Patients with and without a history of aura had similar reductions in monthly migraine days and monthly acute migraine-specific medication usage after treatment with erenumab.
Findings from a post hoc secondary analysis of 4 randomized controlled trials that included more than 2500 patients showed that treatment with erenumab (Aimovig; Novartis) is safe and efficacious in patients with episodic or chronic migraine regardless of aura history.1
At the conclusion of the study, no unexpected safety findings were observed, with most adverse events (AEs) deemed mild or moderate in nature. Lead author Messoud Ashina, MD, PhD, DMSc, director, Human Migraine Research Unit, Danish Headache Center, University of Copenhagen, and colleagues noted that although prior history has suggested patients with aura may respond differently to acute therapies, these findings indicate that erenumab is no different for patients both with and without aura.
A total of 2682 patients were randomized during the double-blind treatment phase of the 4 trials, of whom 1400 (52.2%) received 1 or more dose of erenumab 70 mg or 140 mg once per month and 1043 (38.9%) received placebo. Those on erenumab 7 mg or 21 mg were not included in this short-term analysis.
Compared with placebo, the least-squares mean (LSM) difference in monthly migraine days (MMDs) in patients with episodic migraine without a history of aura on 70- and 140-mg erenumab was –1.2 (95% CI, –1.6 to –0.7) and –2.5 (95% CI, –3.2 to –1.8), respectively. For those with a history of aura, the LSM differences were –1.1 (95% CI, –1.7 to –0.6) and –0.9 (95% CI, –1.6 to –0.2) for the same dosed groups.
The calcitonin gene-related peptide (CGRP) monoclonal antibody continued to demonstrate its efficacy in those with chronic migraine. For those without a history of aura, the LSM differences in MMDs were –2.7 (95% CI, –4.1 to –1.3) and –2.1 (95% CI, –3.5 to –0.7) in the 70- and 140-mg groups, respectively, compared to –2.1 (95% CI, –3.8 to –0.5) and –3.1 (95% CI, –4.8 to –1.4) in those with a history of aura.
Reductions in monthly acute migraine-specific medication (AMSM) days, a second primary efficacy end point, were greater in the erenumab vs placebo groups in both history of aura subgroups. In those with episodic migraine with a history of aura, investigators recorded LSM differences of –0.9 (95% CI, –1.4 to –0.3) and –1.3 (95% CI, –2.0 to –0.5) in AMSM days between the 2 dosed groups, respectively.
The subgroup of patients with chronic migraine and a history of aura also saw similar benefits from erenumab on AMSM days. The LSM differences were –2.4 (95% CI, –3.9 to –1.0) and –3.7 (95% CI, –5.0 to –2.3) in the 70- and 140-mg dose groups, respectively, compared with differences of –2.3 (95% CI, –3.5 to –1.0) and –3.0 (95% CI, –4.2 to –1.7), respectively, in those without a history of aura.
The safety profiles were similar across the treatment groups, regardless of aura history. In total, 49.7% of patients without a history of aura reported an AE during the double-blind treatment phase compared to 47.9% of those with a history of aura. Although both groups reported low numbers of discontinuations because of AEs, there were slightly higher in those with a history of aura (2.3%; n = 15) than those without (1.4%; n = 10).
The total erenumab exposure during the long-term analysis was 2002.5 patient-years with a median of 69.4 (interquartile range [IQR], 28.1-63.4) weeks of erenumab treatment for those without a history of aura (n = 1352), compared with 1479.5 patient-years with a median of 44.3 (IQR, 28.0-52.3) weeks on erenumab treatment for those with a history of aura (n = 1147).
In May 2018, erenumab made history as the first novel CGRP inhibitor approved by the FDA for the prevention of migraines. Since then, it has continued to show its safety and efficacy in several post-hoc analyses. Most recently, data from the LIBERTY study (NCT03096834) showed sustained long-term individual responder rates with erenumab for up to 3 years.2