Roflumilast cream 0.15% has demonstrated high efficacy in treating mild to moderate atopic dermatitis (AD) in patients aged 6 years and older, according to results from two Phase 3 trials (INTEGUMENT-1 and INTEGUMENT-2). The studies, led by Eric L. Simpson, MD, MCR, from Oregon Health & Science University, highlight the potential of roflumilast as a once-daily, nonsteroidal option to address unmet needs in AD treatment.
The trials involved 1,337 patients with a mean age of 27.7 years and an average body surface area involvement of 13.6%. Participants were randomized to receive either roflumilast 0.15% cream or a vehicle cream once daily for four weeks. The primary endpoint was achieving a validated Investigator Global Assessment for Atopic Dermatitis (IGA-AD) score of 0 or 1, indicating clear or almost clear skin, with at least a two-grade improvement from baseline.
Efficacy and Safety Results
INTEGUMENT-1 showed that 32% of patients treated with roflumilast achieved the primary endpoint compared to only 15.2% in the vehicle group (p < .001). Similarly, in INTEGUMENT-2, 28.9% of the roflumilast group reached the primary endpoint versus 12% of the vehicle group (p < .001). The studies also assessed the Eczema Area and Severity Index (EASI) 75, a secondary endpoint representing a 75% reduction in eczema severity. In INTEGUMENT-1, 43.2% of roflumilast-treated patients achieved EASI 75 by week 4, compared to 22% of the vehicle group (p < .001). INTEGUMENT-2 showed similar results, with 42% in the roflumilast group achieving EASI 75 versus 19.7% in the vehicle group (p < .001).
The safety profile of roflumilast cream was favorable, with over 95% of patients reporting no signs of application site irritation at each time point. Adverse events were mostly mild to moderate in severity. According to the researchers, this once-daily nonsteroidal cream addresses several unmet needs in the treatment of AD and thus has the potential to substantially improve treatment.
Addressing Unmet Needs in Atopic Dermatitis
"Although the current therapeutic landscape for AD comprises topical steroidal and nonsteroidal medications, unmet treatment needs persist," Simpson and colleagues noted. These unmet needs include the preference for creams over ointments, challenges with adherence to twice-daily dosing regimens, the need for effective nonsteroidal options, and the reduction of application site reactions associated with topical treatments. Roflumilast's efficacy and safety profile suggest it could fill these gaps in AD management.
