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Observational Study
. 2024 Jan 18;24(1):32.
doi: 10.1186/s12883-023-03521-y.

Real-world experience with calcitonin gene-related peptide-targeted antibodies for migraine prevention: a retrospective observational cohort study at two Japanese headache centers

Mamoru Shibata  1 , Kazuki Fujita  2 , Eri Hoshino  2 , Kazushi Minami  3 , Kenzo Koizumi  3 , Satoshi Okada  3 , Fumihiko Sakai  4
Affiliations
Observational Study

Real-world experience with calcitonin gene-related peptide-targeted antibodies for migraine prevention: a retrospective observational cohort study at two Japanese headache centers

Mamoru Shibata et al. BMC Neurol. .

Erratum in

Abstract

Background: Although randomized controlled trials (RCTs) have shown that calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies (CGRP mAbs) are an efficacious and safe therapeutic modality for migraine prevention, their clinical benefits have not been well validated in Japanese patients in the real-world setting. The present study aimed to evaluate the real-world efficacy and safety of galcanezumab, fremanezumab, and erenumab in Japanese patients with migraine.

Methods: This observational retrospective cohort study was conducted at two headache centers in Japan. Patients with migraine who had experienced treatment failure with at least one traditional oral migraine preventive agent were treated with a CGRP mAb de novo. The primary efficacy endpoints were the changes from baseline in monthly migraine days (MMDs) and Headache Impact Test-6 (HIT-6) score after 3 dosing intervals (V3). We explored whether demographic and clinical characteristics predicted therapeutic outcomes at V3.

Results: Sixty-eight patients who completed three doses of a CGRP mAb (85.3% female [58/68], mean age: 46.2 ± 13.1 years) were included in the analysis. There were 19 patients with chronic migraine. The baseline MMDs were 13.4 ± 6.0. After 3 doses, the MMDs significantly decreased to 7.4 ± 5.5 (p < 0.0001), and the 50% response rate was 50.0%. HIT-6 score was significantly reduced from 66.7 ± 5.4 to 56.2 ± 8.7 after 3 doses (P = 0.0001). There was a positive correlation between the changes in MMDs and HIT-6 score from baseline after 2 doses (p = 0.0189). Those who achieved a ≥ 50% therapeutic response after the first and second doses were significantly more likely to do so at V3 (crude odds ratio: 3.474 [95% CI: 1.037 to 10.4], p = 0.0467). The most frequent adverse event was constipation (7.4%). None of the adverse events were serious, and there was no need for treatment discontinuation.

Conclusions: This real-world study demonstrated that CGRP mAbs conferred Japanese patients with efficacious and safe migraine prevention, and an initial positive therapeutic response was predictive of subsequent favorable outcomes. Concomitant measurement of MMDs and HIT-6 score was useful in evaluating the efficacy of CGRP mAbs in migraine prevention.

Keywords: Calcitonin gene-related peptide (CGRP); Headache Impact Test-6 (HIT-6); Japanese; Migraine; Monoclonal antibody; Real world.

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Conflict of interest statement

MS and FS received speaker honoraria from Daiichi Sankyo Company, Limited, Eli Lilly Japan, Otsuka Pharmaceutical Co., Ltd., and Amgen. The other authors do not have any competing interests.

Figures

Fig. 1
Fig. 1
Study design. After confirming a diagnosis of migraine, consecutive eligible patients were enrolled. After the baseline period of more than 4 weeks, the enrolled patients were treated with 3 doses of one of the CGRP mAbs
Fig. 2
Fig. 2
Enrollment and analysis of study participants
Fig. 3
Fig. 3
Previously used TOMPs by the study participants
Fig. 4
Fig. 4
Effects of all the CGRP mAbs on MMDs. A Temporal profile of MMDs in patients treated with any CGRP mAb (n = 68). Data are shown as mean ± SD. Statistical analysis was performed using the Kruskal–Wallis test with Dunn’s post hoc test. ***p < 0.001, ****p < 0.0001. B 50%, 75%, and 100% RRs at V1, V2, and V3
Fig. 5
Fig. 5
Effects of each CGRP mAb on MMDs. Temporal profiles of MMDs in patients treated with galcanezumab (n = 31, A), fremanezumab (n = 24, B), and erenumab (n = 13, C). Data are shown as mean ± SD. Statistical analysis was performed using one-way ANOVA with Dunnett’s post hoc test for galcanezumab and the Kruskal–Wallis test with Dunn’s post hoc test for fremanezumab and erenumab. *p < 0.05, **p < 0.01, ***p < 0.001, ****p < 0.0001. D Overlay line graph depicting the temporal profiles of each CGRP mAb
Fig. 6
Fig. 6
Effects of all the CGRP mAbs on HIT-6 score. Temporal profile of the HIT-6 score in patients treated with any CGRP mAb (n = 68). Data are shown as mean ± SD. Statistical analysis was performed using one-way ANOVA with Dunnett’s post hoc test. ****p < 0.0001
Fig. 7
Fig. 7
Effects of each CGRP mAb on HIT-6 score. Temporal profiles of HIT-6 score in patients treated with galcanezumab (n = 31, A), fremanezumab (n = 24, B), and erenumab (n = 13, C). Data are shown as mean ± SD. Statistical analysis was performed using one-way ANOVA with Dunnett’s post hoc test for galcanezumab and erenumab and the Kruskal–Wallis test with Dunn’s post hoc test for erenumab. *p < 0.05, **p < 0.01, ***p < 0.001, ****p < 0.0001. D Overlay line graph depicting the temporal profiles of each CGRP mAb. Between-group comparisons at each timepoint were performed with Dunnett’s post hoc test. #p < 0.05, galcanezumab vs. fremanezumab
Fig. 8
Fig. 8
Schematic representation depicting a possible favorable effect of combinatorial treatment with CGRP mAbs, which mainly act mainly at peripheral sites, and centrally acting preventive drugs, such as Ca2+ blockers, tricyclic antidepressants (TCAs), and antiepileptic drugs (AEDs)
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