Department of Neurology, University Hospital, LMU Munich, Munich, Germany.
Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.
J Headache Pain. 2023 May 23;24(1):59. doi: 10.1186/s10194-023-01593-2.
Monoclonal antibodies targeting the CGRP pathway are effective and safe for prophylactic treatment of episodic (EM) and chronic migraine (CM). In case of treatment failure of a CGRP pathway targeting mAb, physician has to decide whether using another anti-CGRP pathway mAb is useful. This interim analysis of Finesse Study evaluates effectiveness of the anti-CGRP mAb fremanezumab in patients with a history of other prior anti-CGRP pathway mAb treatments (switch patients).
FINESSE, a non-interventional, prospective, multicentre, two-country (Germany-Austria) study observing migraine patients receiving fremanezumab in clinical routine. This subgroup analysis presents data on documented effectiveness over 3 months after the first dose of fremanezumab in switch patients. Effectiveness was evaluated based on reduction in average number of migraine days per month (MMDs), MIDAS and HIT-6 scores changes as well as in number of monthly days with acute migraine medication use.
One hundred fifty-three out of 867 patients with a history of anti-CGRP pathway mAb treatment prior to initiation of fremanezumab were analysed. Switch to fremanezumab led to ≥ 50% MMD reduction in 42.8% of migraine patients, with higher response rate in EM (48.0%) than in CM patients (36.5%). A ≥ 30% MMD reduction was achieved by 58.7% in CM patients. After three months, monthly number of migraine days decreased by 6.4 ± 5.87 (baseline: 13.6 ± 6.5; p < 0.0001) in all patients, 5.2 ± 4.04 in EM and 7.7 ± 7.45 in CM patients. MIDAS scores decreased from 73.3 ± 56.8 (baseline) to 50.3 ± 52.9 (after 3 months; p = 0.0014), HIT-6 scores decreased from 65.9 ± 5.0 to 60.9 ± 7.2 (p < 0.0001). Concomitant use of acute migraine medication had decreased from 9.7 ± 4.98 (baseline) to 4.9 ± 3.66 (3 months) (p < 0.0001).
Our results show that about 42.8% of anti-CGRP pathway mAb-non-responder benefit from switching to fremanezumab. These results suggest that switching to fremanezumab may be a promising option for patients experiencing poor tolerability or inadequate efficacy with prior other anti-CGRP pathway mAb use.
FINESSE Study is registered on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (EUPAS44606).
靶向 CGRP 通路的单克隆抗体对于发作性（EM）和慢性偏头痛（CM）的预防性治疗是有效且安全的。如果靶向 CGRP 通路的 mAb 治疗失败，医生必须决定是否使用另一种抗 CGRP 通路 mAb 是否有用。这项 Finesse 研究的中期分析评估了抗 CGRP mAb 依瑞奈司他在有既往抗 CGRP 通路 mAb 治疗史（转换患者）的患者中的疗效。
Finesse 是一项非干预性、前瞻性、多中心、两国（德国-奥地利）研究，观察接受依瑞奈司他临床常规治疗的偏头痛患者。本亚组分析报告了首次依瑞奈司他治疗后 3 个月内的记录疗效数据。基于每月偏头痛天数（MMD）减少、MIDAS 和 HIT-6 评分变化以及每月急性偏头痛药物使用天数的变化来评估疗效。
在开始依瑞奈司他治疗前有抗 CGRP 通路 mAb 治疗史的 867 名患者中，有 153 名患者被分析。转换为依瑞奈司他治疗后，42.8%的偏头痛患者的 MMD 减少≥50%，EM 患者的反应率（48.0%）高于 CM 患者（36.5%）。CM 患者中有 58.7%达到 MMD 减少≥30%。三个月后，所有患者的偏头痛天数每月减少 6.4±5.87（基线：13.6±6.5；p<0.0001），EM 患者减少 5.2±4.04，CM 患者减少 7.7±7.45。MIDAS 评分从 73.3±56.8（基线）降至 50.3±52.9（治疗 3 个月后；p=0.0014），HIT-6 评分从 65.9±5.0 降至 60.9±7.2（p<0.0001）。急性偏头痛药物的同时使用从 9.7±4.98（基线）减少到 4.9±3.66（3 个月）（p<0.0001）。
我们的结果表明，约 42.8%的抗 CGRP 通路 mAb 无应答者从转换为依瑞奈司他中获益。这些结果表明，对于因先前使用其他抗 CGRP 通路 mAb 而出现不耐受或疗效不佳的患者，转换为依瑞奈司他可能是一种有前途的选择。
Finesse 研究在欧洲药物流行病学和药物警戒网络（EUPAS44606）上注册。
Zotero 插件
