In the final 3 months of treatment in the first head-to-head study of these agents, 55.4% of those on erenumab achieved at least 50% reduction in monthly migraine days compared with 31.2% on topiramate.
Newly announced data from HER-MES (NCT03828539), a first of its kind comparator study, showed significantly lower discontinuation rates due to adverse events (AEs) as well as superior efficacy in reducing monthly migraine days (MMDs) for patients with episodic and chronic migraine when treated with erenumab (Aimovig; Amgen) as opposed to topiramate (Topamax; Janssen).1,2
This 24-week, randomized, double-blind, double-dummy, controlled trial was the first and only head-to-head study of erenumab, the first FDA-approved calcitonin gene-related peptide (CGRP) inhibitor, against topiramate, one of the most-prescribed migraine prevention medications. A total of 777 patients with at least 4 migraine days per month were randomly assigned 1:1 to either subcutaneous erenumab (70 or 140 mg/month) plus topiramate placebo or oral topiramate at the individual dose with optimal efficacy (50-100 mg/day) plus erenumab placebo.
"HER-MES is the first study that directly compared the therapeutic effects of an antibody and a small molecule in migraine prevention," trial investigator Uwe Reuter, MD, PhD, MBA, managing medical director, Charité Universitätsmedizin, Berlin, said in a statement.1 "The positive outcomes strengthen the efficacy and safety profile of erenumab as a migraine prevention treatment for patients with migraine."
During the double-blind treatment period, 10.6% (41 of 388) of patients in the erenumab group discontinued medication due to AEs, compared to 38.9% (151 of 388) in the topiramate group, with an OR of 0.19 (95% CI, 0.13-0.27; P <.001) and a relative risk (RR) of 0.27 (95% CI, 0.20-0.37; P <.001). In total, 26.6% of the topiramate group aborted medication by the end of week 6, whereas only 8.3% of those on erenumab ended their treatment.
The secondary outcome of a responder rate of at least 50% in MMD was observed in 55.4% (n = 214) of the erenumab group and 31.2% (n = 121) in the topiramate group (OR, 2.76 [95% CI, 2.06-3.71]; P <.001; RR, 1.78 [95% CI, 1.50-2.11]; P <.001). During months 4-6, those in the erenumab group (–5.86) showed significantly greater reduction in mean MMD than those on topiramate (–4.02; P <.001).
At baseline, those in the erenumab and topiramate groups reported headache impact test (HIT-6) values of 63.6 and 63.9, respectively, which was considered in the highest level of the 4 HIT-6 categories. The reduction regarding the impact of headache on function was reported as –10.9 in the erenumab group and –7.7 in the topiramate group (P <.001). Results on the short form health survey version 2 (SF-36v2) showed a significantly larger improvement in quality of life for patients in the erenumab group than for patients in the topiramate group.
"We're extremely encouraged by these new results, which demonstrate lower discontinuation rates due to adverse events and superior efficacy versus topiramate in migraine prevention and strengthen our confidence that Aimovig has significant potential to help many more patients living with migraine," Rob Lenz, MD, PhD, senior vice president, Global Development, Amgen, said in a statement.1 "Amgen is dedicated to helping the millions of people who live with this debilitating neurological disease get back to what's important to them while living with more migraine-free days."
Study treatment-related AEs were more frequent in the topiramate group, with 81.2% of patients experiencing at least 1 AE, compared with 55.4% of patients the erenumab group. Paraesthesia, disturbance in attention, fatigue, and nausea, were among the most frequent AEs that led to discontinuation in the topiramate group. Similarly, those in the erenumab group experienced fatigue, nausea, disturbance in attention, and dizziness as the most common AEs.