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

Tsubasa Takizawa, Seiya Ohtani, Narumi Watanabe, Naoki Miyazaki, Kei Ishizuchi, Koji Sekiguchi, Chisato Iba, Mamoru Shibata, Ryo Takemura, Satoko Hori, Jin Nakahara

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To evaluate the efficacy and safety of galcanezumab in patients with migraine in a real-world setting in Japan. Background: 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. Methods: 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. Results: 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%). Conclusion: 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.

Original languageEnglish
Article number512
JournalBMC Neurology
Volume22
Issue number1
DOIs
Publication statusPublished - 2022 Dec

Keywords

  • Associated symptoms
  • Galcanezumab
  • Migraine
  • Premonitory symptoms
  • Real-world evidence

ASJC Scopus subject areas

  • Clinical Neurology

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