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Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis

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...

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Autores principales: Goadsby, Peter J, Dodick, David W, Martinez, James M, Ferguson, Margaret B, Oakes, Tina M, Zhang, Qi, Skljarevski, Vladimir, Aurora, Sheena K
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6691875/
https://www.ncbi.nlm.nih.gov/pubmed/31004075
http://dx.doi.org/10.1136/jnnp-2018-320242
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author Goadsby, Peter J
Dodick, David W
Martinez, James M
Ferguson, Margaret B
Oakes, Tina M
Zhang, Qi
Skljarevski, Vladimir
Aurora, Sheena K
author_facet Goadsby, Peter J
Dodick, David W
Martinez, James M
Ferguson, Margaret B
Oakes, Tina M
Zhang, Qi
Skljarevski, Vladimir
Aurora, Sheena K
author_sort Goadsby, Peter J
collection PubMed
description 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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spelling pubmed-66918752019-08-26 Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis Goadsby, Peter J Dodick, David W Martinez, James M Ferguson, Margaret B Oakes, Tina M Zhang, Qi Skljarevski, Vladimir Aurora, Sheena K J Neurol Neurosurg Psychiatry Migraine 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. BMJ Publishing Group 2019-08 2019-04-19 /pmc/articles/PMC6691875/ /pubmed/31004075 http://dx.doi.org/10.1136/jnnp-2018-320242 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 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/.
spellingShingle Migraine
Goadsby, Peter J
Dodick, David W
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
title Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis
title_full Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis
title_fullStr Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis
title_full_unstemmed Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis
title_short Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis
title_sort onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis
topic Migraine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6691875/
https://www.ncbi.nlm.nih.gov/pubmed/31004075
http://dx.doi.org/10.1136/jnnp-2018-320242
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