Sarah Stabler1,2,3, Jonathan Giovannelli1,2,3,4, David Launay1,2,3,4, Angélique Cotteau-Leroy5, Marion Heusele1,2, Guillaume Lefèvre1,2,6, Louis Terriou1,2, Marc Lambert1,2,3,4, Sylvain Dubucquoi3,4,6, Eric Hachulla1,2,3,4, Vincent Sobanski1,2,3,4. 1. University of Lille, Institute for Translational Research in Inflammation (INFINITE), Lille, France. 2. CHU Lille, Département de médecine interne et immunologie clinique, Lille, France. 3. Centre de Référence des Maladies Autoimmunes et Systémiques Rares du Nord et Nord-Ouest de France, Lille, France. 4. INSERM, U1286, Lille, France. 5. CHU Lille, Service de Pharmacie, Lille, France. 6. CHU Lille, Institut d'Immunologie, Lille, France.
Abstract
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.
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.
Authors: Balazs Odler; Martin Windpessl; Marcell Krall; Maria Steiner; Regina Riedl; Carina Hebesberger; Martin Ursli; Emanuel Zitt; Karl Lhotta; Marlies Antlanger; Daniel Cejka; Philipp Gauckler; Martin Wiesholzer; Marcus Saemann; Alexander R Rosenkranz; Kathrin Eller; Andreas Kronbichler Journal: Front Immunol Date: 2021-10-29 Impact factor: 7.561
Authors: Mario E Alamilla-Sanchez; Miguel A Alcala-Salgado; Cesar D Alonso-Bello; Gandhy T Fonseca-Gonzalez Journal: Int J Nephrol Renovasc Dis Date: 2021-12-11