Roflumilast Cream 0.15% Well Tolerated in Atopic Dermatitis Patients with Prior Treatment Failures

Eric L Simpson, MD

Arcutis Biotherapeutics today announced data from phase 3 clinical trials for atopic dermatitis and scalp and body psoriasis at the 2025 American Academy of Dermatology Meeting, being held March 7-11, in Orlando, FL.

Roflumilast cream 0.15% demonstrated strong safety and tolerability in patients with atopic dermatitis (AD) who had previously experienced inadequate response, intolerance, or contraindications to topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or crisaborole, according to a pooled analysis of the replicate 4-week phase 3 INTEGUMENT-1 and INTEGUMENT-2 trials.¹

Among 1,137 study participants (884 roflumilast, 453 vehicle), adverse local effects were minimal, with application site pain occurring in only 1.5% of those using roflumilast vs 0.7% using vehicle among those with prior TCS failure. In patients with prior TCI failure, rates were 1.8% (roflumilast) and 2.5% (vehicle), while in those with prior crisaborole failure, 1.4% using roflumilast reported pain compared with none using vehicle.

Participants who had discontinued crisaborole due to stinging, burning, or poor tolerability (n=34 roflumilast, n=13 vehicle) reported no application site treatment-emergent adverse events (TEAEs). Investigator-rated tolerability was high, with 98% or more of participants with TCS failure, 97% or more of those with TCI failure, and 95% or more who had failed crisaborole experiencing minimal or no irritation at all at all study timepoints. Patient-reported tolerability was similarly favorable, with fewer than 3% of participants describing hot, tingling, or stinging sensations that caused definite discomfort, according to the study abstract.¹

Standard topical therapies for atopic dermatitis such as the 3 evaluated in the study are often limited by safety concerns, further reinforcing the suitability of roflumilast cream 0.15% as an alternative for those unable to benefit from them. Roflumilast 0.15% cream is approved for the treatment of mild-to-moderate AD in persons aged 6 years and older.

On February 26, 2025, the FDA accepted the a supplemental new drug application (sNDA) for roflumilast cream 0.05% to treat atopic dermatitis (AD) in children aged 2 to 5 years, according to a press release from Arcutis.²

For data on the body and scalp findings, please click here.

For more 2025 AAD Meeting coverage, please click here.

References
1. Simpson E, Eichenfield L, Gooderham L, et al. Pooled Safety and Local Tolerability of Roflumilast Cream 0.15% from the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Trials of Patients With Atopic Dermatitis: Subgroup Analysis of Patients With Prior Inadequate Response, Intolerance, and/or Contraindications to Topical Treatments. Abstract presented at the 2025 American Academy of Dermatology Meeting; March 7-11, 2025. Orlando, FL.
2. US FDA accepts supplemental new drug application for Arcutis' Zoryve (roflumilast) cream 0.05% for the treatment of children aged 2 to 5 with mild to moderate atopic dermatitis. Arcutis Biotherapeutics. Press release. February 26, 2025. Accessed February 26, 2025. https://www.globenewswire.com/news-release/2025/02/26/3032866/0/en/U-S-FDA-Accepts-Supplemental-New-Drug-Application-for-Arcutis-ZORYVE-roflumilast-Cream-0-05-for-the-Treatment-of-Children-Aged-2-to-5-with-Mild-to-Moderate-Atopic-Dermatitis.html