Aimovig Demonstrates Superior Tolerability and Efficacy Over Topiramate in First Head-to-Head Migraine Prevention Study
核心洞察
Novartis announced positive results from the HER-MES Phase IV study, the first randomized, double-blind, head-to-head comparison of Aimovig (erenumab) against topiramate in patients with episodic and chronic migraine.
Aimovig showed superior tolerability with fewer treatment discontinuations due to adverse events and superior efficacy with a greater proportion of patients achieving at least 50% reduction in monthly migraine days.
The study enrolled 777 adult patients and reinforces Aimovig's position as the most prescribed anti-CGRP therapy worldwide, with more than 480,000 patients prescribed across 44 countries since launch.
Novartis announced positive results from HER-MES, the first Phase IV, randomized, double-blind, double-dummy, head-to-head study comparing Aimovig (erenumab) against topiramate in patients with episodic and chronic migraine. The study met its primary and secondary endpoints, demonstrating that Aimovig had superior tolerability and efficacy compared to topiramate, an anticonvulsant commonly used as standard of care in migraine prevention.
Study Design and Patient Population
The HER-MES study (NCT03828539) enrolled 777 adult patients suffering from ≥4 monthly migraine days (MMDs) who were naïve to, not suitable for, or had previously failed up to three prophylactic migraine treatments. The study was conducted across 82 centers from February 2019 to July 2020, with patients randomized 1:1 to receive either Aimovig (70 mg or 140 mg) or topiramate at the highest tolerated dose (50-100 mg daily) during a 24-week double-blind treatment phase.
Primary and Secondary Endpoints Met
The primary outcome explored treatment discontinuation rates due to adverse events, with Aimovig demonstrating superior tolerability compared to topiramate. A higher proportion of patients remained on Aimovig treatment than on topiramate throughout the study period.
For the secondary endpoint, Aimovig showed superior efficacy in terms of achieving at least 50% reduction in MMDs compared to baseline in the last three months of the 24-week treatment phase. A significantly higher number of patients in the Aimovig treatment arm experienced a ≥50% reduction in MMDs compared to those receiving topiramate.
Clinical Significance and Expert Commentary
"The data generated by this first of a kind head-to-head study reinforces the value of erenumab as a safe and effective migraine prevention treatment. The findings also provide novel insights into migraine therapy for physicians and patients," said Prof. Uwe Reuter, Managing Medical Director at Charité Universitätsmedizin.
Estelle Vester-Blokland, Global Head Neuroscience Medical Affairs at Novartis Pharmaceuticals, emphasized that "with Aimovig continuing to be the anti-CGRP treatment with the longest safety and efficacy experience, these results further emphasize its potential to provide significant relief from migraine with an infrequent dosing compared with the oral treatment."
Aimovig's Established Clinical Profile
Aimovig is the first European Medicines Agency (EMA), Swissmedic, and U.S. Food and Drug Administration (FDA)-approved migraine preventive treatment that targets the CGRP receptor (CGRP-R). The treatment is self-administered once monthly via the SureClick autoinjector, does not require a loading dose, and has demonstrated efficacy across more than 3,000 patients in clinical trials.
The drug is currently the most prescribed anti-CGRP therapy worldwide, with more than 480,000 patients prescribed across 44 countries since launch. Aimovig is the only CGRP-R inhibitor with up to 5-year clinical trial data in episodic and chronic migraine, providing extensive long-term safety and efficacy data.
Safety Profile
The safety profile observed in the HER-MES study was generally consistent with previous Aimovig clinical trials. In earlier clinical studies, the most common adverse reactions were injection site reactions and constipation, with a discontinuation rate of only two percent due to adverse events.
Disease Burden and Treatment Landscape
Migraine is a highly debilitating neurological disease that significantly impacts patients' lives, including time spent with family, friends, and at work. The World Health Organization has reported migraine to be one of the top 10 causes of years lived with disability for both men and women, yet it remains under-recognized and under-treated.
The condition involves recurrent attacks of moderate-to-severe head pain that is typically pulsating, often unilateral, and associated with nausea, vomiting, and sensitivity to light, sound, and odors. Existing preventive therapies have often been repurposed from other indications and are frequently associated with poor tolerability and lack of efficacy, resulting in high discontinuation rates among patients.