Patient-Reported Outcomes with Roflumilast Foam 0.3% in Patients with Psoriasis of the Scalp and Body in the Phase 3 ARRECTOR Trial

Introduction: Patients with psoriasis of the scalp or body consider itch the most burdensome symptom. Roflumilast is a highly potent phosphodiesterase 4 inhibitor under investigation as a novel, once-daily foam for treatment of psoriasis of the scalp and body. The impact of roflumilast foam 0.3% on patient-reported outcomes (PROs) in patients with psoriasis of the scalp and body from the phase 3 trial (ARRECTOR; NCT05028582) are reported here. Methods: Patients aged ≥12 years with psoriasis of the scalp and body affecting ≤25% of overall body surface area, minimum Scalp-Investigator Global Assessment (S‑IGA) of Moderate, and minimum Body-IGA (B-IGA) of Mild were randomized 2:1 to once-daily roflumilast foam 0.3% or vehicle for 8 weeks. PROs included the Psoriasis Symptom Diary (PSD; ≥18 years only), Scalpdex, Dermatology Life Quality Index (DLQI; ≥17 years only), Scalp Itch- and Worst Itch-Numeric Rating Scale (SI-NRS and WI‑NRS, respectively; each rated from 0 [no itch] to 10 [worst itch imaginable]). Results: Overall, 281 patients were treated with roflumilast foam 0.3% and 151 were treated with vehicle. In patients with SI-NRS and/or WI-NRS ≥2 at baseline, significantly greater proportions of the roflumilast group than the vehicle group achieved scores of 0 or 1 at Week 8 for SI-NRS (52.3% vs 24.1%; P<0.0001) and/or WI‑NRS (55.4% vs 19.8%; P<0.0001). Similar improvements were observed in other PROs at Week 8, with a significantly greater proportion of the roflumilast group achieving PSD total scores of 0 (19.6% vs 7.1%; P=0.0012). The roflumilast group also had significantly greater reductions in least-squares mean change from baseline in PSD items related to itching/pain/scaling (–10.9 vs –5.8; P<0.0001), Scalpdex score (–23.4 vs –12.8; P<0.0001), and DLQI (–4.4 vs –2.4; P<0.0001). Conclusion: Roflumilast foam 0.3% improved quality of life, including patient reported itching, pain, and scaling, related to psoriasis of the scalp and body. Sponsorship: Arcutis Biotherapeutics, Inc.