Early beginning of alemtuzumab: Changing the multiple sclerosis treatment paradigm. Interim analysis of the LEMVIDA study

J.E. Meca-Lallana , J.C. Álvarez-Cermeño , B. Casanova Estruch , G. Izquierdo Ayuso , R. Ortiz Castillo , A. Rodríguez-Antigüedad , C. Calles Hernández , en nombre del Grupo de Estudio LEMVIDA
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Abstract

Introduction

LEMVIDA is a real-world prospective study of 3-year follow-up on quality of life of patients with multiple sclerosis (MS) receiving alemtuzumab in Spain.

Methods

This is an interim analysis evaluating the baseline characteristics of patients who started alemtuzumab between October 2016-September 2018. For 3 additional subanalysis patients were categorised by baseline EDSS score; time of alemtuzumab initiation during the recruitment period (cohort 1: October 2016-March 2017, cohort 2: April-September 2017, cohort 3: October 2017-March 2018 and cohort 4: April-September 2018); and the presence of highly active MS criteria.

Results

161 patients were analysed: 67.1% female, age 38.7 ± 9.4 years, MS duration 8.5 ± 6.0 years, EDSS 3.3 ± 1.7 and number of relapses in the previous 2 years 1.8 ± 1.3. 48.3% of patients presented gadolinium-enhanced (Gd+) lesions (mean: 5.2 ± 6.9) and 63.1% had received prior treatment with fingolimod or natalizumab. Baseline EDSS scores and number of Gd+ lesions were higher in cohort 1 than in cohort 4 (4.1 ± 1.8 vs 3.2 ± 1.7; P = .040 and 10.9 ± 11.9 vs 4.5 ± 5.7; P = .020). The frequency of prior treatment with fingolimod and natalizumab was lower in cohort 4 (60.6%) than in cohort 1 (70.6%) (comparison between groups not analysed).

Conclusions

Unlike phase 3 studies of alemtuzumab, the patients included in LEMVIDA are older, have a longer duration of MS, higher disability and have received previous immunosuppressants. However, throughout the recruitment period, there is a tendency towards an early beginning of treatment with alemtuzumab, probably due to the evidence of higher effectiveness in the early stages of MS.

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阿利珠单抗的早期应用:改变多发性硬化症的治疗模式。LEMVIDA研究中期分析。
简介LEMVIDA是一项真实世界的前瞻性研究,对西班牙接受阿仑珠单抗治疗的多发性硬化症(MS)患者的生活质量进行为期3年的随访:这是一项中期分析,评估了2016年10月至2018年9月期间开始使用阿仑妥珠单抗的患者的基线特征。在另外3项子分析中,患者按基线EDSS评分、招募期间开始使用阿利珠单抗的时间进行分类(队列1:2016年10月至2017年3月,队列2:2016年10月至2017年3月,队列3:2016年10月至2018年9月):队列 1:2016 年 10 月至 2017 年 3 月,队列 2:2017 年 4 月至 9 月,队列 3:2017 年 10 月至 2018 年 3 月,队列 4:2018 年 4 月至 9 月);以及是否存在高度活跃的 MS 标准:分析了 161 名患者:67.1% 为女性,年龄(38.7±9.4)岁,MS 病程(8.5±6.0)年,EDSS(3.3±1.7)分,前 2 年复发次数(1.8±1.3)次。48.3%的患者出现钆增强(Gd+)病灶(平均值:5.2 ± 6.9),63.1%的患者曾接受过芬戈莫德或纳他珠单抗治疗。第一组患者的基线EDSS评分和Gd+病灶数量高于第四组(4.1 ± 1.8 vs 3.2 ± 1.7;P = .040;10.9 ± 11.9 vs 4.5 ± 5.7;P = .020)。曾接受芬戈莫德和纳他珠单抗治疗的患者在队列4(60.6%)中的比例低于队列1(70.6%)(未分析组间比较):与阿来珠单抗的 3 期研究不同,LEMVIDA 纳入的患者年龄较大、多发性硬化症病程较长、残疾程度较高,并且曾接受过免疫抑制剂治疗。然而,在整个招募期间,患者倾向于尽早开始使用阿来珠单抗治疗,这可能是由于有证据表明阿来珠单抗在多发性硬化症早期阶段具有更高的疗效。
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