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Multicenter Study
. 2025 Apr 1;64(4):1989-1998.
doi: 10.1093/rheumatology/keae409.

Relapses and serious adverse events during rituximab maintenance therapy in ANCA-associated vasculitis: a multicentre retrospective study

Chrysoula G Gialouri  1   2 , Aglaia Chalkia  3 , Christos Koutsianas  1 , Katerina Chavatza  4 , Evangelia Argyriou  5 , Alexandros Panagiotopoulos  1 , Anastasios Karamanakos  6 , Aikaterini Dimouli  6 , Christina Tsalapaki  1 , Konstantinos Thomas  4 , Philippos Orfanos  2 , Pagona Lagiou  2 , George Katsikas  6 , Kyriaki Boki  5 , Dimitrios Boumpas  4 , Dimitrios Petras  3 , Dimitrios Vassilopoulos  1
Affiliations
Multicenter Study

Relapses and serious adverse events during rituximab maintenance therapy in ANCA-associated vasculitis: a multicentre retrospective study

Chrysoula G Gialouri et al. Rheumatology (Oxford). .

Abstract

Objectives: There are limited real-life data regarding the efficacy and safety of rituximab (RTX) as a remission maintenance agent in microscopic polyangiitis (MPA) and granulomatosis-with-polyangiitis (GPA). We aimed to estimate the incidence and risk factors for relapses, as well for serious adverse events (SAEs) in MPA/GPA patients during RTX maintenance.

Methods: A retrospective cohort of newly diagnosed/relapsing GPA/MPA patients who received RTX maintenance (≥1 RTX cycle, ≥6 months follow-up) following complete remission (BVAS version-3 = 0 plus prednisolone ≤7.5 mg/day) with induction regimens. SAEs included serious infections, COronaVIrus-Disease 2019 (COVID-19)-associated hospitalizations, deaths, cardiovascular events, malignancies and hypogammaglobulinemia. The incidence rates (IRs) and relapse-free survival were estimated through Kaplan-Meier plots. Cox regression was conducted to investigate factors associated with the time-to-relapse.

Results: A total of 101 patients were included: 48% females, 69% GPA, 53% newly diagnosed, median age 63 years. During follow-up (294.5 patient-years, median: 3 RTX cycles), 30 relapses (57% major) occurred among 24 patients (24%, IR 10.2/100 patient-years). Kidney involvement (adjusted hazard ratio/aHR: 0.20; 95% CI: 0.06-0.74, P = 0.016), prior induction with RTX plus CYC (vs RTX monotherapy: aHR = 0.02; 95% CI: 0.001-0.43, P = 0.012) and shorter time interval until complete remission (aHR = 1.07; 95% CI: 1.01-1.14, P = 0.023) were associated with decreased relapse risk. We recorded 17 serious infections (IR 5.8/100 patient-years), 11 COVID-19-associated hospitalizations (IR 3.7/100 patient-years), 4 malignancies (IR 1.4/100 patient-years), 6 cardiovascular events (IR 2/100 patient-years) and 10 deaths (IR 3.4/100 patient-years).

Conclusion: In this real-world study, relapses during RTX maintenance occurred in approximately 1 out of 4 patients. Kidney involvement, induction with RTX plus CYC, and earlier achievement of complete remission were associated with lower relapse risk. The serious infections rate was consistent with previous reports, whereas an increased rate of COVID-19-associated hospitalizations was observed.

Keywords: ANCA-associated vasculitis; infections; maintenance; relapse; rituximab.

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Figures

Figure 1.
Figure 1.
A flow-chart depicting the therapeutic decisions after relapses during RTX-maintenance therapy. aI.m. GCs or increment of oral GCs dose. bContinuation of RTX-maintenance therapy as was scheduled without additional interventions. cFive relapses (three major and two minor) in five patients. Among the patients with major relapse, one patient achieved complete remission with RTX induction and then received a new RTX maintenance course, but the study ended before 6 months of follow-up, while the other two patients had not achieved complete remission with RTX induction by the end of the study. Both patients with minor relapse were lost to follow-up (one after relapse and the other after achievement of complete remission with GCs). RTX: rituximab; LFU: lost to follow-up; GCs: glucocorticoids
Figure 2.
Figure 2.
Relapse (major or minor)- and major relapse–free survival: (A) and (B) in the total cohort, and (C) and (D) according to kidney involvement
See this image and copyright information in PMC

References

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