Improvements in Scalp Outcomes With Roflumilast Foam 0.3% for Psoriasis of the Scalp and Body From the Phase 3 ARRECTOR Trial
Author(s)
Linda Stein Gold, MD1, Bruce Strober, MD, PhD2, Ron Vender, MD3, Raj Chovatiya, MD, PhD4, April Armstrong, MD, MPH5, David Krupa, MS6, Jennifer C. Jaworski, MS, BCMAS, CMPP6, Melissa S. Seal, PhD6, Diane Hanna, DNP, DCNP6, Brett Stephenson, PharmD6.
1Henry Ford Health System, Detroit, MI, USA, 2Yale University School of Medicine and Central Connecticut Dermatology, Cromwell, CT, USA, 3Dermatrials Research Inc., Hamilton, ON, Canada, 4Chicago Medical School, Rosalind Franklin University of Medicine and Science and Center for Medical Dermatology + Immunology Research, Chicago, IL, USA, 5David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA, 6Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
1Henry Ford Health System, Detroit, MI, USA, 2Yale University School of Medicine and Central Connecticut Dermatology, Cromwell, CT, USA, 3Dermatrials Research Inc., Hamilton, ON, Canada, 4Chicago Medical School, Rosalind Franklin University of Medicine and Science and Center for Medical Dermatology + Immunology Research, Chicago, IL, USA, 5David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA, 6Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
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.
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.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO144
Topic
Clinical Outcomes
Topic Subcategory
Clinician Reported Outcomes
Disease
Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)