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Safety and patient experience with at‐home infusion of ocrelizumab for multiple sclerosis

OBJECTIVE: This study aimed to evaluate safety (infusion‐related reactions [IRRs]) and patient satisfaction (patient‐reported outcomes [PROs]) for at‐home ocrelizumab administration for patients with multiple sclerosis (MS). METHODS: This open‐label study included adult patients with an MS diagnosis...

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Autores principales: Barrera, Britney, Simpson, Haley, Engebretson, Eric, Sillau, Stefan, Valdez, Brooke, Parra‐González, José, Winger, Ryan C., Epperson, Lou Anne, Banks, Ashley, Pierce, Kathryn, Spotts, Melanie, O'Gean, Katie, Alvarez, Enrique, Gross, Robert, Piquet, Amanda L., Schreiner, Teri, Corboy, John R., Pei, Jinglan, Vollmer, Timothy L., Nair, Kavita V.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10109340/
https://www.ncbi.nlm.nih.gov/pubmed/36811392
http://dx.doi.org/10.1002/acn3.51745
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author Barrera, Britney
Simpson, Haley
Engebretson, Eric
Sillau, Stefan
Valdez, Brooke
Parra‐González, José
Winger, Ryan C.
Epperson, Lou Anne
Banks, Ashley
Pierce, Kathryn
Spotts, Melanie
O'Gean, Katie
Alvarez, Enrique
Gross, Robert
Piquet, Amanda L.
Schreiner, Teri
Corboy, John R.
Pei, Jinglan
Vollmer, Timothy L.
Nair, Kavita V.
author_facet Barrera, Britney
Simpson, Haley
Engebretson, Eric
Sillau, Stefan
Valdez, Brooke
Parra‐González, José
Winger, Ryan C.
Epperson, Lou Anne
Banks, Ashley
Pierce, Kathryn
Spotts, Melanie
O'Gean, Katie
Alvarez, Enrique
Gross, Robert
Piquet, Amanda L.
Schreiner, Teri
Corboy, John R.
Pei, Jinglan
Vollmer, Timothy L.
Nair, Kavita V.
author_sort Barrera, Britney
collection PubMed
description OBJECTIVE: This study aimed to evaluate safety (infusion‐related reactions [IRRs]) and patient satisfaction (patient‐reported outcomes [PROs]) for at‐home ocrelizumab administration for patients with multiple sclerosis (MS). METHODS: This open‐label study included adult patients with an MS diagnosis who had completed a ≥ 600‐mg ocrelizumab dose, had a patient‐determined disease steps score of 0 to 6 and had completed PROs. Eligible patients received a 600‐mg ocrelizumab home‐based infusion over 2 h, followed by 24‐h and 2‐week post‐infusion follow‐up calls. IRRs and adverse events (AEs) were documented during infusions and follow‐up calls. PROs were completed before and 2 weeks post infusion. RESULTS: Overall, 99 of 100 expected patients were included (mean [SD] age, 42.3 [7.7] years; 72.7% female; 91.9% White). The mean (SD) infusion time was 2.5 (0.6) hours, and 75.8% of patients completed their ocrelizumab infusion between 2 to 2.5 h. The IRR incidence rate was 25.3% (95% CI: 16.7%, 33.8%)—similar to other shorter ocrelizumab infusion studies—and all AEs were mild/moderate. In total, 66.7% of patients experienced AEs, including itch, fatigue, and grogginess. Patients reported significantly increased satisfaction with the at‐home infusion process and confidence in the care provided. Patients also reported a significant preference for at‐home infusion compared with prior infusion center experiences. INTERPRETATION: IRRs and AEs occurred at acceptable rates during in‐home infusions of ocrelizumab over a shorter infusion time. Patients reported increased confidence and comfort with the home infusion process. Findings from this study provide evidence of the safety and feasibility of home‐based ocrelizumab infusion over a shorter infusion period.
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spelling pubmed-101093402023-04-18 Safety and patient experience with at‐home infusion of ocrelizumab for multiple sclerosis Barrera, Britney Simpson, Haley Engebretson, Eric Sillau, Stefan Valdez, Brooke Parra‐González, José Winger, Ryan C. Epperson, Lou Anne Banks, Ashley Pierce, Kathryn Spotts, Melanie O'Gean, Katie Alvarez, Enrique Gross, Robert Piquet, Amanda L. Schreiner, Teri Corboy, John R. Pei, Jinglan Vollmer, Timothy L. Nair, Kavita V. Ann Clin Transl Neurol Research Articles OBJECTIVE: This study aimed to evaluate safety (infusion‐related reactions [IRRs]) and patient satisfaction (patient‐reported outcomes [PROs]) for at‐home ocrelizumab administration for patients with multiple sclerosis (MS). METHODS: This open‐label study included adult patients with an MS diagnosis who had completed a ≥ 600‐mg ocrelizumab dose, had a patient‐determined disease steps score of 0 to 6 and had completed PROs. Eligible patients received a 600‐mg ocrelizumab home‐based infusion over 2 h, followed by 24‐h and 2‐week post‐infusion follow‐up calls. IRRs and adverse events (AEs) were documented during infusions and follow‐up calls. PROs were completed before and 2 weeks post infusion. RESULTS: Overall, 99 of 100 expected patients were included (mean [SD] age, 42.3 [7.7] years; 72.7% female; 91.9% White). The mean (SD) infusion time was 2.5 (0.6) hours, and 75.8% of patients completed their ocrelizumab infusion between 2 to 2.5 h. The IRR incidence rate was 25.3% (95% CI: 16.7%, 33.8%)—similar to other shorter ocrelizumab infusion studies—and all AEs were mild/moderate. In total, 66.7% of patients experienced AEs, including itch, fatigue, and grogginess. Patients reported significantly increased satisfaction with the at‐home infusion process and confidence in the care provided. Patients also reported a significant preference for at‐home infusion compared with prior infusion center experiences. INTERPRETATION: IRRs and AEs occurred at acceptable rates during in‐home infusions of ocrelizumab over a shorter infusion time. Patients reported increased confidence and comfort with the home infusion process. Findings from this study provide evidence of the safety and feasibility of home‐based ocrelizumab infusion over a shorter infusion period. John Wiley and Sons Inc. 2023-02-22 /pmc/articles/PMC10109340/ /pubmed/36811392 http://dx.doi.org/10.1002/acn3.51745 Text en © 2023 The Authors. Annals of Clinical and Translational Neurology published by Wiley Periodicals LLC on behalf of American Neurological Association. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Articles
Barrera, Britney
Simpson, Haley
Engebretson, Eric
Sillau, Stefan
Valdez, Brooke
Parra‐González, José
Winger, Ryan C.
Epperson, Lou Anne
Banks, Ashley
Pierce, Kathryn
Spotts, Melanie
O'Gean, Katie
Alvarez, Enrique
Gross, Robert
Piquet, Amanda L.
Schreiner, Teri
Corboy, John R.
Pei, Jinglan
Vollmer, Timothy L.
Nair, Kavita V.
Safety and patient experience with at‐home infusion of ocrelizumab for multiple sclerosis
title Safety and patient experience with at‐home infusion of ocrelizumab for multiple sclerosis
title_full Safety and patient experience with at‐home infusion of ocrelizumab for multiple sclerosis
title_fullStr Safety and patient experience with at‐home infusion of ocrelizumab for multiple sclerosis
title_full_unstemmed Safety and patient experience with at‐home infusion of ocrelizumab for multiple sclerosis
title_short Safety and patient experience with at‐home infusion of ocrelizumab for multiple sclerosis
title_sort safety and patient experience with at‐home infusion of ocrelizumab for multiple sclerosis
topic Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10109340/
https://www.ncbi.nlm.nih.gov/pubmed/36811392
http://dx.doi.org/10.1002/acn3.51745
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