Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial

The CHORDS trial evaluated ocrelizumab (OCR) in patients with relapsing‐remitting multiple sclerosis who had a suboptimal response to previous disease‐modifying treatment. The objective of the present study was to assess the safety of shorter OCR infusions in a substudy of CHORDS. After completing f...

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Autores principales: Bermel, Robert A., Waubant, Emmanuelle, Pardo, Gabriel, Bass, Ann, Repovic, Pavle, Newsome, Scott, Lindsey, John W., Kile, Deidre, Pradhan, Ashish, Musch, Bruno, Zabeti, Aram
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Brief Communications
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7951110/
https://www.ncbi.nlm.nih.gov/pubmed/33621404
http://dx.doi.org/10.1002/acn3.51310
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author Bermel, Robert A.
Waubant, Emmanuelle
Pardo, Gabriel
Bass, Ann
Repovic, Pavle
Newsome, Scott
Lindsey, John W.
Kile, Deidre
Pradhan, Ashish
Musch, Bruno
Zabeti, Aram
author_facet Bermel, Robert A.
Waubant, Emmanuelle
Pardo, Gabriel
Bass, Ann
Repovic, Pavle
Newsome, Scott
Lindsey, John W.
Kile, Deidre
Pradhan, Ashish
Musch, Bruno
Zabeti, Aram
author_sort Bermel, Robert A.
collection PubMed
description The CHORDS trial evaluated ocrelizumab (OCR) in patients with relapsing‐remitting multiple sclerosis who had a suboptimal response to previous disease‐modifying treatment. The objective of the present study was to assess the safety of shorter OCR infusions in a substudy of CHORDS. After completing four doses of OCR per initial US prescribing recommendations in the main study, participants in the substudy (N = 129) received a fifth dose over a 2‐h duration (vs. 3.5 h). Infusion‐related reactions occurred in 12.4% of patients. None were severe, life‐threatening or led to treatment discontinuation. Shorter infusion time did not change the safety profile of OCR. Clinicaltrials.gov (NCT0237856).
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spelling pubmed-79511102021-03-17 Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial Bermel, Robert A. Waubant, Emmanuelle Pardo, Gabriel Bass, Ann Repovic, Pavle Newsome, Scott Lindsey, John W. Kile, Deidre Pradhan, Ashish Musch, Bruno Zabeti, Aram Ann Clin Transl Neurol Brief Communications The CHORDS trial evaluated ocrelizumab (OCR) in patients with relapsing‐remitting multiple sclerosis who had a suboptimal response to previous disease‐modifying treatment. The objective of the present study was to assess the safety of shorter OCR infusions in a substudy of CHORDS. After completing four doses of OCR per initial US prescribing recommendations in the main study, participants in the substudy (N = 129) received a fifth dose over a 2‐h duration (vs. 3.5 h). Infusion‐related reactions occurred in 12.4% of patients. None were severe, life‐threatening or led to treatment discontinuation. Shorter infusion time did not change the safety profile of OCR. Clinicaltrials.gov (NCT0237856). John Wiley and Sons Inc. 2021-02-23 /pmc/articles/PMC7951110/ /pubmed/33621404 http://dx.doi.org/10.1002/acn3.51310 Text en © 2021 The Authors. Annals of Clinical and Translational Neurology published by Wiley Periodicals LLC on behalf of American Neurological Association This is an open access article under the terms of the http://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 Brief Communications
Bermel, Robert A.
Waubant, Emmanuelle
Pardo, Gabriel
Bass, Ann
Repovic, Pavle
Newsome, Scott
Lindsey, John W.
Kile, Deidre
Pradhan, Ashish
Musch, Bruno
Zabeti, Aram
Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial
title Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial
title_full Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial
title_fullStr Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial
title_full_unstemmed Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial
title_short Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial
title_sort safety evaluation of shorter infusion for ocrelizumab in a substudy of the phase iiib chords trial
topic Brief Communications
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7951110/
https://www.ncbi.nlm.nih.gov/pubmed/33621404
http://dx.doi.org/10.1002/acn3.51310
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