Lupus
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Randomized Controlled Trial Multicenter Study
Annexin A5 anticoagulant activity in children with systemic lupus erythematosus and the association with antibodies to domain I of β2-glycoprotein I.
Children with systemic lupus erythematosus (SLE) have a high prevalence of antiphospholipid (aPL) antibodies and are at increased risk for aPL-related thrombosis. We investigated the association between annexin A5 anticoagulant activity and antibodies to the domain I portion of β2-glycoprotein I (anti-DI antibodies), and propose a potential mechanism for the pathogenesis of aPL-related thrombosis. Using samples from 183 children with SLE collected during the Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) trial, we examined resistance to the anticoagulant effects of annexin A5, using the annexin A5 resistance (A5R) assay, and evaluated for anti-DI IgG antibodies. ⋯ Children with SLE and positive anti-DI antibodies had significantly lower mean A5R levels compared to those with negative anti-DI antibodies: mean A5R = 155 ± 24% versus 177 ± 30% (p < 0.0001). In multivariate analysis, anti-DI antibodies (p = 0.013) and lupus anticoagulant (LA) (p = 0.036) were both independently associated with reduced A5R. Children with SLE have significantly reduced annexin A5 anticoagulant activity that is associated with the presence of LA and anti-DI antibodies.
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy of mycophenolate mofetil in adolescent patients with lupus nephritis: evidence from a two-phase, prospective randomized trial.
The safety and efficacy of mycophenolate mofetil (MMF) were evaluated in adolescent patients with systemic lupus erythematosus and active or active/chronic class III-V lupus nephritis. During the 24-week induction phase, patients were randomized to oral MMF (target dose 3.0 g/day) or intravenous cyclophosphamide (IVC) (0.5-1.0 g/m(2)/month), plus prednisone. Response was defined as a decrease in 24-hour urine protein:creatinine ratio (P:Cr) to < 3 in patients with baseline nephrotic range proteinuria, or by ≥ 50% if subnephrotic baseline proteinuria, and stabilization (± 25%) or improvement in serum creatinine. ⋯ Seven patients withdrew (MMF, 2; AZA, 5). During both phases, rates of serious adverse events were similar in both arms. During both phases treatment response with MMF was as effective as the comparator.
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Multicenter Study
Influences on bone mineral density in Malaysian premenopausal systemic lupus erythematosus patients on corticosteroids.
The aim of this study was to assess the bone mineral density (BMD) of premenopausal patients with systemic lupus erythematosus (SLE) on corticosteroids (CS) and to determine the influence of CS and other risk factors on BMD. A total of 98 premenopausal patients with SLE were recruited from outpatient clinics in two teaching hospitals. Risk factors for osteoporosis were determined, and BMD was measured using dual-energy x-ray absorptiometry. ⋯ Only 52% of these patients had normal BMD. The duration and cumulative dose of CS intake was significantly correlated to BMD, but not the other commonly assessed risk factors. These findings suggest that premenopausal patients with SLE on CS should have their BMD measured at regular intervals to fully assess their osteoporosis risk.
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Multicenter Study
Systemic lupus erythematosus in three ethnic groups. XII. Risk factors for lupus nephritis after diagnosis.
The purpose of this study was to determine the cumulative incidence of lupus nephritis (LN) and the factors predictive of its occurrence in a multiethnic systemic lupus erythematosus (SLE) cohort. We studied 353 SLE patients as defined by the American College of Rheumatology (ACR) criteria (65 Hispanics, 93 African-Americans and 91 Caucasians). First, we determined the cumulative incidence of LN in all patients. ⋯ Repeated analyses excluding the patients with missing HLA data showed that absence of HLA-DQB1*0201 was also a significant predictor for the occurrence of LN (OR = 2.34, CL = 1.13-5.26, P < 0.04). In conclusion, LN occurred significantly more often in Hispanics and African-Americans with SLE. Sociodemographic, clinical and immunologic/immunogenetic factors seem to be predictive of LN occurring after the diagnosis of SLE has been made.
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Multicenter Study
Validity and reliability of retrospective assessment of disease activity and flare in observational cohorts of lupus patients.
The use of validated retrospective tools to assess disease activity in an observational cohort of patients would allow researchers the flexibility to analyze unique exploratory questions. Valid, reliable tools exist for assessing disease activity and flare for Systemic Lupus Erythematosus (SLE) patients. However, these tools have been designed for use in structured settings. Many of these populations under study are subject to strict inclusion, exclusion criteria and disease management protocols. The ability to apply these tools to populations not subject to such control would allow researchers to explore questions about unique populations, new treatment applications or predictors of clinical outcomes. This study sought to establish the reliability and validity of retrospective medical record abstraction of SLE disease activity and flare instruments by two rheumatologists. ⋯ These data suggest that investigators can reliably reproduce patient disease activity through retrospective chart abstraction using PGA and SLEDAI. Assessing flare is a more difficult concept. The validity of assessing flare at a specific patient-visit is poor. Retrospective assessment of patient flare risk over a specified time period is conceptually more valid and avoids difficulties assessing timing and duration of flare. As there have been no similar published prospective analyses of validity using the SELENA flare tool, it is not clear if this problem was unique to the method of retrospective chart abstraction, the nature of non-protocol study patient visits, the tool itself or a combination of all three aspects.