Chronic migraine (CM) is a disabling condition with high prevalence in the general population. Until the recent approval of monoclonal antibodies targeting the calcitonin gene-related peptide (Anti-CGRP mAbs), OnabotulinumtoxinA (BoNT-A) was the only treatment specifically approved for CM prophylaxis. Direct comparisons between the two treatments are not available so far. We performed an observational, retrospective, multicenter study in Italy to compare the real-world effectiveness of Anti-CGRP mAbs and BoNT-A. Patients with CM who had received either treatment according to Italian prescribing regulations were extracted from available clinical databases. Efficacy outcomes included the change from baseline in monthly headache days (MHD), MIgraine Disability ASsessment test (MIDAS), and monthly acute medications (MAM) evaluated at 6 and 12 months of follow-up. The primary outcome was MHD change from baseline at 12 months. Safety outcomes included serious adverse events (SAE) and treatment discontinuation. Unadjusted and adjusted models were used for the analyses. Two hundred sixteen potentially eligible patients were screened; 183 (86 Anti-CGRP mAbs; 97 BoNT-A) were included. One hundred seventy-one (80 Anti-CGRP mAbs; 91 BoNT-A) and 154 (69 Anti-CGRP mAbs; 85 BoNT-A) patients were included in the efficacy analysis at 6 and 12 months of follow-up, respectively. Anti-CGRP mAbs and BoNT-A both resulted in a mean MHD reduction at 6 (-11.5 and -7.2 days, respectively; unadjusted mean difference -4.3; 95%CI -6.6 to -2.0; p = 0.0003) and 12 months (-11.9 and -7.6, respectively; unadjusted mean difference -4.4; 95%CI -6.8 to -2.0; p = 0.0002) of follow-up. Similar results were observed after adjusting for baseline confounders. Anti-CGRP mAbs showed a significant MIDAS (-31.7 and -19.2 points, p = 0.0001 and p = 0.0296, respectively) and MAM reduction (-5.1 and -3.1 administrations, p = 0.0023 and p = 0.0574, respectively) compared to BoNT-A at 6 and 12 months. No SAEs were reported. One patient receiving fremanezumab discontinued treatment due to arthralgia. Treatment discontinuations, mainly for inefficacy, were comparable. Both Anti-CGRP mAbs and BoNT-A were effective in CM patients with Anti-CGRP mAbs presenting higher effect magnitude, with comparable safety. Still, BoNT-A remains a valuable option for CM patients with contraindications to Anti-CGRP mAbs or for frail categories who are candidates to local therapy with limited risk of systemic administration.

中文翻译：

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抗 CGRP 单克隆抗体与 OnabotulinumtoxinA (RAMO) 相比对慢性偏头痛的真实疗效：一项回顾性、观察性、多中心队列研究

慢性偏头痛（CM）是一种致残性疾病，在普通人群中患病率很高。在最近批准针对降钙素基因相关肽的单克隆抗体（抗 CGRP 单克隆抗体）之前，OnabotulinumtoxinA (BoNT-A) 是唯一专门批准用于 CM 预防的治疗方法。到目前为止，还无法对两种治疗方法进行直接比较。我们在意大利进行了一项观察性、回顾性、多中心研究，以比较抗 CGRP 单克隆抗体和 BoNT-A 的实际有效性。从现有的临床数据库中提取了根据意大利处方规定接受过任一治疗的 CM 患者。疗效结果包括每月头痛天数 (MHD) 相对于基线的变化、偏头痛残疾评估测试 (MIDAS) 以及在 6 个月和 12 个月的随访中评估的每月急性药物治疗 (MAM)。主要结局是 12 个月时 MHD 相对于基线的变化。安全性结果包括严重不良事件（SAE）和治疗停止。未调整和调整的模型用于分析。筛选了 216 名可能符合资格的患者；包括 183 种（86 种抗 CGRP 单克隆抗体；97 种 BoNT-A）。随访 6 个月和 12 个月时，分别纳入了 171 名（80 种抗 CGRP 单克隆抗体；91 名 BoNT-A）和 154 名（69 名抗 CGRP 单克隆抗体；85 名 BoNT-A）患者进行疗效分析。抗 CGRP mAb 和 BoNT-A 均导致平均​​ MHD 在 6（-11.5 和 -7.2 天）时降低；未调整的平均差 -4.3；95%CI -6.6 至 -2.0；p = 0.0003）和 12 个月（分别为 -11.9 和 -7.6；未调整的平均差 -4.4；95%CI -6.8 至 -2.0；p = 0.0002）的随访。调整基线混杂因素后观察到类似的结果。与 BoNT 相比，抗 CGRP mAb 显示显着的 MIDAS（-31.7 和 -19.2 分，分别为 p = 0.0001 和 p = 0.0296）和 MAM 降低（-5.1 和 -3.1 给药，分别为 p = 0.0023 和 p = 0.0574） -A 在 6 个月和 12 个月时。没有报告 SAE。一名接受 fremanezumab 治疗的患者因关节痛而停止治疗。主要因无效而停止治疗的情况具有可比性。抗 CGRP 单克隆抗体和 BoNT-A 对 CM 患者均有效，抗 CGRP 单克隆抗体表现出更高的作用强度，且安全性相当。尽管如此，对于有抗 CGRP 单克隆抗体禁忌症的 CM 患者或适合局部治疗且全身给药风险有限的体弱人群，BoNT-A 仍然是一个有价值的选择。