Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine

A post-hoc analysis

Peter J. Goadsby, David William Dodick, James M. Martinez, Margaret B. Ferguson, Tina M. Oakes, Qi Zhang, Vladimir Skljarevski, Sheena K. Aurora

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
JournalJournal of Neurology, Neurosurgery and Psychiatry
DOIs
StatePublished - Jan 1 2019

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Migraine Disorders
Placebos
Therapeutics

Keywords

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

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology
  • Psychiatry and Mental health

Cite this

Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine : A post-hoc analysis. / Goadsby, Peter J.; Dodick, David William; Martinez, James M.; Ferguson, Margaret B.; Oakes, Tina M.; Zhang, Qi; Skljarevski, Vladimir; Aurora, Sheena K.

In: Journal of Neurology, Neurosurgery and Psychiatry, 01.01.2019.

Research output: Contribution to journalArticle

Goadsby, Peter J. ; Dodick, David William ; Martinez, James M. ; Ferguson, Margaret B. ; Oakes, Tina M. ; Zhang, Qi ; Skljarevski, Vladimir ; Aurora, Sheena K. / Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine : A post-hoc analysis. In: Journal of Neurology, Neurosurgery and Psychiatry. 2019.
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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.",
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T1 - Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine

T2 - A post-hoc analysis

AU - Goadsby, Peter J.

AU - Dodick, David William

AU - Martinez, James M.

AU - Ferguson, Margaret B.

AU - Oakes, Tina M.

AU - Zhang, Qi

AU - Skljarevski, Vladimir

AU - Aurora, Sheena K.

PY - 2019/1/1

Y1 - 2019/1/1

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AB - 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.

KW - calcitonin gene-related peptide

KW - CGRP

KW - clinical trial

KW - galcanezumab

KW - LY2951742

KW - migraine

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