一个第1阶段的开放标签研究,对Ritlecitinib在6-12岁儿童的药理动力学进行研究,这些儿童患有白发症
Mercedes E Gonzalez1, John Browning2, Stacy Smith3
1Pediatric Skin Research, Coral Gables, Florida, USA.
Pediatric dermatology
|February 10, 2025
概括
利特利西提尼的药理动力学参数在6至12岁的儿科患者中被表征为有形脱发症. 药物一般耐受性很好,支持其在这个年龄组的潜在使用.
科学领域:
- 药理学 药理学是指药理学的学科.
- 皮肤病学 皮肤病学
- 儿科医学 儿科医学
背景情况:
- 脱发症 (alopecia areata,简称AA) 是一种自身免疫性疾病,导致脱发,显著影响生活质量,儿童患病率显著.
- 目前,没有FDA批准的系统性治疗方法用于12岁以下儿童的AA.
- 利特利西尼布是一种JAK3 / TEC激酶抑制剂,已批准在12岁及以上的个人中治疗严重的AA.
研究的目的:
- 评估 6 至 < 12 岁的儿科大白症患者里特莱西提尼布的药理动力学 (PK) 参数.
- 评估Ritlecitinib在这个儿科群体中的安全性和耐受性.
主要方法:
- 一项开放的单组研究,涉及6至12岁的儿童参与者,患有AA.
- 参与者每天服用20毫克利特西提尼布,持续7天.
- 药物动力学参数 (Tmax,半衰期,AUC24,Cmax) 和安全结果 (不良事件) 被测量和评估.
主要成果:
- 招募了15名参与者;14人完成了研究.
- 里特利西丁尼的Tmax中位数为~0.5小时,平均半衰期为~1.19小时,平均AUC24和Cmax值分别为437.5 ng·h/mL和208.7 ng/mL.
- 三名参与者经历了四次不良事件; 一例疹导致停止治疗. 没有报告严重或严重的不良事件.
结论:
- 里特利西提尼布的药理动力学特征在6岁至12岁以下的儿童患者中成功表征了AA.
- 在这个儿科队列中,Ritlecitinib 20 mg 每天服用一次通常耐受良好.
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