Erenumab as a Therapy for Hard to Treat Episodic Migraine
The most frequent treatment-emergent adverse event was injection site pain, which occurred in 6% of participants in both groups.
As part of this 12-week, double-blind, placebo-controlled, randomized study (LIBERTY; ClinicalTrials.gov identifier: NCT03096834), researchers enrolled 246 adult participants from 16 countries across Europe and Australia with migraine into 2 groups: 119 in the erenumab group and 124 in the placebo group. These participants had a history of episodic migraines with or without aura for at least 1 year, averaged between 4 and 14 migraines per month, and had between 2-4 unsuccessful treatment prior to the study. Definition of unsuccessful treatments included efficacy and tolerability with 2 to 4 previous therapies. The most common unsuccessful treatments were topiramate, amitriptyline, and propranolol. The primary cause of treatment failure was ineffectiveness, but topiramate was flagged for low tolerability.
At 12 weeks, 36 of 119 individuals in the erenumab group had a 50% or greater reduction in the monthly number of migraine days. In the placebo group, this number was 17 of 124. A significantly higher number of patients in the erenumab group than in the placebo group had a 50% or greater reduction in the number of migraine days per month during weeks 0 to 4 and weeks 5 to 8. By study conclusion, 12% of participants in the erenumab group and 4% in the placebo group had a 75% or greater reduction in the number of migraine days per month (OR 3.2, 95% CI, 1.1–9.0; P =.025).
"Erenumab might be an option for patients with difficult-to-treat migraine who have high unmet needs and few treatment options," researchers concluded. Authors counted the short duration of the trial as a limitation, but plan to address this in an open-label trial extension.
Disclosures: This study was funded by Novartis Pharma. Employees of the study funder had roles in the trial design: data collection, analysis, interpretation, and writing of the report.
Reuter U, Goadsby PJ, Lanteri-Minet M, et al. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study [published October 22, 2018]. Lancet. doi: 10.1016/S0140-6736(18)32534-0