Over a 24-week treatment period, 72.2% of those on erenumab achieved relevant improvement on HIT-6 scores compared with 53.9% of those on topiramate.
Data from the HER-MES study (NCT03828539), a comparator trial between erenumab (Aimovig; Amgen) and topiramate (Topamax; Janssen), showed that patients with migraine on erenumab performed better on patient reported outcomes, including Headache Impact Test (HIT-6) and Short Form 36 Health Survey Questionnaire, version 2 (SF-36 v2).1
Presented at the 2022 American Headache Society (AHS) Annual Meeting, June 9-12, in Denver, Colorado, the study compared adult patients with migraine who were randomized 1:1 to subcutaneous monthly erenumab 70 mg or 140 mg (n = 389), the first FDA approved calcitonin gene-related peptide (CGRP) inhibitor, or topiramate oral daily 50 to 100 mg (n = 388). To be eligible, patients must have been treatment naïve or had failed up to 3 previous migraine preventive treatments and had at least 4 monthly migraine days leading up to the trial.
Lead investigator Uwe Reuter, MD, PhD, MBA, managing medical director, Charité Universitätsmedizin, Berlin, and colleagues assessed functional impairment of headache on daily activities using HIT-6 and health-related quality of life using the SF-36 v2. Additionally, the investigators also assessed the proportion of patients in each group who achieved at least a 5-point difference from baseline to week 24 in HIT-6 and SF-36 v2 domains such as physical component summary (PCS) and mental component summary (MCS).
Overall, a greater proportion of patients in the erenumab group demonstrated a significant improvement on patient-reported outcomes compared with those on topiramate. In total, 72.2% of those on erenumab achieved relevant improvement on HIT-6, as shown by reductions of at least 5 points (P <.001). On SF-36 v2 scores, 47.7% and 25.3% of those in the erenumab group demonstrated at least 5-point improvements on PCS and MCS, respectively, compared with 37.4% and 16.8% of those on topiramate.
Data from HER-MES published in November 2021 showed that erenumab led to significantly lower discontinuation rates due to adverse events (AEs) as well as superior efficacy in reducing monthly migraine days in patients with episodic and chronic migraine. During the double-blind treatment period, 10.6% (41 of 388) of patients in the erenumab group discontinued medication due to AEs, compared with 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.2
The secondary outcome of a responder rate of at least 50% in monthly migraine days 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 monthly migraine days than those on topiramate (–4.02; P <.001).
At the time of the released data, Reuter said in a statement that, "the positive outcomes strengthen the efficacy and safety profile of erenumab as a migraine prevention treatment for patients with migraine."2