Aimovig may be safe, effective for migraines with, without aura history

Aimovig appeared safe and effective for treating migraine with and without history of aura, according to results of a secondary analysis of randomized clinical trials published in JAMA Neurology.

“Given the importance of calcitonin gene-related peptide (CGRP) in the regulation of vascular tone and the associations between migraine with aura and cardiovascular disease, well-established safety data on patients with migraine with aura are needed,” Messoud Ashina, MD, PhD, DMSc, of the department of neurology at Rigshospitalet Glostrup in Denmark, and colleagues wrote. “[Aimovig (erenumab; Amgen, Novartis)], which is known in the U.S. as erenumab-aooe, is a human anti-CGRP receptor monoclonal antibody that was developed for migraine prevention. Erenumab has demonstrated clinical efficacy in episodic migraine and chronic migraine, reducing both monthly migraine days (MMDs) and acute migraine-specific medication (AMSM) use.”

Researchers sought to examine the efficacy and safety profiles of erenumab among patients with migraine with aura by examining four double-blind, placebo-controlled randomized clinical trials conducted across North America, Europe, Russia and Turkey between Aug. 6, 2013, and Nov. 12, 2019. They analyzed data of individuals aged 18 to 65 years who had episodic migraine or chronic migraine and who were randomly assigned to either erenumab or placebo. Participants received at least one dose of erenumab 70 mg or 140 mg (n = 1,400) once per month or placebo (n = 1,043) via subcutaneous injection during the double-blind treatment phase and open-label or dose-blinded active treatment, and erenumab 70 mg or 140 mg once per month via subcutaneous injection during extension phases. Change from baseline MMDs and monthly AMSM days served as efficacy assessments. Patient incidences of adverse events represented safety endpoints. Researchers categorized patients based on their history of aura. Participant mean age was 41.7 years and 84.1% were women.

Results showed those who received erenumab exhibited greater reductions from baseline MMDs and AMSM days compared with those who received placebo for patients with and without aura history during the double-blind treatment phase. These reductions continued throughout the extension phases. Among those with episodic migraine and aura history, Ashina and colleagues noted least-squares mean differences in change from baseline MMDs at week 12 of –1.1 (95% CI, –1.7 to –0.6) among those who received erenumab 70 mg and –0.9 (95% CI, –1.6 to –0.2) among those who received erenumab 140 mg compared with placebo. Among those with chronic migraine with aura history, they reported least-squares mean differences from placebo treatment of –2.1 (95% CI, –3.8 to –0.5) among those who received erenumab 70 mg and –3.1 (95% CI, –4.8 to –1.4) among those who received erenumab 140 mg.

“The safety profile of long-term erenumab treatment was similar in patients with and without a history of aura and was comparable to that of placebo over 12 weeks, with no increased emergence of adverse events over time,” Ashina and colleagues wrote. “These findings suggest that erenumab may be safe and effective for this patient population.”