Erenumab treatment for migraine prevention in Japanese patients: Efficacy and safety results from a Phase 3, randomized, double-blind, placebo-controlled study

Abstract

Objectives: Erenumab is a human anti-calcitonin gene-related peptide receptor monoclonal antibody approved for migraine prevention. Global studies have demonstrated its efficacy in chronic and episodic migraine (EM). Here we report the outcomes from a Phase 3 study of erenumab in Japanese patients with chronic migraine (CM) or EM.

Methods: Japanese patients with EM (<15 headache days/month, including ≥4 migraine days/month) or CM (≥15 headache days/month, including ≥8 migraine days/month) were randomized 1:1 to placebo or erenumab 70 mg once monthly for a 24-week double-blind treatment phase (DBTP). The primary endpoint of change from baseline in mean monthly migraine days (MMD) over months 4, 5, and 6 of the DBTP was compared between erenumab and placebo groups. Secondary efficacy and safety endpoints were also assessed.

Results: A total of 261 patients were randomized to placebo (n = 131) or erenumab 70 mg (n = 130); all patients were included in the efficacy and safety analyses. The mean (standard deviation) MMD at baseline was 11.84 (5.70) for the placebo group and 12.40 (5.99) for erenumab 70 mg. The mean (standard error) change in MMD was -1.98 (0.38) for the placebo group (n = 131) and -3.60 (0.38) for erenumab 70 mg (n = 130). The difference in MMD reduction between groups was -1.67 (95% CI: -2.56, -0.78, p < 0.001) for EM and -1.57 (95% CI: -3.39, 0.24, p = 0.089) for CM. Adverse events (AEs) were consistent with earlier studies. The most frequent AEs (placebo, erenumab) were nasopharyngitis (28.2% and 26.9%, respectively), back pain (4.6% and 5.4%), and constipation (0.8% and 4.6%).

Conclusion: Treatment with erenumab 70 mg once monthly demonstrated favorable efficacy and safety findings in Japanese patients with EM or CM.

Keywords: Japan; chronic migraine; episodic migraine; erenumab.

Conflict of interest statement

Takao Takeshima: Nothing to disclose. Fumihiko Sakai: Consulting fees from Amgen. Koichi Hirata: Royalties from Amgen, Astellas, Daiichi Sankyo, Eisai, Merck Sharp & Dohme, and Pfizer. Noboru Imai: Nothing to disclose. Yasuhiko Matsumori: Nothing to disclose. Ryuji Yoshida: Employee of Amgen. Cheng Peng: Employee and stockholder of Amgen. Sunfa Cheng: Employee and stockholder of Amgen. Daniel D. Mikol: Employee and stockholder of Amgen Inc.

© 2021 Amgen Inc. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.

Figures

FIGURE 1

Study schema. CM, chronic migraine; eDiary, electronic diary; EM, episodic migraine; IP, investigational product; QM, once monthly; SC, subcutaneously

FIGURE 2

Flow of patients through the DBTP of the study. *All randomized patients received ≥1 dose of the investigational product and had ≥1 monthly migraine day measurement and were included in the efficacy and safety analysis sets. DBTP, double‐blind treatment phase; N, total number of patients; n, subset of patients

FIGURE 3

Change in MMD over months 4, 5, and 6. Mean change is shown inside each bar. Error bars indicate SE. Mean difference between groups along with a 95% CI and p‐value is reported on the right. CM, chronic migraine; EM, episodic migraine; MMD, monthly migraine days

FIGURE 4

Percentage of patients achieving a ≥50% reduction in MMD over months 4, 5, and 6. Percentage is calculated as n/N × 100%, where n = subset of patients achieving ≥50% reduction in MMD; N = total number of patients. Percentage and n/N are shown inside each bar. MMD, monthly migraine days; OR, odds ratio

FIGURE 5

Change in monthly acute migraine‐specific medication days over months 4, 5, and 6. Mean change is shown inside each bar. Error bars indicate SE. Mean difference between groups along with a 95% CI and p‐value is reported on the right