Treatment with erenumab-aooe, a calcitonin gene-related peptide (CGRP) receptor antagonist, was associated with superior efficacy and a lower discontinuation rate vs topiramate in adults with episodic or chronic migraine, according to findings from a phase 4, head-to-head study.
The randomized, double-blind, double-dummy, controlled HER-MES trial (ClinicalTrials.gov Identifier: NCT03828539) included 777 adults with episodic and chronic migraine (at least 4 migraine days/month) who were treatment-naïve, not suitable for, or had previously failed up to 3 prophylactic migraine treatments (eg, propranolol/metoprolol, amitriptyline and/or flunarizine). Patients were randomly assigned 1:1 to receive either erenumab-aooe 70mg or 140mg subcutaneously once monthly or topiramate at an optimized oral dose (50-100mg/day) for 24 weeks.
The primary endpoint was the proportion of patients with treatment discontinuation due to an adverse event during the double-blind phase. The secondary endpoint was the proportion of patients achieving at least 50% reduction from baseline of monthly migraine days during the last 3 months of the double-blind phase.
Findings showed that treatment with erenumab-aooe was associated with a significantly lower discontinuation rate due to adverse events compared with topiramate (10.6% vs 38.9%). Moreover, 55.4% of patients treated with erenumab-aooe achieved at least a 50% reduction in monthly migraine days compared with 31.2% of those treated with topiramate.
The most frequent adverse events that led to discontinuation of topiramate were paraesthesia, disturbance in attention, fatigue, and nausea. The most frequent adverse events that led to discontinuation of erenumab-aooe were fatigue, nausea, disturbance in attention and dizziness.
“HER-MES is the first study that directly compared the therapeutic effects of an antibody and a small molecule in migraine prevention,” said Uwe Reuter, MD, PhD, MBA, trial investigator and managing medical director at Charité Universitätsmedizin in Berlin. “The positive outcomes strengthen the efficacy and safety profile of erenumab as a migraine prevention treatment for patients with migraine.”
Erenumab-aooe is marketed under the brand name Aimovig® and is indicated for the preventive treatment of migraine in adults.
- First and only randomized, double-blind, head-to-head study comparing Aimovig® (erenumab-aooe), an anti-CGRP pathway therapy, to topiramate published in Cephalalgia. News release. Amgen. Accessed November 10, 2021. https://www.prnewswire.com/news-releases/first-and-only-randomized-double-blind-head-to-head-study-comparing-aimovig-erenumab-aooe-an-anti-cgrp-pathway-therapy-to-topiramate-published-in-cephalalgia-301419005.html.
- Reuter U, Ehrlich M, Gendolla A, et al. Erenumab versus topiramate for the prevention of migraine – a randomised, double-blind, active-controlled phase 4 trial. Cephalalgia. Published online November 7, 2021. doi: 10.1177/03331024211053571