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Safety results of administering ocrelizumab per a shorter infusion protocol in patients with primary progressive and

Timothy L Vollmer1, Jeffrey A Cohen2, Enrique Alvarez1

  • 1Department of Neurology, Rocky Mountain Multiple Sclerosis Center at Anschutz Medical Campus, University of Colorado Denver, Denver, CO, USA.

Multiple Sclerosis and Related Disorders
|October 12, 2020
PubMed
Abstract

Insights

Shorter ocrelizumab infusions for multiple sclerosis (MS) are safe and effective. The SaROD study found similar infusion-related reaction rates compared to standard infusions, allowing for reduced administration times.

Area of Science:

  • Neurology
  • Immunology
  • Pharmacology

Background:

  • Ocrelizumab is an approved treatment for multiple sclerosis (MS).
  • Current administration involves lengthy infusions, impacting patient convenience.
  • The SaROD study aimed to assess shorter infusion durations.

Purpose of the Study:

  • To evaluate the safety and tolerability of shorter-duration ocrelizumab infusions.
  • To compare infusion-related reaction (IRR) rates between standard and shortened infusion protocols.
  • To assess the feasibility of reducing ocrelizumab infusion times.

Main Methods:

  • Phase IIIb open-label SaROD study.
  • Two cohorts received ocrelizumab infusions over reduced timeframes (approx. 2 hours or 1.5 hours).
  • Primary endpoint: Grade 3-4 infusion-related reactions (IRRs) in Cohort 1; secondary endpoints included all grades of IRRs.

Main Results:

  • Mean infusion times were reduced by approximately 1.09 hours (Cohort 1) and 0.79 hours (Cohort 2).
  • Infusion-related reactions occurred in 36% of patients and were mild-to-moderate.
  • No Grade 3-4 IRRs, discontinuations, serious adverse events, or new safety signals were observed.

Conclusions:

  • Shorter-duration ocrelizumab infusions are associated with an acceptable safety profile.
  • The rate of infusion-related reactions was comparable to pivotal Phase III trials.
  • Reduced infusion times are feasible without compromising patient safety in MS treatment.
Keywords:
Infusion-related reactionOcrelizumabPrimary progressive multiple sclerosisRelapsing multiple sclerosisShorter infusion

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