Abstract Details

Title Efficacy and safety of erenumab in episodic migraine patients with 2–4 prior preventive treatment failures: Results from the Phase 3b LIBERTY study

Topic Headache

Presentation(s) ES1 - (-)

Poster/Presentation
Number 009

Objective

Background Erenumab is a fully human monoclonal antibody that inhibits the canonical CGRP receptor. Clinical studies have demonstrated the efficacy and safety of erenumab in patients with episodic and chronic migraine. Current oral preventive therapies are associated with low adherence rates due to the lack of efficacy and/or poor tolerability. It is therefore important to assess the safety and efficacy of erenumab in patients who have failed multiple therapies.

Design/Methods LIBERTY (NCT03096834) was a 12-week, double-blind, randomized study. Patients (N=246) were randomized (1:1) to receive erenumab 140mg and placebo. The primary endpoint was the proportion of patients achieving ≥50% reduction in mean monthly migraine days (MMDs) during Weeks 9-12 (Month 3). Secondary endpoints included change from baseline to Month 3 in MMDs and monthly acute migraine-specific medication days (MSMDs) and safety/tolerability.

Results At baseline, proportion of patients who failed 2, 3, and 4 prior PMTs were 38.6%, 37.8%, and 22.8%, respectively. The mean (SD) MMDs and MSMDs were 9.3 (2.64) and 4.6 (2.89), respectively. At week 12, the proportion of patients achieving ≥50% reduction in MMD was higher in those treated with erenumab 140mg vs placebo (30.3% vs 13.7%; OR [95% CI]: 2.73 [1.43, 5.19]; p=0.002). At week 12, there were greater reductions in MMDs and MSMDs with erenumab 140mg vs placebo (mean difference [95% CI] in MMD: −1.61 [−2.70, −0.52]; p=0.004; mean difference (95% CI) in MSMD: −1.73 [−2.46, −1.01]; p<0.001). Safety and tolerability profile of erenumab was comparable to placebo. No patients in the erenumab group discontinued due to adverse events.

Conclusions These results confirm the efficacy and safety of erenumab in this first dedicated study of a difficult to treat population with 2–4 prior preventive migraine treatment failures.

Authors/Disclosures
Uwe Reuter	Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TEVA. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Liily Deutschland. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TEVA. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. The institution of Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Allergan. Uwe Reuter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Medscape . Uwe Reuter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for StreaMEdUp. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. The institution of Uwe Reuter has received research support from Novartis.
Peter Goadsby, MD, PhD, FRS (University of California, Los Angeles)	Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli-Lilly. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aurene. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CoolTech LLC. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PureTech Health LLC. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vial. Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon Biopharma. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Massachusetts Medical Society. The institution of Dr. Goadsby has received research support from NIHR. The institution of Dr. Goadsby has received research support from Kallyope. Dr. Goadsby has received publishing royalties from a publication relating to health care. Dr. Goadsby has received publishing royalties from a publication relating to health care. Dr. Goadsby has a non-compensated relationship as a Trustee with Migraine Trust that is relevant to AAN interests or activities. Dr. Goadsby has a non-compensated relationship as a Trustee with Organisation for Understanding Cluster Headache (UK) that is relevant to AAN interests or activities. Dr. Goadsby has a non-compensated relationship as a Executive roles with American Headache Society that is relevant to AAN interests or activities.
Michel Lanteri-Minet, MD (CHU De Nice)	Dr. Lanteri-Minet has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Lanteri-Minet has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eli Lilly. The institution of Dr. Lanteri-Minet has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Lanteri-Minet has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. The institution of Dr. Lanteri-Minet has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Medtronic. Dr. Lanteri-Minet has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TEVA. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UPSA. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IPSEN. Dr. Lanteri-Minet has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. The institution of Dr. Lanteri-Minet has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Pfizer. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Savia BioElectronics. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ReckittBenckiser. The institution of Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zambon. Dr. Lanteri-Minet has received publishing royalties from a publication relating to health care.
Michel D. Ferrari, MD, PhD (Leiden University Hospital)	Dr. Ferrari has nothing to disclose.
Shihua Wen, PhD (Novartis)	Dr. Wen has received personal compensation for serving as an employee of novartis.
Jan Klatt, MD	No disclosure on file

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