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

Robert A. Bermel; Emmanuelle Waubant; Gabriel Pardo; Ann Bass; Pavle Repovic; Scott Newsome; John W. Lindsey; Deidre Kile; Ashish Pradhan; Bruno Musch; Aram Zabeti

doi:10.1002/acn3.51310

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

Robert A. Bermel, Emmanuelle Waubant, Gabriel Pardo, Ann Bass, Pavle Repovic, Scott Newsome, John W. Lindsey, Deidre Kile, Ashish Pradhan, Bruno Musch, Aram Zabeti

School of Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

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).

Original language	English (US)
Pages (from-to)	711-715
Number of pages	5
Journal	Annals of Clinical and Translational Neurology
Volume	8
Issue number	3
DOIs	https://doi.org/10.1002/acn3.51310
State	Published - Mar 2021

ASJC Scopus subject areas

General Neuroscience
Clinical Neurology

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title = "Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial",

abstract = "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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AU - Bermel, Robert A.

AU - Waubant, Emmanuelle

AU - Pardo, Gabriel

AU - Bass, Ann

AU - Repovic, Pavle

AU - Newsome, Scott

AU - Lindsey, John W.

AU - Kile, Deidre

AU - Pradhan, Ashish

AU - Musch, Bruno

AU - Zabeti, Aram

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

Abstract

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