A 3-year migraine management with anti-CGRP monoclonal antibodies: an intention-to-treat analysis of real-world evidence

Background: The present prospective, real-world study aims to assess anti-CGRP monoclonal antibodies (mAbs) effectiveness across a 3-year follow-up by means of a conservative intention to treat (ITT) analysis. Methods: We enrolled 179 subjects (75.4% females, 51.3 [49.2-53.4] years, 87.2% with chronic migraine and medication overuse) who started mAbs between 2018 and 2020. We recorded clinical data supported by a prospectively filled headache diary up to a 3-year follow-up. The ITT analysis was performed with a multivariate linear mixed model considering the entire population. Results: We described a reduction in monthly migraine days (MMDs) of -10.9 [-12.1 - -9.8] during the first year of treatment (C1), -10.9 [-12.1- -9.7] during the second year (C2) and -11.5 [-12.8 - -10.3] during the third year (C3) (p=0.193). Residual MMDs were: 23.4 [22.5-24.3] to 11.8 [10.4-13.1] during C1, 19.1 [17.5-20.6] to 11.6 [10.3-12.9] during C2, and 16.1 [14.7-17.6] to 10.6 [9.1-11.9] during C3 (p=0.001). Conclusion: In our cohort, mAbs induced a meaningful and sustained reduction in MMDs across a 3-year follow-up. The ITT analysis revealed a remaining high burden of disease. While confirming mAbs effectiveness in migraine prevention, these findings underscore the need for more treatment approaches and for exploring other non-CGRP dependent pathways.研究背景：本项前瞻性真实世界研究旨在通过保守意向治疗（intention to treat，ITT）分析，评估抗降钙素基因相关肽单克隆抗体（anti-CGRP monoclonal antibodies，mAbs）在3年随访周期内的临床疗效。 研究方法：本研究共招募179例受试者（其中女性占比75.4%，年龄为51.3[49.2-53.4]岁，87.2%合并慢性偏头痛及药物过度使用），所有受试者均于2018至2020年间开始接受mAbs治疗。研究通过前瞻性填写的头痛日记收集临床数据，随访周期长达3年。本研究采用多元线性混合模型对全部受试者进行ITT分析。 研究结果：治疗第一年（C1）、第二年（C2）及第三年（C3）期间，受试者的每月偏头痛天数（monthly migraine days，MMDs）分别较基线减少-10.9[-12.1~-9.8]、-10.9[-12.1~-9.7]及-11.5[-12.8~-10.3]（p=0.193）。残余MMDs分别为：C1期间从23.4[22.5~24.3]降至11.8[10.4~13.1]，C2期间从19.1[17.5~20.6]降至11.6[10.3~12.9]，C3期间从16.1[14.7~17.6]降至10.6[9.1~11.9]（p=0.001）。 研究结论：在本研究队列中，mAbs可使MMDs在3年随访周期内出现具有临床意义的持续性降低。ITT分析显示，受试者仍存在较高的疾病负担。本研究结果在证实mAbs用于偏头痛预防有效性的同时，也凸显了开发更多治疗方案以及探索其他非CGRP依赖通路的必要性。