Early onset of efficacy with erenumab for migraine prevention in Japanese patients: Analysis of two randomized, double-blind, placebo-controlled studies

Koichi Hirata, Takao Takeshima, Fumihiko Sakai, Noboru Imai, Yasuhiko Matsumori, Yoshihisa Tatsuoka, Yotaro Numachi, Ryuji Yoshida, Cheng Peng, Daniel D Mikol, Gabriel Paiva da Silva Lima, Sunfa Cheng, Koichi Hirata, Takao Takeshima, Fumihiko Sakai, Noboru Imai, Yasuhiko Matsumori, Yoshihisa Tatsuoka, Yotaro Numachi, Ryuji Yoshida, Cheng Peng, Daniel D Mikol, Gabriel Paiva da Silva Lima, Sunfa Cheng

Abstract

Purpose: In two 24-week migraine prevention studies in Japan, erenumab was associated with significantly greater reductions in migraine frequency versus placebo over Weeks 13-24 (primary endpoint). This post hoc analysis evaluated the onset of efficacy within the first 4 weeks after the initiation of erenumab from the 24-week double-blind periods of these studies.

Methods: Placebo-adjusted differences in least squares mean (LSM) change from baseline in weekly migraine days (WMD) were assessed weekly in each study and by migraine type (episodic (EM]/chronic [CM]) (Study 20170609).

Results: A total of 407 patients from Study 20120309 (70 mg: N = 135; 140 mg: N = 136; placebo: N = 136) and 261 patients from Study 20170609 ([EM] 70 mg: N = 78; placebo: N = 81; [CM] 70 mg: N = 52; placebo: N = 50) were included. For Study 20120309, onset of efficacy was observed as early as Week 1 in favor of erenumab versus placebo. Placebo-adjusted differences in LSM (95% confidence interval [CI]) change from baseline in WMD at Week 1 were -0.38 (-0.71 to -0.05; p = .022) and -0.49 (-0.82 to -0.16; p = .004) in favor of erenumab 70 and 140 mg, respectively. For Study 20170609, significant placebo-adjusted differences were observed with erenumab 70 mg at Week 1 in patients with EM (LSM [95% CI]: -0.55 [-0.97 to -0.12; p = .012]), and at Week 2 in patients with CM (LSM [95% CI]: -0.81 [-1.53 to -0.09; p = .028]) and for the overall population (LSM [95% CI]: -0.71 [-1.09 to -0.33; p < .001]).

Conclusions: Erenumab treatment significantly reduced WMD compared with placebo. Onset of erenumab efficacy occurred as early as Week 1 in patients with migraine.

Keywords: calcitonin gene-related peptide; chronic migraine; episodic migraine; erenumab; onset of efficacy.

Conflict of interest statement

Koichi Hirata: No funding was received for the current manuscript. Health, Labour and Welfare Sciences Research Grants received by the Ministry of Health, Labour and Welfare, Japan for the current work. Consulting fees received from Lundbeck, Otsuka, Eli Lilly, and Amgen. Payment or honoraria (lectures, presentations, speaker's bureaus, etc.) received from Eli Lilly, Lundbeck, Otsuka, Eisai, Amgen, Pfizer, and Daiichi Sankyo. Takao Takeshima: Payment or honoraria (lecture fees) received from Eisai and Eli Lilly. Fumihiko Sakai: Consulting fees received from Amgen, Eli Lilly, Otsuka, and Lundbeck. Noboru Imai: Payment or honoraria (speaker's bureaus) received from Amgen, Daiichi Sankyo, Eli Lilly, and Otsuka. Yasuhiko Matsumori: Payment or honoraria (lecturer fees) received from Eli Lilly, Otsuka, and Daiichi Sankyo. Yoshihisa Tatsuoka: Advisory fees received from Eli Lilly, Otsuka, and Daiichi Sankyo. Payment or honoraria (lecturer fees) received from Eisai, Otsuka, Kyowa Kirin, Takeda, and Daiichi Sankyo. Grants received for commissioned/joint research received from Amgen, Allergan, Eli Lilly, Otsuka, Kyowa Kirin, and Ono. Yotaro Numachi: Employee of Amgen K.K. and shareholder of Amgen Inc. Ryuji Yoshida: Employee of Amgen K.K. Cheng Peng: Employee and shareholder of Amgen Inc. Daniel Mikol: Former employee of Amgen and held Amgen stock. Current employee of NervGen and hold NervGen stock. Gabriel Paiva da Silva Lima and Sunfa Cheng: Employee and shareholder of Amgen Inc.

© 2022 The Authors. Brain and Behavior published by Wiley Periodicals LLC.

Figures

FIGURE 1
FIGURE 1
Study design: (a) Study 20120309 and (b) Study 20170609. F/U, follow‐up; QM, every month; SC, subcutaneous
FIGURE 2
FIGURE 2
Change from baseline in weekly migraine days at Weeks 1–4 in Study 20120309. LSM, least squares mean. *p < .05; **p < .01; ***p < .001
FIGURE 3
FIGURE 3
Change from baseline in weekly migraine days at Weeks 1–4 in Study 20170609. LSM, least squares mean. *p < .05; **p < .01; ***p < .001
FIGURE 4
FIGURE 4
Change from baseline in weekly migraine days at Weeks 1–4 in patients with (a) episodic migraine (EM) and (b) chronic migraine (CM) in Study 20170609. LSM, least squares mean. *p < .05; **p < .01; ***p < .001.

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