Roflumilast Cream Shows Strong Tolerability in Patients with AD Failing Other Topicals: Daily Dose

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On March 7, 2025, we reported on new data from the phase 3 INTEGUMENT-1 and INTEGUMENT-2 clinical trials presented at the 2025 American Academy of Dermatology Meeting, held March 7-11, in Orlando, FL.

The study

Researchers conducted a pooled analysis of the replicate, 4-week phase 3 trials. The studies examined roflumilast cream 0.15% 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.

For the pooled analysis, investigators focused on the safety and local tolerability of roflumilast cream among 1137 participants.

The findings

Roflumilast cream 0.15% demonstrated strong safety and tolerability, investigators reported. 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.

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