Sustained Benefits of OnabotulinumtoxinA Treatment in Chronic Migraine: Results from a PREEMPT Pooled Analysis (1699)

2020 
Objective: Determine the proportion of individuals with chronic migraine (CM) that achieved Background: ‘Conversion’ and ‘reversion’ have been utilized to describe headache day reductions beneath the threshold for CM diagnosis (15 MHD). Further exploration into the impacts of preventive treatment, and a greater understanding of natural disease history to assess if disease modification has occurred, may be informative. Design/Methods: Observed data from the PREEMPT program (24-week, 2 onabotulinumtoxinA cycle, randomized, double-blind placebo-controlled phase, followed by 32-week, 3 onabotulinumtoxinA cycle, open-label phase) were pooled for analysis. Several methods to assess MHD reductions were utilized: 1) Results: 1384 participants were randomized to onabotulinumtoxinA (n=688) or placebo (n=696) in the double-blind phase; most continued into the open-label phase (n=607 onabotulinumtoxinA/onabotulinumtoxinA, n=629 placebo/onabotulinumtoxinA). A higher proportion of onabotulinumtoxinA-treated individuals compared to placebo achieved Conclusions: In PREEMPT, a high proportion of individuals treated with onabotulinumtoxinA achieved sustained MHD reductions for 6 continuous months. Disclosure: 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.Dr. Diener has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Has received honoraria for participation in clinical trials and for contribution to advisory boards or oral presentations from Addex Pharma, Allergan, Almirall, Autonomic Technologies, AstraZeneca, Bayer Vital, Berlin Chemie, Boehringer Ingelheim, Bristol. Dr. Diener has received personal compensation in an editorial capacity for Has received honoraria for participation in clinical trials and for contribution to advisory boards or oral presentations from Addex Pharma, Allergan, Almirall, Autonomic Technologies, AstraZeneca, Bayer Vital, Berlin Chemie, Boehringer Ingelheim, Bristol. Dr. Diener has received research support from He has received financial support for research projects from Allergan, Almirall, AstraZeneca, Bayer, GSK, Janssen-Cilag, MSD, and Pfizer.. 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.L. Yedigarova is an employee of Allergan and receives salary compensation.Dr. Lipton has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Lipton has received compensation for serving on the Board of Directors of eNeura and Biohaven. Dr. Lipton holds stock and/or stock options in Biohaven which sponsored research in which Dr. Lipton was involved as an investigator. Dr. Lipton holds stock and/or stock options in Biohaven. Dr. Lipton has received research support from Migraine Research Foundation the National Headache Foundation and Amgen.
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