Erenumab prevents the occurrence of migraine attacks and not just migraine days: Post-hoc analyses of a phase III study

Abstract

Background: This post-hoc analysis was conducted to evaluate the effect of erenumab on monthly migraine days, monthly migraine attacks, and attack duration in patients with episodic migraine to investigate whether erenumab actually prevents the occurrence of migraine attacks and/or shortens them.

Methods: We conducted a post-hoc analysis of the data from the STRIVE study, in 955 patients with episodic migraine. Relative changes from baseline to mean over months 4, 5 and 6 of the double-blind treatment phase in monthly migraine days, monthly migraine attacks and mean migraine attack duration were assessed.

Results: Erenumab reduced monthly migraine days and monthly migraine attacks compared with placebo in a similar way. Erenumab had only a minor impact on shortening the duration of migraine attacks.

Conclusion: These post-hoc analyses demonstrate that the decrease in monthly migraine days by erenumab is mainly driven by a reduction in the frequency of monthly migraine attacks and to a much lesser extent by shortening the duration of migraine attacks.Trial registration: This study is registered at ClinicalTrials.gov (NCT02456740).

Keywords: STRIVE study; episodic migraines; erenumab; monthly migraine attacks; monthly migraine days.

Conflict of interest statement

Declaration of conflicting interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Hans-Christoph Diener— Received honoraria for participation in clinical trials, contribution to advisory boards or oral presentations from: Alder, Allergan, Amgen, electroCore, Lilly, Lundbeck, Novartis, Pfizer, Teva and Weber & Weber. Financial support for research projects was provided by Allergan and electroCore. Headache research of HCD is supported by the German Research Council (DFG) and the German Ministry of Education and Research (BMBF); serves on the editorial boards of Cephalalgia and Lancet Neurology; chairs the Clinical Guidelines Committee of the German Society of Neurology. Peer Tfelt-Hansen– No disclosure. Messoud Ashina – Consultant, speaker or scientific advisor for AbbVie, Allergan, Amgen, Alder, Biohaven, Eli Lilly, Lundbeck, Novartis, and Teva, and primary investigator for Alder, Amgen, Allergan, Eli Lilly, Lundbeck, Novartis and Teva trials; has no ownership interest and does not own stocks of any pharmaceutical company; serves as associate editor of Cephalalgia, and associate editor of the Journal of Headache and Pain; president of the International Headache Society. Gabriel Paiva Da Silva Lima and Soeren Rasmussen— Employees and stocks: Amgen Inc. Shannon Ritter– employee and stocks: Novartis. Ronald Zielman– Employee: Novartis.

Figures

Figure 1.

Study design.4 aRandomized; bRe-randomized; c16 weeks after last dose of placebo or erenumab SC, subcutaneous; QM, once per month. Note: This post-hoc analysis focuses on double-blind treatment phase only.

Figure 2.

Percentage reduction from baseline in mean MMD, MMA and monthly average migraine attack duration (days) over the last three months of the DBTP (efficacy analysis set). DBTP, double-blind treatment; MMA, monthly migraine attacks; MMD, monthly migraine day. * p-value †p-value < 0.05 for all pairwise comparisons between erenumab and placebo. ‡p-value < 0.01 for all pairwise comparisons between erenumab and placebo.