Long-term efficacy and safety of erenumab in patients with chronic migraine in whom prior preventive treatments had failed: A subgroup analysis
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Objective: To assess the long-term efficacy and safety of erenumab in the subgroup of patients with chronic migraine (CM) in whom prior preventive treatments had failed (TF) (≥1, ≥2, and ≥3 TF medication categories) and never failed (preventive naïve or prior preventive treatments had not failed), using the data from a 52-week, open-label treatment period (OLTP) of the parent study. Background: Erenumab is a fully human monoclonal antibody that selectively binds to and inhibits the canonical calcitonin gene-related peptide receptor. There are limited long-term data evaluating the efficacy and safety of erenumab in patients with CM in whom prior preventive treatments had failed. Methods: Patients who had completed the 12-week double-blind treatment period (DBTP) in the parent study were eligible to participate in the 52-week OLTP, during which they received erenumab every 4 weeks. The TF subgroups (≥1, ≥2, and ≥3 TF medication categories) were not mutually exclusive; patients in whom prior preventive treatments from ≥3 medication categories had failed were also counted in the ≥2 and ≥1 medication categories. Endpoints included monthly migraine days (MMD), monthly acute migraine-specific medication days (MSMD), achievement of ≥50%, ≥75%, and 100% reduction from baseline in MMD, and exposure-adjusted patient incidence rates of adverse events (AEs; per 100 patient-years). Results: Erenumab treatment provided sustained mean reductions in MMD and MSMD relative to the parent study baseline throughout the 52 weeks of the OLTP across all TF subgroups. At Week 52, the mean MMD change was −8.6 (SD 6.6) (baseline: 18.4 [SD 4.5] days) in the ≥1 TF subgroup. A post hoc completer analysis (52 weeks [OLTP] erenumab) showed that compared with erenumab 70 mg, the 140 mg dose was associated with numerically greater reductions in the mean MMD (Week 40: −8.6 and −7.2 days; Week 52: −9.7 and −7.9 days [≥1 TF subgroup]) and a higher proportion of patients achieved ≥50%, ≥75%, and 100% response thresholds across all subgroups at Weeks 40 and 52. Overall the exposure-adjusted patient incidence rates of AEs did not increase during the OLTP versus the DBTP (≥1 TF subgroup: 141.9/100 versus 317.9/100 patient-years), and no new safety signals occurred. Conclusion: The long-term treatment with erenumab was well tolerated and showed sustained efficacy in patients with CM in whom prior preventive treatments had failed, with numerically greater treatment effects for 140 mg versus 70 mg.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Headache |
| Vol/bind | 62 |
| Udgave nummer | 5 |
| Sider (fra-til) | 624-633 |
| Antal sider | 10 |
| ISSN | 0017-8748 |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
Messoud Ashina is a consultant or scientific advisor for AbbVie, Allergan, Amgen, Eli Lilly, Lundbeck, Novartis, and Teva; currently primary investigator for AbbVie, Amgen and Lundbeck; research grants from Lundbeck Foundation, Novo Nordisk Foundation, and Novartis. Stewart J. Tepper was an employee of the Cleveland Clinic during this study. Grants for research (no personal compensation): Allergan, Amgen, ElectroCore, Eli Lilly, Neurolief, Novartis, Satsuma, Teva, Zosano. Consultant and/or Advisory Boards (honoraria): Aeon, Align Strategies, Allergan/Abbvie, Alphasights, Amgen, Aperture Venture Partners, Aralez Pharmaceuticals Canada, Axsome Therapeutics, Becker Pharmaceutical Consulting, BioDelivery Sciences International, Biohaven, ClearView Healthcare Partners, CoolTech, CRG, Currax, Decision Resources, DeepBench, DRG, Eli Lilly, Equinox, ExpertConnect, GLG, Guidepoint Global, Healthcare Consultancy Group, Health Science Communications, HMP Communications, Impel, Lundbeck, M3 Global Research, Magellan Rx Management, Medicxi, Navigant Consulting, Neurolief, Nordic BioTech, Novartis, Pulmatrix, Reckner Healthcare, Relevale, SAI MedPartners, Satsuma, Slingshot Insights, Spherix Global Insights, Sudler and Hennessey, Synapse Medical Communications, System Analytic, Teva, Theranica, Thought Leader Select, Trinity Partners, XOC, Zosano Salary: Dartmouth‐Hitchcock Medical Center, American Headache Society, Thomas Jefferson University. CME honoraria: American Academy of Neurology, American Headache Society, Cleveland Clinic Foundation, Diamond Headache Clinic, Elsevier, Forefront Collaborative, Hamilton General Hospital, Ontario, Canada, Headache Cooperative of New England, Henry Ford Hospital, Detroit, Inova, Medical Learning Institute Peerview, Medical Education Speakers Network, Miller Medical Communications, North American Center for CME, Physicians Education Resource, Rockpointe, ScientiaCME, WebMD/Medscape. Jan Lewis Brandes has received research grants or support from Allergan, Amgen, Biohaven, CoLucid, Teva, and Zotrip; is a consultant for Amgen, Eli Lilly, Promius, and Supernus; served on an advisory board for Teva; and a speakers bureau for Amgen, Teva, Depomed, Promius, Avanir, and Supernus. Uwe Reuter has received consulting fees, speaking/teaching fees or research grants from Abbvie, Allergan, Amgen, Autonomic Technologies, ElectroCore, Eli Lilly, Lundbeck, Medscape, Novartis, StreamMedUp, and Teva Pharmaceuticals. Guy P. Boudreau has nothing to disclose. Mark Weatherall has received honoraria and fees for lecturing from Allergan, Novartis, Teva pharmaceuticals, Eli Lilly, and Sapphire Medical Clinics. Andreas R. Gantenbein has received honoraria for consulting or lecturing from Allergan, Almirall, Curatis, Eli Lilly, Mepha, Novartis, Pfizer, Roche, and Teva Pharmaceuticals. David Doležil has received consulting fees and speaking and/or teaching fees from Allergan, Amgen, Biogen Idec, Novartis, Bayer, Eli Lilly, and Teva. Jan Klatt was an employee of Novartis at the time of the study and manuscript preparation. Andrea Wang and Sunfa Cheng are employees and stockholders of Amgen. Daniel D. Mikol was an employee of Amgen at the time of the study and manuscript preparation and is a current employee of NervGen Pharma. Ananda Krishna Karanam is an employee of Novartis.
Funding Information:
This study was fully funded by Amgen Inc., Thousand Oaks, CA. Erenumab is co‐developed in partnership with Amgen and Novartis.
Publisher Copyright:
© 2022 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.
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