Serious Infectious Events and Immunoglobulin Replacement Therapy in Patients With Autoimmune Disease Receiving Rituximab: A Retrospective Cohort Study.


Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213

Informations de publication

Date de publication:
01 03 2021
Historique:
received: 17 07 2019
accepted: 09 02 2020
pubmed: 19 2 2020
medline: 29 4 2021
entrez: 19 2 2020
Statut: ppublish

Résumé

Rituximab (RTX) is widely administered to patients with autoimmune disease (AID). This study aimed to estimate the incidence of serious infectious events (SIEs) after RTX initiation in patients with AID. We also described the characteristics and risk factors of SIEs, and immunoglobulin replacement therapy (IgRT) strategies. Patients treated between 2005 and 2016 were included in this retrospective monocentric cohort study. An RTX course was defined as the complete RTX treatment regimen received by a given patient for AID. SIEs and IgRT were right-censored at 24 months after RTX initiation. Two hundred twenty-one patients were included (corresponding to 276 RTX courses). Reasons for RTX initiation included connective tissue disease (38%), systemic vasculitis (36%), and autoimmune cytopenia (22%). The 1- and 2-year incidences of SIEs were 17.3 (95% confidence interval [CI], 12.0-22.5) and 11.3 (95% CI, 8.1-14.5) per 100 person-years, respectively. Forty-seven SIEs were observed, mostly comprising pneumonias (45%) and bacteremias (21%). When documented, the microorganisms were bacterial (55%) and fungal (12%). Identified risk factors of SIEs were age, history of diabetes, history of cancer, concomitant steroid treatment, and low CD4 lymphocyte count at RTX initiation. IgRT was started in 22 RTX courses (8%). In patients with AID treated with RTX, the 1- and 2-year incidence of SIE was 17.3 and 11.3 per 100 person-years, respectively. Reports of SIE characteristics, risk factors, and IgRT strategies highlight the need for an appropriate and individualized assessment prior to and following RTX to prevent SIEs, particularly in patients with comorbidities.

Sections du résumé

BACKGROUND
Rituximab (RTX) is widely administered to patients with autoimmune disease (AID). This study aimed to estimate the incidence of serious infectious events (SIEs) after RTX initiation in patients with AID. We also described the characteristics and risk factors of SIEs, and immunoglobulin replacement therapy (IgRT) strategies.
METHODS
Patients treated between 2005 and 2016 were included in this retrospective monocentric cohort study. An RTX course was defined as the complete RTX treatment regimen received by a given patient for AID. SIEs and IgRT were right-censored at 24 months after RTX initiation.
RESULTS
Two hundred twenty-one patients were included (corresponding to 276 RTX courses). Reasons for RTX initiation included connective tissue disease (38%), systemic vasculitis (36%), and autoimmune cytopenia (22%). The 1- and 2-year incidences of SIEs were 17.3 (95% confidence interval [CI], 12.0-22.5) and 11.3 (95% CI, 8.1-14.5) per 100 person-years, respectively. Forty-seven SIEs were observed, mostly comprising pneumonias (45%) and bacteremias (21%). When documented, the microorganisms were bacterial (55%) and fungal (12%). Identified risk factors of SIEs were age, history of diabetes, history of cancer, concomitant steroid treatment, and low CD4 lymphocyte count at RTX initiation. IgRT was started in 22 RTX courses (8%).
CONCLUSIONS
In patients with AID treated with RTX, the 1- and 2-year incidence of SIE was 17.3 and 11.3 per 100 person-years, respectively. Reports of SIE characteristics, risk factors, and IgRT strategies highlight the need for an appropriate and individualized assessment prior to and following RTX to prevent SIEs, particularly in patients with comorbidities.

Identifiants

pubmed: 32067031
pii: 5739783
doi: 10.1093/cid/ciaa127
doi:

Substances chimiques

Rituximab 4F4X42SYQ6

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

727-737

Commentaires et corrections

Type : CommentIn

Informations de copyright

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Auteurs

Sarah Stabler (S)

University of Lille, Institute for Translational Research in Inflammation (INFINITE), Lille, France.
CHU Lille, Département de médecine interne et immunologie clinique, Lille, France.
Centre de Référence des Maladies Autoimmunes et Systémiques Rares du Nord et Nord-Ouest de France, Lille, France.

Jonathan Giovannelli (J)

University of Lille, Institute for Translational Research in Inflammation (INFINITE), Lille, France.
CHU Lille, Département de médecine interne et immunologie clinique, Lille, France.
Centre de Référence des Maladies Autoimmunes et Systémiques Rares du Nord et Nord-Ouest de France, Lille, France.
INSERM, U1286, Lille, France.

David Launay (D)

University of Lille, Institute for Translational Research in Inflammation (INFINITE), Lille, France.
CHU Lille, Département de médecine interne et immunologie clinique, Lille, France.
Centre de Référence des Maladies Autoimmunes et Systémiques Rares du Nord et Nord-Ouest de France, Lille, France.
INSERM, U1286, Lille, France.

Angélique Cotteau-Leroy (A)

CHU Lille, Service de Pharmacie, Lille, France.

Marion Heusele (M)

University of Lille, Institute for Translational Research in Inflammation (INFINITE), Lille, France.
CHU Lille, Département de médecine interne et immunologie clinique, Lille, France.

Guillaume Lefèvre (G)

University of Lille, Institute for Translational Research in Inflammation (INFINITE), Lille, France.
CHU Lille, Département de médecine interne et immunologie clinique, Lille, France.
CHU Lille, Institut d'Immunologie, Lille, France.

Louis Terriou (L)

University of Lille, Institute for Translational Research in Inflammation (INFINITE), Lille, France.
CHU Lille, Département de médecine interne et immunologie clinique, Lille, France.

Marc Lambert (M)

University of Lille, Institute for Translational Research in Inflammation (INFINITE), Lille, France.
CHU Lille, Département de médecine interne et immunologie clinique, Lille, France.
Centre de Référence des Maladies Autoimmunes et Systémiques Rares du Nord et Nord-Ouest de France, Lille, France.
INSERM, U1286, Lille, France.

Sylvain Dubucquoi (S)

Centre de Référence des Maladies Autoimmunes et Systémiques Rares du Nord et Nord-Ouest de France, Lille, France.
INSERM, U1286, Lille, France.
CHU Lille, Institut d'Immunologie, Lille, France.

Eric Hachulla (E)

University of Lille, Institute for Translational Research in Inflammation (INFINITE), Lille, France.
CHU Lille, Département de médecine interne et immunologie clinique, Lille, France.
Centre de Référence des Maladies Autoimmunes et Systémiques Rares du Nord et Nord-Ouest de France, Lille, France.
INSERM, U1286, Lille, France.

Vincent Sobanski (V)

University of Lille, Institute for Translational Research in Inflammation (INFINITE), Lille, France.
CHU Lille, Département de médecine interne et immunologie clinique, Lille, France.
Centre de Référence des Maladies Autoimmunes et Systémiques Rares du Nord et Nord-Ouest de France, Lille, France.
INSERM, U1286, Lille, France.

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