Department of Neurology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Division of Drug Informatics, Keio Univiersity Faculty of Pharmacy, 1-5-30 Shibakouen, Minato-ku, Tokyo, 105-8512, Japan.
J Headache Pain. 2023 Mar 9;24(1):23. doi: 10.1186/s10194-023-01556-7.
Anti-calcitonin gene-related peptide monoclonal antibodies (CGRPmAbs) are a favourable option for patients with migraine who experience distressful headache disability and fail to respond to traditional preventive treatment options. However, since CGRPmAb has been available for only 2 years in Japan, the difference between good and poor responders remains unknown. We aimed to investigate the clinical characteristics of patients with migraine in Japan who responded well to CGRPmAb based on real-world data.
We analysed patients who visited Keio University Hospital, Tokyo, Japan, between the 12 of August 2021 and 31 of August 2022, and were prescribed one of three CGRPmAbs (erenumab, galcanezumab, and fremanezumab) for more than 3 months. We recorded the patients' basic migraine characteristics, such as pain quality, monthly migraine days (MMD)/monthly headache days (MHD), and the number of prior treatment failures. We defined good responders as patients whose MMDs decreased by more than 50% after 3 months of treatment and other patients as poor responders. We compared the baseline migraine characteristics between the two groups and performed logistic regression analysis based on the items that showed statistically significant differences.
In total, 101 patients were considered eligible for the responder analysis (galcanezumab: 57 (56%), fremanezumab: 31 (31%), and erenumab: 13 (13%)). After 3 months of treatment, 55 (54%) patients achieved ≥ 50% reduction in MMDs. Comparisons between ≥ 50% responders and non-responders revealed that age was significantly higher (p = 0.003), and MHD and total prior treatment failures were significantly lower (p = 0.027, 0.040, respectively), in responders than in non-responders. Age was a positive predictive factor, and the total number of prior treatment failures and past medical history of immuno-rheumatologic diseases were negative predictive factors of CGRPmAb responsiveness in Japanese patients with migraine.
Patients with migraine who are older, with fewer prior treatment failures and no past history of immuno-rheumatologic disease, may respond well to CGRPmAbs.
降钙素基因相关肽单克隆抗体（CGRPmAb）是一种治疗偏头痛的有效方法，适用于经历痛苦头痛残疾且对传统预防治疗方案无反应的患者。然而，由于 CGRPmAb 在日本仅使用了 2 年，因此良好反应者和不良反应者之间的差异仍不清楚。我们旨在根据真实世界的数据，研究日本对 CGRPmAb 反应良好的偏头痛患者的临床特征。
我们分析了 2021 年 8 月 12 日至 2022 年 8 月 31 日期间在日本庆应义塾大学医院就诊且接受三种 CGRPmAb（erenumab、galcanezumab 和 fremanezumab）治疗超过 3 个月的患者。我们记录了患者的基本偏头痛特征，如疼痛质量、每月偏头痛天数（MMD）/每月头痛天数（MHD）和既往治疗失败次数。我们将 MMD 减少超过 50%的患者定义为良好反应者，其他患者为不良反应者。我们比较了两组患者的基线偏头痛特征，并根据具有统计学差异的项目进行了逻辑回归分析。
共有 101 名患者被认为符合应答者分析条件（galcanezumab：57 例（56%），fremanezumab：31 例（31%），erenumab：13 例（13%））。治疗 3 个月后，55 例（54%）患者 MMD 减少≥50%。在≥50%应答者和非应答者之间的比较中，应答者的年龄明显更高（p=0.003），MHD 和总既往治疗失败次数明显更低（p=0.027、0.040）。年龄是阳性预测因素，既往治疗失败总数和免疫风湿性疾病既往史是日本偏头痛患者对 CGRPmAb 反应的阴性预测因素。
年龄较大、既往治疗失败次数较少且无免疫风湿性疾病既往史的偏头痛患者可能对 CGRPmAb 反应良好。
