Erenumab Succeeds Where Other Migraine Treatments Failed

Uwe Reuter, MD

Results of a study among patients who previously failed 2-4 preventative migraine treatments (PMT) show that erenumab is effective and safe for the treatment of migraines.

After 12 weeks, the proportion of patients achieving ≥50% reduction in monthly migraine days (MMD) was 30.3% in those treated with erenumab compared to 13.7% in those taking placebo (OR [95% CI]: 2.73 [1.43, 5.19]; p=0.002).

“The people we included in our study were considered more difficult to treat, meaning that up to 4 other preventative treatments hadn’t worked for them,” said study author Uwe Reuter, MD, of The Charité—University Medicine Berlin in Germany. “Our study found that erenumab reduced the average number of monthly migraine headaches by more than 50% for nearly a third of study participants. That reduction in migraine headache frequency can greatly improve a person’s quality of life.”

The LIBERTY trial was a 12-week, double-blind study of 246 patients randomized (1:1) to receive either erenumab 140mg or placebo. The proportion of patients enrolled in the study who had previously failed 2, 3, or 4 PMTs were 38.6%, 37.8%, and 22.8%, respectively. On average, study participants experienced 9 migraine headaches per month and used an acute migraine drug to stop an attack 5 times per month.

Erenumab is a monoclonal antibody that targets a receptor for calcitonin gene-related peptide (CGRP). This peptide transmits migraine pain signals which erenumab blocks by occupying the nerves to which CGRP would usually bind.

Secondary endpoints in the study included change from baseline to month 3 in MMDs and monthly acute migraine-specific medication days (MSMDs). At 12 weeks, participants in the erenumab study arm had 1.6 times greater reduction in MMDs and 1.7 times greater reduction in MSMDs than participants taking placebo.

Erenumab was the first drug in its category when Novartis filed with the US Food and Drug Administration (FDA) last year. The FDA approved the Biologics License Application for treatment in patients who experience migraines 4 or more days each month.

“Migraine is a serious, chronic neurological disease with a profound and limiting impact on patients’ abilities to carry out everyday tasks,” said Vas Narasimhan, MD, who is currently CEO of Novartis.

The safety and tolerability profile of erenumab was comparable to placebo and no patients in the erenumab group discontinued due to adverse events.

“Our results show that people who thought their migraines were difficult to prevent may actually have hope of finding pain relief,” said Reuter. “More research is now needed to understand who is most likely to benefit from this new treatment.”

Additionally, the short, 3-month length of the study limited the results. Further study is needed to confirm whether benefits from erenumab continue on a long-term scale.