Roflumilast Cream Shows Consistent Results in AD Across Skin Types

Newly published pooled analyses of the INTEGUMENT trials suggest that ZORYVE (roflumilast) cream 0.15% showed significant improvements in atopic dermatitis (AD) symptoms, regardless of race, ethnicity, or Fitzpatrick skin type.

Results from the studies showed that higher percentages of patients treated with roflumilast achieved Validated Investigator Global Assessment (vIGA-AD) Success compared to those treated with the vehicle, with consistent results across all racial and ethnic groups. Among white patients, 32.3% achieved success versus 13.3% receiving  vehicle. For Black or African American patients, the rates were 25.8% treatment vs. 11.5% vehicle, and among Asian patients, 33.7% vs. 21.8%, respectively. Similar trends were observed for Hispanic and non-Hispanic patients and across all Fitzpatrick skin types.

“Given that the clinical presentation of AD may differ among patients by race, ethnicity, and Fitzpatrick skin type, it is reassuring to see the consistency of efficacy, safety, and tolerability of a treatment across these various subgroups,” said Vimal H. Prajapati MD, FRCPC, DABD, clinical associate professor at the University of Calgary and co-founder/co-director of the Skin Health & Wellness Centre, Dermphi Centre, Dermphi Shop, and Dermatology Research Institute, in a news release. “ZORYVE cream 0.15% consistently achieved meaningful and significant improvements in disease clearance and itch reduction, in all subgroups. This analysis can give confidence to clinicians that ZORYVE provides effective and well-tolerated relief of atopic dermatitis signs and symptoms across individuals with diverse skin types.”

Roflumilast-treated patients also showed greater improvement in itch, as assessed by the Worst Itch-Numeric Rating Scale (WI-NRS), outperforming the vehicle in every category. Treatment-emergent adverse events rates were low and similar across subgroups. The most common reported reactions were headache, nausea, and application site pain.

"We formulated ZORYVE cream with all AD patients in mind, and we are pleased to present these data from our Phase 3 INTEGUMENT studies, which demonstrated ZORYVE’s ability to significantly, consistently, and safely improve AD symptoms regardless of race, ethnicity, or skin type,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, in a press release. “It is critical that our clinical data represent the diversity in the world around us, and these results further reinforce our commitment to providing meaningful innovation for immune-mediated skin diseases.”

Source: Arcutis press release. September 25, 2024.