依替替班单抗治疗对降钙素基因相关肽单克隆抗体和降钙素基因相关肽受体治疗无应答者的疗效：一项回顾性队列研究。

Efficacy of eptinezumab in non-responders to subcutaneous monoclonal antibodies against CGRP and the CGRP receptor: A retrospective cohort study.

机构信息

Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.

Clinician Scientist Program, Berlin Institute of Health at Charité (BIH), Berlin, Germany.

出版信息

Cephalalgia. 2024 Oct;44(10):3331024241288875. doi: 10.1177/03331024241288875.

DOI:10.1177/03331024241288875

PMID:39469839

Abstract

BACKGROUND

Migraine patients unresponsive to calcitonin gene-related peptide (CGRP)(-receptor, -R) monoclonal antibodies (mAbs) may benefit from switching between CGRP(-R) mAbs. However, some patients do not tolerate or respond to any subcutaneous mAbs. This study evaluates the efficacy of the intravenous CGRP mAb eptinezumab in these therapy-refractory patients.

METHODS

In this retrospective cohort study, patients with migraine who previously failed erenumab and at least one CGRP mAb (fremanezumab and/or galcanezumab) received eptinezumab 100 mg, followed by a second dose of 100 mg or 300 mg after 12 weeks. Monthly headache days, monthly migraine days, acute medication days, and migraine pain intensity were recorded from standardized headache diaries during the four weeks before the first infusion (baseline), and during weeks 9-12 and 21-24 of treatment. Patient-reported outcomes were analyzed at baseline, weeks 12, and 24.

RESULTS

From January 2023 to February 2024, 41 patients received eptinezumab 100 mg. Of these, 38 (93%) received a second infusion after 12 weeks, with 29 (71%) increasing the dose to 300 mg. The percentage of patients with a ≥30% reduction rate in monthly migraine days was 23.1% at week 12 and 29.7% at week 24. Monthly migraine days decreased from 16.3 ± 8.0 at baseline to 15.4 ± 8.1 days during weeks 9-12 and 14.4 ± 8.0 days during weeks 21-24 ( = 0.07). During weeks 21-24, 38.5% reported a clinically meaningful reduction in HIT-6 scores and 52.4% in MIDAS scores. No adverse events were reported.

CONCLUSIONS

Eptinezumab may be an effective and well-tolerated option for some treatment-refractory migraine patients unresponsive to subcutaneous CGRP-(R) mAbs.

摘要

背景

对降钙素基因相关肽（CGRP）（-受体，-R）单克隆抗体（mAb）无反应的偏头痛患者可能受益于 CGRP（-R）mAb 之间的转换。然而，一些患者不能耐受或对任何皮下 mAb 都没有反应。本研究评估了静脉内 CGRP mAb 依替替唑珠单抗在这些治疗抵抗患者中的疗效。

方法

在这项回顾性队列研究中，先前对依那西普和至少一种 CGRP mAb（依洛尤单抗和/或加尼替唑珠单抗）无反应的偏头痛患者接受 100mg 依替替唑珠单抗治疗，然后在 12 周后给予第二次 100mg 或 300mg 剂量。在第一次输注前四周（基线）、治疗第 9-12 周和第 21-24 周期间，从标准化头痛日记中记录每月头痛天数、每月偏头痛天数、急性药物治疗天数和偏头痛疼痛强度。在基线、第 12 周和第 24 周分析患者报告的结果。

结果

从 2023 年 1 月至 2024 年 2 月，41 名患者接受了 100mg 依替替唑珠单抗治疗。其中，38 名（93%）在 12 周后接受了第二次输注，其中 29 名（71%）增加剂量至 300mg。在第 12 周和第 24 周，每月偏头痛天数减少≥30%的患者比例分别为 23.1%和 29.7%。每月偏头痛天数从基线时的 16.3±8.0 天减少到第 9-12 周的 15.4±8.1 天和第 21-24 周的 14.4±8.0 天（=0.07）。在第 21-24 周，38.5%的患者报告 HIT-6 评分有临床意义的降低，52.4%的患者报告 MIDAS 评分有临床意义的降低。没有报告不良事件。