Real-world evidence of galcanezumab for migraine treatment in Japan: a retrospective analysis

BMC Neurology

Research

Ryo Takemura¹  Naoki Miyazaki¹  Tsubasa Takizawa²  Narumi Watanabe²  Jin Nakahara²  Kei Ishizuchi²  Chisato Iba²  Koji Sekiguchi²  Seiya Ohtani³  Mamoru Shibata⁴  Satoko Hori⁵ 

[1] Biostatistics Unit, Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan;Department of Neurology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-Ku, 160-8582, Tokyo, Japan;Department of Neurology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-Ku, 160-8582, Tokyo, Japan;Division of Drug Informatics, Keio University Faculty of Pharmacy, Tokyo, Japan;Department of Neurology, Tokyo Dental College Ichikawa General Hospital, Chiba, Japan;Division of Drug Informatics, Keio University Faculty of Pharmacy, Tokyo, Japan;

关键词: Galcanezumab;    Migraine;    Real-world evidence;    Associated symptoms;    Premonitory symptoms;   

DOI  :  10.1186/s12883-022-03041-1

 received in 2022-08-02, accepted in 2022-12-21,  发布年份 2022

来源: Springer

【 摘 要 】

ObjectiveTo evaluate the efficacy and safety of galcanezumab in patients with migraine in a real-world setting in Japan.BackgroundGalcanezumab 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.MethodsWe 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.ResultsFifty-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%).ConclusionThis 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.

【 授权许可】

CC BY   
© The Author(s) 2022

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