Incidence of serious infections in patients with ANCA-associated vasculitis receiving immunosuppressive therapy: A systematic review and meta-analysis

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Abstract

Introduction

Rituximab and azathioprine are used to induce or maintain remission in patients with ANCA-associated vasculitis (AAV). We evaluated the incidence of serious infections and infection-related deaths in patients with AAV treated with rituximab and azathioprine, during the maintenance of remission period.

Methods

We searched PubMed and EMBASE for randomized clinical trials (RCTs) and observational studies evaluating immunosuppressive agents in patients with AAV. We defined serious or severe infections according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The study was registered on PROSPERO (CRD42022366269).

Results

From 1,265 abstracts, we identified 21 studies (7 RCTs and 14 observational), with relevant data. We included data from 1,284 and 2,938 individuals for assessment in our primary and secondary outcomes, respectively. The overall cumulative incidence of serious infections was 15.99% (CI 95%: 6.95–27.53%) during the total follow-up period (induction and maintenance) and 7.62% (CI 95%: 4.43–11.43%) during the maintenance period. Additionally, we found a 0.49% overall case fatality rate (CI 95%: 0.02–1.37%) and a 0.09% infection-related mortality rate (CI 95%: 0.00–0.51%) during maintenance treatment. Notably, we found a 14.61% (CI 95%: 10.19–19.61%) cumulative incidence of serious infections among patients who received rituximab and a 5.93% (CI 95%: 1.19–13.26%) cumulative incidence of serious infections among patients who received azathioprine during maintenance. Moreover, the cumulative incidence of serious infections during the total follow-up period (induction and maintenance) was 20.81% (CI 95%:4.56–43.70%) for the combination of cyclophosphamide and azathioprine and 14.12% (CI 95%: 5.20–26.00%) for rituximab.

Discussion

The cumulative incidence of serious infections during total follow-up and maintenance was within expected limits, while fatal infections during maintenance treatment were uncommon. Additionally, treatment with rituximab for both induction and maintenance did not exceed the anticipated by previous studies incidence of serious infections. Clinical practice and long-term follow up data are needed to corroborate these findings.

Systematic review registration

Identifier: PROSPERO (CRD42022366269).

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Most cited references 67

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The PRISMA 2020 statement: an updated guideline for reporting systematic reviews

Matthew J L Page, Joanne E McKenzie, Patrick Bossuyt … (2027)

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.

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Measuring inconsistency in meta-analyses.

Julian P T Higgins, Simon G Thompson, Jonathan J Deeks … (2003)

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RoB 2: a revised tool for assessing risk of bias in randomised trials

Jonathan A C Sterne, Jelena Savović, Matthew J L Page … (2023)

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Author and article information

Contributors

Athanasios Vassilopoulos: URI : http://loop.frontiersin.org/people/2139938/overview

Stephanos Vassilopoulos: URI : http://loop.frontiersin.org/people/2139979/overview

Markos Kalligeros: URI : http://loop.frontiersin.org/people/2181660/overview

Fadi Shehadeh: URI : http://loop.frontiersin.org/people/1988798/overview

Eleftherios Mylonakis: URI : http://loop.frontiersin.org/people/97872/overview

Journal

Journal ID (nlm-ta): Front Med (Lausanne)

Journal ID (iso-abbrev): Front Med (Lausanne)

Journal ID (publisher-id): Front. Med.

Title: Frontiers in Medicine

Publisher: Frontiers Media S.A.

ISSN (Electronic): 2296-858X

Publication date (Electronic): 01 March 2023

Publication date Collection: 2023

Volume: 10

Electronic Location Identifier: 1110548

Affiliations

[1] ¹Infectious Diseases Division, Rhode Island Hospital , Providence, RI, United States

[2] ²Warren Alpert Medical School of Brown University , Providence, RI, United States

[3] ³School of Electrical and Computer Engineering, National Technical University of Athens , Athens, Greece

Author notes

Edited by: Smaragdi Marinaki, Laiko General Hospital of Athens, Greece

Reviewed by: Aglaia Chalkia, University of Cambridge, United Kingdom; George E. Fragoulis, Laiko General Hospital of Athens, Greece

*Correspondence: Eleftherios Mylonakis emylonakis@ 123456lifespan.org

This article was submitted to Rheumatology, a section of the journal Frontiers in Medicine

Article

DOI: 10.3389/fmed.2023.1110548

PMC ID: 10014619

PubMed ID: 36936221

SO-VID: d762f1d0-7fda-42d5-9dc3-9245cebf219f

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

History

Date received : 28 November 2022

Date accepted : 13 February 2023

Page count

Figures: 6, Tables: 3, Equations: 0, References: 68, Pages: 15, Words: 8122

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Incidence of serious infections in patients with ANCA-associated vasculitis receiving immunosuppressive therapy: A systematic review and meta-analysis

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Abstract

Introduction

Methods

Results

Discussion

Systematic review registration

Related collections

Road 2 Open Meta

Most cited references 67

The PRISMA 2020 statement: an updated guideline for reporting systematic reviews

Measuring inconsistency in meta-analyses.

RoB 2: a revised tool for assessing risk of bias in randomised trials

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Cited by 3

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