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Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe
OBJECTIVE: To examine treatment utilization patterns and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine in routine clinical practice. BACKGROUND: Clinical trials support onabotulinumtoxinA for the prophylaxis of headache in patients with chronic migraine, but real-wo...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5734384/ https://www.ncbi.nlm.nih.gov/pubmed/28758415 http://dx.doi.org/10.1177/0333102417724150 |
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author | Matharu, Manjit Pascual, Julio Nilsson Remahl, Ingela Straube, Andreas Lum, Arlene Davar, Gudarz Odom, Dawn Bennett, Lee Proctor, Christina Gutierrez, Lia Andrews, Elizabeth Johannes, Catherine |
author_facet | Matharu, Manjit Pascual, Julio Nilsson Remahl, Ingela Straube, Andreas Lum, Arlene Davar, Gudarz Odom, Dawn Bennett, Lee Proctor, Christina Gutierrez, Lia Andrews, Elizabeth Johannes, Catherine |
author_sort | Matharu, Manjit |
collection | PubMed |
description | OBJECTIVE: To examine treatment utilization patterns and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine in routine clinical practice. BACKGROUND: Clinical trials support onabotulinumtoxinA for the prophylaxis of headache in patients with chronic migraine, but real-world data are limited. DESIGN/METHODS: A prospective, observational, post-authorization study in adult patients with chronic migraine treated with onabotulinumtoxinA. Data were collected at the first study injection and approximately every three months for ≤52 weeks for utilization and ≤64 weeks for safety data, and summarized using descriptive statistics. RESULTS: Eighty-five physicians (81% neurologists) at 58 practices in the United Kingdom, Germany, Spain, and Sweden participated and recruited 1160 patients (84.2% female, median age 46.6 years). At baseline, 85.8% of patients had physician diagnoses of chronic migraine/transformed migraine and reported an average of 11.3 (SD = 6.9) severe headache days per 28 days; 50.6% had previously used onabotulinumtoxinA for chronic migraine. A total of 4017 study treatments were observed. The median number of injection sites (n = 31) and total dose (155 U) were consistent across all treatment sessions, with a median 13.7 weeks observed between sessions. At least one treatment-related adverse event was reported by 291 patients (25.1%); the most frequently reported treatment-related adverse event was neck pain (4.4%). Most patients (74.4%) were satisfied/extremely satisfied with onabotulinumtoxinA treatment. CONCLUSIONS: Patient demographics/characteristics are consistent with published data on the chronic migraine population. Utilization of onabotulinumtoxinA treatment for chronic migraine appears to be consistent with the Summary of Product Characteristics and published PREEMPT injection paradigm. No new safety signals were identified. |
format | Online Article Text |
id | pubmed-5734384 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-57343842017-12-22 Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe Matharu, Manjit Pascual, Julio Nilsson Remahl, Ingela Straube, Andreas Lum, Arlene Davar, Gudarz Odom, Dawn Bennett, Lee Proctor, Christina Gutierrez, Lia Andrews, Elizabeth Johannes, Catherine Cephalalgia Original Articles OBJECTIVE: To examine treatment utilization patterns and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine in routine clinical practice. BACKGROUND: Clinical trials support onabotulinumtoxinA for the prophylaxis of headache in patients with chronic migraine, but real-world data are limited. DESIGN/METHODS: A prospective, observational, post-authorization study in adult patients with chronic migraine treated with onabotulinumtoxinA. Data were collected at the first study injection and approximately every three months for ≤52 weeks for utilization and ≤64 weeks for safety data, and summarized using descriptive statistics. RESULTS: Eighty-five physicians (81% neurologists) at 58 practices in the United Kingdom, Germany, Spain, and Sweden participated and recruited 1160 patients (84.2% female, median age 46.6 years). At baseline, 85.8% of patients had physician diagnoses of chronic migraine/transformed migraine and reported an average of 11.3 (SD = 6.9) severe headache days per 28 days; 50.6% had previously used onabotulinumtoxinA for chronic migraine. A total of 4017 study treatments were observed. The median number of injection sites (n = 31) and total dose (155 U) were consistent across all treatment sessions, with a median 13.7 weeks observed between sessions. At least one treatment-related adverse event was reported by 291 patients (25.1%); the most frequently reported treatment-related adverse event was neck pain (4.4%). Most patients (74.4%) were satisfied/extremely satisfied with onabotulinumtoxinA treatment. CONCLUSIONS: Patient demographics/characteristics are consistent with published data on the chronic migraine population. Utilization of onabotulinumtoxinA treatment for chronic migraine appears to be consistent with the Summary of Product Characteristics and published PREEMPT injection paradigm. No new safety signals were identified. SAGE Publications 2017-07-31 2017-12 /pmc/articles/PMC5734384/ /pubmed/28758415 http://dx.doi.org/10.1177/0333102417724150 Text en © International Headache Society 2017 http://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Original Articles Matharu, Manjit Pascual, Julio Nilsson Remahl, Ingela Straube, Andreas Lum, Arlene Davar, Gudarz Odom, Dawn Bennett, Lee Proctor, Christina Gutierrez, Lia Andrews, Elizabeth Johannes, Catherine Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe |
title | Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe |
title_full | Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe |
title_fullStr | Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe |
title_full_unstemmed | Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe |
title_short | Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe |
title_sort | utilization and safety of onabotulinumtoxina for the prophylactic treatment of chronic migraine from an observational study in europe |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5734384/ https://www.ncbi.nlm.nih.gov/pubmed/28758415 http://dx.doi.org/10.1177/0333102417724150 |
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