Arcutis Reports Results From INTEGUMENT-OLE Long-term Extension Trial Of Roflumilast Cream 0.15%

(RTTNews) - Arcutis Biotherapeutics, Inc. (ARQT) announced interim results from the INTEGUMENT-OLE long-term open-label study of roflumilast cream 0.15% in adults and children ages 6 years and older with atopic dermatitis. The company said efficacy was not only maintained but improved over time, with 46.1% and 51.0% of participants who rolled over from the roflumilast cream treatment arm in INTEGUMENT-1 or -2 achieving validated Investigator Global Assessment-Atopic Dermatitis success at week 28 and week 56, respectively. In the study, 61.5% and 66.2% of participants who rolled over from the roflumilast cream arm in INTEGUMENT-1 or -2 showed a 75% improvement from baseline in Eczema Area and Severity Index after 28 weeks and 56 weeks, respectively.

Arcutis plans to submit a supplemental New Drug Application late in the third quarter of 2023 for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis in individuals ages 6 years and older.

Shares of Arcutis are up 6% in pre-market trade on Thursday.

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