In a cohort of Chinese and Japanese pediatric patients, researchers deemed the topical treatment both safe and effective.
Crisaborole ointment 2% was both safe and effective in treating mild-to-moderate cases of atopic dermatitis in a cohort of Chinese and Japanese pediatric patients, according to a poster presented at the Revolutionizing Atopic Dermatitis conference in Washington, DC.1
Researchers conducted a post-hoc analysis of a previous phase 3 study in order to determine and analyze the safety and efficacy of crisaborole in a cohort of pediatric patients with the condition across different age subgroups. They cited prior research establishing the safety and efficacy of crisaborole; however, they noted that the effects of the treatment on pediatric patients have not been fully, separately investigated.
Additionally, they cited research demonstrating potential differences in disease course based on ethnicity or race, further noting that atopic dermatitis has a higher disease prevalence in Asian patients than in white patients.
The study being analyzed, CrisADe CLEAR, was multicenter, randomized, double-blind, and vehicle-controlled in nature. Chinese and Japanese patients ages 2 and older had mild-to-moderate atopic dermatitis. All patients were evaluated using the Investigator’s Static Global Assessment (ISGA) and had received a score of 2 or 3. They were also required to have an affected body surface area of 5% or greater, excluding the scalp, for inclusion in the study.
In the study, they underwent a screening period, treatment period, and follow-up period, which lasted 60 days in total. During the treatment period, 260 patients were randomly assigned to receive topical crisaborole ointment 2% on a twice-daily basis. 131 patients were assigned to the vehicle-control group, again receiving the treatment twice per day. This treatment pattern remained consistent for the 28-day treatment period.
During the post-hocanalysis, researchers examined age groups from the CrisADe CLEAR study and stratified patients into 3 separate age groups: 2 to 6 years, 7 to 11 years, and 12 to 17 years.
“Across all age subgroups, patients treated with crisaborole had a greater reduction in the percent change from baseline in EASI total score at day 29 compared to those who received vehicle," study authors wrote. “Patients aged 2-6 years had the largest relative reduction in percent change from baseline in EASI total score at day 29 when comparing crisaboroleversus vehicle-treated patients.”
Furthermore, researchers found that patients ages 2 to 6 and 12 to 17 had higher rates of ISGA improvement when treated with crisaborole as opposed to the vehicle, though all age subgroups experienced higher rates of treatment effectiveness and success when treated with the crisaborole ointment as opposed to their vehicle group counterparts. They also experienced an overall greater reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) score by week 4.
Treatment-emergent adverse events were mostly mild in nature, and most frequently involved application site pain, atopic dermatitis, folliculitis, or application site discoloration.
“Patients treated with crisaborole in each age subgroup had consistent, comparable improvement in all primary and key secondary efficacy endpoints,” study authors wrote. “Crisaborole was well tolerated in all age subgroups, with no new safety signals identified.”