Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial.
Journal
Annals of clinical and translational neurology
ISSN: 2328-9503
Titre abrégé: Ann Clin Transl Neurol
Pays: United States
ID NLM: 101623278
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
received:
17
11
2020
accepted:
14
01
2021
pubmed:
24
2
2021
medline:
3
11
2021
entrez:
23
2
2021
Statut:
ppublish
Résumé
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).
Identifiants
pubmed: 33621404
doi: 10.1002/acn3.51310
pmc: PMC7951110
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Immunologic Factors
0
ocrelizumab
A10SJL62JY
Types de publication
Clinical Trial, Phase III
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
711-715Informations de copyright
© 2021 The Authors. Annals of Clinical and Translational Neurology published by Wiley Periodicals LLC on behalf of American Neurological Association.
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