Erenumab Displays Success in Patients Who Failed 2 or More Preventative Migraine Treatments

Uwe Rueter, MD, MBA, Charité University Medicine Berlin

Uwe Reuter, MD, MBA

Erenumab (Aimovig, Amgen/Novartis) has shown both efficacy and safety in patients who previously failed 2 to 4 preventative migraine treatments (PMTs), according to data from the LIBERTY study.¹

Presented at the American Academy of Neurology’s (AAN) 70^th Annual Meeting in Los Angeles, California, by Uwe Reuter, MD, MBA, the phase 3b randomized clinical trial revealed that after 12 weeks, the proportion of patients on the calcitonin gene-related peptide (CGRP) inhibitor achieving a ≥50% reduction in monthly migraine days (MMDs) was 30.3%, compared to 13.7% of those administered placebo (odds ratio [OR], 2.73; 95% CI, 1.43 to 5.19; P <.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 Reuter, a study author from the Charite&#769;—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 study randomized 246 patients 1:1 to either 140-mg subcutaneous erenumab or placebo, with the mean MMDs and migraine-specific medication days (MSMDs) at baseline for each group at baseline being 9.3 and 2.64, and 4.6 and 2.89, respectively. Overall, 38.6% of the patients included had failed with 2 PMTs, 37.8% had failed with 3 PMTs, and 22.8% had failed with 4 PMTs. The reductions in MMDs (mean difference, -1.61; 95% CI, -2.70 to -0.52; P = .004) and MSMDs (mean difference, -1.73; 95% CI, -2.46 to -1.01; P <.001) were greater with erenumab at week 12 than placebo.

According to Amgen, patients receiving erenumab also experienced statistically significant improvements from baseline in comparison with placebo in all secondary endpoints: ≥75% reduction in MMDs, 100% reduction in MMDs, and improvement in physical functioning and ability to complete everyday tasks (measured by the Migraine Physical Function Impact Diary [MPFID]).

In terms of safety, erenumab was well tolerated and comparable to placebo, with 97% of patients on erenumab completing the double-blind phase of the trial, and no adverse events (AEs) leading to the discontinuation of treatment in the intervention group. Meanwhile. 0.8% of the placebo group experienced AEs that led to discontinuation.

"We are encouraged by these new findings, which add to the growing body of clinical evidence supporting potential use of [erenumab] across a broad spectrum of patients with migraine, all of whom live with what is considered one of the most disabling diseases," Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in a statement.² "These data support the overall efficacy and safety profile we have seen consistently during extensive clinical study of [erenumab], and speak to its potential to help fill treatment gaps in more difficult patient populations whose migraine has not been adequately managed with current therapies."

An open-label extension phase of the LIBERTY trial is still ongoing, according to Amgen. In July 2017, a Biologics License Application (BLA) for the therapy was accepted by the US Food and Drug Administration (FDA). It currently has a Prescription Drug User Fee Act action date of May 17, 2018.

The therapy was originally developed through a 2015 partnership between Novartis and Amgen, in which the 2 pharmaceutical giants seeking to develop treatments for both migraine and Alzheimer disease. In 2017, the partnership was expanded to include co-commercialization of the therapy.

Juline Bryson, MD, an attending migraine neurologist in the Department of Neurology at Wake Forest Baptist Medical Center, told MD Mag, a sister publication of NeurologyLive, that the therapy poses a serious chance to fill a major unmet need. "It’s really important, because people are really affected. People lose jobs and their marriages over being in this pain. I want to stress again that migraines are a disorder," she said.³

REFERENCES

1. Reuter U, Goadbsy P, Lanteri-Minet M, Ferrari M, Wen S, Klatt J. Efficacy and safety of erenumab in episodic migraine patients with 2—4 prior preventive treatment failures: Results from the Phase 3b LIBERTY study. Abstract presented at: AAN 70^th Annual Meeting; April 17, 2018; Los Angeles, California. aan.com/PressRoom/Home/GetDigitalAsset/12692. Accessed April 17, 2018.

2. Amgen Presents First-Of-Its-Kind Data at AAN Annual Meeting Reinforcing Robust and Consistent Efficacy of Aimovig™ (erenumab) For Migraine Patients with Multiple Treatment Failures [press release]. Thousand Oaks, CA: Amgen Corporate Affairs. April 17, 2018. amgen.com/en-au/media/news-releases/2018/04/amgen-presents-firstofitskind-data-at-aan-annual-meeting-reinforcing-robust-and-consistent-efficacy-of-aimovig-erenumab-for-migraine-patients-with-multiple-treatment-failures. Accessed April 17, 2018.

3. Kunzmann K. Erenumab, Inhibitors Could Fill Unmet Gap in Migraine Care. MD Magazine website. mdmag.com/medical-news/erenumab-inhibitors-could-fill-unmet-gap-in-migraine-care. Published September 3, 2017. Accessed April 17, 2018.