Outcomes, unmet needs, and challenges in the management of patients who withdraw from anti-CGRP monoclonal antibodies: A prospective cohort study.

IF 5 2区 医学 Q1 CLINICAL NEUROLOGY Cephalalgia Pub Date : 2024-11-01 DOI:10.1177/03331024241273968
Andrea Burgalassi, Marina Romozzi, Giulia Vigani, Roberto De Icco, Bianca Raffaelli, Alberto Boccalini, Francesco De Cesaris, Paolo Calabresi, Pierangelo Geppetti, Alberto Chiarugi, Luigi Francesco Iannone
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Abstract

Background: The anti-calcitonin gene-related peptide (CGRP), or its receptor (CGRP/R) monoclonal antibodies (mAbs), offer targeted, effective, and tolerated drugs for migraine. However, about 25% of patients fail to achieve a clinically meaningful response, usually leading to discontinuation. These patients often have a lengthy migraine history and multiple prior preventive treatment failures, resulting in limited therapeutic options. Herein, we describe the cause for and outcome of withdrawal of anti-CGRP/R mAb and evaluate the treatment course until discontinuation.

Methods: We conducted a prospective analysis on migraine patients attending the Florence Headache Center in Italy, who discontinued treatment with anti-CGRP/R mAbs. The primary objectives were to describe the reasons for anti-CGRP mAbs discontinuation and the treatment course. Secondary objectives were the evaluation of the absolute change from baseline in monthly headache days, response rates, persistence in medication overuse, absolute change from baseline of the overall number and days of analgesics use per month, change of MIDAS and HIT-6 at three, six, and 12 months, and the last month of treatment.

Results: Among 472 patients, 136 (28.8%) discontinued mAb treatment after an average of 9.0 ± 6.1 (mean ± SD) months. The majority (96/136, 70.6%) discontinued due to ineffectiveness, followed by lost to follow-up during treatment (18/136, 13.1%) and adverse events (10/136, 7.3%). In total, 77.9% of the 136 patients ceased treatment within the first year. Following discontinuation, 48.5% initiated new pharmacological treatment, 39.7% were lost to follow-up, and 11.8% opted not to start another treatment. The majority of patients that started a new pharmacology treatment switched to another anti-CGRP/R (46/68, 67.6%). The second most-used treatment was onabotulinumtoxinA (7/68, 10.2%; all patients in this subgroup were naïve to this treatment), followed by an anticonvulsive medication (7/68, 10.2%). The response status (≥50% reduction in monthly headache days) was achieved by 30.5%, 34.6%, and 40.0% of patients at month 3, 6, and 12 of treatment, respectively. Considering only the comprehensive last month of treatment before withdrawn the percentage of responders was 16.9%.

Conclusion: Although anti-CGRP/R mAbs have provided a substantial amelioration of migraine management, a relevant proportion of patients remains unresponsive and requires additional therapeutic support. Further research is required to identify non-responder features and address unmet needs in migraine treatment.

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抗 CGRP 单克隆抗体停药患者的治疗结果、未满足的需求和面临的挑战:前瞻性队列研究。
背景:抗钙调蛋白基因相关肽(CGRP)或其受体(CGRP/R)单克隆抗体(mAbs)是治疗偏头痛的靶向、有效且耐受的药物。然而,约有25%的患者无法获得有临床意义的反应,通常导致停药。这些患者通常有较长的偏头痛病史,且之前多次预防性治疗失败,导致治疗选择有限。在此,我们描述了停用抗CGRP/R mAb的原因和结果,并评估了停药前的治疗过程:我们对在意大利佛罗伦萨头痛中心就诊的偏头痛患者进行了前瞻性分析,这些患者停止了抗 CGRP/R mAb 的治疗。首要目标是描述停用抗 CGRP mAbs 的原因和治疗过程。次要目标是评估每月头痛天数与基线相比的绝对变化、反应率、药物过度使用的持续性、每月镇痛药使用总数和天数与基线相比的绝对变化、MIDAS和HIT-6在3个月、6个月和12个月以及治疗最后一个月的变化:在 472 名患者中,136 人(28.8%)在平均 9.0 ± 6.1(平均 ± SD)个月后停止了 mAb 治疗。大多数患者(96/136,70.6%)因疗效不佳而中断治疗,其次是治疗期间失去随访(18/136,13.1%)和不良反应(10/136,7.3%)。在 136 名患者中,共有 77.9% 的患者在第一年内停止了治疗。在停止治疗后,48.5%的患者开始了新的药物治疗,39.7%的患者失去了随访,11.8%的患者选择不再开始其他治疗。在开始接受新的药物治疗的患者中,大多数都转用了另一种抗 CGRP/R(46/68,67.6%)。第二种最常用的治疗方法是阿糖胞苷(onabotulinumtoxinA)(7/68,10.2%;该亚组中的所有患者均未接受过该治疗),其次是抗惊厥药物(7/68,10.2%)。在治疗的第 3、6 和 12 个月,分别有 30.5%、34.6% 和 40.0% 的患者达到了应答状态(每月头痛天数减少≥50%)。仅考虑撤药前最后一个月的综合治疗,应答者的比例为16.9%:尽管抗CGRP/R mAbs大大改善了偏头痛的治疗效果,但仍有相当一部分患者没有反应,需要额外的治疗支持。需要进一步开展研究,以确定无应答患者的特征,并解决偏头痛治疗中尚未满足的需求。
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来源期刊
Cephalalgia
Cephalalgia 医学-临床神经学
CiteScore
10.10
自引率
6.10%
发文量
108
审稿时长
4-8 weeks
期刊介绍: Cephalalgia contains original peer reviewed papers on all aspects of headache. The journal provides an international forum for original research papers, review articles and short communications. Published monthly on behalf of the International Headache Society, Cephalalgia''s rapid review averages 5 ½ weeks from author submission to first decision.
期刊最新文献
Abnormal electromyographical trigeminal activation through stimulation of the offending artery (Z-L response): An intraoperative tool during microvascular decompression for trigeminal neuralgia. A call for academic pragmatic clinical trials to address open questions in migraine prevention. Outcomes, unmet needs, and challenges in the management of patients who withdraw from anti-CGRP monoclonal antibodies: A prospective cohort study. Internal jugular vein valve incompetence: A key consideration in patients with exercise-induced headache. Headache trajectories in children and adolescents with new onset continuous headache.
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