Comparing the Risk of Infusion-Related Reactions and Tolerability in Patients Given Cetirizine or Diphenhydramine Prior to Ocrelizumab Infusion (PRECEPT)

Medicina (Kaunas). 2024 Apr 19;60(4):659. doi: 10.3390/medicina60040659.

Abstract

Background: Ocrelizumab is an effective medication for multiple sclerosis. However, infusion-related reactions (IRRs) are a concern for patients and may lead to discontinuation of ocrelizumab. To minimize IRRs, pre-medications are administered. However, from our experience, these medications, especially diphenhydramine, can cause marked drowsiness. The primary objective of this study was to evaluate whether cetirizine is non-inferior to diphenhydramine in limiting the proportion and severity of reactions from ocrelizumab infusions. Methods: Twenty participants were serially randomized in a 1:1 ratio to receive 10 mg of cetirizine or 25 mg of diphenhydramine orally prior to their first three ocrelizumab infusions. Results: The rate of IRRs in this study was similar across both treatment groups with no increase in the risk of severity, and no grade 3 IRRs. Further, patients receiving cetirizine experienced a reduction in fatigue. While there was not a significant difference in global satisfaction, this score increased over time in the cetirizine arm while it remained unchanged in the diphenhydramine arm. Conclusions: Overall, our results suggest that cetirizine does not increase the risk of infusion-related reactions compared to diphenhydramine.

Keywords: infusion reactions; multiple sclerosis; ocrelizumab; patient reported outcomes; pre-medication.

Publication types

  • Randomized Controlled Trial
  • Comparative Study

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized* / administration & dosage
  • Antibodies, Monoclonal, Humanized* / adverse effects
  • Antibodies, Monoclonal, Humanized* / therapeutic use
  • Cetirizine* / administration & dosage
  • Cetirizine* / adverse effects
  • Cetirizine* / therapeutic use
  • Diphenhydramine* / administration & dosage
  • Diphenhydramine* / therapeutic use
  • Female
  • Humans
  • Infusions, Intravenous / adverse effects
  • Male
  • Middle Aged
  • Multiple Sclerosis / drug therapy

Substances

  • Diphenhydramine
  • Cetirizine
  • Antibodies, Monoclonal, Humanized
  • ocrelizumab

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