Risk factors for serious infections in ANCA-associated vasculitis.

Severe infections contribute to morbidity and mortality in antineutrophil cytoplasm antibody-associated vasculitis (AAV). This study aimed to identify risk factors associated with severe infections in participants of the Rituximab versus Cyclophosphamide for ANCA-Associated Vasculitis (RAVE) trial. Data on 197 patients recruited into the RAVE trial were analysed. Participants received either rituximab (RTX) or cyclophosphamide (CYC), followed by azathioprine (AZA). Clinical and laboratory data of patients with and without severe infections (≥grade 3, according to the Common Terminology Criteria for Adverse Events version 3.0) were compared. Risk factors for severe infections were investigated using Cox-regression models. Eighteen of 22 (82%) severe infections occurred within 6 months after trial entry, most commonly respiratory tract infections (15/22, 68%). At baseline, lower absolute numbers of CD19+ cells were observed in patients with severe infections either receiving RTX or CYC/AZA at baseline, while CD5+B and CD3+T cells did not differ between groups. In Cox-regression analysis, higher baseline serum immunoglobulin M levels were associated with the risk of severe infections, whereby a higher baseline total CD19+B cell number and prophylaxis against The use of low-dose TMP/SMX is associated with reduced risk of severe infections in patients with AAV treated with either RTX or CYC/AZA. Reduced B cell subpopulations at start of treatment might be a useful correlate of reduced immunocompetence.

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© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.

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Competing interests: BO received speaker fees and travel support from Otsuka. Fernando Fervenza reports receiving research grants from Genentech. PG reports receiving speaker fees from Otsuka and consulting fees from Vifor Pharma, UriSalt and Delta4. DG received consulting fees from ChemoCentryx, Aurinia and GSK. DJ has received research grants, consultancy or lecture fees from Amgen, Astra-Zeneca, BMS, Boehringer-Ingelheim, Chemocentryx, GSK, Kessai, NICE, Novartis, Otsuka, Roche/Genentech, Takeda, UCB and Vifor. AK reports receiving research grants from Vifor Pharma and Otsuka, speaking fees from Vifor Pharma, and Terumo BCT, and consulting fees from Vifor Pharma, Otsuka, UriSalt, Delta4 and Catalyst Biosciences.