INTEGUMENT Trials: Once-Daily Roflumilast Cream Reduces AD Symptoms
Roflumilast cream, 0.15%, significantly improved symptoms of mild to moderate atopic dermatitis (AD) in two phase 3 clinical trials.
Researchers for the INTEGUMENT-1 and INTEGUMENT-2, publishing their results in JAMA Dermatology, evaluated the efficacy and safety of roflumilast cream, 0.15%, as a once-daily treatment for mild to moderate atopic dermatitis (AD). The two randomized, double-blind, vehicle-controlled trials included a total of 1,337 participants aged six years and older across the US, Canada, and Poland.
According to the results, patients treated with roflumilast saw significant improvements in multiple efficacy endpoints, including the primary endpoint of Validated Investigator Global Assessment for AD (vIGA-AD) success (defined as clear or almost clear skin with at least a two-grade improvement from baseline). By week 4, 32.0% of roflumilast-treated patients in INTEGUMENT-1 and 28.9% in INTEGUMENT-2 reached the endpoint, compared to 15.2% and 12.0% of vehicle-treated patients, respectively.
Significant reductions in pruritus were also observed, with itch improvement occurring as early as 24 hours after the first application in both trials. Roflumilast was well-tolerated, with low rates of treatment-related adverse events and minimal application-site reactions. Importantly, the once-daily application regimen and the water-based cream formulation address key barriers to treatment adherence in AD, including patient preference for non-ointment formulations and fear of adverse effects.
"This once-daily nonsteroidal cream addresses several unmet needs in the treatment of AD and thus has the potential to substantially improve treatment," the authors concluded. "Additional research, including subgroup analyses, will provide more data regarding the efficacy and safety of roflumilast cream, 0.15%, in patients with AD."
Source: Simpson E, et al. JAMA Dermatology. 2024. Doi:10.1001/jamadermatol.2024.3121