Open AccessEarly onset of efficacy with erenumab for migraine prevention in Japanese patients: Analysis of two randomized, double‐blind, placebo‐controlled studies
Author(s) -
Hirata Koichi,
Takeshima Takao,
Sakai Fumihiko,
Imai Noboru,
Matsumori Yasuhiko,
Tatsuoka Yoshihisa,
Numachi Yotaro,
Yoshida Ryuji,
Peng Cheng,
Mikol Daniel D.,
Lima Gabriel Paiva da Silva,
Cheng Sunfa
Publication year - 2022
Publication title -
brain and behavior
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.915
H-Index - 41
ISSN - 2162-3279
DOI - 10.1002/brb3.2526
Subject(s) - placebo , migraine , medicine , post hoc analysis , clinical endpoint , population , confidence interval , double blind , randomized controlled trial , gastroenterology , alternative medicine , environmental health , pathology
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.