PURPOSE OF THE STUDY.
To assess the efficacy and safety of crisaborole ointment, which is a phosphodiesterase 4 inhibitor, for the topical treatment of atopic dermatitis.
This study includes the results from 2 identically designed phase 3 clinical trials conducted in the United States that included a total of 1522 individuals who were 2 years of age or older. About 85% of study participants were less than 18 years of age, and 55% of study participants were female. About 60% of study participants were white and 28% were black.
Patients aged 2 years or older were enrolled in 2 identically designed, vehicle-controlled, double-blind studies and were randomly assigned (2:1, crisaborole:vehicle). Study participants had an Investigator’s Static Global Assessment (ISGA) score of mild to moderate atopic dermatitis. Exclusion criteria prohibited previous use of biologic therapy or systemic corticosteroids within 28 days or topical corticosteroids or topical calcineurin inhibitors within 14 days. Instructions included the application of a layer of the study drug to cover all atopic dermatitis–affected areas at baseline twice daily for the duration of the 28-day study period. The primary efficacy end point was an ISGA score at day 29 of clear (score 0) or almost clear (score 1) with a 2-grade or more improvement from baseline.
There were no significant differences across treatment groups or across studies in either disease severity or baseline demographics. More patients treated with crisaborole achieved efficacy in an ISGA score at day 29 than vehicle-treated patients (first phase 3 study: 32.8% vs 25.4%, P = .38; second phase 3 study: 31.4% vs 18%, P < .001). Furthermore, patients treated with crisaborole achieved efficacy in an ISGA score and improvement in pruritus earlier than those treated with vehicle alone. Crisaborole was well tolerated, with infrequent adverse events of a mild to moderate severity level.
Crisaborole demonstrated improvement in overall disease severity, pruritus, and other signs of atopic dermatitis with a favorable safety profile.
This study highlights the results of 2 large phase 3 trials that demonstrated the clinical efficacy and benefit of crisaborole for the treatment of mild to moderate atopic dermatitis. As a phosphodiesterase 4 inhibitor, crisaborole represents a novel, nonsteroidal topical therapy that has been recently FDA approved to improve management for atopic dermatitis.
- Copyright © 2017 by the American Academy of Pediatrics