@article{9cdbc9fbd81947ec93b64781acb253e0,
title = "Reduction in migraine pain intensity in patients treated with erenumab: A post hoc analysis of two pivotal randomized studies",
abstract = "Background: Erenumab (erenumab-aooe in the US) effectively reduces monthly migraine days in episodic and chronic migraine. This traditional outcome does not capture the intensity of headache pain on days with migraine. Methods: This post hoc analysis of two pivotal randomized, placebo-controlled studies in patients with episodic migraine and chronic migraine examined the effect of erenumab 70 and 140 mg on migraine pain. Cumulative monthly migraine pain intensity is the sum of the peak pain intensity scores (0 = no migraine to 3 = migraine day with severe pain) on migraine days. Change from baseline in cumulative monthly migraine pain and average monthly pain intensity was assessed over months 4 to 6 for episodic migraine and month 3 for chronic migraine; change in average monthly pain intensity was assessed among monthly migraine days responders/non-responders. Results: Efficacy analysis included 946 patients for the episodic migraine study and 656 patients for the chronic migraine study. Cumulative monthly migraine pain decreased significantly with erenumab versus placebo (p < 0.001, for episodic migraine and chronic migraine). In addition, monthly average migraine pain intensity decreased significantly with erenumab versus placebo for episodic migraine (p < 0.01); decreases were non-significant for chronic migraine. In comparison with placebo-treated patients, a greater proportion of erenumab-treated patients were pain intensity responders regardless of threshold used. Episodic migraine and chronic migraine patients with a ≥50% reduction in monthly migraine days (responders) had a greater reduction in monthly average pain intensity than non-responders. Conclusions: Erenumab reduced cumulative monthly migraine pain in episodic migraine and chronic migraine patients and significantly reduced monthly average migraine pain in episodic migraine, demonstrating treatment benefit beyond reduction in migraine frequency. Clinical Trial Registration: ClinicalTrials.gov, NCT02456740; ClinicalTrials.gov, NCT02066415",
keywords = "CGRP receptor, Headache, efficacy, headache frequency, monoclonal antibody, pain",
author = "Lipton, {Richard B.} and Dodick, {David W.} and David Kudrow and Uwe Reuter and Nadia Tenenbaum and Feng Zhang and Lima, {Gabriel Paiva da Silva} and Chou, {Denise E.} and Mikol, {Daniel D.}",
note = "Funding Information: DD 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. 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. UR discloses consulting fees, speaking/teaching fees, and/or research grants from Allergan, Amgen, Autonomic Technologies, CoLucid, ElectroCore, Novartis, Pharm Allergan, Eli Lilly, and Teva Pharmaceuticals. NT is an employee and stockholder of Novartis Pharma AG. FZ, GL, DEC, and DDM are employees and stockholders of Amgen Inc. Funding Information: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by Amgen Inc. and Novartis. Funding Information: The authors thank Allison Gillies, PhD (ICON, North Wales, PA), whose work was funded by Amgen Inc., and Annalise Nawrocki, PhD (Amgen Inc., Thousand Oaks, CA) for medical writing assistance in the preparation of this manuscript. Publisher Copyright: {\textcopyright} International Headache Society 2021.",
year = "2021",
month = dec,
doi = "10.1177/03331024211028966",
language = "English (US)",
volume = "41",
pages = "1458--1466",
journal = "Cephalalgia",
issn = "0333-1024",
publisher = "SAGE Publications Ltd",
number = "14",
}