Objective: Systemic lupus erythematosus (SLE) is a complex disease with variable presentations, course and prognosis. We sought to develop evidence-based recommendations addressing the major issues in the management of SLE. Methods: The EULAR Task Force on SLE comprised 19 specialists and a clinical epidemiologist. Key questions for the management of SLE were compiled using the Delphi technique. A systematic search of PubMed and Cochrane Library Reports was performed using McMaster/Hedges clinical queries' strategies for questions related to the diagnosis, prognosis, monitoring and treatment of SLE. For neuropsychiatric, pregnancy and antiphospholipid syndrome questions, the search was conducted using an array of relevant terms. Evidence was categorised based on sample size and type of design, and the categories of available evidence were identified for each recommendation. The strength of recommendation was assessed based on the category of available evidence, and agreement on the statements was measured across the 19 specialists. Results: Twelve questions were generated regarding the prognosis, diagnosis, monitoring and treatment of SLE, including neuropsychiatric SLE, pregnancy, the antiphospholipid syndrome and lupus nephritis. The evidence to support each proposition was evaluated and scored. After discussion and votes, the final recommendations were presented using brief statements. The average agreement among experts was 8.8 out of 10. Conclusion: Recommendations for the management of SLE were developed using an evidence-based approach followed by expert consensus with high level of agreement among the experts.Approximately half a million people in Europe and a quarter of a million people in the USA (projections based on prevalence rates of 30-50 per 100 000) have systemic lupus erythematosus (SLE).1 The great majority of these patients are women in their childbearing years. SLE is a complex disease with variable presentations, course and prognosis characterised by remissions and flares.2 3 Because of the systemic nature of the disease, multiple medical specialties are involved in the care of these patients. To avoid fragmentation and optimise management, there is a presently unmet need to establish an integrated approach based on widely accepted principles and evidencebased recommendations.Recommendations and/or guidelines represent a popular way of integrating evidence-based medicine to clinical practice. These are systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances. 4 To this end and under the auspices of EULAR, we undertook the task of developing guidelines for the management of various aspects of SLE. To ensure a high level of intrinsic quality and comparability of this approach, we used the EULAR standard operating procedures. 5 We present here 12 key recommendations, selected from a panel of experts, for the management (diagnosis, treatment, monitoring) of SLE using a combination of research-based...
Modern immunosuppressive regimens reduce the acute rejection rate by combining a cornerstone immunosuppressant like tacrolimus or cyclosporine with adjunctive agents like corticosteroids, mycophenolate mofetil (MMF) or azathioprine, often associated with untoward side effects.A 6-month randomized study was conducted in 47 European centers. Triple therapy with tacrolimus (trough levels 5-15 ng/mL), corticosteroids (dosage 10 mg/day) and MMF (1 g/day) was administered for 3 months. From day 92, patients either continued with triple therapy (control, n = 277), or stopped steroids (n = 279), or stopped MMF (n = 277). Surrogate markers for long-term benefits were changes in lipid profiles and occurrence of hematological, gastrointestinal and infectious complications.The 6-month acute rejection incidence (biopsy-proven) was similar in all groups (17.0% vs. 15.1% vs. 14.8%, p = 0.744), although the incidence after month 3 was higher in the steroid stop group than in the two other groups. Mean reductions in total cholesterol In a study population of immunologically low-risk patients' withdrawal of corticosteroids or MMF from a tacrolimus-based therapy at 3 months was feasible. A longer follow-up will be needed to confirm the expected advantages for the long-term outcome and to assess the long-term safety of this minimization of immunosuppressive therapy.
This study was conducted to determine kidney transplantation (KTx) outcomes for Greek patients with renal failure caused by lupus nephritis (LN) compared with matched controls, kidney recipients with other causes of end-stage renal disease (ESRD). Twenty-six patients with systemic lupus erythematosus (SLE) subjected to 26 kidney transplants were studied. For comparative purposes a case-control group was selected, matched for gender, source of donor, age and time of KTx. Patient and graft survival estimates were calculated with the Kaplan-Meier product limit estimator and survival estimates were compared with the log-rank test. All patients received cyclosporine or tacrolimus in combination with azathioprine or mycophenolate mofetil for chronic immunosuppression in addition to steroids. Fourteen transplants were from living-related donors and 12 were from deceased donors. The graft survival rates for lupus patients were 88% at 1 year, 67% at 5 years, 38% at 10 years, poorer than the control survival rates of 92%, 92% and 84% (P=0.004). Patient survival in the lupus group did not differ from that of the controls. Survival in the lupus group was 92% at 1 year, 77% at 5 years and 77% at 10 years vs. 96%, 92% and 92% (P=0.26). Chronic allograft nephropathy was the major cause of graft loss. Recurrent LN was detected in two patients, but only one lead to graft failure. SLE patients compared with controls had significantly higher rates of hypertension, cardiovascular disease, infections and malignancies. Compared with matched controls, SLE patients had inferior but still satisfactory graft survival rates, whereas patient survival rates were similar.
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