Background
Rituximab (RTX) is widely administered to patients with autoimmune diseases (AID). This study aimed to estimate the incidence of serious infectious events (SIE) after RTX initiation in patients with AID. We also described the characteristics and risk factors of SIE, 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. SIE and IgRT were right-censored at 24 months after RTX initiation.
Results
Two hundred and 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 SIE were 17.3 (12.0-22.5) and 11.3 (8.1-14.5) per 100 person-years, respectively. Forty-seven SIE were observed, mostly comprising pneumonias (45%) and bacteremias (21%). When documented, the microorganisms were bacterial (55%) and fungal (12%). Identified risk factors of SIE 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%).
Conclusion
In patients with AID treated with RTX, the 1- and 2-year incidence of SIE were 17.3 and 11.3 per 100 person-years, respectively. Reports of SIE characteristics, risk factors and IgRT strategies highlights the need for an appropriate and individualized assessment prior to and following RTX to prevent SIE, particularly in patients with comorbidities.
This is the first study to show that optimization of IFX is more frequent and faster in obese and overweight patients with CD and occurs within 12 months after beginning IFX, suggesting that an induction regimen with higher doses of IFX and a tight control of IFX concentrations may be needed in these patients.
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