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 = -