López-Bravo Alba, Mínguez-Olaondo Ane, Nieves-Castellanos Candela, Ruibal-Salgado Marta, Sánchez-Mateos Noemí Morollón, Navarro-Pérez María Pilar, Alpuente Alicia, Torres-Ferrús Marta, García-Ull Jésica, Gago-Veiga Ana, García-Azorín David, González-Martínez Alicia, Sierra Álvaro, Santos-Lasaosa Sonia
Neurology Department, Hospital Reina Sofia, Tudela, Navarra, Spain.
Aragon Institute for Health Research (IIS Aragón), Zaragoza, Spain.
Headache. 2025 Jun;65(6):994-1004. doi: 10.1111/head.14913. Epub 2025 Mar 26.
Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are the first migraine-specific prophylactic medication. Clinical data regarding patient treatment satisfaction (TS) with CGRP mAbs are limited.
A multicenter prospective cohort study was conducted in patients with ≥8 headache days/month who started treatment with erenumab, galcanezumab, or fremanezumab. Monthly migraine days (MMD), monthly headache days (MHD), Migraine Disability Assessment (MIDAS), and the six-item Headache Impact Test (HIT-6) scores were collected. Patients' satisfaction with treatment (effectiveness, convenience, side effects, and global satisfaction) was assessed by the Treatment Satisfaction Questionnaire for Medication, version 1.4 (TSQM-1.4©).
A total of 400 patients were included. The median (interquartile range [IQR]) TS scores were high (≥70%) across all domains of the TSQM-1.4 after 3 and 6 months of CGRP mAb therapy: 72.2 (50.0-83.3) and 83.3 (61.1-88.9) for effectiveness, 83.3 (72.2-100) and 83.3 (77.8-100) for convenience, and finally, a score of 78.6 (50.0-92.9) and 85.7 (71.4-92.9) for global satisfaction. The median (IQR) reduction in MHD and MMD was 10.0 (3.0-17.0; p < 0.001) and 8.0 (4.0-12.0; p < 0.001) days after 3 months of treatment, and 10.0 (3.0-17.0; p < 0.001) and 9.0 (5.0-17.0; p < 0.001) days after 6 months. The median (IQR) HIT-6 score decreased from 68.0 (65.0-72.0) to 60.0 (51.0-66.0; p < 0.001) at Month 3 and to 56.0 (48.0-64.0; p < 0.001) at Month 6. Finally, the median (IQR) MIDAS score decreased from 70 (40.0-120.0) to 24 (7.8-60.0; p < 0.001) and 17 (5.0-45.0; p < 0.001) at Months 3 and 6, respectively. The median change from baseline in MMD was significantly associated with effectiveness at 3 (β = -0.93, 95% CI -1.34 to -0.53; p < 0.001) and 6 months (β = -1.56, 95% CI -2.15 to -0.97; p < 0.001). Similarly, reductions in MMD were significantly associated with the global satisfaction dimension of the questionnaire (β = -0.82, 95% CI -1.27 to -0.37; p < 0.001) and (β = -1.80, 95% CI -2.42 to -1.18; p < 0.001).
Most patients were satisfied with CGRP mAbs' effectiveness, tolerability, and convenience in a real-world setting. Interestingly, increasing TS was associated with meaningful reductions in frequency, impact, and disability caused by migraine.
降钙素基因相关肽单克隆抗体（CGRP单克隆抗体）是首款偏头痛特异性预防性药物。关于患者对CGRP单克隆抗体治疗满意度（TS）的临床数据有限。
对每月头痛天数≥8天且开始使用erenumab、galcanezumab或fremanezumab治疗的患者进行了一项多中心前瞻性队列研究。收集每月偏头痛天数（MMD）、每月头痛天数（MHD）、偏头痛残疾评估（MIDAS）以及六项头痛影响测试（HIT-6）评分。通过药物治疗满意度问卷1.4版（TSQM-1.4©）评估患者对治疗的满意度（有效性、便利性、副作用和总体满意度）。
共纳入400例患者。在CGRP单克隆抗体治疗3个月和6个月后，TSQM-1.4所有领域的TS评分中位数（四分位间距[IQR]）都很高（≥70%）：有效性方面为72.2（50.0 - 83.3）和83.3（61.1 - 88.9），便利性方面为83.3（72.2 - 100）和83.3（77.8 - 100），总体满意度方面最后得分为78.6（50.0 - 92.9）和85.7（71.4 - 92.9）。治疗3个月后，MHD和MMD的中位数（IQR）减少分别为10.0（3.0 - 17.0；p < 0.001）和8.0（4.0 - 12.0；p < 0.001）天，6个月后分别为10.0（3.0 - 17.0；p < 0.001）和9.0（5.0 - 17.0；p < 0.001）天。HIT-6评分中位数（IQR）在第3个月从68.0（65.0 - 72.0）降至60.0（51.0 - 66.0；p < 0.001），在第6个月降至56.0（48.0 - 64.0；p < 0.001）。最后，MIDAS评分中位数（IQR）在第3个月和第6个月分别从70（40.0 - 120.0）降至24（7.8 - 60.0；p < 0.001）和17（5.0 - 45.0；p < 0.001）。MMD相对于基线的中位数变化在3个月（β = -0.93，95%CI -1.34至 -0.53；p < 0.001）和6个月（β = -
