Real-world efficacy of galcanezumab for the treatment of migraine in Korean patients
Real-world efficacy of galcanezumab for the treatment of migraine in Korean patients
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DOI：
10.1177/03331024221076481
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发表时间：
2022-03-18
期刊：
影响因子：
4.9
通讯作者：
Lee, Mi Ji
中科院分区：
文献类型：
--
作者：
Kwon, Soonwook;Gil, Young-Eun;Lee, Mi Ji
背景和目的：我们旨在提供关于抗降钙素基因相关肽单克隆抗体治疗韩国偏头痛患者有效性的真实数据。方法我们前瞻性招募了2020年6月至2021年4月在一所大学医院接受galcanezumab治疗的偏头痛患者。在连续三次每月注射后评估治疗反应。根据中度/重度头痛天数减少>= 50%评估50%的应答率。结果共纳入87例患者。大多数患者为女性（83.9%）。他们的平均年龄为41.7 ± 12.3岁（范围17-72岁）。65名患者（74.7%）患有慢性偏头痛，35名患者（40.2%）有药物过度使用头痛史，32名患者（36.8%）以前对五类预防性药物无反应或无法耐受。治疗3个月后，每月头痛天数、中度/重度头痛天数、透明天数和急性药物使用天数的平均变化分别为-7.2 +/- 8.43、-4.3 +/- 9.76、7.3 +/- 8.50和-4.1 +/- 7.93。对于既往使用0-1、2-4和5种预防性药物治疗失败的患者，50%应答率分别为58.3%、44.2%和40.6%。头痛影响测试-6和偏头痛残疾评估测试评分也下降（分别为-4.4 +/- 8.09和-32.9 +/- 77.04）。结论在我们的队列中，galcanezumab的有效性和安全性与临床试验报告的结果相当，而在难治性患者亚组中观察到的应答率高于临床试验报告的应答率。我们提供了galcanezumab治疗亚洲偏头痛患者获益的真实证据。
Background and objective We aimed to provide real-world data on the effectiveness of an anti-calcitonin gene-related peptide monoclonal antibody administered for treating migraine in Korean patients. Methods We prospectively recruited patients with migraine who received galcanezumab treatment at a single university hospital from June 2020 to April 2021. The treatment response was assessed after three consecutive monthly injections. A 50% responder rate was evaluated based on >= 50% reduction in the number of moderate/severe headache days. Results Overall, 87 patients were included in the analysis. Most patients were women (83.9%). They had a mean age of 41.7 +/- 12.3 years (range 17-72). Sixty-five patients (74.7%) had chronic migraine, 35 patients (40.2%) had a history of medication-overuse headache, and 32 patients (36.8%) were previously unresponsive to or found intolerable five classes of preventive medication. After three months of treatment, mean changes in numbers of monthly headache days, moderate/severe headache days, crystal clear days, and days of acute medication use were -7.2 +/- 8.43, -4.3 +/- 9.76, 7.3 +/- 8.50, and -4.1 +/- 7.93, respectively. The 50% responder rates were 58.3%, 44.2%, and 40.6% for patients with unsuccessful previous use of 0-1, 2-4, and 5 preventive medication classes, respectively. Headache Impact Test-6 and Migraine Disability Assessment Test scores also decreased (-4.4 +/- 8.09 and -32.9 +/- 77.04, respectively). Conclusion In our cohort, the effectiveness and safety of galcanezumab were comparable with those reported in clinical trials, whereas a higher response rate was observed in the difficult-to-treat patient subset than that reported in trials. We provide real-world evidence of galcanezumab treatment benefits in Asian patients with migraine.