Data from a long-term phase 2 study in episodic migraine suggest that those treated with erenumab maintain reductions in both monthly migraine days and use of acute migraine medications in the long-term.
The results of a phase 2, open-label, 5-year study (NCT01952574) of patients with episodic migraine treated with erenumab (Aimovig; Amgen/Novartis) suggest that these patients experienced sustained reductions in both monthly migraine days and use of acute migraine medications.
Of the 383 patients who completed the 12-week double-blind, placebo-controlled treatment period and entered into the open-label phase, 216 completed the study. For those patients, there was an average reduction in monthly migraine days of 5.3 days from the baseline mean of 8.7 days. Additionally, by the study’s end, individuals using acute medications to treat their migraine headaches reported an average reduction of 4.4 days of use from their baseline of 6.2 days.
The data are expected to be presented at the Migraine Trust Virtual Symposium, taking place on Sunday, October 11, 2020. For more info on the public session, click here.
“When we, as clinicians, hear about the data coming from the clinical trials, the first question is for how long did patients receive these preventive medications and what were the data on efficacy and the safety tolerability,” Messoud Ashina, MD, PhD, DMSc, professor of neurology, Faculty of Health and Medical Sciences, University of Copenhagen, told NeurologyLive. “This is a group of patients that have been treated in this clinical trial. So, then we ask, how sustained are these effects? When we start treating our patients, we don't treat them only for 2 months, or 3 months. We treat them for 1 year or 2 years, or sometimes 3 years—or sometimes many years.”
Importantly, there were no new safety signals identified over the 5-year period, with the most common adverse events (AEs) being nasopharyngitis, upper respiratory tract infection, and influenza. Erenumab was approved as the first member of its class, the calcitonin gene-related peptide (CGRP) inhibitors, in May 2018 based on findings from 3 clinical trials showing a dramatic improvement with the once-monthly self-injectable.
All patients in the study initially received 70-mg monthly erenumab, with 250 patients increasing their dosage to 140 mg monthly after a protocol amendment in order to evaluate the long-term safety of the higher dose. Ashina noted that these data are rather unique as they are the longest dataset for these CGRP monoclonal antibodies thus far, which provide physicians a unique set of long-term information.
“As a clinician, I can say to my patients, that even at five years that the patient's performed very well how I can tell them that—at least I would say—approximately 70% of patients, they still had an at least 50% response at 5 years,” Ashina said.
Additional datasets on erenumab are expected to be presented at the Migraine Trust Virtual Symposium, including interim data from the open-label LIBERTY study (NCT03096834) and results of the phase 3 EMPOwER study (NCT03333109). Amgen noted that both studies reinforce the known safety and efficacy profile of the agent for patients of various backgrounds across the spectrum of episodic migraine.
The 2-year interim results of the LIBERTY study suggested that there was sustained efficacy and no increases in AE rates for those with episodic migraine who failed 2-4 prior preventive treatments taking erenumab. The results of the EMPOwER study, on the other hand, point to the positive performance of erenumab in adult patients with episodic migraine from Asia, the Middle East, and Latin America.
"Aimovig continues to have the longest safety and efficacy trial data among treatments for migraine in the calcitonin gene-related peptide class of medications," said Darryl Sleep, MD, senior vice president, Global Medical, and chief medical officer, Amgen, ina statement. "Many people with this debilitating neurological disease live in dread of the next attack. As the first FDA-approved treatment and most prescribed preventive therapy in this class, Aimovig continues to be at the forefront of preventive migraine treatment and clinical research. These long-term results further demonstrate the potential of Aimovig to help the millions of patients who may be candidates for preventive treatment."