Efficacy and safety of crisaborole ointment in children with atopic dermatitis: meta-analysis of single proportions
10.3760/cma.j.cn114015-20220503-00388
- VernacularTitle:克立硼罗软膏治疗儿童特应性皮炎有效性和安全性的单组率meta分析
- Author:
Jiale LI
1
;
Haipian LI
;
Zhaoqi HUANG
;
Xiaolan MO
Author Information
1. 广州市妇女儿童医疗中心药学部，广州 510623
- Publication Type:Journal Article
- Keywords:
Dermatitis, atopic;
Child;
Efficiency;
Safety;
Meta-analysis;
Crisaborole
- From:
Adverse Drug Reactions Journal
2022;24(10):508-514
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the efficacy and safety of crisaborole ointment (crisaborole) treatment in children with atopic dermatitis (AD).Methods:PubMed, Embase, Medline, CNKI, Wanfang Medicine, VIP, and Chinese Medical Journal Databases were searched (up to March 2022) and the literature on randomized controlled trials (RCTs) and cohort studies of crisaborole treatment in children with AD was collected. The quality of RCTs and cohort studies was evaluated using the modified Jadad scale and Newcastle-Ottawa scale, respectively. Data on effective rate and incidence of adverse event in children treated with crisaborole were extracted. The meta-analysis of single proportions was performed with Stata 15 software.Results:A total of 8 studies (4 RCTs and 4 prospective cohort studies, respectively) were entered in the analysis, including 1 855 children (aged from 3 months to 17 years) treated with crisaborole. The 8 studies were all of high quality. The meta-analysis of single proportions showed that the effective rate of children with AD treated with crisaborole for 14-28 days was 46% [95% confidence interval ( CI): 32%-61%], the incidence of adverse events during treatment was 28% (95 %CI: 19%-38%), and the incidence of treatment discontinuation due to adverse events was 1% (95 %CI: 0-2%). Most of the adverse events caused by crisaborole were local skin reactions, mainly characterized by local pain, itching, dermatitis, paresthesia, and local infection, etc. Seven of the 8 studies reported the pain at the application site, and the incidence of pain at the application site was 17% (95 %CI: 11%-24%). Most adverse events were mild to moderate and could be alleviated without treatment. Serious adverse events occurred in 8 patients (0.4%), 7 of which were unrelated to the treatment drugs. Conclusion:Crisaborole has good efficacy and safety in the treatment of mild to moderate AD in children.
