Efficacy and safety of erenumab in women with a history of menstrual migraine

Abstract

Background: We performed a post hoc, subgroup analysis of a phase 3, randomized, double-blind, placebo-controlled study of erenumab for prevention of episodic migraine (STRIVE) to determine the efficacy and safety of erenumab in women with self-reported menstrual migraine.

Methods: Patients received placebo, erenumab 70 mg, or erenumab 140 mg subcutaneously once monthly during the 6-month double-blind treatment phase of STRIVE. Women who reported history of menstrual migraine and who were ≤ 50 years old were included in the analysis. Endpoints were change from baseline in monthly migraine days (MMD) and monthly acute migraine-specific medication days (MSMD; among patients who took acute migraine-specific medications at baseline), proportion of patients achieving ≥ 50% reduction from baseline in MMD, and incidence of adverse events.

Results: Among 814 women enrolled in STRIVE, 232 (28.5%) reported a history of menstrual migraine and were ≤ 50 years old. Of the 232 patients, 214 (92%) had a baseline MMD > 5, suggesting a high proportion of women with attacks outside of the 5-day perimenstrual window (2 days before and 3 days after the start of menstruation). Information on "migraine days" includes (and does not discriminate between) perimenstrual and intermenstrual migraine attacks. Between-group differences from placebo over months 4-6 for erenumab 70 mg and 140 mg were - 1.8 (P = 0.001) and - 2.1 (P < 0.001) days for MMD and - 1.6 (P = 0.002) and - 2.4 (P < 0.001) days for acute MSMD, respectively. The odds of having a ≥ 50% reduction from baseline in MMD over months 4-6 were 2.2 (P = 0.024) and 2.8 (P = 0.002) times greater for erenumab 70 mg and 140 mg, respectively, than for placebo. Erenumab had an overall safety profile comparable to placebo.

Conclusion: Data from this subgroup analysis of women with menstrual migraine are consistent with data from the overall STRIVE episodic migraine population, supporting the efficacy and safety of erenumab in women who experience menstrual migraine.

Trial registration: ClinicalTrials.gov, NCT02456740. Registered 28 May 2015.

Keywords: Episodic migraine; Erenumab; Headache; Menstrually related migraine; Migraine prevention; Perimenstrual attacks; Pure menstrual migraine.

Conflict of interest statement

JMP is a consultant/on advisory boards for Alder Biopharmaceuticals, Allergan, Amgen, Biohaven, Promius Pharma and receives research funding from NIH/NIA K23AG049466-05. KP has received personal compensation from Allergan, Amgen/Novartis, Eli Lilly, and Teva for consulting, serving on a scientific advisory board, and/or speaking and is a clinical trial investigator for Amgen/Novartis (erenumab), Eli Lilly (galcanezumab), and Autonomic Technologies Inc. (sphenopalatine ganglion stimulation). HG has received research support from Allergan, Amgen, Bayer, Novartis, Menarini, and Teva and is a speaker for Allergan, Novartis, and Teva. JB has nothing to disclose. AR is an advisor for Allergan, Amgen, Amneal, Assertio, Autonomic Technologies Inc., Biohaven, Cala Health, Neurolief, Promius, Satsuma, Teva, Theranica, Xoc, and Zosano and is on a speakers’ bureau for Amgen and Teva. RK is a consultant for Amgen. FZ is an employee of Amgen Inc. HP and DDM are employees and stockholders of Amgen.

Figures

Fig. 1

Change from baseline in MMD. Data are shown as LSM with 95% CIs. The gray shaded area represents months 4–6. Abbreviations: CI, confidence interval; LSM, least squares mean; MMD, monthly migraine days

Fig. 2

Change from baseline in monthly acute MSMD among patients with a self-reported history of menstrual migraine who took migraine-specific medications at baseline. Data are shown as LSM with 95% CIs. The gray shaded area represents months 4–6. Abbreviations: CI, confidence interval; LSM, least squares mean; MSMD, migraine-specific medication days

Fig. 3

Proportion of patients achieving ≥ 50% reduction from baseline in MMD. Data are shown as percentages. The gray shaded area represents months 4–6. *Statistically significantly different from placebo. Abbreviations: MMD, monthly migraine days; OR, odds ratio