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

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.

Twelve-month efficacy of CGRP monoclonal antibodies and predictive value of short-term response: results of an Australian multicentre study

“…Iannone et al reported lower rates of treatment continuation at 12 months compared with our cohort 19. The reported adverse event rate varies in the literature between 19.5% and 73.3%,2 13 20 with similar reported events.…”

Predicting response to CGRP-monoclonal antibodies in patients with migraine in Japan: a single-centre retrospective observational study

“…Patients completed the Generalized Anxiety Disorder-7 (GAD-7) questionnaire [27,28] and Patient Health Questionnaire-9 (PHQ-9) [29] upon CGRPmAb administration to determine the extent of anxiety and depression, respectively. We also collected patient migraine-preventive drug data, including failures of preventative drugs (lomerizine, propranolol, valproate, amitriptyline, or topiramate) before CGRPmAb treatment and response frequency to triptan (0, 1, 2, 3 out of three uses) [10].…”

“…Previous reports on clinical trials and real-world research show that CGRPmAbs produce substantially better outcomes than other treatments, without causing severe adverse effects [3][4][5][6][7][8][9]. However, CGRPmAbs also have disadvantages; they are more expensive, cause minor adverse effects such as injection site reactions and constipation, and are ineffective in some patients [10]. Currently, in Japan, CGRPmAbs (galcanezumab, fremanezumab, and erenumab) can be used for patients with ≥ 4 migraine days per month and for those who have experienced treatment ineffectiveness/intolerance, or have strong concerns about side effects, with at least one traditional migraine-preventive drug (i.e., lomerizine, propranolol, valproate) [10].…”

“…However, CGRPmAbs also have disadvantages; they are more expensive, cause minor adverse effects such as injection site reactions and constipation, and are ineffective in some patients [10]. Currently, in Japan, CGRPmAbs (galcanezumab, fremanezumab, and erenumab) can be used for patients with ≥ 4 migraine days per month and for those who have experienced treatment ineffectiveness/intolerance, or have strong concerns about side effects, with at least one traditional migraine-preventive drug (i.e., lomerizine, propranolol, valproate) [10]. Regarding the expense of CGRPmAbs in Japan, the cost of CGRPmAbs is reimbursed as long as the criteria for approved indications of CGRPmAbs have been met.…”

A Scoping Review and Meta-Analysis of Anti-CGRP Monoclonal Antibodies: Predicting Response

“…Consequently, the reported median number of previous medication failures in study cohorts ranged from 4 to 7, representing a therapy-resistant or difficult-to-treat subset of migraine patients. Within this population, there was a small but consistent negative association between the number of previous CM: chronic migraine [47,48,50,[53][54][55][56][57][58][59][61][62][63]65,66,68,69,74,75,78].…”