Roflumilast cream effective, tolerable in adults, children aged at least 6 years
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Arcutis Biotherapeutics announced positive topline results from its phase 3 trial of roflumilast cream in adults and children aged 6 years and older with mild to moderate atopic dermatitis, according to a company press release.
“Itch reduction is particularly important in atopic dermatitis, being so prevalent and burdensome that the disease is often referred to as ‘the itch that rashes,’” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, told Healio. “We are happy to have shown the rapid onset of response in both efficacy and itch as early as week 2 and week 1, respectively.”
The phase 3, parallel group, double-blind study, INTEGUMENT-2, evaluated roflumilast cream 0.15% — a once-daily, non-steroidal topical phosphodiesterase-4 inhibitor — or vehicle applied once daily for 4 weeks in individuals aged 6 years and older with mild to moderate atopic dermatitis. The study included 683 subjects with at least 3% affected body surface area.
The study met its primary endpoint with 28.9% of individuals treated with roflumilast vs. 12% of those treated with vehicle achieving an IGA score of clear or almost clear and a 2-grade improvement from baseline (P < .0001).
Additionally, the study also achieved secondary endpoints, including 42% of the roflumilast group vs. 19.7% of the vehicle group showing a 75% improvement in EASI at week 4 (P < .0001). Also, of those aged 12 years and older treated with roflumilast, 30.2% achieved a 4-point reduction in Worst Itch Numeric Scale, whereas only 12.4% of vehicle-treated subjects exhibited the same response (P < .01).
The cream was well tolerated with most treatment emergent adverse events being mild to moderate in severity. Incidents were low in both active treatment and vehicle arms, prompting trial discontinuation in only 1.8% and 0.9% of the roflumilast and vehicle groups, respectively.
“With the combined safety/tolerability and efficacy profile of roflumilast cream, we are filling a gap in the unmet need for treatments, especially steroid-free topical treatments, for atopic dermatitis,” Burnett said. “It’s also important for a therapy to offer more than just effectiveness but also safety and tolerability, particularly for a chronic disease that has such a large prevalence in both children and adults.”
The company plans to move forward with filing a supplemental new drug application with the FDA for roflumilast cream 0.15% in this indication in the second half of 2023, according to the release.