Abstract
Background/AimsThe Japanese National Hospital Organization evidence-based medicine (EBM) Study group for Adverse effects of Corticosteroid therapy (J-NHOSAC) is a Japanese hospital-based cohort study investigating the safety of the initial use of glucocorticoids (GCs) in patients with newly diagnosed autoimmune diseases. Using the J-NHOSAC registry, the purpose of this observational study is to analyse the rates, characteristics and associated risk factors of intracellular infections in patients with newly diagnosed autoimmune diseases who were initially treated with GCs.Methodology/Principal FindingsA total 604 patients with newly diagnosed autoimmune diseases treated with GCs were enrolled in this registry between April 2007 and March 2009. Cox proportional-hazards regression was used to determine independent risk factors for serious intracellular infections with covariates including sex, age, co-morbidity, laboratory data, use of immunosuppressants and dose of GCs. Survival was analysed according to the Kaplan-Meier method and was assessed by the log-rank test. There were 127 serious infections, including 43 intracellular infections, during 1105.8 patient-years of follow-up. The 43 serious intracellular infections resulted in 8 deaths. After adjustment for covariates, diabetes (Odds ratio [OR]: 2.5, 95% confidence interval [95% CI] 1.1–5.9), lymphocytopenia (≦1000/μl, OR: 2.5, 95% CI 1.2–5.2) and use of high-dose (≧30 mg/day) GCs (OR: 2.4, 95% CI 1.1–5.3) increased the risk of intracellular infections. Survival curves showed lower intracellular infection-free survival rate in patients with diabetes, lymphocytopaenia and high-dose GCs treatments.Conclusions/SignificancePatients with newly diagnosed autoimmune diseases were at high risk of developing intracellular infection during initial treatment with GCs. Our findings provide background data on the risk of intracellular infections of patients with autoimmune diseases. Clinicians showed remain vigilant for intracellular infections in patients with autoimmune diseases who are treated with GCs.
Highlights
Despite the considerable benefits of glucocorticoids (GCs) in controlling serious inflammation and improving the functional status of a plethora of disorders [1], serious adverse effects dampen the enthusiasm for their use, long-term [2]
The Japanese National Hospital Organization evidence-based medicine (EBM) Study group for Adverse effects of Corticosteroid therapy (J-NHOSAC) is a Japanese non-interventional prospective study, based on a nationwide registry of severe adverse events (AEs) in newly diagnosed autoimmune disease patients treated with moderate doses of GCs in a clinical setting [10]. This original strategy can be used to determine the exact incidence of serious infections and their risk factors and using the J-NHOSAC registry we previously reported that infections were the most common AEs occurring in newly diagnosed autoimmune disease patients, who were initially treated with GCs [10]
Statistical analysis We identified the risk factors of intracellular infections by univariate and multivariate Cox-proportional hazard models analysis The variables included in the analysis were: age, sex, types of primary autoimmune diseases, comorbidities, medications and performance status (Karnofsky score) or laboratory data on entry
Summary
Despite the considerable benefits of glucocorticoids (GCs) in controlling serious inflammation and improving the functional status of a plethora of disorders [1], serious adverse effects dampen the enthusiasm for their use, long-term [2]. Bacterial and fungal infections are the most common serious infections occurring in patients receiving GCs [3], intracellular infections are a concern [4]. Moderate- to high-dose GC therapy leads to an increased risk of opportunistic infections, including intracellular infections [5,6]. There is little information regarding the rate of intracellular infection in a large series of patients receiving GCs in clinical practice. Most studies of GCs toxicity are retrospective and risk factors for intracellular infections have not been completely elucidated in prospective studies. There is a paucity of well-controlled studies detailing the infectious risks, concerning intracellular infections, and much of the information is in the form of case reports and literature reviews [8,9]. Many of these reports offer little detail regarding the dose or duration of GC administration
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