Comparison of one-bag and multibag desensitization protocols for the prevention of rituximab hypersensitivity

Abstract

Purpose: Rituximab is prone to infusion-related reactions, which commonly requires desensitization to maintain its administration. Conventional desensitization protocols are using multistep infusion by diluting solutions. However, the process of diluting drugs and stepwise delivery needs additional time and effort. The objective of this study was to investigate the safety and efficacy of a nondiluting, one-bag protocol of rituximab desensitization. Methods: A retrospective study was performed by reviewing the medical records of patients who underwent rituximab desensitization between 2009 and 2018. The completion rate, occurrence and severity of breakthrough reactions (BTR), and time required to complete the therapy were compared between one-bag protocol and multibag protocol. Results were analyzed by generalized estimation equation method, and odds ratios (ORs) of completion rate and BTR incidence were estimated. Results: Total 190 cases of desensitization therapy were performed in 49 patients; the incidence of BTR was 16.84% and the overall completion rate was 96.32%. No significant difference in completion rate was found (OR, 3.58; 95% confidence interval [CI], 0.79-16.38) and there was no significant difference in BTR incidence (OR, 0.81; 95% CI, 0.23-2.82) in one-bag protocol. BTR in the one-bag protocol tended to occur even through entire steps, whereas most of the BTR in the multibag protocol occurred at later steps of the process. The average time spent in the desensitization was 60 minutes shorter in the one-bag than the multibag protocol (258.15 minutes vs. 329.81 minutes, P< 0.001). Conclusion: One-bag desensitization protocol showed no significant difference in safety and efficiency compared to the conventional multibag protocol, with shortening the time required for completion. (

Desensitization for the prevention of drug hypersensitivity reactions

“…There were no statistically significant differences regarding the rate of completion or the incidence of BTRs compared to multi-bag methods, while the amount of time required for the preparation was significantly reduced. In addition, the incidence of BTR decreased in the later course of treatment, which was consistent with multi-bag protocols [43][44][45][46]. Therefore, it is anticipated that the one-bag protocol can replace the multiple-bag protocol, thus reducing time and effort, maintaining the stability of the agents, preventing erroneous dilutions, and reducing the risk of exposure of medical staff to antineoplastic agents.…”

“…To overcome these shortcomings, a one-bag protocol was proposed in which a single concentration was used and only the rate of administration was increased (Table 2) [43][44][45][46]. Successful completion of desensitization with a one-bag protocol has been reported for all platinum, taxane, and monoclonal antibodies.…”

Analysis of Breakthrough Reactions in 1,143 Desensitization Procedures in a Single Tertiary Hospital Using a One-Bag Desensitization Protocol

“…Sala-Cunill et al showed equivalent outcomes of efficacy (99% of success rate), tolerability, and safety in one-bag desensitization protocol from a 5-year experience (8). We also have previously reported that the efficacy and safety of one-bag desensitization protocol is not inferior to multi-bag protocol in taxane desensitization (14)(15)(16). The incidence of BTRs differed according to the type of drugs.…”

“…One-bag protocols without dilution have been recently reported with advantages of reduction in time and the risk of potential errors without compromising the safety, efficacy, and tolerability of the process (9)(10)(11)(12)(13). We have also designed one-bag desensitization protocols for antineoplastic agents that are non-inferior compared to multi-bag protocols (14)(15)(16) and have been applying the standardized one-bag protocol since 2018.…”