A modified premedication protocol significantly reduces ocrelizumab-induced infusion reactions
Author(s): ,
W. Conte
Affiliations:
Dept of Neurology, The University of Chicago, Chicago, IL, United States
,
N. Arndt
Affiliations:
Dept of Neurology, The University of Chicago, Chicago, IL, United States
,
V. Cipriani
Affiliations:
Dept of Neurology, The University of Chicago, Chicago, IL, United States
,
A. Dellaria
Affiliations:
Dept of Neurology, The University of Chicago, Chicago, IL, United States
A. Javed
Affiliations:
Dept of Neurology, The University of Chicago, Chicago, IL, United States
ECTRIMS Online Library. Conte W. 10/10/18; 228460; P616
William Conte
William Conte
Contributions
Abstract

Abstract: P616

Type: Poster Sessions

Abstract Category: Therapy - Risk management for disease modifying treatments

Introduction: Ocrelizumab is a monoclonal antibody directed against CD20+ B cells that is approved for RRMS and PPMS. One of the known side effects is infusion reactions, which was reported to be 34-40% in the clinical trials.
In an attempt to decrease the occurrence of infusion reactions, a modified premedication protocol was implemented at The University of Chicago MS Center in addition to what is recommended in the PI. The night and morning prior to infusion, patients were instructed to take cetirizine 10mg and ranitidine 75mg, as well as adequate hydration. Immediately prior to the infusion, they received diphenhydramine 50mg, methylprednisolone 125mg, and acetaminophen 650mg.
Objectives: The primary objective was to compare whether addition of cetirizine, ranitidine, and hydration to standard of care further decreases chances of ocrelizumab-related infusion reactions. The secondary objective was to examine predictors of infusion reactions.
Methods: A retrospective chart review was undertaken to record age, race, smoking status, body mass index (BMI), and whether an individual was instructed to take the modified premedications for patients who received ocrelizumab at The University of Chicago. Presence of infusion reactions were ascertained by examining documentation by infusion nurses.
Results: 207 patients received ocrelizumab from the time the drug entered the market through April 2018. 110 patients were instructed to take the modified premedication protocol. There was a significant decrease in odds of infusion reactions with our modified premedication protocol (OR 0.40, p=0.02).
Among the patient characteristics, we found that age and male sex decreased odds (OR 0.94, p=0.001; OR 0.34, p=0.034), and BMI increased odds (OR 1.07, p=0.029) for infusion reactions. Race and smoking status did not have a statistically significant odds ratio.
Conclusion: A modification in the premedication protocol for ocrelizumab showed significant reductions in infusion-related reactions. We suggest that this should be more widely implemented. Our study also found that male sex and increasing age were protective against infusion reactions whereas increasing BMI was a risk factor for infusion reactions.
Disclosure: William L. Conte: Honorarium from Sanofi Genzyme
Nancy Arndt: Honoraria from Sanofi Genzyme, Bayer, Biogen, and Teva.
Veronica P. Cipriani: Honorarium from Genentech.
Andrea Dellaria: nothing to disclose.
Adil Javed: Honoraria from EMD-Serono, Sanofi-Genzyme, Novartis, Biogen, and Genentech.

Abstract: P616

Type: Poster Sessions

Abstract Category: Therapy - Risk management for disease modifying treatments

Introduction: Ocrelizumab is a monoclonal antibody directed against CD20+ B cells that is approved for RRMS and PPMS. One of the known side effects is infusion reactions, which was reported to be 34-40% in the clinical trials.
In an attempt to decrease the occurrence of infusion reactions, a modified premedication protocol was implemented at The University of Chicago MS Center in addition to what is recommended in the PI. The night and morning prior to infusion, patients were instructed to take cetirizine 10mg and ranitidine 75mg, as well as adequate hydration. Immediately prior to the infusion, they received diphenhydramine 50mg, methylprednisolone 125mg, and acetaminophen 650mg.
Objectives: The primary objective was to compare whether addition of cetirizine, ranitidine, and hydration to standard of care further decreases chances of ocrelizumab-related infusion reactions. The secondary objective was to examine predictors of infusion reactions.
Methods: A retrospective chart review was undertaken to record age, race, smoking status, body mass index (BMI), and whether an individual was instructed to take the modified premedications for patients who received ocrelizumab at The University of Chicago. Presence of infusion reactions were ascertained by examining documentation by infusion nurses.
Results: 207 patients received ocrelizumab from the time the drug entered the market through April 2018. 110 patients were instructed to take the modified premedication protocol. There was a significant decrease in odds of infusion reactions with our modified premedication protocol (OR 0.40, p=0.02).
Among the patient characteristics, we found that age and male sex decreased odds (OR 0.94, p=0.001; OR 0.34, p=0.034), and BMI increased odds (OR 1.07, p=0.029) for infusion reactions. Race and smoking status did not have a statistically significant odds ratio.
Conclusion: A modification in the premedication protocol for ocrelizumab showed significant reductions in infusion-related reactions. We suggest that this should be more widely implemented. Our study also found that male sex and increasing age were protective against infusion reactions whereas increasing BMI was a risk factor for infusion reactions.
Disclosure: William L. Conte: Honorarium from Sanofi Genzyme
Nancy Arndt: Honoraria from Sanofi Genzyme, Bayer, Biogen, and Teva.
Veronica P. Cipriani: Honorarium from Genentech.
Andrea Dellaria: nothing to disclose.
Adil Javed: Honoraria from EMD-Serono, Sanofi-Genzyme, Novartis, Biogen, and Genentech.

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