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No “Wearing‐Off Effect” Seen in Quarterly or Monthly Dosing of Fremanezumab: Subanalysis of a Randomized Long‐Term Study
OBJECTIVE: To evaluate whether quarterly or monthly administration of fremanezumab for migraine prevention exhibits a pattern of decreased efficacy toward the end of the dosing interval (wearing‐off effect). BACKGROUND: The main goals of migraine preventive treatment are to reduce the frequency, sev...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756709/ https://www.ncbi.nlm.nih.gov/pubmed/33009665 http://dx.doi.org/10.1111/head.13994 |
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author | Blumenfeld, Andrew M. Stevanovic, Darko M. Ortega, Mario Cohen, Joshua M. Seminerio, Michael J. Yang, Ronghua Jiang, Bo Tepper, Stewart J. |
author_facet | Blumenfeld, Andrew M. Stevanovic, Darko M. Ortega, Mario Cohen, Joshua M. Seminerio, Michael J. Yang, Ronghua Jiang, Bo Tepper, Stewart J. |
author_sort | Blumenfeld, Andrew M. |
collection | PubMed |
description | OBJECTIVE: To evaluate whether quarterly or monthly administration of fremanezumab for migraine prevention exhibits a pattern of decreased efficacy toward the end of the dosing interval (wearing‐off effect). BACKGROUND: The main goals of migraine preventive treatment are to reduce the frequency, severity, and duration of migraine attacks, and migraine‐associated disability. Wearing‐off refers to the phenomenon whereby clinical symptoms return or worsen before the next dose of a drug is due and has been reported previously with migraine preventive medications. DESIGN AND METHODS: This was a long‐term, 12‐month, multicenter, randomized, double‐blind, parallel‐group phase 3 study (NCT02638103) that included chronic (CM) and episodic migraine (EM) patients who rolled over from the 12‐week phase 3 HALO CM (NCT02621931) and EM trials (NCT02629861), as well as an additional subset of 312 new patients. Patients with CM or EM received fremanezumab either monthly or quarterly. In this post hoc analysis, for selected months, the difference in the average number of migraine days between weeks 1‐2 and weeks 3‐4, between weeks 1‐3 and week 4, and between weeks 1‐2 and weeks 11‐12 were calculated. RESULTS: A total of 1890 patients (CM, 1110; EM, 780) were enrolled. At months 3, 6, 9, and 15, there were no substantial differences in mean weekly migraine days between weeks 1‐2 and weeks 3‐4 or between weeks 1‐3 and week 4 with quarterly or monthly fremanezumab in the CM or EM subgroups. There were no substantial increases in mean weekly migraine days between weeks 1‐2 and weeks 11‐12 during the first quarter of treatment (months 1‐3) or the second quarter of treatment (months 4‐6) with quarterly or monthly fremanezumab in the CM or EM subgroups. Across both dosing subgroups in CM and EM patients, the mean weekly number of migraine days decreased substantially (30%‐42%) during the first 2 weeks; decreases in weekly migraine days remained steady during the last 2 weeks of the first quarter, with a similar maintenance of response during the second quarter. CONCLUSIONS: This analysis of data from a long‐term, phase 3 study showed that patients receiving quarterly fremanezumab or monthly fremanezumab did not experience a wearing‐off effect toward the end of the dosing interval. |
format | Online Article Text |
id | pubmed-7756709 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-77567092020-12-28 No “Wearing‐Off Effect” Seen in Quarterly or Monthly Dosing of Fremanezumab: Subanalysis of a Randomized Long‐Term Study Blumenfeld, Andrew M. Stevanovic, Darko M. Ortega, Mario Cohen, Joshua M. Seminerio, Michael J. Yang, Ronghua Jiang, Bo Tepper, Stewart J. Headache Research Submissions OBJECTIVE: To evaluate whether quarterly or monthly administration of fremanezumab for migraine prevention exhibits a pattern of decreased efficacy toward the end of the dosing interval (wearing‐off effect). BACKGROUND: The main goals of migraine preventive treatment are to reduce the frequency, severity, and duration of migraine attacks, and migraine‐associated disability. Wearing‐off refers to the phenomenon whereby clinical symptoms return or worsen before the next dose of a drug is due and has been reported previously with migraine preventive medications. DESIGN AND METHODS: This was a long‐term, 12‐month, multicenter, randomized, double‐blind, parallel‐group phase 3 study (NCT02638103) that included chronic (CM) and episodic migraine (EM) patients who rolled over from the 12‐week phase 3 HALO CM (NCT02621931) and EM trials (NCT02629861), as well as an additional subset of 312 new patients. Patients with CM or EM received fremanezumab either monthly or quarterly. In this post hoc analysis, for selected months, the difference in the average number of migraine days between weeks 1‐2 and weeks 3‐4, between weeks 1‐3 and week 4, and between weeks 1‐2 and weeks 11‐12 were calculated. RESULTS: A total of 1890 patients (CM, 1110; EM, 780) were enrolled. At months 3, 6, 9, and 15, there were no substantial differences in mean weekly migraine days between weeks 1‐2 and weeks 3‐4 or between weeks 1‐3 and week 4 with quarterly or monthly fremanezumab in the CM or EM subgroups. There were no substantial increases in mean weekly migraine days between weeks 1‐2 and weeks 11‐12 during the first quarter of treatment (months 1‐3) or the second quarter of treatment (months 4‐6) with quarterly or monthly fremanezumab in the CM or EM subgroups. Across both dosing subgroups in CM and EM patients, the mean weekly number of migraine days decreased substantially (30%‐42%) during the first 2 weeks; decreases in weekly migraine days remained steady during the last 2 weeks of the first quarter, with a similar maintenance of response during the second quarter. CONCLUSIONS: This analysis of data from a long‐term, phase 3 study showed that patients receiving quarterly fremanezumab or monthly fremanezumab did not experience a wearing‐off effect toward the end of the dosing interval. John Wiley and Sons Inc. 2020-10-28 2020 /pmc/articles/PMC7756709/ /pubmed/33009665 http://dx.doi.org/10.1111/head.13994 Text en © 2020 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Research Submissions Blumenfeld, Andrew M. Stevanovic, Darko M. Ortega, Mario Cohen, Joshua M. Seminerio, Michael J. Yang, Ronghua Jiang, Bo Tepper, Stewart J. No “Wearing‐Off Effect” Seen in Quarterly or Monthly Dosing of Fremanezumab: Subanalysis of a Randomized Long‐Term Study |
title | No “Wearing‐Off Effect” Seen in Quarterly or Monthly Dosing of Fremanezumab: Subanalysis of a Randomized Long‐Term Study |
title_full | No “Wearing‐Off Effect” Seen in Quarterly or Monthly Dosing of Fremanezumab: Subanalysis of a Randomized Long‐Term Study |
title_fullStr | No “Wearing‐Off Effect” Seen in Quarterly or Monthly Dosing of Fremanezumab: Subanalysis of a Randomized Long‐Term Study |
title_full_unstemmed | No “Wearing‐Off Effect” Seen in Quarterly or Monthly Dosing of Fremanezumab: Subanalysis of a Randomized Long‐Term Study |
title_short | No “Wearing‐Off Effect” Seen in Quarterly or Monthly Dosing of Fremanezumab: Subanalysis of a Randomized Long‐Term Study |
title_sort | no “wearing‐off effect” seen in quarterly or monthly dosing of fremanezumab: subanalysis of a randomized long‐term study |
topic | Research Submissions |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756709/ https://www.ncbi.nlm.nih.gov/pubmed/33009665 http://dx.doi.org/10.1111/head.13994 |
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