LOS ANGELES — Two phase 3 studies presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting confirmed that the investigational crisaborole topical ointment, 2%, was safe and effective for patients with mild-to-moderate atopic dermatitis.
“Current treatments include topical steroids and calcineurin inhibitors, which are beneficial but have limitations. We are always looking for new treatments that are both safe and effective for our patients,” researcher Mark Boguniewicz, MD, of the National Jewish Health, Denver, CO and the University of Colorado School of Medicine, said in a press release. “Crisaborole 2% ointment is a novel topical anti-inflammatory ointment without steroids. If it is approved by the FDA, it would represent a new treatment option for health care providers to offer their patients who have mild-to-moderate atopic dermatitis.”
Boguniewicz and colleagues performed two multicenter, double-blind, vehicle-controlled investigations to test the safety and efficiency of crisaborole. The researchers used the Investigator’s Static Global Assessment (ISGA) to examine atopic dermatitis (AD) disease severity. Time to improvement in pruritus, severity of pruritus, and signs of AD were evaluated through supportive efficacy endpoints.
Patients with mild-to-moderate AD, aged 2 years and older, were randomly given crisaborole or vehicle twice daily. Participants were evaluated on days 8, 15, 22, and 29. Study 1 consisted of 503 crisaborole and 256 vehicle patients, while study 2 comprised of 513 crisaborole and 250 vehicle patients.
On day 29 of the study, a greater amount of participants treated with crisaborole attained ISGA success (Study 1: 32.8% vs. 25.4%; Study 2: 31.4% vs. 18.0%). In addition, more crisaborole-treated patients reported their eczema as “clear” or “almost clear” (study 1: 51.7% vs 40.6%; study 2: 48.5% vs 29.7%).
Overall, by day 29, a superior percentage of patients treated with crisaborole achieved success for all clinical signs of AD. Infrequent, transient, and mildly/moderately severe treatment related adverse events were reported.
Boguniewicz noted, “Improvements in pruritus were achieved earlier with crisaborole than with vehicle – and getting relief from itching is so important for our patients – and a greater proportion of crisaborole-treated patients saw improvement for all clinical signs of atopic dermatitis by day 29.” — by Alaina Tedesco
Boguniewicz M, et al. Abstract L25. Presented at: the American Academy of Allergy, Asthma & Immunology Annual Meeting; March 4-7, 2016; Los Angeles.
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