Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial.
Ann Clin Transl Neurol
seattle; washington; swedish neuro
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).
Neurosciences (Brain & Spine)
Bermel, Robert A; Waubant, Emmanuelle; Pardo, Gabriel; Bass, Ann; Repovic, P; Newsome, Scott; Lindsey, John W; Kile, Deidre; Pradhan, Ashish; Musch, Bruno; and Zabeti, Aram, "Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial." (2021). Articles, Abstracts, and Reports. 4443.