Real-world evidence of galcanezumab for migraine treatment in Japan: a retrospective analysis.
Real-world evidence of galcanezumab for migraine treatment in Japan: a retrospective analysis.
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DOI：
10.1186/s12883-022-03041-1
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发表时间：
2022-12-31
期刊：
影响因子：
2.6
通讯作者：
Nakahara, Jin
中科院分区：
文献类型：
--
作者：
Takizawa, Tsubasa;Ohtani, Seiya;Watanabe, Narumi;Miyazaki, Naoki;Ishizuchi, Kei;Sekiguchi, Koji;Iba, Chisato;Shibata, Mamoru;Takemura, Ryo;Hori, Satoko;Nakahara, Jin
目的：评估Galcanezumab在日本真实环境中治疗偏头痛患者的有效性和安全性。Galcanezumab是日本批准的第一个抗降钙素基因相关肽的单抗。据我们所知，日本的任何国际期刊都没有发表过关于Galcanezumab的真实研究。我们回顾了在2021年8月至2022年2月期间在庆应义乌大学医院接受三剂Galcanezumab治疗的偏头痛患者。我们评估了每月偏头痛天数、应答率、偏头痛相关症状和先兆症状的变化。我们还调查了注射部位的反应和不良事件。在研究期间，52名患者接受了三剂Galcanezumab治疗。与基线时相比，3个月时每月偏头痛天数减少了5.9天(95%可信区间，4.2-7.7)。3个月时50%应答率为61.5%。64.9%、50.0%和63.9%的患者畏光、畏音和恶心/呕吐的严重程度得到改善。62.5%的患者报告有先兆症状，没有随后的头痛。注射部位反应是最常见的不良反应(34.6%)。这项研究揭示了Galcanezumab在日本治疗偏头痛的有效性和安全性。Galcanezumab还改善了偏头痛相关症状。然而，尽管头痛减轻了，但 >； 中有50%的患者在3个月时报告了没有后续头痛的先兆症状。网上版载有补充材料，可在10.1186/s12883-022-03041-1查阅。
To evaluate the efficacy and safety of galcanezumab in patients with migraine in a real-world setting in Japan. Galcanezumab is the first anti-calcitonin gene-related peptide monoclonal antibody approved in Japan. To the best of our knowledge, no real-world studies on galcanezumab have been published in any international journal from Japan. We retrospectively examined patients with migraine who received three doses of galcanezumab between August 2021 and February 2022 at the Keio University Hospital. We assessed changes in monthly migraine days, responder rate, and migraine-associated and premonitory symptoms. We also investigated injection site reactions and adverse events. Fifty-two patients received three doses of galcanezumab during the study period. Compared with those at baseline, the monthly migraine days decreased by 5.9 days (95% confidence interval, 4.2–7.7) at 3 months. The 50% responder rate was 61.5% at 3 months. A total of 64.9%, 50.0%, and 63.9% of patients showed improvement in the severity of photophobia, phonophobia, and nausea/vomiting, respectively. Premonitory symptoms without subsequent headache were reported in 62.5% of patients. Moreover, injection site reaction was the most common adverse event (34.6%). This study revealed the efficacy and safety of galcanezumab for migraineurs in Japan. Galcanezumab also improved migraine-associated symptoms. However, despite a reduction in headaches, premonitory symptoms without subsequent headache were reported in > 50% of the patients at 3 months. The online version contains supplementary material available at 10.1186/s12883-022-03041-1.
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