Novartis announces positive results from a phase IV study showing superior tolerability and efficacy of Aimovig compared with topiramate in migraine prevention .

Novartis announced that HER-MES, the first Phase IV, randomized, double-blind, double-dummy, head-to-head study of Aimovig (erenumab) against topiramate , an anticonvulsant, in patients with episodic and chronic migraine met its primary and secondary endpoints. The results of HER-MES showed that Aimovig had a superior tolerability and efficacy profile than topiramate, with less discontinuation over the course of the 24-week treatment phase. Aimovig also showed superior efficacy, with a greater proportion of patients achieving a 50% reduction in their monthly migraine days (MMDs). HER-MES aimed to determine the tolerability and efficacy of Aimovig 70 mg and 140 mg compared with topiramate, an anticonvulsant commonly used as standard of care in migraine prevention , in the highest tolerated dose (50-100 mg daily). The study enrolled 777 adult patients suffering from greater than 4 MMDs and who were naïve to, not suitable for or had previously failed up to three prophylactic migraine treatments. The primary outcome of HER-MES explored the Aimovig treatment discontinuation rate due to adverse events compared with topiramate during the double-blind treatment phase of the study. Overall, Aimovig showed superior tolerability against topiramate, with a higher proportion of patients remaining on Aimovig than on topiramate. The secondary endpoint looked into the superiority of Aimovig compared with topiramate in terms of a 50% reduction in MMDs to baseline in the last three months of the 24-week, double-blind treatment phase. A higher number of patients in the Aimovig treatment arm experienced a significant ( greater than 50%) reduction in MMDs compared with those on topiramate treatment arm. The safety profile in the HER-MES study was generally consistent with those seen in previous Aimovig clinical trials. Additional findings and detailed results of primary and secondary endpoints from this trial will be presented at an upcoming scientific congress. Aimovig is the only CGRP-R inhibitor with up to 5-year clinical trial data in episodic and chronic migraine, adding to the breadth of data showcasing the expanded long-term safety and efficacy of the treatment for migraine patients. About HER-MES : HER-MES (NCT03828539) is a two-armed, randomized, double-blind, double-dummy, parallel group, Phase IV study to assess the tolerability and efficacy of Aimovig (erenumab) versus topiramate in a patient-centered setting. The primary endpoint was treatment discontinuation rate due to adverse events compared with topiramate during the double-blind treatment phase of the study. The secondary endpoint was efficacy of 70 mg and 140 mg erenumab versus topiramate in terms of a 50% reduction in monthly migraine days to baseline in the last three months (months 4, 5 and 6) of the double-blind, 24-week treatment phase5 in the highest tolerated dose (50-100 mg daily). The HER-MES study enrolled 777 adult patients with episodic or chronic migraine (?4 migraine days per month) who had not previously received migraine prevention treatment or had unsuccessfully discontinued up to three previous therapies with propranolol/metoprolol, amitriptyline and flunarizine. After a 2-week screening and 4-week baseline phase, patients were randomized 1:1 to erenumab or topiramate. In the double-blind, 24-week treatment phase, patients in the erenumab arm received either 70 mg or 140 mg directly after the baseline phase according to the current expert information, as estimated by the investigator. An increase in dose from 70 mg to 140 mg was possible at any time during the study. Patients in the topiramate arm were given topiramate at the highest tolerated dose (50-100 mg), starting with a 6-week titration phase, according to the latest expert information5. The HER-MES study has been fully developed in Germany. The study was conducted in 82 centers from the end of February 2019 to the end of July 2020.