Annals of Clinical and Translational Neurology (Mar 2021)

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

  • Robert A. Bermel,
  • Emmanuelle Waubant,
  • Gabriel Pardo,
  • Ann Bass,
  • Pavle Repovic,
  • Scott Newsome,
  • John W. Lindsey,
  • Deidre Kile,
  • Ashish Pradhan,
  • Bruno Musch,
  • Aram Zabeti

DOI
https://doi.org/10.1002/acn3.51310
Journal volume & issue
Vol. 8, no. 3
pp. 711 – 715

Abstract

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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).