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Clinical Trial
. 2021 Mar;8(3):711-715.
doi: 10.1002/acn3.51310. Epub 2021 Feb 23.

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

Robert A Bermel  1 , Emmanuelle Waubant  2 , Gabriel Pardo  3 , Ann Bass  4 , Pavle Repovic  5 , Scott Newsome  6 , John W Lindsey  7 , Deidre Kile  8 , Ashish Pradhan  8 , Bruno Musch  8 , Aram Zabeti  9
Affiliations
Clinical Trial

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

Robert A Bermel et al. Ann Clin Transl Neurol. 2021 Mar.

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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Conflict of interest statement

R Bermel has received consulting fees from Biogen, EMD Serono, F. Hoffmann‐La Roche Ltd, Genentech, Inc., Genzyme, Novartis and Viela Bio. E Waubant is a site primary investigator for ongoing trials with Genentech and Biogen. She has received research funding from the National Institutes of Health, Patient‐Centered Outcomes. Research Institute, National Multiple Sclerosis Society and Race to Erase MS. She has received honoraria for lectures from Medscape, The Corpus and the American Association of Neurology, and for consulting work from Jazz Pharmaceuticals, Emerald and DBV. She is co‐chief editor for Multiple Sclerosis and Related Disorders. G Pardo has received consulting fees from and/or serves on the speaker’s bureau for Alexion, Biogen, Celgene/BMS, EMD Serono, Genentech, Inc., Novartis and Sanofi Genzyme. A Bass has served on advisory boards and/or speaker bureaus and received research funding from Actelion, Biogen, EMD Serono, F. Hoffmann‐La Roche Ltd, Genentech, Inc., Mallinckrodt, Novartis, Sanofi‐Genzyme and TG Therapeutics. P Repovic has received consulting or speaking honoraria from Alexion, Biogen, Celgene, EMD Serono, Genentech, Inc, Genzyme, Novartis, Teva, and Viela. S Newsome has participated in scientific advisory boards for Biogen, Genentech, Celgene, Novartis, and EMD Serono, and he is an advisor for the Gerson Lehrman Group, BioIncept, and Autobahn Therapeutics, and a clinical adjudication committee member for a MedDay Pharmaceuticals clinical trial. He has received grant/research funding (paid directly to institution) from Biogen, Genentech, Department of Defense, National MS Society, and the Patient Centered Outcomes Research Institute. J Lindsey has received personal compensation for speaking or consulting for EMD Serono, Celgene and Genzyme; is participating in clinical trials funded by Genentech, Inc., Biogen, Atara, EMD Serono and AbbVie; and has received research funding from the National Multiple Sclerosis Society and Genentech. D Kile is a contractor for Genentech, Inc. A Pradhan is an employee of Genentech, Inc., and a shareholder of F. Hoffmann‐La Roche Ltd. B Musch is an employee of Genentech, Inc., and a shareholder of F. Hoffmann‐La Roche Ltd. A Zabeti received honoraria for speakers’ bureaus or advisory councils from Acorda, Biogen, Celgene, Genentech, Inc., Genzyme/Sanofi, Novartis and Serono.

Figures

Figure 1
Figure 1
CHORDS study and shorter infusion substudy design.
See this image and copyright information in PMC

References

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