434 Efficacy and safety of crisaborole ointment, 2%, in Chinese and Japanese pediatric patients aged 2–17 years with mild-to-moderate atopic dermatitis

Abstract

Abstract Atopic dermatitis (AD) is a common, chronic immuno-inflammatory skin disorder that commonly arises during childhood. Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate AD. This study aims to evaluate the efficacy and safety of crisaborole ointment, 2%, in pediatric Chinese and Japanese patients aged 2–17 years with mild-to-moderate AD. This post hoc analysis of a double-blind, vehicle-controlled, phase 3 study (CrisADe CLEAR; NCT04360187) evaluated the safety and efficacy of crisaborole in Chinese and Japanese patients aged ≥2 years with mild-to-moderate AD (involving ≥5% treatable body surface area). Patients were randomly assigned 2 : 1 to receive crisaborole or vehicle, respectively, twice-daily for 28 days. In this analysis, subgroups consisting of Chinese and Japanese patients aged 2–6 years, 2–11 years, and 12–17 years from the overall population were assessed. Efficacy endpoints included percent change from baseline in Eczema Area and Severity Index (EASI) total score at Day 29, improvement in Investigator’s Static Global Assessment (ISGA) score [score of 0 (clear) or 1 (almost clear)] at Day 29, success per ISGA (score of 0 or 1 with a ≥2-grade improvement from baseline) at Day 29, and change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS; used with permission from Regeneron Pharmaceuticals, Inc., and Sanofi) score at Week 4 (patients ≥12 years only). Safety was also assessed. Of 391 patients in the overall study, 93 were aged 2–6 years, 99 were aged 7–11 years, and 40 were aged 12–17 years. A greater reduction in percent change from baseline in EASI total score at Day 29 was shown in crisaborole- vs. vehicle-treated patients for patients aged 2–6 years and the overall population, with comparable reductions in other age subgroups (ClinicalTrials.gov, NCT04360187). Patients in the crisaborole group vs. the vehicle group had higher rates of ISGA improvement (age 2–6 subgroup) and success per ISGA (age 12–17 subgroup); comparable response rates were seen in other age subgroups (ClinicalTrials.gov, NCT04360187). Patients who received crisaborole showed a greater reduction vs. those who received vehicle in change from baseline in PP-NRS score at Week 4 in the overall population, with a comparable reduction seen in patients aged ≥12 years (ClinicalTrials.gov, NCT04360187). Crisaborole-treated patients in the overall population and each age subgroup had consistent but comparable improvement in all primary and key secondary efficacy endpoints. In patients aged 2–6 years, 55.4% and 62.2% of those who received crisaborole and vehicle, respectively, experienced all-cause treatment-emergent adverse events (TEAEs). All-cause TEAEs occurred in 52.2% and 34.4% of patients aged 7–11 years who received crisaborole and vehicle, respectively; in the aged 12–17 years subgroup, 36% and 40% of patients who received crisaborole and vehicle experienced all-cause TEAEs, respectively. The TEAEs occurring in ≥1% of patients across all subgroups included atopic dermatitis and treatment-related application site pain. Application site pain was most frequently reported in the face and neck. Most TEAEs were mild. There were no new safety findings. Crisaborole was effective and well tolerated in Chinese and Japanese patients aged 2–17 years with mild-to-moderate AD.