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

Ann Clin Transl Neurol. 2021 Mar;8(3):711-715. doi: 10.1002/acn3.51310. Epub 2021 Feb 23.

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).

Publication types

  • Clinical Trial, Phase III
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Antibodies, Monoclonal, Humanized / adverse effects*
  • Female
  • Follow-Up Studies
  • Humans
  • Immunologic Factors / administration & dosage*
  • Immunologic Factors / adverse effects*
  • Male
  • Middle Aged
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Outcome Assessment, Health Care

Substances

  • Antibodies, Monoclonal, Humanized
  • Immunologic Factors
  • ocrelizumab

Grants and funding

This work was funded by Genentech grant .