Vasculitis & polymyalgia rheumatica

Maintenance of remission of antineutrophil cytoplasmic antibody (ANCA) vasculitis by rituximab based on B cell repopulation versus serological flare: a randomised trial

Ann Rheum DisPublished Randomised controlled trial

Authors' conclusion

Rituximab dosed for B cell repopulation results in fewer clinical relapses than when dosed for a rise in ANCA level in maintenance of remission for ANCA vasculitis. Overall safety was equivalent; SAEs due to COVID-19 and rituximab exposure were higher with the B cell strategy.

Study context

Population
Patients with ANCA vasculitis in remission after completing at least 2 years of fixed-schedule RTXmedian follow-up 4.1 years
Participants
115 patients
Comparison
RTX reinfused upon B cell repopulation vs upon significant rise in ANCA level
Primary endpoint
Clinical relapse, defined as a modified BVAS/WG >0
Follow-up
36 months
Methodological detailsprospective, single-centre, open-label
  • Prospective
  • Single-centre
  • Open-label

Primary result

As reported in the abstract

Clinical relapse (Kaplan-Meier) · 3 years after study entry

Log-rank p=0.045

Secondary outcomes

OutcomeB cellANCAP value
RTX exposure, infusions per person · median follow-up 4.1 yearsmean 3.6 (SD 2.4) infusions (3.6 g)mean 0.5 (SD 1.4) infusions (0.5 g)P < 0.001

Safety

OutcomeP value
SAEs due to COVID-19Higher in the B cell armP = 0.049

Total serious adverse events (SAEs), including infectious SAEs, and deaths

Did not differ

Original publication

Maintenance of remission of ANCA vasculitis by rituximab based on B cell repopulation versus serological flare: a randomised trial. Ann Rheum Dis. Published 15 February 2024. doi:10.1136/ard-2023-224489

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