Adverse infusion reactions to rituximab in systemic lupus erythematosus: a retrospective analysis

Ashleigh Hennessey,David Isenberg,Maria Leandro,Joanna Lukawska,Geraldine Cambridge

doi:10.1186/s41927-019-0082-7

Abstract

BackgroundTo undertake a retrospective review of patients with SLE who had received Rituximab in order to determine the rates and associated patient characteristics of clinically significant adverse infusion reactions.MethodsA descriptive analysis was undertaken of each infusion reaction, which was then assessed using the clinical information available to hypothesise on the possible underlying mechanism(s).ResultsRecords of 136 SLE patients previously treated with 481 individual infusions of Rituximab were reviewed. A total of 22 patients (17.6%) had 28 (5.8% of total infusions) documented clinically significant adverse infusion reactions. Average age at first Rituximab infusion in patients without a reaction was 37 years (range 16–73) compared with 30 years (range 18–56) in those with a reaction. A high proportion of men (18.2%) experienced an infusion reaction. Severity and type of reaction varied. 6.4% of those who had a reaction were not retreated.ConclusionsWhile Rituximab remains an important tool in the treatment of SLE it is important to be aware that rates of infusion reactions may be more significant in SLE than in other diseases. A prospective study is required to better characterise the reactions.

Highlights

To undertake a retrospective review of patients with Systemic Lupus Erythematosus (SLE) who had received Rituximab in order to determine the rates and associated patient characteristics of clinically significant adverse infusion reactions
RTX is included in the National Health Service England Guidance for the management of SLE [7], British Society of Rheumatology (BSR) guidelines [8] and the American College of Rheumatology’s renal guidelines for use in SLE nephritis when conventional therapies have failed [9]
Five patients required more than two doses of RTX to achieve clinical response (2 cycles comprised of 3 infusions and 4 cycles comprised of 4 infusions)

Summary

Introduction

To undertake a retrospective review of patients with SLE who had received Rituximab in order to determine the rates and associated patient characteristics of clinically significant adverse infusion reactions. The Centre for Rheumatology at University College London (UCL)/University College London Hospitals (UCLH) introduced the treatment of Rituximab (RTX) for the treatment of SLE in 2000 [1]. The majority of this first cohort, were patients who had failed to respond to and/or had suffered unacceptable side-effects from conventional therapy. The positive effects of RTX in patients with SLE have been described by over 20 rheumatology/nephrology units internationally in openlabel trials and retrospective reviews of cohorts [2, 3], neither of the two major randomized clinical trials EXPLORER [4] (treating patients with non-lupus nephritis) and LUNAR [5] (which focused exclusively on patients with significant renal disease) met their primary end points [3, 6]. RTX is included in the National Health Service England Guidance for the management of SLE [7], BSR guidelines [8] and the American College of Rheumatology’s renal guidelines for use in SLE nephritis when conventional therapies have failed [9]

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