ARRECTOR phase III results: Roflumilast foam for psoriasis of the scalp and body

Topical treatment of scalp psoriasis presents challenges, including formulations that are undesirable or cause pain or itching reducing treatment adherence. 

Roflumilast cream 0.3% is approved by the U.S. Food and Drug Administration for the treatment of patients aged ≥6 years with plaque psoriasis. To further evaluate its potential, Gooderham et al. conducted a phase III, double-blind, randomized controlled trial (ARRECTOR; NCT05028582) assessing the efficacy and safety of roflumilast foam 0.3% in patients aged ≥12 years with psoriasis of the scalp and body. The study included 432 patients, with a mean age of 47.3 years, of whom 56.3% were female. The coprimary endpoints were S-IGA and B-IGA success (clear [0] or almost clear [1] plus ≥2-grade improvement) at Week 8. Results were published in Jama Dermatology. 

Key learnings

At Week 8, a significantly greater proportion of patients in the roflumilast group achieved S-IGA success (66.4% vs 27.8%; p < 0.001) and B-IGA success (45.5% vs 20.1%; p < 0.001) compared with the vehicle group.

Roflumilast showed significantly higher rates of S-IGA success at Week 2 and SI-NRS and WI-NRS at Weeks 2, 4, and 8 vs vehicle (all p < 0.001), with improvements in SI-NRS seen as early as 24 hours post-application (p < 0.02).

Roflumilast was well tolerated, with no new safety signals. Incidence of AEs were low and similar between roflumilast and vehicle: TEAEs (26.7% and 16.6%), treatment-related AEs (5.7% and 2.0%), and treatment-emergent SAEs (0.7% each). 

These results indicate that once-daily roflumilast foam 0.3% significantly improved signs and symptoms of psoriasis of the scalp and body, with low rates of AEs, highlighting its application as a monotherapy for adult and adolescent patients.