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ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study
BACKGROUND: The ExtaviJect® 30G autoinjector was developed to facilitate parenteral self-administration of interferon beta-1b (Extavia®), a first-line disease-modifying therapy in patients with multiple sclerosis. Our aim was to assess patient compliance with treatment when using the autoinjector, p...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3832381/ https://www.ncbi.nlm.nih.gov/pubmed/24255602 http://dx.doi.org/10.2147/MDER.S52590 |
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author | Boeru, Gabriel Milanov, Ivan De Robertis, Francesca Kozubski, Wojciech Lang, Michael Rojas-Farreras, Sònia Tomlinson, Mark |
author_facet | Boeru, Gabriel Milanov, Ivan De Robertis, Francesca Kozubski, Wojciech Lang, Michael Rojas-Farreras, Sònia Tomlinson, Mark |
author_sort | Boeru, Gabriel |
collection | PubMed |
description | BACKGROUND: The ExtaviJect® 30G autoinjector was developed to facilitate parenteral self-administration of interferon beta-1b (Extavia®), a first-line disease-modifying therapy in patients with multiple sclerosis. Our aim was to assess patient compliance with treatment when using the autoinjector, patients’ and nurses’ experiences of using the device, its tolerability, and patient satisfaction. METHODS: This was a 12-week, real-world, prospective, observational, noninterventional study conducted in nine European countries. Questionnaires were used to measure patient compliance and to assess patients’ and nurses’ experiences. All adverse events were recorded by severity, including injection site reactions or pain. Patient satisfaction and health-related quality of life were assessed using the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) and EuroQol-5 Dimension (EQ-5D) instruments, respectively. RESULTS: Of 582 patients enrolled, 568 (98%) received at least one injection and attended the first follow-up visit at 6 weeks, and 542 (93%) attended the second follow-up visit at 12 weeks. For the whole study, 548 of 568 (97%) patients were compliant with treatment. Among the various questions assessing whether the device was easy and quick to use accurately, without fear of the needle, 56%–98% of patients and 59%–98% of nurses were in agreement. There were nine serious adverse events (four disease-related) reported among the 227 (39%) patients reporting adverse events. Scores increased in the TSQM-9 convenience domain between weeks 6 and 12 (P=0.0009), and in the EQ-5D visual analog scale between baseline and week 12 (P<0.0001), indicating improvement in health-related quality of life. CONCLUSION: ExtaviJect 30G was convenient to use and was associated with high levels of compliance. |
format | Online Article Text |
id | pubmed-3832381 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-38323812013-11-19 ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study Boeru, Gabriel Milanov, Ivan De Robertis, Francesca Kozubski, Wojciech Lang, Michael Rojas-Farreras, Sònia Tomlinson, Mark Med Devices (Auckl) Original Research BACKGROUND: The ExtaviJect® 30G autoinjector was developed to facilitate parenteral self-administration of interferon beta-1b (Extavia®), a first-line disease-modifying therapy in patients with multiple sclerosis. Our aim was to assess patient compliance with treatment when using the autoinjector, patients’ and nurses’ experiences of using the device, its tolerability, and patient satisfaction. METHODS: This was a 12-week, real-world, prospective, observational, noninterventional study conducted in nine European countries. Questionnaires were used to measure patient compliance and to assess patients’ and nurses’ experiences. All adverse events were recorded by severity, including injection site reactions or pain. Patient satisfaction and health-related quality of life were assessed using the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) and EuroQol-5 Dimension (EQ-5D) instruments, respectively. RESULTS: Of 582 patients enrolled, 568 (98%) received at least one injection and attended the first follow-up visit at 6 weeks, and 542 (93%) attended the second follow-up visit at 12 weeks. For the whole study, 548 of 568 (97%) patients were compliant with treatment. Among the various questions assessing whether the device was easy and quick to use accurately, without fear of the needle, 56%–98% of patients and 59%–98% of nurses were in agreement. There were nine serious adverse events (four disease-related) reported among the 227 (39%) patients reporting adverse events. Scores increased in the TSQM-9 convenience domain between weeks 6 and 12 (P=0.0009), and in the EQ-5D visual analog scale between baseline and week 12 (P<0.0001), indicating improvement in health-related quality of life. CONCLUSION: ExtaviJect 30G was convenient to use and was associated with high levels of compliance. Dove Medical Press 2013-11-15 /pmc/articles/PMC3832381/ /pubmed/24255602 http://dx.doi.org/10.2147/MDER.S52590 Text en © 2013 Boeru et al. This work is published by Dove Medical Press Ltd, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Ltd, provided the work is properly attributed. |
spellingShingle | Original Research Boeru, Gabriel Milanov, Ivan De Robertis, Francesca Kozubski, Wojciech Lang, Michael Rojas-Farreras, Sònia Tomlinson, Mark ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study |
title | ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study |
title_full | ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study |
title_fullStr | ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study |
title_full_unstemmed | ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study |
title_short | ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study |
title_sort | extaviject® 30g device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective european study |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3832381/ https://www.ncbi.nlm.nih.gov/pubmed/24255602 http://dx.doi.org/10.2147/MDER.S52590 |
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