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This study was carried out to determine the efficacy and safety of once-daily nonsteroidal treatment Roflumilast cream (0.15%) for atopic dermatitis.
In children and adults with mild to moderate atopic dermatitis, once-daily 0.15% Roflumilast cream markedly improves treatment outcomes and is well-tolerated with minimal side effects.
This study was carried out to determine the efficacy and safety of once-daily nonsteroidal treatment Roflumilast cream (0.15%) for atopic dermatitis.
Two pivotal phase 3, randomized, double-blind, vehicle-controlled trials (INTEGUMENT-1 and INTEGUMENT-2) were carried out across leading clinical sites in Poland, Canada, and United States. The trials encompassed volunteers aged 6 years or above suffering from AD. The condition was examined via the Validated Global Assessment for Atopic Dermatitis (vIGA-AD), a 5-point scale ranging from 0 (clear) to 4 (severe).
The enrolled subjects were randomly allocated in a 2:1 ratio to get either Roflumilast cream (0.15%) or vehicle cream once daily for a period of 4 weeks. The key efficacy measure was success on the vIGA-AD at week 4. It was defined as a score of 0 or 1 with at least a 2-point betterment from baseline. Secondary endpoints encompassed the Eczema Area and Severity Index (EASI) and the Worst Itch Numeric Rating Scale (NRS). The study also closely monitored safety and local tolerability.
A total of 1,337 patients (654 in INTEGUMENT-1 and 683 in INTEGUMENT-2) were enrolled. The mean (standard deviation [SD]) age was 27.7 (19.2) years. Notably, 56.9% (761 patients) were females. The mean body surface area affected was 13.6%. Roflumilast-treated patients showed markedly greater success in attaining the primary endpoint when compared to those receiving the vehicle (INTEGUMENT-1: 32.0% vs 15.2%; INTEGUMENT-2: 28.9% vs 12.0%).
At week 4, substantial improvements in EASI (at least a 75% reduction) were also noted in favor of Roflumilast (INTEGUMENT-1: 43.2% vs 22.0%; INTEGUMENT-2: 42.0% vs 19.7%). Roflumilast was exceptionally well-tolerated, with treatment-emergent adverse events occurring at low rates. Notably, 95% of subjects using Roflumilast showed no signs of irritation at the application spot, and 90% experienced either no or only mild sensations.
Roflumilast cream, 0.15%, when used once-daily, led to remarkable AD improvements in both children and adults. This was accompanied by an excellent safety and tolerability profile, positioning Roflumilast as a promising therapeutic option for AD.
JAMA Dermatology
Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials
Eric L. Simpson et al.
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