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Seasonal adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational GEPAT-SMART study
BACKGROUND: Little is known about whether tolerability and adherence to treatment can be influenced by weather and temperature conditions. The objective of this study was to assess monthly and seasonal adherence to and safety of sc IFN-β1a (Rebif®, Merck) in relapsing-remitting multiple sclerosis (R...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6218994/ https://www.ncbi.nlm.nih.gov/pubmed/30400884 http://dx.doi.org/10.1186/s12883-018-1179-0 |
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author | Deftereos, Spyros N. Koutlas, Evangelos Koutsouraki, Efrosini Kyritsis, Athanassios Papathanassopoulos, Panagiotis Fakas, Nikolaos Tsimourtou, Vaia Vlaikidis, Nikolaos Tavernarakis, Antonios Voumvourakis, Konstantinos Arvanitis, Michalis Sakellariou, Dimitrios DeLorenzo, Filippo |
author_facet | Deftereos, Spyros N. Koutlas, Evangelos Koutsouraki, Efrosini Kyritsis, Athanassios Papathanassopoulos, Panagiotis Fakas, Nikolaos Tsimourtou, Vaia Vlaikidis, Nikolaos Tavernarakis, Antonios Voumvourakis, Konstantinos Arvanitis, Michalis Sakellariou, Dimitrios DeLorenzo, Filippo |
author_sort | Deftereos, Spyros N. |
collection | PubMed |
description | BACKGROUND: Little is known about whether tolerability and adherence to treatment can be influenced by weather and temperature conditions. The objective of this study was to assess monthly and seasonal adherence to and safety of sc IFN-β1a (Rebif®, Merck) in relapsing-remitting multiple sclerosis (RRMS) patients using the RebiSmart® electronic autoinjector. METHODS: A multicentre, prospective observational study in Greece in adult RRMS patients with EDSS < 6, under Rebif®/RebiSmart® treatment for ≤6 weeks before enrollment. The primary endpoint was monthly, seasonal and annual adherence over 12 months (defined in text). Secondary endpoints included number of relapses, disability, adverse events. RESULTS: Sixty four patients enrolled and 47 completed all study visits (Per Protocol Set - PPS). Mean annual adherence was 97.93% ± 5.704 with no significant monthly or seasonal variations. Mean relapses in the pre- and post- treatment 12-months were 1.1 ± 0.47 and 0.2 ± 0.54 (p < 0.0001, PPS). 10 patients (22%) showed 3-month disability progression, 19 (40%) stabilization and 18 (38%) improvement. EDSS was not correlated to pre- (r = 0.024, p = 0.87) or post-treatment relapses (r = 0.022, p = 0.88). CONCLUSION: High adherence with no significant seasonal or weather variation was observed over 12 months. While the efficacy on relapses was consistent with published studies, we could not identify a relationship between relapses and disability. TRIAL REGISTRATION: Greek registry of non-interventional clinical trials ID: 200136, date of registration: February 18th, 2013. |
format | Online Article Text |
id | pubmed-6218994 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-62189942018-11-08 Seasonal adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational GEPAT-SMART study Deftereos, Spyros N. Koutlas, Evangelos Koutsouraki, Efrosini Kyritsis, Athanassios Papathanassopoulos, Panagiotis Fakas, Nikolaos Tsimourtou, Vaia Vlaikidis, Nikolaos Tavernarakis, Antonios Voumvourakis, Konstantinos Arvanitis, Michalis Sakellariou, Dimitrios DeLorenzo, Filippo BMC Neurol Research Article BACKGROUND: Little is known about whether tolerability and adherence to treatment can be influenced by weather and temperature conditions. The objective of this study was to assess monthly and seasonal adherence to and safety of sc IFN-β1a (Rebif®, Merck) in relapsing-remitting multiple sclerosis (RRMS) patients using the RebiSmart® electronic autoinjector. METHODS: A multicentre, prospective observational study in Greece in adult RRMS patients with EDSS < 6, under Rebif®/RebiSmart® treatment for ≤6 weeks before enrollment. The primary endpoint was monthly, seasonal and annual adherence over 12 months (defined in text). Secondary endpoints included number of relapses, disability, adverse events. RESULTS: Sixty four patients enrolled and 47 completed all study visits (Per Protocol Set - PPS). Mean annual adherence was 97.93% ± 5.704 with no significant monthly or seasonal variations. Mean relapses in the pre- and post- treatment 12-months were 1.1 ± 0.47 and 0.2 ± 0.54 (p < 0.0001, PPS). 10 patients (22%) showed 3-month disability progression, 19 (40%) stabilization and 18 (38%) improvement. EDSS was not correlated to pre- (r = 0.024, p = 0.87) or post-treatment relapses (r = 0.022, p = 0.88). CONCLUSION: High adherence with no significant seasonal or weather variation was observed over 12 months. While the efficacy on relapses was consistent with published studies, we could not identify a relationship between relapses and disability. TRIAL REGISTRATION: Greek registry of non-interventional clinical trials ID: 200136, date of registration: February 18th, 2013. BioMed Central 2018-11-06 /pmc/articles/PMC6218994/ /pubmed/30400884 http://dx.doi.org/10.1186/s12883-018-1179-0 Text en © The Author(s). 2018 Open Access This 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 Deftereos, Spyros N. Koutlas, Evangelos Koutsouraki, Efrosini Kyritsis, Athanassios Papathanassopoulos, Panagiotis Fakas, Nikolaos Tsimourtou, Vaia Vlaikidis, Nikolaos Tavernarakis, Antonios Voumvourakis, Konstantinos Arvanitis, Michalis Sakellariou, Dimitrios DeLorenzo, Filippo Seasonal adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational GEPAT-SMART study |
title | Seasonal adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational GEPAT-SMART study |
title_full | Seasonal adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational GEPAT-SMART study |
title_fullStr | Seasonal adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational GEPAT-SMART study |
title_full_unstemmed | Seasonal adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational GEPAT-SMART study |
title_short | Seasonal adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational GEPAT-SMART study |
title_sort | seasonal adherence to, and effectiveness of, subcutaneous interferon β-1a administered by rebismart® in patients with relapsing multiple sclerosis: results of the 1-year, observational gepat-smart study |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6218994/ https://www.ncbi.nlm.nih.gov/pubmed/30400884 http://dx.doi.org/10.1186/s12883-018-1179-0 |
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