Objectives

This post hoc analysis of pooled data from two phase III studies (AD-301: NCT02118766; AD-302: NCT02118792) explored the efficacy and safety of crisaborole ointment, 2%, a nonsteroidal phosphodiesterase 4 inhibitor, for the treatment of mild-to-moderate atopic dermatitis (AD) in pediatric patients (aged 2 to < 18 years) only, stratified by baseline characteristics.

Methods

Pediatric patients with mild or moderate AD per Investigator’s Static Global Assessment (ISGA) and percentage of treatable body surface area (%BSA) ≥ 5 at baseline were assessed. Crisaborole or vehicle (2:1 randomization ratio) was applied twice daily for 28 days. Of the 1313 pediatric patients included in this study, 874 received crisaborole and 439 received vehicle. ISGA success was defined as clear (0) or almost clear (1) with ≥ 2-grade improvement from baseline. Efficacy and safety were stratified by age group, sex, baseline ISGA, baseline %BSA per published severity strata, and prior AD therapy.

Results

Overall, the proportions of crisaborole-treated and vehicle-treated pediatric patients with ISGA success at week 4 were 32.5 and 21.5%, respectively. ISGA success rates at day 29 (week 4) were generally higher in crisaborole-treated (21.9–38.1%) than vehicle-treated (15.7–26.9%) patients across subgroups. Rates of treatment-related application site pain were 2.4–10.1% for crisaborole-treated patients and 0.6–2.2% for vehicle-treated patients across subgroups. No new safety concerns were noted in any patient subgroup.

Conclusion

Crisaborole improved global disease severity and was reasonably well tolerated across all pediatric baseline characteristic subgroups. Application site discomfort was greater with crisaborole than with vehicle, but few patients discontinued treatment.

Clinicaltrials.gov registration numbers

NCT02118766; NCT02118792 (registration date: April 21, 2014).

中文翻译：

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Crisaborole 治疗 2 至 < 18 岁儿童轻度至中度特应性皮炎的亚组分析

目标

这项对来自两项 III 期研究（AD-301：NCT02118766；AD-302：NCT02118792）的汇总数据的事后分析探讨了 2% 非甾体磷酸二酯酶 4 抑制剂 crisaborole 软膏治疗轻度至- 仅儿童患者（2 至 < 18 岁）的中度特应性皮炎 (AD)，按基线特征分层。

方法

评估了根据研究者的静态全局评估 (ISGA) 和基线时可治疗体表面积百分比 (%BSA) ≥ 5 的轻度或中度 AD 儿科患者。Crisaborole 或载体（2:1 随机化比）每天两次，持续 28 天。在这项研究中包括的 1313 名儿科患者中，874 名接受了 crisaborole，439 名接受了载体。ISGA 成功被定义为明确 (0) 或几乎明确 (1) 与基线相比 ≥ 2 级改善。疗效和安全性按年龄组、性别、基线 ISGA、每个公布的严重程度层的基线 %BSA 和先前的 AD 治疗进行分层。

结果

总体而言，crisaborole 治疗和载体治疗的儿科患者在第 4 周 ISGA 成功的比例分别为 32.5% 和 21.5%。在第 29 天（第 4 周）的 ISGA 成功率在各亚组中，crisaborole 治疗（21.9-38.1%）的患者普遍高于载体治疗（15.7-26.9%）患者。在各亚组中，crisaborole 治疗的患者与治疗相关的应用部位疼痛发生率为 2.4-10.1%，载体治疗的患者为 0.6-2.2%。在任何患者亚组中均未发现新的安全问题。

结论

Crisaborole 改善了全球疾病的严重程度，并且在所有儿科基线特征亚组中均具有良好的耐受性。crisaborole 的应用部位不适比车辆更大，但很少有患者停止治疗。

Clinicaltrials.gov 注册号

NCT02118766; NCT02118792（注册日期：2014年4月21日）。