Department of Neurology, Seoul National University Hospital, Seoul, South Korea.
Seoul National University College of Medicine, Seoul, South Korea.
Sci Rep. 2023 Sep 8;13(1):14825. doi: 10.1038/s41598-023-42110-4.
To assess factors associated with galcanezumab response in a real-world study of Korean patients with migraine. Predictors of the efficacy of monoclonal antibodies targeting calcitonin gene-related peptide (CGRP) or its receptor (anti-CGRP(-R) mAb) have been rarely investigated in Asians. We prospectively recruited and followed up patients with migraine who received monthly galcanezumab treatment in a single university hospital from June 2020 to October 2021. We defined the treatment response with ≥ 50% reduction in moderate/severe headache days in the 3rd month of treatment compared to baseline. Responders and non-responders were compared in terms of demographics, disease characteristics and severity, and previous response to migraine prophylactic treatments. Potential predictors of anti-CGRP(-R) mAb response were tested by using the univariable and multivariable logistic regression analyses. Among 104 patients (81.7% female; mean age 42.0 ± 13.02; 76.9% chronic migraine; and 45.5% medication overuse headache) included, 58 (55.7%) were responders. Non-responders had more chronic migraine, medication overuse headache, monthly headache days, days with acute medication, and daily headaches (i.e. chronic migraine persisting everyday without remission). The multivariable logistic analysis showed chronic migraine (OR 0.05 [95% CI 0.00-0.82], p = 0.036) and the number of previously failed preventive medication classes (OR 0.55 [95% CI 0.33-0.92], p = 0.024] were independently associated with treatment response. Chronic migraine and multiple failures from preventive medication are associated with poor galcanezumab response. Further studies are needed to investigate if earlier treatment before disease chronification or multiple failures may lead to a greater therapeutic gain from anti-CGRP(-R) mAb treatment.
在一项针对韩国偏头痛患者的真实世界研究中评估与加奈珠单抗反应相关的因素。针对降钙素基因相关肽 (CGRP) 或其受体 (抗 CGRP(-R) mAb) 的单克隆抗体疗效的预测因子在亚洲人中很少被研究。我们前瞻性招募并随访了 2020 年 6 月至 2021 年 10 月在一家大学医院接受每月加奈珠单抗治疗的偏头痛患者。我们将治疗 3 个月时与基线相比中度/重度头痛天数减少≥50%定义为治疗反应。 responders 和 non-responders 在人口统计学、疾病特征和严重程度以及偏头痛预防性治疗的既往反应方面进行了比较。使用单变量和多变量逻辑回归分析测试了抗 CGRP(-R) mAb 反应的潜在预测因素。在纳入的 104 名患者中(81.7%为女性;平均年龄 42.0±13.02;76.9%为慢性偏头痛;45.5%为药物过度使用性头痛),58 名(55.7%)为 responders。 non-responders 具有更多的慢性偏头痛、药物过度使用性头痛、每月头痛天数、急性药物使用天数和每日头痛(即慢性偏头痛每天持续存在而无缓解)。多变量逻辑分析显示,慢性偏头痛(OR 0.05 [95%CI 0.00-0.82],p=0.036)和以前失败的预防性药物治疗次数(OR 0.55 [95%CI 0.33-0.92],p=0.024)与治疗反应独立相关。慢性偏头痛和预防药物的多次失败与加奈珠单抗反应不良相关。需要进一步研究以探讨在疾病慢性化或多次失败之前更早治疗是否可以从抗 CGRP(-R) mAb 治疗中获得更大的治疗效果。