Long-Term Efficacy of Ritlecitinib up to Month 24 From the ALLEGRO Phase 2b/3 and Long-Term Phase 3 Clinical Studies in Alopecia Areata

Melissa Piliang, J. Soung, B. King, Jerry Shapiro, Lidia Rudnicka, Paul Farrant, Nina Magnolo, Bianca Piraccini, Xin Luo, Deborah Woodworth, G. Schaefer, A. Lejeune, Robert Wolk
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引用次数: 1

Abstract

Introduction: Ritlecitinib demonstrated efficacy and safety to Week 48 in patients aged ≥12 years with alopecia areata (AA) in ALLEGRO-2b/3 (NCT03732807). ALLEGRO-LT (NCT04006457) is an ongoing, phase 3, open-label study investigating the long-term safety and efficacy of ritlecitinib in AA. We report updated interim efficacy results of ritlecitinib up to Month 24 from ALLEGRO-2b/3 and ALLEGRO-LT. Methods: Patients aged ≥12 years with AA and ≥50% scalp hair loss who rolled-over to ALLEGRO-LT from ALLEGRO-2b/3 were included. Data are reported for patients who received: 1) daily ritlecitinib 50-mg with a 4-week 200-mg daily loading dose (“200/50-mg”); 2) daily ritlecitinib 50-mg with no loading dose (“50-mg”). Outcomes include the proportions of patients with response (based on Severity of Alopecia Tool [SALT] score ≤20, SALT ≤10, and Patients’ Global Impression of Change [PGI-C] score of “moderately improved” or “greatly improved”) through Month 24, and the proportions of patients sustaining SALT ≤20 response from Month 12 through Month 24. Observed and imputed (modified last observation carried forward [mLOCF]) data, to account for missing values, are reported (data cutoff: December 9, 2022). Results: The 200/50-mg and 50-mg groups included 194 and 191 patients; 127 (65.5%) and 111 (58.1%) were ongoing at the data cutoff. SALT ≤20 response rates in the 200/50-mg and 50-mg groups increased from Month 12 (45.9% and 45.1% [observed]; 41.8% and 40.3% [mLOCF]) to Month 24 (63.1% and 60.8% [observed]; 50.8% and 46.1% [mLOCF]). SALT ≤10 response rates increased between Months 12 and 24 for the 200/50-mg group (39.4% to 51.1% [observed]; 35.6% to 40.9% [mLOCF]) and 50-mg group (34.2% to 50.8% [observed]; 30.9% to 37.7% [mLOCF]). Of SALT ≤20 responders at Month 12, 92.8% (200/50-mg) and 79.7% (50-mg) (observed) sustained this response through Month 24. PGI-C response rates were maintained from Month 12 (200/50-mg: 69.4% [observed], 65.3% [mLOCF]; 50-mg: 61.6% [observed], 57.7% [mLOCF]) to Month 24 (200/50-mg: 76.4% [observed], 65.4% [mLOCF]; 50-mg: 70.0% [observed], 56.6% [mLOCF]). Conclusion: Ritlecitinib 50-mg (with or without a 200-mg loading dose) demonstrated clinically meaningful and sustained clinician- and patient-reported efficacy through Month 24, which supports its long-term use in patients aged ≥12 years with severe AA.
ALLEGRO脱发症2b/3期和3期长期临床研究显示,利特西替尼的长期疗效可达第24个月
简介在ALLEGRO-2b/3(NCT03732807)研究中,利特西替尼对年龄≥12岁的斑秃(AA)患者的疗效和安全性均达到了第48周。ALLEGRO-LT(NCT04006457)是一项正在进行的3期开放标签研究,旨在调查利特西替尼治疗AA的长期安全性和疗效。我们报告了ALLEGRO-2b/3和ALLEGRO-LT截至第24个月的最新中期疗效结果。研究方法纳入年龄≥12岁、头皮脱发≥50%且从ALLEGRO-2b/3转入ALLEGRO-LT的AA患者。报告了接受以下治疗的患者的数据1)每日服用瑞替西替尼 50 毫克,同时服用为期 4 周的每日 200 毫克负荷剂量("200/50-毫克");2)每日服用瑞替西替尼 50 毫克,同时不服用负荷剂量("50-毫克")。研究结果包括:到第24个月出现应答的患者比例(基于脱发严重程度工具[SALT]评分≤20分、SALT≤10分和患者总体变化印象[PGI-C]评分 "中度改善 "或 "大幅改善"),以及从第12个月到第24个月保持SALT≤20分应答的患者比例。报告了观察数据和估算数据(修改后的最后观察结转数据 [mLOCF]),以考虑缺失值(数据截止日期:2022 年 12 月 9 日)。结果:200/50毫克组和50毫克组分别有194名和191名患者;数据截止时,127名(65.5%)和111名(58.1%)患者仍在接受治疗。200/50毫克组和50毫克组的SALT≤20应答率从第12个月(45.9%和45.1% [观察值];41.8%和40.3% [mLOCF])上升到第24个月(63.1%和60.8% [观察值];50.8%和46.1% [mLOCF])。在第 12 个月至第 24 个月期间,200/50 毫克组(39.4% 至 51.1% [观察值];35.6% 至 40.9% [毫升有机碳])和 50 毫克组(34.2% 至 50.8% [观察值];30.9% 至 37.7% [毫升有机碳])的 SALT ≤10 反应率有所上升。在第 12 个月 SALT ≤20 的应答者中,92.8%(200/50 毫克)和 79.7%(50 毫克)(观察组)在第 24 个月保持了这种应答。PGI-C 反应率从第 12 个月开始保持不变(200/50 毫克:69.4% [观察],50 毫克:79.7% [观察]):69.4%[观察],65.3%[mLOCF];50 毫克:61.6%[观察],57.7%[mLOCF])至第 24 个月(200/50 毫克:76.4%[观察],57.7%[mLOCF]):76.4%[观察],65.4%[mLOCF];50 毫克:70.0%[观察],57.7%[mLOCF70.0%[观察],56.6%[mLOCF])。结论利特西替尼50毫克(无论是否服用200毫克负荷剂量)在第24个月时显示出了有临床意义的、持续的临床医生和患者报告疗效,支持在年龄≥12岁的重症AA患者中长期使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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