Roflumilast safe for children aged 2 to 5 years with atopic dermatitis
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Key takeaways:
- More children treated with roflumilast vs. vehicle achieved IGA 0 or 1 (25.4% vs. 10.7%).
- Of the 93.8% of patients who completed the study, 93.4% elected to continue to the open-label, extension trial.
Roflumilast cream 0.05% achieved positive results in a pediatric trial of a phase 3 program treating children aged 2 to 5 years with mild to moderate atopic dermatitis, according to an Arcutis Biotherapeutics press release.
The phase 3, double-blind, vehicle-controlled trial, INTEGUMENT-PED, of roflumilast cream, a steroid-free, topical phosphodiesterase (PDE4) inhibitor, met its primary endpoint and all secondary endpoints, according to the press release.
“Roflumilast cream was formulated with the atopic dermatitis patient in mind, delivering drug without disrupting the skin barrier or the use of sensitizing excipients and irritants,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, said in the release. “The consistent safety and tolerability profile of roflumilast cream sets our next generation PDE4 inhibitor apart.”
In the trial, a total of 652 children with a mean body surface area involvement of 22% received once-daily roflumilast cream 0.05% or vehicle for 4 weeks. Results showed that 25.4% of those treated with roflumilast achieved the primary endpoint of an IGA score of 0 or 1 (clear or almost clear) plus a 2-point improvement from baseline by week 4, whereas only 10.7% of vehicle-treated patients achieved the same (P < .0001).
The secondary endpoint of EASI 75 was also achieved by 39.4% of roflumilast-treated patients by week 4 compared with 20.6% of vehicle-treated patients (P < .0001). A greater proportion of children treated with roflumilast also saw a 4-point reduction in itch according to the Worst Itch Numeric Scale by week 4 compared with vehicle-treated children (35.3% vs. 18%; P = .0002).
The drug was considered well-tolerated with a low incidence of adverse events. The most frequent adverse events included upper respiratory tract infection, pyrexia, diarrhea and vomiting. Discontinuation due to adverse events was similar between groups.
Ultimately, 93.8% of those treated with roflumilast completed the full 4-week study, of which 93.4% elected to continue to the open-label, extension trial, INTEGUMENT-OLE.