Journal Article

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

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

2022

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,BMC
• Subject: Antibodies, Monoclonal - adverse effects / Antibodies, Monoclonal, Humanized / Associated symptoms / Care and treatment / Diagnosis / Double-Blind Method / Drug therapy / Galcanezumab / Headache - drug therapy / Humans / Japan - epidemiology / Medicine / Medicine & Public Health / Migraine / Migraine Disorders - drug therapy / Neurochemistry / Neurology / Neurosurgery / Premonitory symptoms / Real-world evidence / Retrospective Studies / Symptomatology / Treatment Outcome