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Effects of onabotulinumtoxinA treatment in patients with and without allodynia: results of the COMPEL study

BACKGROUND: OnabotulinumtoxinA is effective in treating chronic migraine (CM), but there are limited data assessing how allodynia affects preventive treatment responses. This subanalysis of the 108-week, multicenter, open-label COMPEL Study assessed the efficacy and safety of onabotulinumtoxinA in p...

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Autores principales: Young, William B., Ivan Lopez, J., Rothrock, John F., Orejudos, Amelia, Manack Adams, Aubrey, Lipton, Richard B., Blumenfeld, Andrew M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Milan 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6734222/
https://www.ncbi.nlm.nih.gov/pubmed/30669961
http://dx.doi.org/10.1186/s10194-018-0952-1
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author Young, William B.
Ivan Lopez, J.
Rothrock, John F.
Orejudos, Amelia
Manack Adams, Aubrey
Lipton, Richard B.
Blumenfeld, Andrew M.
author_facet Young, William B.
Ivan Lopez, J.
Rothrock, John F.
Orejudos, Amelia
Manack Adams, Aubrey
Lipton, Richard B.
Blumenfeld, Andrew M.
author_sort Young, William B.
collection PubMed
description BACKGROUND: OnabotulinumtoxinA is effective in treating chronic migraine (CM), but there are limited data assessing how allodynia affects preventive treatment responses. This subanalysis of the 108-week, multicenter, open-label COMPEL Study assessed the efficacy and safety of onabotulinumtoxinA in people with CM with and without allodynia. METHODS: Patients (n = 715) were treated with onabotulinumtoxinA 155 U every 12 weeks for 9 treatment cycles. The Allodynia Symptom Checklist was used to identify patients with allodynia (scores ≥3). The primary outcome for this subanalysis was reduction in monthly headache days from baseline for weeks 105 to 108 in groups with and without allodynia. Other outcomes included assessments of moderate to severe headache days, disability (using the Migraine Disability Assessment [MIDAS] questionnaire), and health-related quality of life (Migraine-Specific Quality-of-Life Questionnaire [MSQ] v2). Adverse events and their relation to treatment were recorded. RESULTS: OnabotulinumtoxinA was associated with a significant mean (SD) reduction in headache day frequency at week 108 relative to baseline in patients with (n = 289) and without (n = 426) allodynia (− 10.8 [7.1] and − 12.5 [7.4], respectively; both P < 0.001) that was significantly greater in patients without allodynia (P = 0.044 between-subgroup comparison). Moderate to severe headache days were significantly reduced at week 108 in patients with and without allodynia (− 9.6 [6.9] and − 10.5 [7.2]; both P < 0.001); reduction was similar between groups. MIDAS scores improved significantly at week 108 (− 53.0 [50.3] and − 37.7 [53.0]; both P < 0.001), with a significant between-group difference in favor of those with allodynia (P = 0.005). Similarly, MSQ subscale scores (Role Function Preventive, Role Function Restrictive, Emotional Function) significantly improved at week 108 for patients with and without allodynia: 20.6 (21.9) and 16.9 (20.7), 28.0 (23.3) and 24.7 (22.7), and 27.6 (26.5) and 24.9 (26.1), respectively (all P < 0.001). OnabotulinumtoxinA was well tolerated in patients with and without allodynia. CONCLUSION: Results indicate that onabotulinumtoxinA is associated with reductions from baseline in multiple efficacy outcomes for up to 108 weeks whether or not allodynia is present. The allodynia group showed a smaller treatment response for reduction in headache days, but a similar or greater treatment response for improvement in other measures. No new safety concerns were identified. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s10194-018-0952-1) contains supplementary material, which is available to authorized users.
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spelling pubmed-67342222019-09-12 Effects of onabotulinumtoxinA treatment in patients with and without allodynia: results of the COMPEL study Young, William B. Ivan Lopez, J. Rothrock, John F. Orejudos, Amelia Manack Adams, Aubrey Lipton, Richard B. Blumenfeld, Andrew M. J Headache Pain Research Article BACKGROUND: OnabotulinumtoxinA is effective in treating chronic migraine (CM), but there are limited data assessing how allodynia affects preventive treatment responses. This subanalysis of the 108-week, multicenter, open-label COMPEL Study assessed the efficacy and safety of onabotulinumtoxinA in people with CM with and without allodynia. METHODS: Patients (n = 715) were treated with onabotulinumtoxinA 155 U every 12 weeks for 9 treatment cycles. The Allodynia Symptom Checklist was used to identify patients with allodynia (scores ≥3). The primary outcome for this subanalysis was reduction in monthly headache days from baseline for weeks 105 to 108 in groups with and without allodynia. Other outcomes included assessments of moderate to severe headache days, disability (using the Migraine Disability Assessment [MIDAS] questionnaire), and health-related quality of life (Migraine-Specific Quality-of-Life Questionnaire [MSQ] v2). Adverse events and their relation to treatment were recorded. RESULTS: OnabotulinumtoxinA was associated with a significant mean (SD) reduction in headache day frequency at week 108 relative to baseline in patients with (n = 289) and without (n = 426) allodynia (− 10.8 [7.1] and − 12.5 [7.4], respectively; both P < 0.001) that was significantly greater in patients without allodynia (P = 0.044 between-subgroup comparison). Moderate to severe headache days were significantly reduced at week 108 in patients with and without allodynia (− 9.6 [6.9] and − 10.5 [7.2]; both P < 0.001); reduction was similar between groups. MIDAS scores improved significantly at week 108 (− 53.0 [50.3] and − 37.7 [53.0]; both P < 0.001), with a significant between-group difference in favor of those with allodynia (P = 0.005). Similarly, MSQ subscale scores (Role Function Preventive, Role Function Restrictive, Emotional Function) significantly improved at week 108 for patients with and without allodynia: 20.6 (21.9) and 16.9 (20.7), 28.0 (23.3) and 24.7 (22.7), and 27.6 (26.5) and 24.9 (26.1), respectively (all P < 0.001). OnabotulinumtoxinA was well tolerated in patients with and without allodynia. CONCLUSION: Results indicate that onabotulinumtoxinA is associated with reductions from baseline in multiple efficacy outcomes for up to 108 weeks whether or not allodynia is present. The allodynia group showed a smaller treatment response for reduction in headache days, but a similar or greater treatment response for improvement in other measures. No new safety concerns were identified. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s10194-018-0952-1) contains supplementary material, which is available to authorized users. Springer Milan 2019-01-22 /pmc/articles/PMC6734222/ /pubmed/30669961 http://dx.doi.org/10.1186/s10194-018-0952-1 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Research Article
Young, William B.
Ivan Lopez, J.
Rothrock, John F.
Orejudos, Amelia
Manack Adams, Aubrey
Lipton, Richard B.
Blumenfeld, Andrew M.
Effects of onabotulinumtoxinA treatment in patients with and without allodynia: results of the COMPEL study
title Effects of onabotulinumtoxinA treatment in patients with and without allodynia: results of the COMPEL study
title_full Effects of onabotulinumtoxinA treatment in patients with and without allodynia: results of the COMPEL study
title_fullStr Effects of onabotulinumtoxinA treatment in patients with and without allodynia: results of the COMPEL study
title_full_unstemmed Effects of onabotulinumtoxinA treatment in patients with and without allodynia: results of the COMPEL study
title_short Effects of onabotulinumtoxinA treatment in patients with and without allodynia: results of the COMPEL study
title_sort effects of onabotulinumtoxina treatment in patients with and without allodynia: results of the compel study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6734222/
https://www.ncbi.nlm.nih.gov/pubmed/30669961
http://dx.doi.org/10.1186/s10194-018-0952-1
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