Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial.
Robert A BermelEmmanuelle WaubantGabriel PardoAnn BassPavle RepovicScott NewsomeJohn W LindseyDeidre KileAshish PradhanBruno MuschAram ZabetiPublished in: Annals of clinical and translational neurology (2021)
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).
Keyphrases
- multiple sclerosis
- low dose
- end stage renal disease
- study protocol
- clinical trial
- primary care
- chronic kidney disease
- ejection fraction
- phase iii
- newly diagnosed
- randomized controlled trial
- emergency department
- rheumatoid arthritis
- disease activity
- clinical practice
- systemic lupus erythematosus
- peritoneal dialysis
- replacement therapy
- patient reported