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Home infusions of natalizumab for people with multiple sclerosis: a pilot randomised crossover trial

OBJECTIVE: The delivery of healthcare at home has expanded to intravenous infusions of monoclonal antibodies. A recently developed model of care for home infusions of natalizumab for people with relapsing‐remitting multiple sclerosis was evaluated. This pilot study of home infusions of natalizumab a...

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Autores principales: Schultz, Timothy J., Thomas, Anne, Georgiou, Paul, Juaton, Mahasen S., Cusack, Lynette, Simon, Lorraine, Naidoo, Kerisha, Webb, Kevin, Karnon, Jonathan, Ravindran, Janakan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8351394/
https://www.ncbi.nlm.nih.gov/pubmed/34288591
http://dx.doi.org/10.1002/acn3.51410
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author Schultz, Timothy J.
Thomas, Anne
Georgiou, Paul
Juaton, Mahasen S.
Cusack, Lynette
Simon, Lorraine
Naidoo, Kerisha
Webb, Kevin
Karnon, Jonathan
Ravindran, Janakan
author_facet Schultz, Timothy J.
Thomas, Anne
Georgiou, Paul
Juaton, Mahasen S.
Cusack, Lynette
Simon, Lorraine
Naidoo, Kerisha
Webb, Kevin
Karnon, Jonathan
Ravindran, Janakan
author_sort Schultz, Timothy J.
collection PubMed
description OBJECTIVE: The delivery of healthcare at home has expanded to intravenous infusions of monoclonal antibodies. A recently developed model of care for home infusions of natalizumab for people with relapsing‐remitting multiple sclerosis was evaluated. This pilot study of home infusions of natalizumab and usual care (attendance in a hospital out‐patients’ clinic) compared safety, feasibility, patient satisfaction, effectiveness and costs. METHODS: In this randomised AB/BA crossover trial, 37 adults were randomised to usual care (n = 19) or home infusions (n = 18). After three infusions, patients crossed over to the alternate treatment for another three infusions. Patient safety outcomes and adherence, satisfaction, quality of life, disability and costs were compared. RESULTS: No adverse events were recorded from 207 infusions from 35 patients across both home and clinic infusions. There was no difference in adherence (p = 0.71) and infection rates (p = 0.84) between home and clinic settings. Satisfaction with “convenience” of home infusions was significantly greater (p = 0.008) but there were no differences in quality of life measures. Excluding pharmacy, costs were A$74 lower per infusion at home, including A$16 of patients” out‐of‐pocket costs. INTERPRETATION: There were no differences in safety and effectiveness between clinic and home infusions of natalizumab. The home infusions were shown to be feasible, more convenient and less expensive than usual care. Larger scale studies are required to verify these preliminary findings, particularly around safety and management of hypersensitivity adverse events in the home setting and for equivalence of clinical outcomes.
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spelling pubmed-83513942021-08-15 Home infusions of natalizumab for people with multiple sclerosis: a pilot randomised crossover trial Schultz, Timothy J. Thomas, Anne Georgiou, Paul Juaton, Mahasen S. Cusack, Lynette Simon, Lorraine Naidoo, Kerisha Webb, Kevin Karnon, Jonathan Ravindran, Janakan Ann Clin Transl Neurol Research Articles OBJECTIVE: The delivery of healthcare at home has expanded to intravenous infusions of monoclonal antibodies. A recently developed model of care for home infusions of natalizumab for people with relapsing‐remitting multiple sclerosis was evaluated. This pilot study of home infusions of natalizumab and usual care (attendance in a hospital out‐patients’ clinic) compared safety, feasibility, patient satisfaction, effectiveness and costs. METHODS: In this randomised AB/BA crossover trial, 37 adults were randomised to usual care (n = 19) or home infusions (n = 18). After three infusions, patients crossed over to the alternate treatment for another three infusions. Patient safety outcomes and adherence, satisfaction, quality of life, disability and costs were compared. RESULTS: No adverse events were recorded from 207 infusions from 35 patients across both home and clinic infusions. There was no difference in adherence (p = 0.71) and infection rates (p = 0.84) between home and clinic settings. Satisfaction with “convenience” of home infusions was significantly greater (p = 0.008) but there were no differences in quality of life measures. Excluding pharmacy, costs were A$74 lower per infusion at home, including A$16 of patients” out‐of‐pocket costs. INTERPRETATION: There were no differences in safety and effectiveness between clinic and home infusions of natalizumab. The home infusions were shown to be feasible, more convenient and less expensive than usual care. Larger scale studies are required to verify these preliminary findings, particularly around safety and management of hypersensitivity adverse events in the home setting and for equivalence of clinical outcomes. John Wiley and Sons Inc. 2021-07-21 /pmc/articles/PMC8351394/ /pubmed/34288591 http://dx.doi.org/10.1002/acn3.51410 Text en © 2021 The Authors. Annals of Clinical and Translational Neurology published by Wiley Periodicals LLC on behalf of American Neurological Association https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Research Articles
Schultz, Timothy J.
Thomas, Anne
Georgiou, Paul
Juaton, Mahasen S.
Cusack, Lynette
Simon, Lorraine
Naidoo, Kerisha
Webb, Kevin
Karnon, Jonathan
Ravindran, Janakan
Home infusions of natalizumab for people with multiple sclerosis: a pilot randomised crossover trial
title Home infusions of natalizumab for people with multiple sclerosis: a pilot randomised crossover trial
title_full Home infusions of natalizumab for people with multiple sclerosis: a pilot randomised crossover trial
title_fullStr Home infusions of natalizumab for people with multiple sclerosis: a pilot randomised crossover trial
title_full_unstemmed Home infusions of natalizumab for people with multiple sclerosis: a pilot randomised crossover trial
title_short Home infusions of natalizumab for people with multiple sclerosis: a pilot randomised crossover trial
title_sort home infusions of natalizumab for people with multiple sclerosis: a pilot randomised crossover trial
topic Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8351394/
https://www.ncbi.nlm.nih.gov/pubmed/34288591
http://dx.doi.org/10.1002/acn3.51410
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