Sustained Efficacy And Safety Of Erenumab In Episodic Migraine Patients Failing 2–4 Prior Preventive Treatments: 2-Year Interim Results Of The Liberty Open-Label Extension Study

Authors: Uwe Reuter, MD, PhD,1 Peter J. Goadsby, MD, PhD,2 Michel Lanteri-Minet, MD, PhD,3,4 Tracy Stites, PhD,5 Shihua Wen, PhD,5 Nadia Tenenbaum, MD,5 Michel D. Ferrari, MD, PhD,6 Shaloo Pandhi, MD,7

Affiliations: 1. Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany; 2. NIHR-Wellcome Trust, King’s Clinical Research Facility, King’s College London, London, UK; and Department of Neurology, University of California, Los Angeles, Los Angeles CA; 3. Pain Department, CHU Nice, Nice, France; FHU InovPain; 4. Université Côte d’Azur, Nice, France; 5. Novartis Pharmaceutical Corporation, East Hanover, NJ, USA; 6. Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands; 7. Novartis Pharma AG, Basel, Switzerland

Objective:
Our objective was to assess the efficacy and safety of erenumab at Week 112 of the 3-year open-label treatment phase (OLTP) of the LIBERTY study (NCT03096834).

Design & Setting:
Patients completing the 12-week double-blind treatment phase (DBTP) of the LIBERTY study (N=240) initially randomised to placebo and erenumab 140mg (1:1) were enrolled into the OLTP to receive monthly erenumab 140mg for 3 years.

Patients:
Patients were aged 18–65 years with a history of EM +/- aura for ≥12 months, had migraine for an average of 4–14 days per month during the 3 months before screening, and had prior preventive treatment failure (PPTF, with 2–4 preventive treatments).

Main Outcome Measures:
Outcomes measured included proportion of patients who achieved >=50%/>=75%/100% reduction from DBTP Baseline in monthly migraine days (MMD), change from the DBTP Baseline in MMD, Headache Impact Test total score, Migraine Physical Function Impact Diary (Everyday Activities and Physical Impairment) scores and safety.

Results:
Both patients on continuous erenumab and those who initiated erenumab in the OLTP demonstrated improvement through 2 years of treatment similar to that reported at 1 year. The responder rates for change in MMD from DBTP refer to a cross sectional interindividual observation and not a longitudinal intraindividual responder rate. The change in MMD from DBTP Baseline in the overall group sustained over 2 years (52 weeks:−3.7[4.1]; 112 weeks:−4.2[5.0]). The median erenumab exposure (during OLTP) was 106 weeks. Nearly 86.3% (overall group), 82.2% (continuing erenumab) and 90.2% (initiating erenumab) of patients reported adverse events (AEs) in OLTP. The most frequently reported AEs/100 patient-years during OLTP were nasopharyngitis (33.9), influenza (10.3), and back pain (6.6).

Conclusions:
Efficacy of erenumab was sustained over long-term treatment in EM patients with 2–4 PPTF both in patients continuously treated with erenumab and those initiating erenumab during the OLTP. Erenumab was well tolerated with no new safety signals.

The study was funded by Novartis Pharma AG, Basel, Switzerland. Erenumab is co-developed by Novartis and Amgen.

Uwe Reuter received consulting fees, speaking/teaching fees, from Allergan, Amgen, Autonomic Technologies, CoLucid, ElectroCore, EliLilly, Medscape, Novartis, StreamMedUp, TEVA Pharmaceuticals and research grants from Allergan, Amgen, Autonomic Technologies, CoLucid, ElectroCore, EliLilly, Medscape, Novartis, StreamMedUp, TEVA Pharmaceuticals.

Peter J Goadsby received personal fees from Amgen and Eli-Lilly and Company, Alder Biopharmaceuticals, Allergan, Autonomic Technologies Inc., Clexio, Electrocore LLC, eNeura, Impel Neuropharma, Mundipharma, Novartis, Teva Pharmaceuticals, and Trigemina Inc., MedicoLegal work, Journal Watch, Up-to-Date, Oxford University Press, Massachusetts Medical Society, and Wolters Kluwer.

Michel Lanteri-Minet received honoraria for advisory boards, speaker panels or investigation studies from Allergan, Amgen, Astellas, ATI, BMS, Boehringer, Boston Scientific, CoLucid, Convergence, Glaxo-SmithKline, Grunenthal, Lilly, Medtronic, Menarini, MSD, Novartis, Pfizer, Reckitt Benckiser, Saint-Jude, Sanofi-Aventis, Teva, UCB, Zambon.

Michel D Ferrari consultancy from Medtronic, Electrocore, Amgen, Lilly, Teva, and Novartis, and independent support from the European Community, NWO, NIH and the Dutch Heart Foundation and grants, trial support from Medtronic, Electrocore, Amgen, Lilly, Teva, and Novartis.

Tracy Stites, Shihua Wen, Nadia Tenenbaum and Shaloo Pandhi employees and own stocks in Novartis.

Contact Information:

Prof Uwe Reuter
Charité Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany; Tel: +49 (30) 450 560 274; uwe.reuter@charite.de

Prof Peter J. Goadsby
Wellcome Foundation Building, King’s College London, London SE5 9; Tel: +44 (0)20 7836 5454 peter.goadsby@kcl.ac.uk

Prof Michel Lanteri-Minet
Département d’Evaluation et Traitement de la Douleur, Centre Hospitalier Universitaire (CHU) de Nice, 4 Avenue Reine Victoria, 06003 Nice CEDEX 1, France, Tel: +33492038475 ;lanteri-minet.m@chu-nice.fr

Dr Tracy Stites
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080, USA;
Tel: +1 862778 8300;
Tracy.Stites@novartis.com

Dr Shihua Wen
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080, USA;
Tel: +1 862778 8300;
shihua.wen@novartis.com

Dr Nadia Tenenbaum
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080, USA;
Tel: +1 862778 8300;
Nadia.Tenenbaum@novartis.com

Prof Dr Michel D. Ferrari
Leiden University Medical Centre
2300 RC Leiden
The Netherlands;
Tel: +31 71 526 9111;
m.d.ferrari@lumc.nl

Dr Shaloo Pandhi
Novartis Pharma AG, Forum 1
Novartis Campus, CH-4056 Basel
Switzerland;
Tel: +41 61 324 1111;
shaloo.pandhi@novartis.com

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