Reversion from chronic migraine to episodic migraine following treatment with erenumab: Results of a post-hoc analysis of a randomized, 12-week, double-blind study and a 52-week, open-label extension

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

  • Richard B. Lipton
  • Stewart J. Tepper
  • Stephen D. Silberstein
  • David Kudrow
  • dlt446, dlt446
  • Uwe Reuter
  • David W. Dodick
  • Feng Zhang
  • Gregory A. Rippon
  • Sunfa Cheng
  • Daniel D. Mikol

Objective: To determine reversion rates from chronic migraine to episodic migraine during long-term erenumab treatment. Methods: A daily headache diary was completed during the 12-week, double-blind treatment phase of a placebo-controlled trial comparing erenumab 70 mg, 140 mg, and placebo, and weeks 1–12, 21–24, 37–40, and 49–52 of the open-label treatment phase. Chronic migraine to episodic migraine reversion rates were assessed over the double-blind treatment phase; persistent reversion to episodic migraine over 24 weeks (double-blind treatment phase through the first 12 weeks in the open-label treatment phase), long-term persistent reversion to episodic migraine over 64 weeks (double-blind treatment phase plus open-label treatment phase); delayed reversion to episodic migraine through the first 12 weeks of the open-label treatment phase among patients remaining in chronic migraine during the double-blind treatment phase. Results: In the double-blind treatment phase, 53.1% (95% confidence interval: 47.8–58.3) of 358 erenumab-treated completers had reversion to episodic migraine; monthly reversion rates to episodic migraine were typically higher among patients receiving 140 mg versus 70 mg. Among 181 completers (receiving erenumab for 64 weeks), 98 (54.1% [95% confidence interval: 46.6–61.6]) had reversion to episodic migraine during the double-blind treatment phase; of those, 96.9% (95% confidence interval: 91.3–99.4) had persistent reversion to episodic migraine, 96.8% (95% confidence interval: 91.1–99.3) of whom had long-term persistent reversion to episodic migraine. Delayed reversion to episodic migraine occurred in 36/83 (43.4% [95% confidence interval: 32.5–54.7]) patients; of these, 77.8% (95% confidence interval: 60.9–89.9) persisted in reversion through week 64. Conclusions: Patients with reversion to episodic migraine at week 12 will likely persist as episodic migraine with longer-term erenumab; others may achieve delayed reversion to episodic migraine. Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02066415

OriginalsprogEngelsk
TidsskriftCephalalgia
Vol/bind41
Udgave nummer1
Sider (fra-til)6-16
Antal sider11
ISSN0333-1024
DOI
StatusUdgivet - 2021

Bibliografisk note

Funding Information:
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was funded by Amgen Inc. (Thousand Oaks, CA, USA).

Funding Information:
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: RBL is the Edwin S. Lowe Professor of Neurology at the Albert Einstein College of Medicine in New York. He receives research support from the NIH: 2PO1 AG003949 (mPI), 5U10 NS077308 (PI), R21 AG056920 (Investigator), 1RF1 AG057531 (Site PI), RF1 AG054548 (Investigator), 1RO1 AG048642 (Investigator), R56 AG057548 (Investigator), U01062370 (Investigator), RO1 AG060933 (Investigator), RO1 AG062622 (Investigator), 1UG3FD006795 (mPI), 1U24NS113847 (Investigator), K23 NS09610 (Mentor), K23AG049466 (Mentor), K23 NS107643 (Mentor). He also receives support from the Migraine Research Foundation and the National Headache Foundation. He serves on the editorial board of Neurology, senior advisor to Headache, and associate editor to Cephalalgia. He has reviewed for the NIA and NINDS, holds stock options in eNeura Therapeutics and Biohaven Holdings; serves as consultant, advisory board member, or has received honoraria from: American Academy of Neurology, Allergan, American Headache Society, Amgen, Avanir, Biohaven, Biovision, Boston Scientific, Dr. Reddy’s (Promius), Electrocore, Eli Lilly, eNeura Therapeutics, Equinox, GlaxoSmithKline, Lundbeck (Alder), Merck, Pernix, Pfizer, Supernus, Teva, Trigemina, Vector, and Vedanta. He receives royalties from Wolff’s Headache 7th and 8th Edition, Oxford University Press, 2009, Wiley, and Informa.

Funding Information:
DK reports serving as consultant for Alder, Amgen, Biohaven, Eli Lilly, Nerivio, and Satsuma; and receiving research grants from Alder, Allergan, Amgen, Axsome, Biohaven, Eli Lilly, Satsuma, and Teva.

Funding Information:
DWD reports consulting fees from AEON, Alder, Allergan, Amgen, Amzak Health, Association of Translational Medicine, Autonomic Technologies, Axsome, Biohaven, Charleston Labs, Clexio, Daniel Edelman Inc., Dr Reddy's Laboratories (Promius), ElectroCore, 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; personal fees to develop/deliver educational content for continuing medical education projects from the Academy for Continued Healthcare Learning, Catamount, Chameleon, Global Access Meetings, Global Life Sciences, Global Scientific Communications, Haymarket, HealthLogix, Medicom Worldwide, MedLogix Communications, Mednet, Miller Medical, PeerView, Universal Meeting Management, UpToDate (Elsevier), and WebMD Health/Medscape; personal fees, royalties from Cambridge University Press, Oxford University Press, and Wolters Kluwer Health; board of directors, received stock options from Aural Analytics, Epien, Healint, King-Devick Technologies, Matterhorn, Nocira, Ontologics, Precon Health, Second Opinion/Mobile Health, and Theranica; no personal fees or royalties from Allergan for Patent 17189376.1-1466:vTitle: Botulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis; research funding to institution for salary support from the American Migraine Foundation, Henry Jackson Foundation, PCORI, and US Department of Defense; reimbursement for travel from the American Academy of Neurology, American Brain Foundation, American Headache Society, American Migraine Foundation, Canadian Headache Society, and International Headache Society; personal fees, speaking (not speakers bureau) from Amgen, Lilly, Lundbeck, and Novartis.

Funding Information:
MA reports serving as investigator for Alder, Allergan, Amgen, Eli Lilly, Novartis, and Teva; serving as consultant and investigator for Alder, Allergan, Amgen, Eli Lilly, Lundbeck, Novartis, and Teva; serving as consultant for Alder and Lundbeck; receiving research grants from Novartis; and other research grants from Lundbeck Foundation and Novo Nordisk Foundation.

Publisher Copyright:
© International Headache Society 2020.

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