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Clinical Trial
. 2022 Feb;42(2):108-118.
doi: 10.1177/03331024211053571. Epub 2021 Nov 7.

Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial

Uwe Reuter  1   2 , Marc Ehrlich  3 , Astrid Gendolla  4 , Axel Heinze  5 , Jan Klatt  6 , Shihua Wen  7 , Peggy Hours-Zesiger  6 , Jacqueline Nickisch  3 , Christian Sieder  3 , Christian Hentschke  3 , Monika Maier-Peuschel  3
Affiliations
Clinical Trial

Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial

Uwe Reuter et al. Cephalalgia. 2022 Feb.

Abstract

Background: We compared the tolerability and efficacy of erenumab, a monoclonal antibody binding to the calcitonin gene-related peptide receptor, to topiramate for migraine prophylaxis in adults.

Methods: HER-MES was a 24-week, randomised, double-blind, double-dummy, controlled trial conducted in 82 sites in Germany. Patients with ≥4 migraine days per month and naïve to study drugs were randomly assigned (1:1) to either subcutaneous erenumab (70 or 140 mg/month) plus topiramate placebo (erenumab group) or oral topiramate at the individual dose with optimal efficacy (50-100 mg/day) plus erenumab placebo (topiramate group).The primary endpoint was medication discontinuation due to an adverse event during the double-blind phase. The proportion of patients that achieved ≥50% reduction from baseline in monthly migraine days during the last 3 months of the double-blind phase was a secondary endpoint.

Results: Seven hundred and seventy-seven patients were randomised (from 22 February 2019 to 29 July, 2020) and 95.1% completed the study. In the erenumab group, 10.6% discontinued medication due to adverse events compared to 38.9% in the topiramate group (odds ratio, 0.19; 95% confidence interval 0.13-0.27; p < 0.001). Significantly more patients achieved a ≥50% reduction in monthly migraine days from baseline with erenumab (55.4% vs. 31.2%; odds ratio 2.76; 95% confidence interval 2.06-3.71; p < 0.001). No new safety signals occurred.

Conclusions: Erenumab demonstrated a favourable tolerability and efficacy profile compared to topiramate.Trial registration: ClinicalTrials.gov NCT03828539, URL: https://clinicaltrials.gov/ct2/show/NCT03828539.

Keywords: CGRP; Erenumab; head-to-head study; migraine; prophylaxis; topiramate.

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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: UR has received grants, non-financial support, personal fees, and fees to the institution from Amgen, Abbvie, Allergan, Alder, Eli Lilly, Medscape, Novartis, StreaMedUp, and Teva Pharmaceutical.

AG has received non-financial support and personal fees for talks and adboards, non-personal support for participation in clinical trials from Allergan, Eli Lilly, Hormosan, Teva Pharmaceutical, Grunenthal, Mundipharma, Esanum, DGS.

AH reports personal fees from Eli Lilly, Novartis, and Teva Pharmaceutical.

CS, ME, JN and CH are employees of Novartis.

JK holds stock in Novartis and was an employee of Novartis during the time this study was planned and conducted.

SW, PHZ, and MMP are employees of, and hold stock in, Novartis.

Figures

Figure 1.
Figure 1.
Study profile.
Figure 2.
Figure 2.
Cumulative percentage of patients who discontinued medication due to adverse events. Shading indicates the 6-week topiramate/placebo up-titration phase.
See this image and copyright information in PMC

References

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