You are here

Article Text

Article menu

Download PDFPDF

Migraine
Research paper
Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis
  1. Peter J Goadsby1,
  2. David W Dodick2,
  3. James M Martinez3,
  4. Margaret B Ferguson3,
  5. Tina M Oakes3,
  6. Qi Zhang4,
  7. Vladimir Skljarevski3,
  8. Sheena K Aurora3
  1. 1 NIHR-Wellcome Trust King’s Clinical Research Facility, Kings College, London, UK
  2. 2 Mayo Clinic Scottsdale, Scottsdale, Arizona, USA
  3. 3 Eli Lilly and Company, Indianapolis, Indiana, USA
  4. 4 Sanofi, Bridgewater, New Jersey, USA
  1. Correspondence to Professor Peter J Goadsby, Wellcome Foundation Building, King’s College Hospital, London SE5 9PJ, UK; peter.goadsby{at}kcl.ac.uk

Abstract

Background and objective As new migraine prevention treatments are developed, the onset of a preventive effect, how long it is maintained and whether patients initially non-responsive develop clinically meaningful responses with continued treatment can be assessed.

Methods Analyses were conducted post-hoc of a double-blind, placebo-controlled, phase II-a study in patients with episodic migraine receiving galcanezumab 150 mg or placebo biweekly for 12 weeks (Lancet Neurol 13:885, 2014). The number of migraine headache days per week, and onset of efficacy measured as the first week galacanezumab separated from placebo were determined. Patients with ≥50%, ≥75% and 100% reduction in migraine headache days from baseline at months 1, 2 and 3 were calculated and defined as sustained responses. Non-responders (<50% response) at month 1 or 2 who then showed ≥50%, ≥75% and 100% response at later time-points were calculated.

Results Patients were randomised to galcanezumab (n=107) or placebo (n=110). A significant (p=0.018) change of −0.89±0.11 (galcanezumab) vs −0.53±0.11 (placebo) migraine headache days indicated onset at week 1. Forty-seven per cent of galcanezumab and 25% of placebo patients responding at month 1 maintained response through months 2 and 3. Of non-responders at month 1, 27% on galcanezumab and 20% on placebo responded on months 2 and 3, and 50% of galcanezumab non-responders in months 1 and 2 responded on month 3, vs 24% on placebo.

Conclusions The onset of efficacy of galcanezumab is within 1 week in a majority of patients, and patients receiving galcanezumab are twice more likely to maintain responses than placebo patients. Early non-responders may respond by month 2 or month 3.

Trial registration number NCT01625988.

  • LY2951742
  • calcitonin gene-related peptide
  • CGRP
  • galcanezumab
  • migraine
  • clinical trial

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/jnnp-2018-320242

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors PJG contributed to the conception and interpretation of data of the work, drafting of the manuscript, and critical revision for important intellectual content. DWD contributed to the conception of the work, analysis and interpretation of data, and critical revision of the manuscript for important intellectual content. JMM contributed to the conception of the work, interpretation of data and critical revision of the manuscript for important intellectual content. MBF contributed to the conception and design of the work, interpretation and analysis of data, drafting of the manuscript, and critical revision for important intellectual content. TMO contributed to the conception of the work, interpretation of data and critical revision of the manuscript for important intellectual content. QZ contributed to the conception and design of the work, analysis and interpretation of data, drafting of the manuscript, and critical revision of the manuscript for important intellectual content. VS contributed to the conception of the work, interpretation of data and critical revision of the manuscript for important intellectual content. SKA contributed to the interpretation of data and critical revision of the manuscript for important intellectual content.

    • Funding This work was supported by Eli Lilly and Company, Indianapolis, Indiana, USA

    • Competing interests The studies included in the analyses were sponsored and/or supported by Eli Lilly and Company. VS, MBF, JMM, TMO and SKA are full-time employees of Eli Lilly and Company and/or one of its subsidiaries, and are stockholders. QZ was an employee of Eli Lilly and Company at the time the manuscript was written and is presently an employee of Sanofi and is an Eli Lilly and Company stockholder. PJG reports grants and personal fees from Amgen and Eli Lilly and Company; personal fees from Alder BioPharmaceuticals, Allergan, Autonomic Technologies, Dr Reddy’s Laboratories, Biohaven Pharmaceuticals, Electrocore, eNeura, Novartis,Impel Neuropharma, Mundipharma, Teva Pharmaceuticals and Trigemina; and personal fees from MedicoLegal work, UptoDate, Oxford University Press, Massachusetts Medical Society and Wolters Kluwer; and a patent magnetic stimulation for headache assigned to eNeura without fee. Within the last 12 months, DWD reports personal fees from Amgen, lder, Allergan, Autonomic Technologies, Biohaven, Eli Lilly, eNeura, Foresight Capital, Neurolief, Zosano, WL Gore, Vedanta Associates, Promius Pharma, Nocira, Novartis, Electrocore, Teva, Ipsen, Impel, Satsuma, Charleston Laboratories and Theranica; compensation for activities related to data safety monitoring committee from Axsome; compensation related to CME content development: HealthLogiX, Medicom Worldwide, MedLogix Communications, MedNet, Miller Medical Communications, PeerView Operation Services America, WebMD/Medscape, American Academy of Neurology, American Headache Society, PeerView Institute for Medical Education, Chameleon Communications, Academy for Continued Healthcare Learning, Universal Meeting Management, Haymarket Medical Education, Global Scientific Communications, UpToDate and Meeting LogiX; royalties from editorial or book publishing: Oxford University Press, Cambridge University Press, Wiley-Blackwell, Sage and Wolters Kluwer Health; consulting use agreement through employer: Neuro Assessment Systems and Myndshft; holds equity in Aural Analytics, Healint, Theranica, Second Opinion/Mobile Health and Epien; and board of directors position: King-Devick Technologies and Ontologics.

    • Patient consent for publication Not required.

    • Ethics approval The study was approved by the appropriate institutional review board for each study site.

    • Provenance and peer review Not commissioned; externally peer reviewed.