INTEGUMENT-OLE: Efficacy and Safety of Roflumilast Cream 0.15% in AD Maintained to 56 Weeks

Results from the INTEGUMENT-OLE long-term study suggested that roflumilast cream 0.15% for the treatment of atopic dermatitis (AD) is effective and well-tolerated over a treatment period of up to 56 weeks in adults and children aged six years and older.

Researchers for the open-label study looked at once-daily application of roflumilast in adults in children aged six years and older. Patients who completed the 4-week INTEGUMENT-1 and INTEGUMENT-2 pivotal trials were eligible to enroll in the open-label extension study for 24 or 52 months. Patients who achieved a Global Assessment-Atopic Dermatitis (vIGA-AD) score of clear (0) were switched to twice-weekly application of the roflumilast cream 0.15% (n = 130) for benefit maintenance. Secondary endpoints included vIGA-AD score of 0 or 1 at assessment time, vIGA-AD success, WI-RNS score over time, and EASI score over time, according to an Arcutis press release about the results. 

Key data highlights:

• Roflumilast cream demonstrated sustained improvements in AD signs and symptoms, including itch relief, throughout the 56-week treatment period.
• At Week 56, 66.2% of participants who used roflumilast cream 0.15% once daily, both during the initial 4-week study and the subsequent 52-week extension, achieved a 75% improvement in the Eczema Area and Severity Index (EASI-75).
• Participants who reached disease clearance and commenced a proactive twice-weekly dosing regimen maintained disease control for a median duration of 281 days.

"The challenge with managing AD with topical therapy is managing the cycle of flares and keeping the disease controlled over a long period of time," Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis, told Practical Dermatology. "Our study found that roflumilast cream 0.15% could keep AD under control for a long period of time and was well-tolerated with a favorable safety profile with up to 56 weeks of treatment. One thing we did differently with this study was allow those who reached “clear” status to shift from a once per day application to a proactive 2 times per week treatment. Doing this proactive dosing schedule allowed patients to maintain disease control for a median of 281 days, so that is 9 months where patients were kept to a level of ‘clear’ or ‘almost clear’ without any flares."

These data were presented for the first time at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference (RAVE) Conference in Chicago, which included the Revolutionizing Atopic Dermatitis (RAD) meeting. 

Source: Arcutis press release. June 10, 2024.