Reduction in ocrelizumab-induced infusion reactions by a modified premedication protocol

Mult Scler Relat Disord. 2019 Jan;27:397-399. doi: 10.1016/j.msard.2018.11.027. Epub 2018 Nov 27.

Abstract

Background: Ocrelizumab is a monoclonal antibody directed against CD20+ B cells that is approved for MS. The most common side effect is infusion-associated reactions (IARs). This study examines whether a modified premedication protocol reduces incidence of IARs and further examines predictors of IARs.

Methods: Patients took cetirizine 10 mg, ranitidine 75 mg, and increased hydration the night before the ocrelizumab infusion. This regimen was repeated the next day prior to arrival. Just prior to the infusion, patients were pretreated with IV diphenhydramine 50 mg, IV methylprednisolone 125 mg, and oral acetaminophen 650 mg. Rates of IARs with this modified protocol were compared to patients who had received only pretreatment medications.

Results: 207 patients received ocrelizumab. With the modified premedication protocol, we found significant decreased odds of IARs (OR 0.40, p = 0.024, 95% CI (0.18, 0.88). Among the baseline characteristics, there was a significant reduction of IARs with increasing age (OR 0.94, p = 0.001) and male sex (OR 0.34, p = 0.034). Body mass index (BMI) increased the odds of IARs (OR 1.07, p = 0.029). Race and smoking status did not affect IARs.

Conclusion: The modified premedication protocol described herein significantly decreases rates of IARs by 60% and suggests that the additional premedication regimen is beneficial. Age and male sex are protective for IARs while BMI is a risk factor for IARs.

Keywords: B-cells; Immunomodulation; Infusion reactions; Multiple sclerosis; Ocrelizumab.

MeSH terms

  • Acetaminophen / administration & dosage
  • Administration, Intravenous
  • Adult
  • Age Factors
  • Anti-Inflammatory Agents / administration & dosage
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Antibodies, Monoclonal, Humanized / adverse effects*
  • Body Mass Index
  • Cetirizine / administration & dosage
  • Diphenhydramine / administration & dosage
  • Female
  • Humans
  • Immunologic Factors / administration & dosage*
  • Immunologic Factors / adverse effects*
  • Male
  • Methylprednisolone / administration & dosage
  • Middle Aged
  • Multiple Sclerosis / drug therapy*
  • Premedication*
  • Ranitidine / administration & dosage
  • Sex Factors
  • Treatment Outcome
  • Young Adult

Substances

  • Anti-Inflammatory Agents
  • Antibodies, Monoclonal, Humanized
  • Immunologic Factors
  • Acetaminophen
  • Ranitidine
  • Diphenhydramine
  • ocrelizumab
  • Methylprednisolone
  • Cetirizine