{"title":"偏头痛患者转换降钙素基因相关肽或其受体的单克隆抗体。西班牙队列研究结果。","authors":"","doi":"10.1016/j.neurop.2024.100168","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Switching between calcitonin gene-related peptide (CGRP) and monoclonal antibodies (mAbs) may be a beneficial strategy after discontinuation. The aim of this study was to evaluate switching outcomes of effectiveness/tolerability.</p></div><div><h3>Methods</h3><p>Retrospective multicentric study of migraine patients who switched to another CGRP–mAb due to lack of tolerability or effectiveness (defined as <<!--> <!-->30% reduction of monthly headache days [MHD]). Assessment was performed before and 3 months after switch. The main outcome was the response rate of MHD. Secondary outcomes included other effectiveness/tolerability measures.</p></div><div><h3>Results</h3><p>90patients were included: 75(83.3%) women, 72(80%) chronic, and 18(20%) episodic migraine. Mean age was 45.9<!--> <!-->±<!--> <!-->11 years and mean duration of migraine was 29.2<!--> <!-->±<!--> <!-->12.4 years. Mean time under first mAb prior to switch was 10.4<!--> <!-->±<!--> <!-->4.9 months. Most frequent switches were erenumab-galcanezumab 38 (42.2%) and erenumab–fremanezumab 21 (23.3%). Lack of effectiveness (50/90, 55.6%) or tolerability (40/90, 44.4%) provoked switching. Most common adverse events (AEs) leading to discontinuation were constipation and flu-like syndrome in 16 (40%) patients each. Response rate (RR) of MHD 30%–50% occurred in 10 patients (11.1%), ≥<!--> <!-->50% in 32 (35.6%) and <<!--> <!-->30% in 48 (53.3%) patients. Significant reduction was proved after switch in MHD (20 [IQR:15–29] vs 13 [IQR:7–23]; <em>p</em> <!--><<!--> <!-->.001) and monthly migraine days (15 [IQR:12–20] vs 10 [IQR:7–16]; <em>p</em> <!--><<!--> <!-->.001). After switching, 38 (42.2%) experienced AEs, but tolerability improved in 50% of patients who discontinued due to lack of tolerability. RR compared between switches to different CGRP-mAb classes showed no differences.</p></div><div><h3>Conclusion</h3><p>Switching may become an individualized strategy in migraine refractory patients who discontinue CGRP–mAbs due to lack of effectiveness/tolerability. In this study, supportive data are provided to the growing evidence of switch and future needs are highlighted.</p></div>","PeriodicalId":74283,"journal":{"name":"Neurology perspectives","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2667049624000255/pdfft?md5=ada1201f651792129ddd40e7444e7615&pid=1-s2.0-S2667049624000255-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Switching of monoclonal antibodies against the calcitonin gene-related peptide or its receptor in migraine. Results from a Spanish Cohort\",\"authors\":\"\",\"doi\":\"10.1016/j.neurop.2024.100168\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Switching between calcitonin gene-related peptide (CGRP) and monoclonal antibodies (mAbs) may be a beneficial strategy after discontinuation. The aim of this study was to evaluate switching outcomes of effectiveness/tolerability.</p></div><div><h3>Methods</h3><p>Retrospective multicentric study of migraine patients who switched to another CGRP–mAb due to lack of tolerability or effectiveness (defined as <<!--> <!-->30% reduction of monthly headache days [MHD]). Assessment was performed before and 3 months after switch. The main outcome was the response rate of MHD. Secondary outcomes included other effectiveness/tolerability measures.</p></div><div><h3>Results</h3><p>90patients were included: 75(83.3%) women, 72(80%) chronic, and 18(20%) episodic migraine. Mean age was 45.9<!--> <!-->±<!--> <!-->11 years and mean duration of migraine was 29.2<!--> <!-->±<!--> <!-->12.4 years. Mean time under first mAb prior to switch was 10.4<!--> <!-->±<!--> <!-->4.9 months. Most frequent switches were erenumab-galcanezumab 38 (42.2%) and erenumab–fremanezumab 21 (23.3%). Lack of effectiveness (50/90, 55.6%) or tolerability (40/90, 44.4%) provoked switching. Most common adverse events (AEs) leading to discontinuation were constipation and flu-like syndrome in 16 (40%) patients each. Response rate (RR) of MHD 30%–50% occurred in 10 patients (11.1%), ≥<!--> <!-->50% in 32 (35.6%) and <<!--> <!-->30% in 48 (53.3%) patients. Significant reduction was proved after switch in MHD (20 [IQR:15–29] vs 13 [IQR:7–23]; <em>p</em> <!--><<!--> <!-->.001) and monthly migraine days (15 [IQR:12–20] vs 10 [IQR:7–16]; <em>p</em> <!--><<!--> <!-->.001). After switching, 38 (42.2%) experienced AEs, but tolerability improved in 50% of patients who discontinued due to lack of tolerability. RR compared between switches to different CGRP-mAb classes showed no differences.</p></div><div><h3>Conclusion</h3><p>Switching may become an individualized strategy in migraine refractory patients who discontinue CGRP–mAbs due to lack of effectiveness/tolerability. In this study, supportive data are provided to the growing evidence of switch and future needs are highlighted.</p></div>\",\"PeriodicalId\":74283,\"journal\":{\"name\":\"Neurology perspectives\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-07-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2667049624000255/pdfft?md5=ada1201f651792129ddd40e7444e7615&pid=1-s2.0-S2667049624000255-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Neurology perspectives\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2667049624000255\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Neurology perspectives","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2667049624000255","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
背景在降钙素基因相关肽（CGRP）和单克隆抗体（mAbs）之间切换可能是停药后的一种有益策略。方法对因缺乏耐受性或有效性（定义为每月头痛天数 [MHD] 减少 30%）而转用另一种 CGRP-mAb 的偏头痛患者进行多中心回顾性研究。评估在换药前和换药后 3 个月进行。主要结果是每月头痛天数的反应率。次要结果包括其他有效性/耐受性指标：90名患者中，75名（83.3%）为女性，72名（80%）为慢性偏头痛患者，18名（20%）为发作性偏头痛患者。平均年龄为（45.9 ± 11）岁，偏头痛平均持续时间为（29.2 ± 12.4）年。换药前使用第一种 mAb 的平均时间为 10.4 ± 4.9 个月。最常见的转换是艾伦单抗-加卡尼珠单抗38例（42.2%）和艾伦单抗-非马尼珠单抗21例（23.3%）。疗效不佳（50/90，55.6%）或耐受性不佳（40/90，44.4%）是导致换药的原因。导致停药的最常见不良事件（AE）是便秘和流感样综合征，各占 16 例（40%）。10 名患者（11.1%）的 MHD 反应率（RR）为 30%-50%，32 名患者（35.6%）的反应率≥50%，48 名患者（53.3%）的反应率为 <30%。换药后，MHD（20 [IQR:15-29] vs 13 [IQR:7-23]; p <.001）和每月偏头痛天数（15 [IQR:12-20] vs 10 [IQR:7-16]; p <.001）明显减少。换药后，38 例（42.2%）患者出现 AEs，但在因耐受性不足而停药的患者中，50% 的耐受性有所改善。结论对于因缺乏有效性/耐受性而停用 CGRP-mAbs 的偏头痛难治性患者，转换可能是一种个体化策略。本研究为越来越多的转换证据提供了支持性数据，并强调了未来的需求。
Switching of monoclonal antibodies against the calcitonin gene-related peptide or its receptor in migraine. Results from a Spanish Cohort
Background
Switching between calcitonin gene-related peptide (CGRP) and monoclonal antibodies (mAbs) may be a beneficial strategy after discontinuation. The aim of this study was to evaluate switching outcomes of effectiveness/tolerability.
Methods
Retrospective multicentric study of migraine patients who switched to another CGRP–mAb due to lack of tolerability or effectiveness (defined as < 30% reduction of monthly headache days [MHD]). Assessment was performed before and 3 months after switch. The main outcome was the response rate of MHD. Secondary outcomes included other effectiveness/tolerability measures.
Results
90patients were included: 75(83.3%) women, 72(80%) chronic, and 18(20%) episodic migraine. Mean age was 45.9 ± 11 years and mean duration of migraine was 29.2 ± 12.4 years. Mean time under first mAb prior to switch was 10.4 ± 4.9 months. Most frequent switches were erenumab-galcanezumab 38 (42.2%) and erenumab–fremanezumab 21 (23.3%). Lack of effectiveness (50/90, 55.6%) or tolerability (40/90, 44.4%) provoked switching. Most common adverse events (AEs) leading to discontinuation were constipation and flu-like syndrome in 16 (40%) patients each. Response rate (RR) of MHD 30%–50% occurred in 10 patients (11.1%), ≥ 50% in 32 (35.6%) and < 30% in 48 (53.3%) patients. Significant reduction was proved after switch in MHD (20 [IQR:15–29] vs 13 [IQR:7–23]; p < .001) and monthly migraine days (15 [IQR:12–20] vs 10 [IQR:7–16]; p < .001). After switching, 38 (42.2%) experienced AEs, but tolerability improved in 50% of patients who discontinued due to lack of tolerability. RR compared between switches to different CGRP-mAb classes showed no differences.
Conclusion
Switching may become an individualized strategy in migraine refractory patients who discontinue CGRP–mAbs due to lack of effectiveness/tolerability. In this study, supportive data are provided to the growing evidence of switch and future needs are highlighted.
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