Phase 2 clinical study of delgocitinib ointment in pediatric patients with atopic dermatitis
Phase 2 clinical study of delgocitinib ointment in pediatric patients with atopic dermatitis
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DOI：
10.1016/j.jaci.2019.08.004
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发表时间：
2019-12-01
影响因子：
14.2
通讯作者：
Nagata, Takeshi
中科院分区：
文献类型：
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作者：
Nakagawa, Hidemi;Nemoto, Osamu;Nagata, Takeshi
背景资料：局部使用Delgocitinib（JTE-052）是一种新型Janus激酶抑制剂，已被证明对成人特应性皮炎（AD）具有临床有效性。然而，局部delgocitinib在儿童患者AD的疗效仍不清楚。目的：我们试图评估delgocitinib软膏在儿童患者AD的疗效和安全性。方法：在这2期临床研究（JapicCTI-173553）日本患者年龄2至15岁AD随机在1：1：1的比例接受0.25%或0.5% delgocitinib软膏或车辆软膏，每天两次，持续4周。主要疗效终点为治疗结束时（EOT）改良的湿疹面积和严重程度指数评分较基线的百分比变化。结果：在EOT时，与溶媒组相比，两个delgocitinib组的改良湿疹面积和严重程度指数评分均显著降低。0.25%组和0.5%组相对于基线的最小二乘平均百分比变化分别为-54.2%和-61.8%，而溶媒组为-4.8%（两种比较均为P <.001）。同样，在EOT时，与溶媒组相比，两个Delgocitinib组的所有其他疗效参数（包括研究者总体评估和瘙痒评分）均显著改善。在两个delgocitinib组的不良事件的严重程度是轻微的，没有严重的不良事件reported.Conclusions：Delgocitinib软膏改善临床体征和症状的儿童AD患者，耐受性良好。这些研究结果表明，Delgocitinib软膏可能是儿童AD患者的一种有前景的治疗选择。
Background: Topical delgocitinib (JTE-052), a novel Janus kinase inhibitor, had been shown to be clinically effective in adults with atopic dermatitis (AD). However, the efficacy of topical delgocitinib in pediatric patients with AD remained unclear.Objective: We sought to evaluate the efficacy and safety of delgocitinib ointment in pediatric patients with AD.Methods: In this phase 2 clinical study (JapicCTI-173553) Japanese patients aged 2 through 15 years with AD were randomized in a 1:1:1 ratio to receive 0.25% or 0.5% delgocitinib ointment or vehicle ointment twice daily for 4 weeks. The primary efficacy end point was the percentage change from baseline in the modified Eczema Area and Severity Index score at the end of treatment (EOT).Results: At EOT, modified Eczema Area and Severity Index scores in both delgocitinib groups were significantly reduced compared with that in the vehicle group. The least-squares mean percentage change from baseline was -54.2% in the 0.25% group and -61.8% in the 0.5% group versus -4.8% in the vehicle group (P < .001 for both comparisons). Similarly, all other efficacy parameters, including Investigator's Global Assessment and pruritus scores, in both delgocitinib groups were significantly improved compared with those in the vehicle group at EOT. Adverse events in both delgocitinib groups were mild in severity, and no serious adverse events were reported.Conclusions: Delgocitinib ointment improved clinical signs and symptoms in pediatric patients with AD and was well tolerated. These study results indicate that delgocitinib ointment can be a promising therapeutic option for pediatric patients with AD.