Roflumilast Foam 0.3% in Patients With Psoriasis of the Scalp and Body: Improvements in Patient-Reported Outcomes and Quality of Life
Author(s)
Melinda J. Gooderham, MSc, MD, FRCPC1, Javier Alonso-Llamazares, MD2, Neal Bhatia, MD3, Laura K. Ferris, MD, PhD4, Leon H. Kircik, MD5, Wei Jing Loo, MD6, Kim A. Papp, MD, PhD7, David Krupa, MS8, Brett Stephenson, PharmD8, Melissa S. Seal, PhD8, Diane Hanna, DNP, DCNP, FAANP8, David R. Berk, MD8, Patrick Burnett, MD, PhD8.
1SKiN Centre for Dermatology, Probity Medical Research, and Queen’s University, Peterborough, ON, Canada, 2Driven Research LLC, Coral Gables, FL, USA, 3Therapeutics Clinical Research, San Diego, CA, USA, 4University of North Carolina, Department of Dermatology, Chapel Hill, NC, USA, 5Icahn School of Medicine at Mount Sinai, New York, NY, USA, 6DermEffects, Probity Medical Research, and Western University, London, ON, Canada, 7Probity Medical Research and Alliance Clinical Trials, Waterloo, ON, Canada, 8Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
1SKiN Centre for Dermatology, Probity Medical Research, and Queen’s University, Peterborough, ON, Canada, 2Driven Research LLC, Coral Gables, FL, USA, 3Therapeutics Clinical Research, San Diego, CA, USA, 4University of North Carolina, Department of Dermatology, Chapel Hill, NC, USA, 5Icahn School of Medicine at Mount Sinai, New York, NY, USA, 6DermEffects, Probity Medical Research, and Western University, London, ON, Canada, 7Probity Medical Research and Alliance Clinical Trials, Waterloo, ON, Canada, 8Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
OBJECTIVES: Assess the efficacy and patient-reported endpoints with roflumilast foam 0.3% (a potent phosphodiesterase 4 inhibitor) versus vehicle foam in patients with psoriasis of the scalp and body, including the impact on quality of life assessed via Psoriasis Symptom Diary (PSD), Scalpdex, and Dermatology Life Quality Index (DLQI).
METHODS: This phase 3 trial (ARRECTOR; NCT05028582) was conducted in patients aged ≥12 years with psoriasis of the scalp and body of at least moderate on the Scalp-Investigator Global Assessment (S-IGA) and mild on the Body-IGA (B-IGA) and affecting ≤25% of body surface area overall. Patients were randomized 2:1 to apply roflumilast foam 0.3% or vehicle foam once daily for 8 weeks. Patient-reported outcomes included Scalp Itch-Numeric Rating Scale (SI‑NRS), Worst Itch-NRS (WI-NRS), DLQI (patients aged ≥17 years), PSD (patients aged ≥18 years), and Scalpdex. All P values are nominal.
RESULTS: There were 281 and 151 patients randomized to receive roflumilast foam 0.3% or vehicle foam, respectively. Among patients with SI-NRS and/or WI-NRS ≥2 at baseline, greater proportions in the roflumilast group than the vehicle group achieved scores of 0 (none) or 1 (minimal itch) at week 8 (SI-NRS: 52.3% vs 24.1%; P<0.0001; WI‑NRS: 55.4% vs 19.8%; P<0.0001). Least-squares mean improvement from baseline in DLQI was higher in the roflumilast versus vehicle group (4.37 vs 2.44; P<0.0001). Improvements were observed across PSD domains for psoriasis (severity and bothersomeness) and emotional (embarrassment) domains. Significantly greater reductions were observed for roflumilast versus vehicle at week 8 in Scalpdex total score (-23.4 vs -12.8; P<0.0001) and Scalpdex domain scores (emotions: -23.1 vs -12.4; symptoms: -29.0 vs -15.0; function: -20.7 vs 11.7; all P<0.0001).
CONCLUSIONS: Treatment with roflumilast foam 0.3% improved patient-reported outcomes and quality of life in patients with psoriasis of the scalp and body.
METHODS: This phase 3 trial (ARRECTOR; NCT05028582) was conducted in patients aged ≥12 years with psoriasis of the scalp and body of at least moderate on the Scalp-Investigator Global Assessment (S-IGA) and mild on the Body-IGA (B-IGA) and affecting ≤25% of body surface area overall. Patients were randomized 2:1 to apply roflumilast foam 0.3% or vehicle foam once daily for 8 weeks. Patient-reported outcomes included Scalp Itch-Numeric Rating Scale (SI‑NRS), Worst Itch-NRS (WI-NRS), DLQI (patients aged ≥17 years), PSD (patients aged ≥18 years), and Scalpdex. All P values are nominal.
RESULTS: There were 281 and 151 patients randomized to receive roflumilast foam 0.3% or vehicle foam, respectively. Among patients with SI-NRS and/or WI-NRS ≥2 at baseline, greater proportions in the roflumilast group than the vehicle group achieved scores of 0 (none) or 1 (minimal itch) at week 8 (SI-NRS: 52.3% vs 24.1%; P<0.0001; WI‑NRS: 55.4% vs 19.8%; P<0.0001). Least-squares mean improvement from baseline in DLQI was higher in the roflumilast versus vehicle group (4.37 vs 2.44; P<0.0001). Improvements were observed across PSD domains for psoriasis (severity and bothersomeness) and emotional (embarrassment) domains. Significantly greater reductions were observed for roflumilast versus vehicle at week 8 in Scalpdex total score (-23.4 vs -12.8; P<0.0001) and Scalpdex domain scores (emotions: -23.1 vs -12.4; symptoms: -29.0 vs -15.0; function: -20.7 vs 11.7; all P<0.0001).
CONCLUSIONS: Treatment with roflumilast foam 0.3% improved patient-reported outcomes and quality of life in patients with psoriasis of the scalp and body.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO215
Topic
Clinical Outcomes
Topic Subcategory
Clinician Reported Outcomes
Disease
Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)