A treatment for patients with episodic migraines could at least halve the number of days they experience them every month, researchers have found.
This April, healthcare organisation Novartis announced the results of a study that looked specifically at episodic migraine patients who had previously failed 2 to 4 preventive treatments, due to lack of efficacy and/or intolerable side effects.
The study findings showed that over twice as many patients taking Aimovig™ (erenumab) achieved at least a 50% reduction in monthly migraine days compared to placebo in week 12 of the trial, Novartis said.1
Novartis said the LIBERTY study was, “the first trial of its kind specifically designed to study patients with episodic migraine who have failed 2 to 4 prior preventive treatments”.
The data, presented at this year’s annual meeting of the American Academy of Neurology (AAN) in Los Angeles, showed the potential of investigational erenumab as an effective preventive treatment option for these patients, who have exhausted currently available treatment options without gaining relief, Novartis said.
According to Novartis, erenumab is “the only fully human monoclonal antibody under regulatory review that was designed to selectively block the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation”.
In the LIBERTY trial, 246 patients who had experienced two to four previous preventive treatment failures were randomised to receive monthly subcutaneous injections of either erenumab 140mg or placebo for 12 weeks. More than twice as many patients taking erenumab achieved at least a 50% reduction in monthly migraine days compared to placebo (weeks 9-12: 30.3% with erenumab, 13.7% with placebo, p<0.002, odds ratio 2.73).
Migraine is the third most common disease globally, affecting an estimated 1 in 7 people which equates to almost 200,000 attacks each day in the UK alone.2 The success of available migraine prophylaxis treatments is often limited by inadequate effectiveness, adverse events and poor patient adherence partly as a result of poorly tolerated current treatment options.3
Commenting on the findings, Dr Mark Toms, chief scientific officer at Novartis UK said: “There has been no real advancement in migraine treatment for the past twenty years and “There has been no real advancement in migraine treatment for the past twenty years and we’re proud to be breaking new ground in neurology for the millions of people in the UK living with the painful and disruptive symptoms of migraine.”
He added:“Whilst these data further reinforce erenumab’s efficacy and safety profile it also highlights the clear unmet need that exists for targeted migraine prophylactic treatment and we are committed to working closely with the relevant regulatory bodies to make erenumab available to those that need it as soon as possible.”
According to the study findings, patients taking erenumab also had statistically significant and clinically meaningful improvements from baseline compared to placebo across all secondary endpoints, including a reduction in monthly migraine days, a decrease in acute migraine-specific drug use,and 75% or greater reduction in monthly migraine days.
Patients also had a 100% reduction in monthly migraine days, and an improved physical functioning and ability to complete everyday activities as measured by the Migraine Physical Function Impact Diary (MPFID) scales, researchers found.
Over 97% of erenumab patients completed the double-blind phase of the LIBERTY study, and researchers found there were no adverse events leading to discontinuation of treatment in the erenumab group.
Novartis said the brand name Aimovig™ has been provisionally approved by the FDA and EMA for the investigational product erenumab (AMG 334), but the product itself has not been approved for sale in any country.
References
- Reuter, U et al. Efficacy and safety of erenumab in episodic migraine patients with 2–4 prior preventive treatment failures: Results from the Phase 3b LIBERTY study. Emerging science abstract presented at AAN, 24 April 2018, Los Angeles.
- The Migraine Trust. Facts and Figures-Key Facts and Figures about Migraine. Available at: https://www.migrainetrust.org/about-migraine/migraine-what-is-it/facts-f…. Accessed April 2018.
- Diener HC, Charles A, Goadsby PJ, Holle D. New therapeutic approaches for the prevention and treatment of migraine. Lancet Neurol. 2015;14:1010–1022. doi: 10.1016/S1474-4422(15)00198-2.
