Background/Purpose: Rituximab, a chimeric monoclonal anti-CD20 antibody, is approved to be infused over 4 hours and 15 minutes (first infusion), and 3 hours and 15 minutes (second infusion) due to the potential for infusion reactions. The risk of infusion reactions has been shown to be the greatest with the first infusion. Previously we reported our experience with rapid rituximab infusion in 10 rheumatoid arthritis patients, receiving a total of 26 rapid infusions. We now report a current safety analysis of 28 patients receiving a total of 132 rapid infusions in a single rheumatology practice. The objective is to evaluate the safety, tolerability, and practicality of a rapid infusion protocol for rituximab in RA patients (n=28) in a single community setting.

Methods: Patients, who were prescribed rituximab for the treatment of moderate to severe RA, were recruited from October 2006 to November 2013 and given the opportunity to participate in the rapid infusion protocol. All patients provided written informed consent. Each treatment course consisted of 2 rituximab 1000 mg infusions given 2 weeks apart. The first infusion followed the conventional infusion schedule. Rapid infusion protocol was administered on the second and/or all subsequent infusions over 2 hours. All patients received premedication. Vital signs were recorded at baseline and at 15, 30, 60, 90, and 120 minutes.  

Results:  A total of 57 patients received rituximab infusions (280 infusions) from October 2006 to November 2013. Out of these, 50 patients with a diagnosis of rheumatoid arthritis met the criteria to be followed on the short infusion protocol. A total of 28 patients agreed to be followed on rapid rituximab protocol. 132 infusions were included in this analysis with the mean treatment interval of 9.4 months. 93% of the patient population had failed or were intolerant to prior TNF-alpha inhibitors and 7% were biologic naïve. A total of 7 infusion reactions were reported over 132 rapid rituximab infusions (28 patients), as compared to 8 infusion reactions over 148 conventional infusions (22 patients). There was no significant difference in the incidence of infusion reactions between rapid and conventional infusions (p=0.97). In both rapid and conventional infusions, no patients discontinued rituximab due to infusion related symptoms or reactions. Overall, all symptoms reported were mild and resolved within 24 hours after the infusion. No serious infections or serious adverse events were reported in either rapid or conventional infusion groups.

Conclusion: The current analysis provides reassurance that rapid rituximab infusion is safe and well tolerated. Our experience of administering this protocol over 7 years proves that rapid infusion is as safe as the conventional infusion. In addition to safety, patients reported greater satisfaction with the short infusion duration. This data and previously reported data on rapid infusion in rheumatoid arthritis patients assures physicians that this strategy can be safely implemented in a single community practice setting.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-of-rapid-rituximab-infusion-in-rheumatoid-arthritis-in-a-single-community-practice/