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• W3093745937 abstract "Objective: To evaluate long-term efficacy and safety of erenumab (erenumab-aooe in the US). Background: Efficacy (1 year) and safety (3 years) of erenumab results from a comprehensive clinical development program resulted in approval for migraine prevention in over 40 countries to date. Longer-term efficacy and safety data are important for patients and clinicians. Design/Methods: 4+-year, interim analysis of a 5-year, open-label treatment period (OLTP) in patients with episodic migraine (EM) who initially received 70 mg erenumab monthly and later switched to 140 mg monthly (protocol amendment after ~2 years). Results: Of 250 patients who switched from 70 to 140 mg, 221 (88%) completed the OLTP or remained on 140 mg at 4+ years. Mean (SD) change in monthly migraine days (MMD) from baseline of 8.7 (2.7) to end of the 4+-year period was −5.8 (3.8); ≥50%/≥75%/100% response rates were 77%/56%/33%. Among patients using acute migraine-specific medication (AMSM) at baseline (6.1 [2.7] treatment days), mean (SD) change was −4.6 (3.3) days. Median (Q1, Q2) exposure for patients receiving ≥1 dose of open-label erenumab (n=383) was 58.5 (17.0, 62.2) months. Exposure-adjusted AE and SAE incidence rates were 124.9/100-patient-years and 3.8/100-patient-years. Nasopharyngitis (10.9/100-patient-years), upper respiratory tract infection (6.8/100-patient-years), and influenza (4.7/100-patient-years) were the most frequent AEs. Constipation did not increase with long-term treatment; 1.3/100-patient-years (n/N:9/383) for 70 mg and 2.6/100-patient-years (n/N:15/250) for 140 mg during 4+ years and 4.3/100-patient-years (n/N: 11/1043) for placebo, 5.6/100-patient-years (n/N:12/893) for 70 mg, and 13.3/100-patient-years (n/N:16/507) for 140 mg from pooled results across four 12-week, placebo-controlled studies. 19 patients (5.0%) discontinued due to AEs. There were no new safety signals nor increases in AE or SAE incidence over 4+ years of exposure vs the double-blind treatment phase. Conclusions: In this interim analysis, long-term erenumab treatment (4+ years) demonstrated sustained reductions in migraine frequency and was well-tolerated and safe. Disclosure: Dr. Ashina has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alder BioPharmaceuticals, Allergan, Amgen, Alder, Eli Lilly, Novartis, and Teva. Dr. Goadsby has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Reports personal fees from Amgen, Eli Lilly, Alder Biopharmaceuticals, Allergan, Biohaven Pharmaceuticals Inc., Clexio, Electrocore LLC, eNeura, Impel NeuroPharma, MundiPharma, Novartis, Teva Pharmaceuticals, Trigemina Inc., and WL Gore. Dr. Goadsby has received personal compensation in an editorial capacity for Journal Watch- Massachusetts Medical Society. Dr. Goadsby has received research support from Amgen and Eli-Lilly and Company.Dr. Reuter has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with consulting%20fee%2C%20speaking%2Fteaching%20fee%2C%20from%20Allergan%2C%20Amgen%2C%20Autonomic%20Technologies%2C%20CoLucid%2C%20ElectroCore%2C%20EliLilly%2C%20Medscape%2C%20Novartis%2C%20StreamMedUp%2C%20%20TEVA%20Pharmaceuticals. Dr. Reuter has received research support from research%20grants%20from%20Allergan%2C%20Amgen%2C%20Autonomic%20Technologies%2C%20CoLucid%2C%20ElectroCore%2C%20EliLilly%2C%20Medscape%2C%20Novartis%2C%20StreamMedUp%2C%20%20TEVA%20Pharmaceuticals.Dr. Silberstein has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Abide Therapeutics; Alder Biopharmaceuticals; Allergan, Inc.; Amgen; Avanir Pharmaceuticals, Inc.; Biohaven Pharmaceuticals; Cefaly; Curelator, Inc.; Dr. Reddy’s Laboratories; Egalet Corporation; GlaxoSmithKline Consumer Health Holdings, LLC.; eNeura Inc.; electroCore Medical, LLC; Impel NeuroPharma, Inc.; Lilly USA, LLC; Medscape, LLC; Novartis, Inc.; Satsuma Pharmaceuticals; Supernus Pharmaceuticals, Inc.; Teva Pharmaceuticals; Theranica; and Trigemina, Inc.David W. Dodick, MD, reports the following conflicts: Personal fees: AEON, Alder BioPharmaceuticals, Allergan, Amgen, Amzak Health, Association of Translational Medicine, Autonomic Technologies, Axsome, Biohaven, Charleston Laboratories, Clexio, Daniel Edelman Inc., Dr Reddy’s Laboratories/Promius, electroCore LLC, Eli Lilly, eNeura, Equinox, Foresite Capital, Impel, Ipsen, Neurolief, Nocira, Novartis, Oppenheimer, Pieris, PSL Group Services, Revance, Salvia, Satsuma, Sun Pharma (India), Supernus, Teva, Theranica, University Health Network, Upjohn (Division of Pfizer), Vedanta, WL Gore, XoC, Zosano, and ZP Opco; Speaking fees: Amgen, Eli Lilly, Lundbeck, and Novartis Canada; CME fees or royalty payments: Academy for Continued Healthcare Learning, Cambridge University Press, Catamount, Chameleon, Global Access Meetings, Global Life Sciences, Global Scientific Communications, Haymarket, HealthLogix, Medicom Worldwide, MedLogix Communications, Mednet, Miller Medical, Oxford University Press, PeerView, Universal Meeting Management, UpToDate (Elsevier), WebMD Health/Medscape, and Wolters Kluwer Health; Consulting without fee: Aural Analytics, Epien, Healint, Second Opinion/Mobile Health; Professional society fees or reimbursement for travel: American Academy of Neurology, American Brain Foundation, American Headache Society, American Migraine Foundation, Canadian Headache Society, and International Headache Society. Dr. Dodick has received compensation for serving on the Board of Directors of Epien, King-Devick Technologies, Matterhorn, Ontologics, and Precon Health. Dr. Dodick has received research support from American Migraine Foundation, Henry Jackson Foundation, PCORI, and US Department of Defense.Dr. Xue has nothing to disclose. Dr. Zhang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Amgen Inc.. Dr. Cheng has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen. Dr. Mikol has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Amgen Inc.. Dr. Mikol has received compensation for serving on the Board of Directors of Amgen Inc.. Dr. Mikol holds stock and/or stock options in Amgen Inc.." @default.
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• W3093745937 date "2020-04-14" @default.
• W3093745937 modified "2023-10-01" @default.
• W3093745937 title "Sustained Efficacy and Long-term Safety of Erenumab in Patients with Episodic Migraine: 4+ Year Results of a 5-year, Open-label Treatment Period (1203)" @default.
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