Section of Clinical Pharmacology and Oncology, Department of Health Sciences, University of Florence, Florence, Italy.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
Eur J Neurol. 2024 Dec;31(12):e16450. doi: 10.1111/ene.16450. Epub 2024 Sep 16.
Although there is extensive evidence about the safety of monoclonal antibodies against calcitonin gene-related peptide (anti-CGRP mAbs) in combination with traditional drugs, scarce data are available on the safety of their combination with other mAbs. This study aimed to evaluate the 6-month effectiveness and tolerability of anti-CGRP mAbs in combination with other mAbs for different diseases.
Patients included in the Italian Headache Registry and treated concomitantly with an anti-CGRP mAb and another mAb were included. Effectiveness outcomes for migraine included reduction from baseline of monthly headache days (MHDs), Migraine Disability Assessment (MIDAS) score, Headache Impact Test-6 (HIT-6) scores, and Patients' Global Impression of Change (PGIC) scale. Adverse events (AEs) were recorded.
Thirty-eight patients were included. In 27 patients (71.1%), the anti-CGRP mAb was added to a previously ongoing mAb. Nine patients (23.7%) discontinued one of the two mAbs before the end of treatment (seven discontinued the anti-CGRP mAb and two the other mAb). One patient discontinued for AEs. Anti-CGRP mAbs were discontinued due to ineffectiveness (n = 5, 55.5%) and one each (11.1%) for clinical remission and lost to follow-up. MHDs significantly decreased from baseline to 3 months (p < 0.0001) and 6 months (p < 0.001), as did the MIDAS and the HIT-6 scores at 3 and 6 months (p < 0.001). For anti-CGRP mAbs, 27.4% of patients reported PGIC ≥ 5 at 3 months and 48.3% at 6 months. Mild AEs associated with introduction of a second mAb were detected in six patients (15.8%).
In this real-world study, anti-CGRP mAbs showed safety and effectiveness when administered concomitantly with other mAbs.
尽管有大量证据表明降钙素基因相关肽（CGRP）单克隆抗体（抗 CGRP mAb）与传统药物联合使用是安全的，但关于其与其他 mAb 联合使用的安全性数据却很少。本研究旨在评估抗 CGRP mAb 与其他 mAb 联合用于治疗不同疾病的 6 个月疗效和耐受性。
纳入同时接受抗 CGRP mAb 和另一种 mAb 治疗的意大利头痛登记研究患者。偏头痛的疗效结局包括每月头痛天数（MHDs）、偏头痛残疾评估（MIDAS）评分、头痛影响测试-6（HIT-6）评分和患者整体变化印象（PGIC）量表自基线的变化。记录不良事件（AE）。
共纳入 38 例患者。在 27 例（71.1%）患者中，抗 CGRP mAb 是在先前正在进行的 mAb 治疗的基础上加用的。9 例（23.7%）患者在治疗结束前停用了两种 mAb 中的一种（7 例停用抗 CGRP mAb，2 例停用其他 mAb）。1 例因 AE 停用。抗 CGRP mAb 因无效（n=5，55.5%）和分别因临床缓解（n=1，11.1%）和失访（n=1，11.1%）而停用。MHDs 自基线至 3 个月（p<0.0001）和 6 个月（p<0.001）显著降低，MIDAS 和 HIT-6 评分在 3 个月和 6 个月时也显著降低（p<0.001）。对于抗 CGRP mAb，3 个月时有 27.4%的患者报告 PGIC≥5，6 个月时有 48.3%的患者报告 PGIC≥5。在 6 例患者（15.8%）中发现了与引入第二种 mAb 相关的轻度 AE。
在这项真实世界研究中，当与其他 mAb 联合使用时，抗 CGRP mAb 显示出安全性和疗效。
