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Positive topline results were announced from a phase 3 study evaluating roflumilast cream, a topical phosphodiesterase-4 inhibitor, in patients with mild to moderate atopic dermatitis.
The INTEGUMENT-2 trial (ClinicalTrials.gov Identifier: NCT04773600) included 683 patients 6 years of age and older with mild to moderate atopic dermatitis involving at least 3% body surface area. Patients were randomly assigned to receive either roflumilast cream 0.15% or vehicle applied once daily for 4 weeks. The primary endpoint of the study was Investigator Global Assessment (IGA) success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4.
Findings demonstrated that 28.9% of patients treated with roflumilast cream met the primary endpoint achieving IGA success at week 4 compared with 12% of those treated with vehicle (P <.0001).
Results also showed that 42% of patients treated with roflumilast cream achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) at week 4 compared with 19.7% of those treated with vehicle (P <.0001). Moreover, a greater proportion of patients in the roflumilast arm achieved a 4-point reduction in Worst Itch Numeric Scale (WI-NRS) at week 4 compared with those in the vehicle arm (30.2% vs 12.4%, respectively; P <.01).
As for safety, roflumilast cream was well tolerated with most treatment emergent adverse events (TEAEs) being mild to moderate in severity. The most common TEAEs for roflumilast cream were headache, nausea, vomiting, diarrhea, and upper respiratory tract infection.
Topline results from an identical phase 3 trial, INTEGUMENT-1 trial (ClinicalTrials.gov Identifier: NCT04845620), were announced in November 2022. The Company plans to file a supplemental New Drug Application with the Food and Drug Administration (FDA) for the atopic dermatitis indication in the second half of 2023.
Roflumilast cream 0.3% is currently marketed under the brand name Zoryve™ for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.
Reference
Arcutis announces positive topline results from second atopic dermatitis pivotal phase 3 trial of roflumilast cream in adults and children aged 6 and older. News release. Arcutis. Accessed December 12, 2022. https://www.globenewswire.com/news-release/2022/12/12/2571826/0/en/Arcutis-Announces-Positive-Topline-Results-from-Second-Atopic-Dermatitis-Pivotal-Phase-3-Trial-of-Roflumilast-Cream-in-Adults-and-Children-Aged-6-and-Older.html.
