利特西替尼治疗脱发患者的患者报告脱发情况及其影响(通过脱发患者优先结果工具进行测量):ALLEGRO 2b/3 期随机临床试验。

IF 8.6 1区 医学 Q1 DERMATOLOGY
Rodney Sinclair, Natasha Mesinkovska, Debanjali Mitra, Dalia Wajsbrot, Ernest H Law, Robert Wolk, Brett King
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引用次数: 0

摘要

研究背景ALLEGRO 2b/3期研究调查了利特西替尼对斑秃患者的疗效和安全性:使用斑秃患者优先结果(AAPPO)工具描述利特西替尼对患者报告的脱发的影响,并评估具有临床意义的毛发再生与患者报告的影响改善之间的关系:在ALLEGRO-2b/3研究中,年龄≥12岁、头皮脱发≥50%的AA患者接受每日一次的瑞替西替尼50或30毫克(±4周200毫克每日负荷剂量)、10毫克或安慰剂治疗24周,然后继续接受瑞替西替尼治疗或从安慰剂换成瑞替西替尼200/50或50毫克治疗24周。AAPPO工具评估了第4周至第48周脱发、情绪症状(ES)和活动受限(AL)的改善情况(次要终点)。计算脱发严重程度工具(SALT)评分≤20分的应答者和未应答者(探索性终点)在第24周和48周时ES和AL领域评分及单项的平均变化:共有718名患者接受了随机治疗。第24周时,接受利特西替尼10-200/50毫克治疗的患者中有5%-36%报告头皮脱发有所改善,而接受安慰剂治疗的患者中仅有9%报告头皮脱发有所改善。眉毛、睫毛和体毛脱发的结果相似。第24周和第48周时,ES和AL评分与基线相比的平均变化较小,组间相似。在第 24 周和第 48 周,SALT 得分≤20 分的应答者与未应答者相比,单个脱发和 ES 项目的平均变化较大:AAPPO工具显示了利特西替尼对患者报告的毛发生长的有益影响,这与临床医生报告结果的改善是一致的:临床试验注册:NCT03732807。信息图表。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Patient-Reported Hair Loss and Its Impacts as Measured by the Alopecia Areata Patient Priority Outcomes Instrument in Patients Treated with Ritlecitinib: The ALLEGRO Phase 2b/3 Randomized Clinical Trial.

Background: The ALLEGRO phase 2b/3 study investigated the efficacy and safety of ritlecitinib in patients with alopecia areata (AA).

Objective: To describe the impact of ritlecitinib on patient-reported hair loss using the Alopecia Areata Patient Priority Outcomes (AAPPO) instrument and evaluate the relationship between clinically meaningful hair regrowth and improvements in patient-reported impacts.

Methods: In ALLEGRO-2b/3, patients aged ≥ 12 years with AA and ≥ 50% scalp hair loss received once-daily ritlecitinib 50 or 30 mg (± 4-week 200-mg daily loading dose), 10 mg, or placebo for 24 weeks and then continued ritlecitinib or switched from placebo to ritlecitinib 200/50 or 50 mg for 24 weeks. The AAPPO instrument evaluated improvement in hair loss, emotional symptoms (ES), and activity limitations (AL) from weeks 4 to 48 (secondary endpoint). Mean changes in ES and AL domain scores and individual items at weeks 24 and 48 were calculated for Severity of Alopecia Tool (SALT) score ≤ 20 responders and nonresponders (exploratory endpoint).

Results: Overall, 718 patients were randomized. At week 24, 5-36% of patients receiving ritlecitinib 10-200/50 mg reported improvement in scalp hair loss versus 9% receiving placebo. The results for eyebrow, eyelash, and body hair loss were similar. Mean change from baseline in ES and AL scores at weeks 24 and 48 was small and similar between groups. Mean change was larger for individual hair loss and ES items at weeks 24 and 48 in SALT score ≤ 20 responders versus nonresponders.

Conclusions: The AAPPO instrument demonstrated the beneficial impact of ritlecitinib on patient-reported hair growth, which was consistent with improvements in clinician-reported outcomes.

Clinical trial registration: NCT03732807. INFOGRAPHIC.

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来源期刊
CiteScore
15.20
自引率
2.70%
发文量
84
审稿时长
>12 weeks
期刊介绍: The American Journal of Clinical Dermatology is dedicated to evidence-based therapy and effective patient management in dermatology. It publishes critical review articles and clinically focused original research covering comprehensive aspects of dermatological conditions. The journal enhances visibility and educational value through features like Key Points summaries, plain language summaries, and various digital elements, ensuring accessibility and depth for a diverse readership.
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