Department of Neurology, Neurological Institute, Taipei Veterans General Hospital, Taipei, Taiwan.
School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
Eur J Neurol. 2024 Sep;31(9):e16372. doi: 10.1111/ene.16372. Epub 2024 Jun 5.
To compare the real-world effectiveness and tolerability of calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) and onabotulinumtoxinA in chronic migraine (CM) patients.
This multicenter study involved retrospective analysis of prospectively collected data of CM patients treated with CGRP mAbs or onabotulinumtoxinA, including difficult-to-treat (DTT) patients (i.e., ≥3 preventive failures). Treatment outcomes were determined at 6 months based on prospective headache diaries and Migraine Disability Assessment (MIDAS).
The study included 316 (55 M/261F, mean age 44.4 ± 13.5 years) and 333 (61 M/272F, mean age 47.9 ± 13.4 years) CM patients treated with CGRP mAbs or onabotulinbumtoxinA, respectively. At 6 months, CGRP mAb treatment was associated with a greater decrease in monthly migraine days (MMDs) (-13.0 vs. -8.7 days/month, p < 0.001) and a higher ≥50% responder rate (RR) (74.7% vs. 50.7%, p < 0.001) compared with onabotulinumtoxinA injections. The findings were consistent in DTT patients (-13.0 vs. -9.1 MMDs, p < 0.001; ≥50% RR: 73.9% vs. 50.3%, p < 0.001) or those with medication-overuse headache (MOH) (-13.3 vs. -9.0 MMDs, p < 0.001; ≥50% RR: 79.0% vs. 51.6%, p < 0.001). Besides, patients receiving CGRP mAbs had greater improvement (-42.2 vs. -11.8, p < 0.001) and a higher ≥50% RR (62.0% vs. 40.0%, p = 0.001) in MIDAS scores and a lower rate of adverse events (AEs) (6.0% vs. 21.0%, p < 0.001). However, none of the patients discontinued treatment due to AEs.
In this multicenter, real-world study, CGRP mAbs were more effective than onabotulinumtoxinA in CM patients, even in DTT or MOH patients. All of these injectables were well tolerated. Further prospective studies are needed to verify these findings.
比较降钙素基因相关肽（CGRP）单克隆抗体（mAb）与肉毒毒素 A 型（onabotulinumtoxinA）在慢性偏头痛（CM）患者中的真实世界疗效和耐受性。
本多中心研究回顾性分析了接受 CGRP mAb 或 onabotulinumtoxinA 治疗的 CM 患者的前瞻性收集数据，包括难治性（DTT）患者（即≥3 次预防治疗失败）。基于前瞻性头痛日记和偏头痛残疾评估（MIDAS）量表，在 6 个月时评估治疗结局。
该研究纳入了 316 例（55 例男性/261 例女性，平均年龄 44.4±13.5 岁）和 333 例（61 例男性/272 例女性，平均年龄 47.9±13.4 岁）接受 CGRP mAb 或 onabotulinumtoxinA 治疗的 CM 患者。在 6 个月时，与 onabotulinumtoxinA 注射相比，CGRP mAb 治疗可使每月偏头痛天数（MMD）减少更多（-13.0 与-8.7 天/月，p<0.001），≥50%应答率（RR）更高（74.7%与 50.7%，p<0.001）。在 DTT 患者（-13.0 与-9.1 MMD，p<0.001；≥50% RR：73.9%与 50.3%，p<0.001）或药物过度使用性头痛（MOH）患者（-13.3 与-9.0 MMD，p<0.001；≥50% RR：79.0%与 51.6%，p<0.001）中，也观察到了类似的结果。此外，接受 CGRP mAb 治疗的患者 MIDAS 评分改善更明显（-42.2 与-11.8，p<0.001），≥50%RR 更高（62.0%与 40.0%，p=0.001），且不良事件（AE）发生率更低（6.0%与 21.0%，p<0.001）。然而，无任何患者因 AE 而停止治疗。
在这项多中心真实世界研究中，CGRP mAb 比 onabotulinumtoxinA 在 CM 患者中更有效，即使是在 DTT 或 MOH 患者中也是如此。这些注射剂的耐受性均良好。需要进一步的前瞻性研究来验证这些发现。
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