Galcanezumab, an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, has demonstrated safety and efficacy for the prevention of migraine among the Japanese population, according study findings published in the journal BMC Neurology.
Criteria for administration of galcanezumab differ between Japan and other countries, with the agent approved for use in Japan in individuals who experience 4 or more migraine days per month, as well as for those who have received treatment with 1 or more migraine-preventive drug that resulted in ineffectiveness, intolerance, or strong concerns over adverse events (AEs).
Researchers sought to evaluate the efficacy and safety of galcanezumab in real-world settings throughout Japan, as well as to assess the effects of the agent on migraine-associated symptoms and premonitory symptoms. They conducted a single-center, retrospective, observational cohort study where they examined patients with migraine who had received 3 doses of galcanezumab between August 2021 and February 2022 at the Keio University Hospital (KUH). Changes in monthly migraine days, responder rates, and symptoms were studied, along with injection-site reactions and other AEs.
Study inclusion criteria were as follows:
- Receipt of 3 doses of galcanezumab (240 mg/120 mg/120 mg) monthly from the headache group at KUH;
- Fulfillment of the diagnostic criteria for migraine, based on the International Classification of Headache Disorders (ICHD), 3rd edition; and
- Age 18 years and older.
All participants were classified as having episodic migraine or chronic migraine, according to the ICHD.
A total of 52 patients received 3 doses of galcanezumab during the study period. The majority of the participants were women; the mean age was 48.3±12.9 years (range, 19-81 years). At baseline, about half of the participants were classified as having episodic migraine.
Researchers found that compared with migraine at baseline, monthly migraine days decreased by 5.9 days (95% CI, 4.2-7.7; P <.001) at 3 months. Additionally, the 50% responder rate at 3 months was 61.5% (95% CI, 47.0-74.7). Overall, 64.9%, 50.0%, and 63.9% of participants demonstrated improvement in severity of photophobia, phonophobia, and nausea/vomiting, respectively.
In all, 62.5% of patients reported experiencing premonitory symptoms without the development of subsequent headache. The most common AE reported among the participants was injection-site reaction.
Several limitations of the study warrant mention. The sample size was small; the design was single-center, retrospective; and the observation period of 3 months was short. Additionally, the primary endpoint — migraine days — was evaluated mainly with the use of questionnaires, not by patients’ actual headache diaries, which were checked only in some instances.
Researchers acknowledged that their study proved galcanezumab is a safe and effective treatment for migraine prevention in Japan.
“Anti-CGRP monoclonal antibody use improved the migraine-associated symptoms and even resulted in disappearance of nausea and vomiting in nearly half of the patients at 3 months. However, despite a reduction in headaches, premonitory symptoms without subsequent headache were reported in more than 50% of the patients at 3 [months]” they concluded.
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
This article originally appeared on Neurology Advisor
Takizawa T, Ohtani S, Watanabe N, et al. Real-world evidence of galcanezumab for migraine treatment in Japan: a retrospective analysis. Published online December 31, 2022. BMC Neurol. doi:10.1186/s12883-022-03041-1