Dr Messoud Ashina Talks Through the 5-Year Safety and Efficacy Data on Erenumab

October 19, 2020
Gianna Melillo
Gianna Melillo

Gianna is an assistant editor of The American Journal of Managed Care® (AJMC®). She has been working on AJMC® since 2019 and has a BA in philosophy and journalism & professional writing from The College of New Jersey.

Data from a 5-year open-label treatment period on the safety profile of erenumab (Aimovig) showed the treatment helped patients with episodic migraine achieve a sustained reduction in the number of monthly migraine days and the number of days in which therapies were needed for acute migraines.

Data from a 5-year open-label treatment period on the safety profile of erenumab (Aimovig) showed the treatment helped patients with episodic migraine (EM) achieve a sustained reduction in the number of monthly migraine days (MMD) and the number of days in which therapies were needed for acute migraines.

“The set of data we have now obtained is very, very important from the clinical point of view,” said Messoud Ashina, MD, PhD, professor of neurology in the Faculty of Health and Medical Sciences at the University of Copenhagen and lead investigator of the study.

Erenumab, which was approved by the FDA in 2018, is a calcitonin gene-related peptide (CGRP) inhibitor administered via self-injection once a month. The treatment blocks the CGRP receptor, which is believed to play a crucial role in migraine. Erenumab can be injected as a 70- or 140-mg dose in adults with migraine. Results from the phase 2 study were initially published during the Migraine Trust Virtual Symposium.

In an interview with The American Journal of Managed Care® (AJMC®), Ashina reviewed the findings and discussed potential next steps for the treatment.

The sustained efficacy of erenumab is integral, as many migraineurs experience a wearing off of treatment effects after 3 or 4 months on a single preventive therapy, Ashina explained. Furthermore, the study found that erenumab’s safety profile was nearly identical to that observed during the double-blind period, and no additional adverse reactions were reported. The most common adverse events included nasopharyngitis and upper respiratory tract infections.

Although roughly 70% of the 216 patients enrolled in open-label phase of the study reported long-term efficacy, researchers do not yet know what accounts for the heterogeneity in terms of response. “So far, we haven’t found any predictors for efficacy, and we need more research and more new studies to explain why this group of patients does not respond to monoclonal antibodies,” Ashina said.

Currently, the Efficacy and Safety of Erenumab in Pediatric Subjects with Episodic Migraine (OASIS EM) trial is underway. When it comes to the treatment’s effects in pediatric populations, Ashina expects to see similar long-term results. “This is one of the areas with a huge unmet need for new treatments,” he said. Medications currently available for children can have side effects and adverse events, making some specialists hesitant to prescribe preventive treatments to younger populations.

“Based on the safety and tolerability that we see in an adult population [with erenumab], we would expect to also see positive results in children,” as this population also has a high frequency of episodic migraine, Ashina said. “But let’s see, because we haven’t seen data yet.”

OASIS EM is estimated to be completed in August 2025.

In addition to studies on erenumab’s efficacy in children, Ashina noted that future studies ought to be conducted on predicting the treatment’s efficacy in patients. If predictive markers of efficacy are found, this will also pave the way for personalized medicine in the future.

“The second issue is with erenumab and also other monoclonal antibodies is about safety and tolerability in patients with different comorbidities,” Ashina explained. As most clinical trials do not include patients with serious comorbidities, real-world data will be essential to understand the effects of erenumab on these patients.

Registry studies can also be used to track any effects that monoclonal antibody treatments may have on pregnant women. Erenumab is currently contraindicated during pregnancy, “but you can imagine that when you have a drug with a long half-life, and if you get pregnant, it might theoretically affect the baby,” Ashina said.