Novartis announced positive results from a phase 4 study comparing treatment with erenumab (Aimovig), a calcitonin gene-related peptide (CGRP) receptor antagonist, to topiramate in patients with episodic and chronic migraine.
The randomized, double-blind, double-dummy, HER-MES study included 777 adult patients suffering from at least 4 migraine days/month and who were naïve to, not suitable for, or had previously failed up to 3 prophylactic treatments. Patients were randomized to receive either erenumab 70mg, 140mg, or the highest tolerated dose of topiramate (50-100mg daily) for 24 weeks.
The primary end point of the study was the number of patients discontinuing treatment due to adverse events during the double-blind treatment phase. The secondary end point was the percentage of patients with at least a 50% reduction of monthly migraine days over the last 3 months of the double-blind period.
Findings showed a higher proportion of patients remained on treatment with erenumab compared with topiramate, demonstrating superior tolerability. Additionally, a greater proportion of erenumab-treated patients achieved at least a 50% reduction in monthly migraine days vs those who received topiramate. The safety profile of erenumab was found to be consistent with that seen in previous studies.
“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,” said Estelle Vester-Blokland, Global Head Neuroscience Medical Affairs, Novartis Pharmaceuticals.