Roflumilast Foam 0.3% for Psoriasis of the Scalp and Body From the Phase 3 ARRECTOR Trial

Document Type

Conference Proceeding

Publication Date

12-1-2025

Publication Title

Value Health

Keywords

roflumilast, adult, aged, body surface, conference abstract, controlled study, disease severity, female, foam, human, major clinical study, male, phase 3 clinical trial, psoriasis, randomized controlled trial, scalp, systemic therapy

Abstract

Objectives: Evaluate the efficacy of roflumilast foam 0.3% to improve scalp symptoms and reduce extent of scalp involvement (ESI) in patients with psoriasis involving the scalp and body. Methods: In the phase 3 ARRECTOR/NCT05028582 trial, patients aged ≥ 12 years with psoriasis of the scalp and body (body surface area affected ≤ 25%, ≥ 10% ESI, at least moderate [≥ 3] Scalp-Investigator Global Assessment [S-IGA], at least mild [ ≥ 2] Body-IGA [B-IGA]) applied roflumilast foam 0.3% or vehicle foam once daily for 8 weeks. Co-primary endpoints were S-IGA and B-IGA success (clear/almost clear [0/1] plus ≥ 2-grade improvement). Secondary endpoints included S-IGA 0, ≥ 75% improvement in Psoriasis Scalp Severity Index (PSSI-75), and ESI over time. Results: Significantly higher proportions of patients randomized to roflumilast (n=281) versus vehicle (n=151) achieved S-IGA success (each P<0.0001) at weeks 2 (30.4% vs 11.7%), 4 (53.8% vs 19.5%), and 8 (66.4% vs 27.8%) and S-IGA 0 (9.0% vs 1.5%; 27.5% vs 3.8%; 40.0% vs 9.1%, respectively; each P ≤ 0.0055). Mean ESI decreased more from baseline to week 8 with roflumilast (34.4% to 9.3%) than vehicle (36.0% to 27.3%). The proportion of patients with ESI 0 increased over time with significantly more achieving this endpoint (each P<0.01) with roflumilast versus vehicle at both week 2 (9.8% vs 1.4%) and week 8 (43.0% vs 10.3%). A higher proportion of patients in the roflumilast than vehicle group achieved PSSI-75 at week 8 (70.9% vs 31.3%; P<0.0001). Topical roflumilast was well tolerated and safety was consistent with previous trials. Conclusions: Roflumilast foam 0.3% significantly reduced scalp symptom severity and ESI, compared with vehicle, including complete clearance of plaques on the scalp in many patients. The favorable safety profile and topical formulation make roflumilast foam 0.3% a compelling non-systemic alternative for patients with moderate-to-severe psoriasis involving the scalp and body, who may otherwise receive systemic therapy.

Volume

28

Issue

12

First Page

S71

Find It @ Sladen

Share

COinS