Long-term efficacy and safety of erenumab in patients with chronic migraine and acute medication overuse: A subgroup analysis
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Objective: Assess the long-term efficacy and safety of erenumab in patients with chronic migraine with acute medication overuse. Background: Overuse of acute medication in patients with chronic migraine has been linked to greater pain intensity and disability and may diminish the effectiveness of preventive therapies. Methods: This 52-week open-label extension study followed a 12-week double-blind placebo-controlled study in which patients with chronic migraine were randomized 3:2:2 to placebo or once-monthly erenumab 70 mg or 140 mg. Patients were stratified by region and medication overuse status. Patients received erenumab 70 mg or 140 mg throughout or switched from erenumab 70 to 140 mg (based on protocol amendment to augment safety data at higher dose). Efficacy was assessed in patients with and without medication overuse at parent study baseline. Results: Of 609 patients enrolled in the extension study, 252/609 (41.4%) met the criteria for medication overuse at parent study baseline. At Week 52, the mean change in monthly migraine days from parent study baseline was −9.3 (95% confidence interval: −10.4, −8.1 days) in the medication overuse subgroup versus −9.3 (−10.1, −8.5 days) in the non-medication overuse subgroup (combined erenumab doses); proportion of patients achieving ≥50% reduction in monthly migraine days at Week 52 was 55.9% (90/161; 48.2%, 63.3%) versus 61.3% (136/222; 54.7%, 67.4%), respectively. Among baseline users of acute migraine-specific medication, the mean change in monthly migraine-specific medication days at Week 52 was −7.4 (−8.3, −6.4 days) in the medication overuse subgroup versus −5.4 (−6.1, −4.7 days) in the non–medication overuse subgroup. Most patients (197/298; 66.1%) in the medication overuse subgroup transitioned to non-overuse status by Week 52. Erenumab 140 mg was associated with numerically greater efficacy than erenumab 70 mg across all endpoints. No new safety signals were identified. Conclusion: Long-term erenumab treatment demonstrated sustained efficacy and safety in patients with chronic migraine with and without acute medication overuse.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Headache |
| Vol/bind | 63 |
| Udgave nummer | 6 |
| Sider (fra-til) | 730-742 |
| Antal sider | 13 |
| ISSN | 0017-8748 |
| DOI | |
| Status | Udgivet - 2023 |
Bibliografisk note
Funding Information:
We thank the study investigators and patients for their participation and commitment to this work. The authors thank Janis Noonan, Joan Smyth, and Karen Stanford of Novartis Ireland Limited, Dublin, Ireland for providing medical writing support.
Funding Information:
was an employee of the Cleveland Clinic during this study: he reports research grants (no personal compensation) from Allergan/Abbvie, Amgen Inc., Eli Lilly and Co, Neurolief, Novartis, Satsuma, Teva, and Zosano; consultant fees from Eon, Allergan/Abbvie, Alphasights, Amgen Inc., Atheneum, Axsome Therapeutics, Becker Pharmaceutical Consulting, BioDelivery Sciences International, Biohaven, Clearview Healthcare Partners, Click Therapeutics, Collegium, CoolTech, CRG, Decision Resources, Defined Health, DRG, Eli Lilly and Co, ExpertConnect, FCB Health, Fenix, GLG, Guidepoint Global, Health Advances, Health Science Communications, HMP Communications, Impel, InteractiveForums, Keyquest, Krog and Partners, Lundbeck, M3 Global Research, Magnolia Innovation, MJH Holdings, Neurofront Therapeutics, Neurolief, Novartis, P Value Communications, Pain Insights Inc., Palion Medical, Pulmatrix, Putnam Associates, SAI MedPartners, Satsuma, Slingshot Insights, Spherix Global Insights, Strategy Inc, System Analytic, Taylor and Francis, Teva, Theranica, Tremeau, Trinity Partners, Unity HA, XOC, Zosano; advisory boards: Eon, Allergan/Abbvie, Amgen Inc., Axsome Therapeutics, Biohaven, Click Therapeutics, Collegium, CoolTech, Eli Lilly and Co, Impel, Lundbeck, Neurolief, Novartis, Pulmatrix, Satsuma, Theranica, Tremeau, XOC, Zosano; salary from American Headache Society, Dartmouth‐Hitchcock Medical Center, Thomas Jefferson University; and CME honoraria: American Academy of Neurology, American Headache Society, Catamount Medical Education, Diamond Headache Clinic, Forefront Collaborative, Haymarket Medical Education, HMP Global, Medical Education Speakers Network, Medical Learning Institute Peerview, Medical Education Speakers Network, Migraine Association of Ireland, Miller Medical Education, National Association for Continuing Education, North American Center for CME, The Ohio State University, Physicians’ Education Resource, PlatformQ Education, Primed, Vindico Medical Education, WebMD/Medscape. receives research support from the NIH, FDA, as well as the National Headache Foundation and the Marx Foundation. He also receives research support from Allergan/Abbvie, Amgen Inc., and Eli Lilly. He receives personal fees as a consultant or advisor from Allergan/Abbvie, Amgen Inc., BDSI, Biohaven Holdings, GlaxoSmithKline, Grifols, Impel NeuroPharma, Novartis, Eli Lilly, Lundbeck, Novartis, and Teva Pharmaceuticals. He holds stock or options in Biohaven Holdings, and Manistee. In addition, he receives royalties for 7th and 8th editions. reports consultant/advisory board fees from Lundbeck, Allergan, Amgen Inc., Avanir Pharmaceuticals Inc., Curelator Inc., Dr. Reddy's Laboratories, eNeura Inc., electroCore Medical LLC, Lilly USA LLC, Medscape LLC, NINDS, Supernus Pharmaceuticals Inc., Teva Pharmaceuticals, and Theranica. reports consulting for Alder, Amgen Inc., Ely Lilly and Co, and Novartis; and research support from Alder, Allergan, Amgen Inc., CoLucid, Eli Lilly and Co, Genentech‐Roche, Teva, UCB, VM Biopharma, and Zosano. is a consultant, speaker, or scientific advisor for AbbVie, Alder, Allergan, Amgen Inc., Biohaven, Eli Lilly and Co, Lundbeck, Novartis, and Teva, and primary investigator for AbbVie, Alder, Allergan, Amgen Inc., Eli Lilly and Co, Lundbeck, Novartis, and Teva trials. He has no ownership interest and does not own stocks of any pharmaceutical company. He reports research grants from Lundbeck Foundation and Novo Nordisk Foundation and a research grant from Novartis. reports consulting fees from AbbVie, Allergan, Amgen Inc., Autonomic Technologies, Eli Lilly and Co, Lundbeck, Novartis, Pfizer, Perfood, and Teva; speaking/teaching fees from Abbvie, Amgen Inc., Eli Lilly and Co, Lundbeck, Medscape, Novartis, Pharm Allergan, and Teva; and advisory board positions for Amgen Inc., Autonomic Technologies, Eli Lilly and Co, Lundbeck, Novartis, Perfood, Pharm Allergan, and Teva. reports consulting for AYYA Biosciences, Abbvie, Allergan, Amgen Inc., Atria Health, Biohaven, CapiThera Ltd., Cerecin, Ceruvia Lifesciences LLC, Cooltech, Ctrl M, Eli Lilly and Co, GSK, Impel, Lundbeck, Nocira, Novartis, Perfood, Pfizer, Praxis, Revance, Satsuma, Theranica, and WL Gore; payment or honoraria for lectures/presentations/educational events for Abbvie, Allergan, Amgen Inc., Biohaven, Eli Lilly and Co, Lundbeck, Pfizer, Novartis, and Teva. He participates on a data safety monitoring Board or advisory board for Abbvie, Allergan, Amgen Inc., Biohaven, Eli Lilly, Lundbeck, and Novartis. He reports honoraria for Academy for Cambridge University Press, Continued Healthcare Learning, Clinical Care Solutions, CME Outfitters, Curry Rockefeller Group, DeepBench, Global Access Meetings, KLJ Associates, Majallin LLC, Medlogix Communications, Miller Medical Communications, MJH Lifesciences, Oxford University Press, Vector Psychometric Group, WebMD Health/Medscape, and Wolters Kluwer. He reports research support from the American Migraine Foundation, Department of Defense, Henry Jackson Foundation, National Institutes of Health, Patient Centered Outcomes Research Institute (PCORI), and Sperling Foundation. He reports leadership or a fiduciary role in other boards, societies, committees, or advocacy groups (paid or unpaid) for the American Brain Foundation, American Migraine Foundation, and International Headache Society Global Patient Advocacy Coalition. He reports stock options/shareholder/patents/board of directors for AYYA Biosciences (options), Atria Health (options), Aural Analytics (options), Epien (options/board), ExSano (options), Healint (options), King‐Devick Technologies (options/board), Man and Science (options), Matterhorn (shares/board), Nocira (options), Ontologics (shares/board), Precon Health (options/board), Second Opinion/Mobile Health (options), Theranica (options). He reports patent 17189376.1‐1466:vTitle: Botulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis (non‐royalty bearing); patent application submitted: Synaquell (Precon Health). and are employees and stockholders of Amgen. was an employee of Amgen at the time of the study and manuscript preparation and is a current employee of NervGen Pharma. was an employee and stockholder of Novartis at the time of the study and manuscript preparation and is a current employee of Merck KGaA, Darmstadt, Germany. Stewart J. Tepper Richard B. Lipton Wolff's Headache Stephen D. Silberstein David Kudrow Messoud Ashina Uwe Reuter David W. Dodick Andrea Wang Sunfa Cheng Daniel D. Mikol Jan Klatt
Funding Information:
The study was funded by Amgen Inc. Erenumab is co‐developed by Amgen Inc. and Novartis.
Publisher Copyright:
© 2023 American Headache Society.
ID: 370799829