Roflumilast cream safe, effective in mild to moderate atopic dermatitis
Click Here to Manage Email Alerts
Roflumilast cream was an effective and safe treatment for mild to moderate atopic dermatitis in adults and children aged 6 years and older, Arcutis Biotherapeutics announced in a press release.
The company’s INTEGUMENT-1 pivotal phase 3 trial of roflumilast cream 0.15%, a once-daily, non-steroidal topical phosphodiesterase-4 inhibitor, met all primary and secondary endpoints, in addition to achieving a favorable safety and tolerability profile, according to the press release.
“Many patients with atopic dermatitis are still being treated with topical steroids for this chronic disease,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, told Healio. “This trial demonstrated several key pieces of data that will support the potential of this treatment as a new option for patients with mild to moderate atopic dermatitis.”
The study met its primary endpoint, with 32% of patients achieving a clear or almost clear IGA score plus a 2-grade improvement from baseline at week 4, compared with 15.2% of individuals treated with vehicle (P < .0001).
Results also showed statistically significant improvements compared with vehicle in all secondary endpoints, including 43.2% of the roflumilast group achieving EASI 75 at week 4 vs. 22% treated with vehicle (P < .0001).
Of patients aged 12 years and older, 33.6% treated with roflumilast achieved a 4-point reduction in the Worst Itch Numeric Scale at week 4 compared with 20.7% treated with vehicle.
The drug was well tolerated with a low number of mostly mild to moderate treatment-related adverse events, which were similar between active treatment and vehicle. There were no serious adverse events.
“The clinical profile observed in the INTEGUMENT-1 study is very supportive,” Burnett said. “If approved, roflumilast cream 0.15% could be a new first line therapy for patients to receive treatment with a non-steroidal once daily cream that is well tolerated and effective.”