The proportion of patients who achieved an at least 50% reduction in monthly migraine days was significantly higher among those on either erenumab dose compared with placebo.
Newly published data from an open-label extension showed that erenumab (Aimovig; Novartis), an FDA-approved migraine preventive, sustained its efficacy and significantly reduced monthly migraine days (MMD) over a 52-week period among patients with chronic migraine (CM) who failed 1 to 3 prior preventive treatments.1
At the final week of observation, the mean MMD changes were –10.8 days among those who’ve never failed a preventive and –8.6 days, –8.0 days, and –7.9 days for those who had failed at least 1, 2, and 3 preventives, respectively. Monthly acute migraine-specific medication days (MSMD) were also reduced with erenumab, represented by changes in –3.7 days, –5.6 days, –5.5 days, and –5.5 days at week 52 in the respective subgroups.
Led by Messoud Ashina, MD, PhD, DMSc, director, Human Migraine Research Unity, Danish Headache Center, University of Copenhagen, the analysis included individuals who completed a 12-week double-blind treatment period (DBTP) of a parent study who then moved on to an open-label treatment period (OLTP). The main objective of the research was to evaluate long-term effects of erenumab in adults with CM in whom prior preventive treatments had failed.
During the OLTP, patients received subcutaneous erenumab once per month, with initial doses of 70 mg. Following an amendment to the protocol, patients receiving the 70 mg dose who had not completed the week 28 visit, or the midpoint of the OTLP, had their dose increased to 140 mg, allowing patients to reach the steady state by week 40. Those who completed the week 28 visit remained on erenumab 70 mg for the remainder of the OTLP, while those who enrolled after the amendment received doses of 140 mg throughout the rest of the study.
Of the 609 enrolled patients in the OLTP, numerically greater reductions in mean MMD and MSMD were observed at weeks 40 and 52 across all subgroups on the higher dose erenumab. Additionally, the differences in MSMD at the same time points across subgroups were even greater with erenumab 140 mg vs 70 mg in patients who used migraine-specific medications at baseline.
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Ashina et al wrote, "this study supports the use of erenumab in CM including patients with multiple prior preventive treatment failures and adds to the growing body of evidence for erenumab in this setting, of patients with CM.” They also noted that the additional benefits seen in the higher dose erenumab group may assist healthcare providers’ clinical decision-making in treating patients who have experienced lack of success on prior preventive medications.
Both erenumab-dosed groups also showed a higher proportion of patients who achieved at least 50% reduction from baseline in MMD at week 52, including 68.0% of those who never failed preventive, followed by 54.8%, 50.3%, and 46.6% of those who had failed 1, 2, or 3 preventives, respectively. Once again, the response was higher at weeks 40 and 52 among those who received 140-mg erenumab vs 70-mg across all subgroups. Notably, a similar pattern was observed for those who achieved reductions of at least 75% and 100% in MMD.
Erenumab a calcitonin gene-related peptide antagonist, continued to show a safety profile that was similar to what had been previously seen. Overall, the exposure-adjusted patient incidence rates of adverse events (AEs) were 98.1/100 patient-years in the never failed subgroup, 141.9/100 patient-years in those who failed at least 1 preventive, 152.2/100 patient-years for 2 failed preventives, and 162.2/100 patient-years for at least 3 failed preventives. There were no fatal AEs reported during the DBTP and the OLTP.
After gaining approval as a migraine preventive in 2018, erenumab has been involved in several additional studies. In April 2022, real-world data from the MAGIC study showed that erenumab is safe and effective among patients with CM and episodic migraine who’ve experienced ineffective prophylactic migraine therapy. In the primary outcome analysis, 32 participants (33.7%) experienced a reduction of at least 50% in MMD at the end of the 12-week treatment period. This reduction was similar to other randomized controlled trials, including the STR1VE trial (NCT0245670; 70 mg: 41.3%; 140 mg: 48.1%) and was higher than that reported in the LIBERTY trial (NCT03096834; 140 mg: 30.0%).2