Roflumilast cream safe, effective for atopic dermatitis in children 6 years and up


Recently announced data from the INTEGUMENT-1 phase 3 clinical trial demonstrated positive safety and efficacy results for atopic dermatitis patients 6 years and older treated with roflumilast cream (Arcutis Biotherapeutics).

Arcutis Biotherapeutics recently announced positive results from its phase 3 pivotal trial, INTEGUMENT-1, investigating roflumilast cream 0.15% for the treatment of atopic dermatitis in adults and pediatric patients 6 years and up. Roflumilast cream is a nonsteroidal topical phosphodiesterase-4 (PDE4) inhibitor.

In the study, roflumilast cream met its primary endpoint with 32.0% of participants treated with roflumilast achieving Investigator Global Assessment (IGA) Success, defined as a validated IGA–Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ with a 2-grade improvement from baseline at week 4, vs 15.2% of participants treated with vehicle (P<0.0001).

“Atopic dermatitis is a chronic and burdensome disease, especially common with children, that has a significant need for rapid-acting topical treatment options outside of corticosteroids, which aren’t suitable for long-term care due to local side effects, safety concerns, and potential for rebound or withdrawal,” said Eric Simpson, MD, MCR, FAAD, professor of dermatology at Oregon Health & Science University in Portland.

He added, “In this pivotal phase 3 study, roflumilast cream demonstrated strong efficacy, meeting the primary endpoint of IGA success, and was well tolerated. In addition, a significant number of adults and children were able to get to clear or almost clear in only four weeks, pointing to the potential for roflumilast cream to become an important new treatment option for atopic dermatitis.”

The cream also showed statistically significant and rapid improvements vs vehicle for all secondary endpoints. This includes 43.2% of individuals treated with roflumilast achieving a 75% reduction in Eczema Area and Severity Index (EASI-75) at week 4 vs 22.0% of those treated with vehicle (P<0.0001).

The study also investigated itch reduction in patients 12 years and older. Results of this investigation demonstrated 33.6% of individuals treated with roflumilast achieved a 4-point reduction in Worst Itch Numeric Scale (WI-NRS) at week 4 vs 20.7% for those treated with vehicle, P<0.01).

Roflumilast was also shown to be well-tolerated with emergent adverse events (TEAEs) being recorded as low and similar between roflumilast and vehicle. Additionally, there were no serious adverse events.

Common adverse events (>1%) included COVID-19, diarrhea, vomiting, headache, nausea, application site pain, and nasopharyngitis.

“Today’s positive data from INTEGUMENT-1 adds to the growing body of evidence for the overall potential of roflumilast cream as an effective and well-tolerated treatment in atopic dermatitis,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis.

“Roflumilast cream is a next-generation PDE4 inhibitor that was well tolerated and safe in this trial, providing rapid and robust clearance of the disease as well as reduction in itch. We are encouraged by these findings and look forward to reporting out the second INTEGUMENT study before the end of the year,” Burnett added.

Arcutis expects results from its phase 3 trial INTEGUMENT-2 by the end of 2022. Pending successful results, Arcutis plants to submit a supplemental New Drug Application (sNDA) in 2023 for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis in patients 6 years and older.


Arcutis Announces Positive Topline Results from INTEGUMENT-1 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis in Adults and Children Aged Six Years and Older. Arcutis Biotherapeutics. November 15, 2022. Accessed November 15, 2022.

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