WEDNESDAY, Sept. 18, 2024 -- Once-daily roflumilast cream improves atopic dermatitis (AD) relative to vehicle cream, according to a study published online Sept. 18 in JAMA Dermatology.

Eric L. Simpson, M.D., from the Oregon Health & Science University in Portland, and colleagues examined the efficacy and safety of once-daily roflumilast cream, 0.15 percent, versus vehicle cream in two phase 3 randomized trials (INTEGUMENT-1 and INTEGUMENT-2), which included patients aged 6 years and older with mild-to-moderate AD. A total of 1,337 patients were included: 654 in INTEGUMENT-1 and 683 in INTEGUMENT-2.

The researchers found that the primary end point (Validated Investigator Global Assessment for Atopic Dermatitis success at week 4) was achieved by significantly more patients treated with roflumilast than vehicle (32.0 versus 15.2 percent in INTEGUMENT-1 and 28.9 versus 12.0 percent in INTEGUMENT-2). For the achievement of at least 75 percent reduction in the Eczema Area and Severity Index, there were significant differences favoring roflumilast at week 4 (43.2 versus 22.0 percent in INTEGUMENT-1 and 42.0 versus 19.7 percent in INTEGUMENT-2). Low rates of treatment-emergent adverse events were seen with roflumilast, which was well tolerated. No signs of irritation were noted in patients treated with roflumilast at each time point.

"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 write.

Several authors disclosed ties to pharmaceutical companies, including Arcutis Biotherapeutics, which sponsored the study and provided the roflumilast and vehicle creams.