Arcutis’s Phase III AD Win Bodes Well For Soon-To-Report Second Study

One analyst said efficacy data for roflumilast in INTEGUMENT-1 suggest limited competitiveness against Incyte’s topical JAK inhibitor, Opzelura, while others were more optimistic.

Arcutis announced Phase III results for roflumilast in atopic dermatitis • Source: Shutterstock

Arcutis Biotherapeutics, Inc.’s Phase III study for roflumilast cream in mild-to-moderate atopic dermatitis (AD) hit its primary endpoint, raising hopes of a second Phase III win before the year is up and, with that, boosting chances for US Food and Drug Administration approval. But how roflumilast will fare in a crowded market for topical AD treatments – especially against existing players like Incyte Corporation’s Opzelura (ruxolitinib) and Pfizer Inc.’s Eucrisa (crisaborole) – remains to be seen.

Arcutis announced positive topline results from the pivotal INTEGUMENT-1 trial of roflumilast cream 0.15% on 15 November

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