ARRECTOR phase III trial evaluating roflumilast foam meets co-primary endpoints in psoriasis

The study met its co-primary endpoints of S-IGA Success and B-IGA Success, and all secondary endpoints. Specifically, 67.3% of individuals treated with roflumilast foam achieved S-IGA Success compared to 28.1% of individuals treated with a matching vehicle foam at week 8 (P<0.0001), and 46.5% of individuals treated with roflumilast foam achieved b-iga success compared to 20.8% of individuals treated with a matching vehicle foam at week 8 (p><0.0001). roflumilast foam also demonstrated statistically significant improvements compared to vehicle on all secondary endpoints, including scalp itch as measured by scalp itch numeric rating scale (si-nrs) and overall itch as measured by worst itch nrs (wi-nrs) at week eight.

Roflumilast foam was well-tolerated, and the overall safety and tolerability profile was consistent with previously published studies of roflumilast cream 0.3% and foam. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and generally similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. Overall, the most common adverse events in the study population included headache, diarrhea, and COVID-19. In the study, 89.0% of patients who were randomized to roflumilast foam completed the full eight weeks, and few subjects discontinued study drug due to adverse events (2.5% and 1.3% in the roflumilast foam and vehicle groups, respectively).