Risk factors for severe infections in patients with rheumatoid arthritis treated with rituximab in the autoimmunity and rituximab registry
Open Access
- 31 August 2010
- journal article
- research article
- Published by Wiley in Arthritis & Rheumatism
- Vol. 62 (9), 2625-2632
- https://doi.org/10.1002/art.27555
Abstract
Objective The risk of severe infection is a crucial factor in the assessment of the short‐term risk:benefit ratio of biologic drugs in rheumatoid arthritis (RA). There is no increase in severe infections in RA patients treated with rituximab (RTX) in controlled trials, but this has not yet been assessed in daily practice. We undertook this study to investigate the occurrence of and risk factors for severe infections in off‐trial patients using data from the AutoImmunity and Rituximab (AIR) registry. Methods The AIR registry was set up by the French Society of Rheumatology. The charts of patients with severe infections were reviewed. Results Of the enrolled patients, 1,303 had at least 1 followup visit at 3 months or later, with a mean ± SD followup period of 1.2 ± 0.8 years (1,629 patient‐years). Eighty‐two severe infections occurred in 78 patients (5.0 severe infections per 100 patient‐years), half of them in the 3 months following the last RTX infusion. Multivariate analysis showed that chronic lung disease and/or cardiac insufficiency (odds ratio 3.0 [95% confidence interval 1.3–7.3], P = 0.01), extraarticular involvement (odds ratio 2.9 [95% confidence interval 1.3–6.7], P = 0.009), and low IgG level (P = 0.005) were significantly associated with increased risk of a severe infection. Conclusion The rate of severe infections in current practice is similar to that reported in clinical trials. The risk factors for severe infections include chronic lung and/or cardiac disease, extraarticular involvement, and low IgG before RTX treatment. This suggests that serum IgG should be checked and the risk:benefit ratio of RTX discussed for patients found to have low levels of IgG.This publication has 18 references indexed in Scilit:
- Progressive multifocal leukoencephalopathy after rituximab therapy in HIV-negative patients: a report of 57 cases from the Research on Adverse Drug Events and Reports projectBlood, 2009
- Time-dependent increase in risk of hospitalisation with infection among Swedish RA patients treated with TNF antagonistsAnnals Of The Rheumatic Diseases, 2007
- Serious infection following anti–tumor necrosis factor α therapy in patients with rheumatoid arthritis: Lessons from interpreting data from observational studiesArthritis & Rheumatism, 2007
- All-cause and cause-specific mortality in rheumatoid arthritis are not greater than expected when treated with tumour necrosis factor antagonistsAnnals Of The Rheumatic Diseases, 2007
- Rituximab for rheumatoid arthritis refractory to anti–tumor necrosis factor therapy: Results of a multicenter, randomized, double‐blind, placebo‐controlled, phase III trial evaluating primary efficacy and safety at twenty‐four weeksArthritis & Rheumatism, 2006
- Rates of serious infection, including site‐specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti–tumor necrosis factor therapy: Results from the British Society for Rheumatology Biologics RegisterArthritis & Rheumatism, 2006
- Anti-TNF Antibody Therapy in Rheumatoid Arthritis and the Risk of Serious Infections and MalignanciesJAMA, 2006
- The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: Results of a phase IIB randomized, double‐blind, placebo‐controlled, dose‐ranging trialArthritis & Rheumatism, 2006
- Predictors of infection in rheumatoid arthritisArthritis & Rheumatism, 2002
- Modified disease activity scores that include twenty-eight-joint counts development and validation in a prospective longitudinal study of patients with rheumatoid arthritisArthritis & Rheumatism, 1995