Abstract Details

Title Assessment of the Efficacy of Erenumab During the Open-Label Treatment (13–24 Weeks) of Subjects with Episodic Migraine Who Failed 2–4 Prior Preventive Treatments: Results of the LIBERTY Study

Topic Headache

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-002

Objective

To assess efficacy of erenumab in the first three months of the open-label extension phase (OLEP; 13–24 weeks) of the LIBERTY study.

Background

Results of the LIBERTY study (NCT03096834) demonstrated efficacy of erenumab 140 mg in episodic migraine patients with prior preventive treatment failures.

Design/Methods In the double-blind treatment phase, 246 patients were randomized to placebo and erenumab 140 mg for 12 weeks, following which, patients completing that phase (N=240) were enrolled in OLEP, to receive monthly erenumab 140 mg. Outcomes measured monthly throughout to week 24 were achievement of at least 50%/75%/100% reduction in monthly migraine days (MMD), change from double-blind treatment phase baseline in MMD, monthly acute migraine-specific medication days (MSMD), Headache Impact Test (HIT-6^TM) total score, everyday activities (EA) and physical impairment (PI) as measured by the Migraine Physical Function Impact Diary (MPFID); in the overall population, patients on continuous erenumab and in patients switching from placebo to erenumab.

Results Overall, 228/240 (95.0%) patients completed the 24 week visit of the OLEP. In the overall population at Week 24, 39.2%, 15.9% and 7.0% patients achieved ≥50%/≥75%/100% reduction in MMD. The mean (standard deviation [SD]) change from double-blind treatment phase baseline in MMD was −2.7 (4.4) and−1.4 (3.0) in MSMD; and −7.6 (8.0), −2.5 (9.2) and −4.0 (9.0) in HIT-6^TM, MPFID-PI and MPFID-EA scores respectively. Patients with continuous use of erenumab showed, sustained efficacy in all outcomes assessed. Patients who switched from placebo to erenumab in the OLEP, showed, improvement from the first measurement at Week 16 on all outcomes assessed.

Conclusions

Efficacy of erenumab was sustained throughout 24 weeks in a hard to treat patient population with multiple prior preventive treatment failures. Overall, efficacy data over 24 weeks (assessed over weeks 13–16, 17–20 and 21–24) was generally in line with prior erenumab trials.

Authors/Disclosures
Peter Goadsby, MD, PhD, FRS (King Abdullah Univeristy of Science and Technology) PRESENTER	Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. 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 $10,000-$49,999 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 $5,000-$9,999 for serving as a Consultant for Kallyope. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Seaport Therapeutics. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dr Reddy's. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Orion Pharma. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen. 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. 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.
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.
Michel Lanteri-Minet, MD (CHU De Nice)	Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 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 Ipsen. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 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. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Orion. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Perfood. 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 on a Scientific Advisory or Data Safety Monitoring board for IPSEN. Dr. Lanteri-Minet has received publishing royalties from a publication relating to health care.
	No disclosure on file
	No disclosure on file
Michel D. Ferrari, MD, PhD (Leiden University Hospital)	Dr. Ferrari has nothing to disclose.
Jan Klatt, MD	No disclosure on file

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