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Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study
BACKGROUND: In a multicentre, single-arm, observational, phase IV study, we evaluated 24-week treatment adherence of relapsing multiple sclerosis (RMS) patients using an electronic auto-injection device (RebiSmart(®)) for subcutaneous injection of interferon (IFN) β-1a. METHODS: A total of 162 adult...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4782351/ https://www.ncbi.nlm.nih.gov/pubmed/26951043 http://dx.doi.org/10.1186/s13104-016-1948-z |
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author | Devonshire, Virginia A. Feinstein, Anthony Moriarty, Patrick |
author_facet | Devonshire, Virginia A. Feinstein, Anthony Moriarty, Patrick |
author_sort | Devonshire, Virginia A. |
collection | PubMed |
description | BACKGROUND: In a multicentre, single-arm, observational, phase IV study, we evaluated 24-week treatment adherence of relapsing multiple sclerosis (RMS) patients using an electronic auto-injection device (RebiSmart(®)) for subcutaneous injection of interferon (IFN) β-1a. METHODS: A total of 162 adult participants with RMS were enrolled into the study to use RebiSmart(®) to self-administer IFN β-1a 44 μg three times weekly for a maximum of 96 weeks. The number of administered injections was recorded in the electronic device log. Adherence to treatment was defined as the administration of ≥80 % of expected injections. Cognitive impairment and injection anxiety were assessed via questionnaires. RESULTS: Overall, 91.8 and 82.9 % of participants were adherent to treatment at weeks 12 and 24, respectively. By weeks 12 and 24, 8.2 and 13.9 % of participants had discontinued treatment. There were no statistically significant differences in adherence rates at weeks 12 and 24 according to cognitive impairment status or injection anxiety. By week 24, 69.9 % of participants were less fearful of injection than when they started the study. According to participant evaluations, the absence of a visible needle, comfort settings, and the calendar for tracking the injection schedule were all important features of the RebiSmart(®) injection system. At week 24, 99.3 % of participants reported that they would like to continue using RebiSmart(®) as their injector. CONCLUSIONS: RebiSmart(®) use is associated with high treatment adherence, as objectively assessed using electronic injection logs. Future research should examine if RebiSmart(®) use improves long-term treatment outcomes in RMS. This study was registered with ClinicalTrials.gov as NCT01128075, on May 20, 2010. |
format | Online Article Text |
id | pubmed-4782351 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-47823512016-03-09 Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study Devonshire, Virginia A. Feinstein, Anthony Moriarty, Patrick BMC Res Notes Research Article BACKGROUND: In a multicentre, single-arm, observational, phase IV study, we evaluated 24-week treatment adherence of relapsing multiple sclerosis (RMS) patients using an electronic auto-injection device (RebiSmart(®)) for subcutaneous injection of interferon (IFN) β-1a. METHODS: A total of 162 adult participants with RMS were enrolled into the study to use RebiSmart(®) to self-administer IFN β-1a 44 μg three times weekly for a maximum of 96 weeks. The number of administered injections was recorded in the electronic device log. Adherence to treatment was defined as the administration of ≥80 % of expected injections. Cognitive impairment and injection anxiety were assessed via questionnaires. RESULTS: Overall, 91.8 and 82.9 % of participants were adherent to treatment at weeks 12 and 24, respectively. By weeks 12 and 24, 8.2 and 13.9 % of participants had discontinued treatment. There were no statistically significant differences in adherence rates at weeks 12 and 24 according to cognitive impairment status or injection anxiety. By week 24, 69.9 % of participants were less fearful of injection than when they started the study. According to participant evaluations, the absence of a visible needle, comfort settings, and the calendar for tracking the injection schedule were all important features of the RebiSmart(®) injection system. At week 24, 99.3 % of participants reported that they would like to continue using RebiSmart(®) as their injector. CONCLUSIONS: RebiSmart(®) use is associated with high treatment adherence, as objectively assessed using electronic injection logs. Future research should examine if RebiSmart(®) use improves long-term treatment outcomes in RMS. This study was registered with ClinicalTrials.gov as NCT01128075, on May 20, 2010. BioMed Central 2016-03-08 /pmc/articles/PMC4782351/ /pubmed/26951043 http://dx.doi.org/10.1186/s13104-016-1948-z Text en © Devonshire et al. 2016 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. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article Devonshire, Virginia A. Feinstein, Anthony Moriarty, Patrick Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study |
title | Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study |
title_full | Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study |
title_fullStr | Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study |
title_full_unstemmed | Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study |
title_short | Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study |
title_sort | adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase iv study |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4782351/ https://www.ncbi.nlm.nih.gov/pubmed/26951043 http://dx.doi.org/10.1186/s13104-016-1948-z |
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