Open AccessSafety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial
Author(s) -
Bermel Robert A.,
Waubant Emmanuelle,
Pardo Gabriel,
Bass Ann,
Repovic Pavle,
Newsome Scott,
Lindsey John W.,
Kile Deidre,
Pradhan Ashish,
Musch Bruno,
Zabeti Aram
Publication year - 2021
Publication title -
annals of clinical and translational neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.824
H-Index - 42
ISSN - 2328-9503
DOI - 10.1002/acn3.51310
Subject(s) - medicine , ocrelizumab , discontinuation , dysgeusia , multiple sclerosis , clinical trial , adverse effect , anesthesia , rituximab , lymphoma , psychiatry
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).