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The efficacy and safety of abatacept in patients with non,life-threatening manifestations of systemic lupus erythematosus: Results of a twelve-month, multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled trial,

ARTHRITIS & RHEUMATISM, Issue 10 2010
J. T. Merrill
Objective To evaluate abatacept therapy in patients with non,life-threatening systemic lupus erythematosus (SLE) and polyarthritis, discoid lesions, or pleuritis and/or pericarditis. Methods In a 12-month, multicenter, exploratory, phase IIb randomized, double-blind, placebo-controlled trial, SLE patients with polyarthritis, discoid lesions, or pleuritis and/or pericarditis were randomized at a ratio of 2:1 to receive abatacept (,10 mg/kg of body weight) or placebo. Prednisone (30 mg/day or equivalent) was given for 1 month, and then the dosage was tapered. The primary end point was the proportion of patients with new flare (adjudicated) according to a score of A/B on the British Isles Lupus Assessment Group (BILAG) index after the start of the steroid taper. Results A total of 118 patients were randomized to receive abatacept and 57 to receive placebo. The baseline characteristics were similar in the 2 groups. The proportion of new BILAG A/B flares over 12 months was 79.7% (95% confidence interval [95% CI] 72.4, 86.9) in the abatacept group and 82.5% (95% CI 72.6, 92.3) in the placebo group (treatment difference ,3.5 [95% CI ,15.3, 8.3]). Other prespecified flare end points were not met. In post hoc analyses, the proportions of abatacept-treated and placebo-treated patients with a BILAG A flare were 40.7% (95% CI 31.8, 49.5) versus 54.4% (95% CI 41.5, 67.3), and the proportions with physician-assessed flare were 63.6% (95% CI 54.9, 72.2) and 82.5% (95% CI 72.6, 92.3), respectively; treatment differences were greatest in the polyarthritis group. Prespecified exploratory patient-reported outcomes (Short Form 36 health survey, sleep problems, fatigue) demonstrated a treatment effect with abatacept. The frequency of adverse events (AEs) was comparable in the abatacept and placebo groups (90.9% versus 91.5%), but serious AEs (SAEs) were higher in the abatacept group (19.8 versus 6.8%). Most SAEs were single, disease-related events occurring during the first 6 months of the study (including the steroid taper period). Conclusion Although the primary/secondary end points were not met in this study, improvements in certain exploratory measures suggest some abatacept efficacy in patients with non,life-threatening manifestations of SLE. The increased rate of SAEs requires further assessment. [source]

Mycophenolic acid area under the curve correlates with disease activity in lupus patients treated with mycophenolate mofetil

ARTHRITIS & RHEUMATISM, Issue 7 2010
Noël Zahr
Objective Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil (MMF), which is widely used to treat systemic lupus erythematosus (SLE). In transplantation, MPA area under the plasma concentration,time curve from 0 to 12 hours (MPA AUC0,12) is correlated with clinical outcome. We undertook the present study to assess possible relationships between SLE activity and MPA AUC0,12. Methods Using a Bayesian estimator, MPA AUC0,12 was determined in 71 consecutive SLE patients (61 women and 10 men; mean ± SD age 34 ± 10 years) receiving a stable MMF dose. On the same day, SLE activity was assessed using the SLE Disease Activity Index (SLEDAI; active disease defined as a SLEDAI score ,6) and the British Isles Lupus Assessment Group (BILAG) index (active disease defined as BILAG A or B). Results Two groups were studied: patients with active SLE (mean ± SD SLEDAI score 11.6 ± 4.4; n = 26) and patients with inactive SLE (mean ± SD SLEDAI score 1.9 ± 1.6; n = 45). MPA AUC0,12 correlated weakly with the dose of MMF (r = 0.33, P = 0.005). Mean ± SD MPA AUC0,12 in the group with active SLE was significantly lower than that in the group with inactive SLE (26.8 ± 13.6 ,g.hour/ml versus 46.5 ± 16.3 ,g.hour/ml; P < 0.0001). MPA AUC0,12 was negatively correlated with the SLEDAI (r = ,0.64, P < 0.0001). In multivariate analysis, MPA AUC0,12 was the sole parameter associated with SLE activity (odds ratio 0.89 [95% confidence interval 0.83,0.96], P = 0.002). The MPA AUC0,12 threshold value of 35 ,g.hour/ml was associated with the lowest risk of active SLE. Conclusion Our data show that SLE activity is strongly correlated with MPA AUC0,12. An individualized dosing regimen of MMF, with a target AUC0,12 of 35 ,g.hour/ml, should be considered for SLE patients. [source]

Antibodies to apolipoprotein A-I, high-density lipoprotein, and C-reactive protein are associated with disease activity in patients with systemic lupus erythematosus

ARTHRITIS & RHEUMATISM, Issue 3 2010
Sean G. O'Neill
Objective Inflammatory disease activity in patients with systemic lupus erythematosus (SLE) may affect the development of atherosclerosis, contributing to their increased risk of cardiovascular disease (CVD). This process may be mediated by anti,apolipoprotein A-I (anti,Apo A-I), anti,high-density lipoprotein (anti-HDL), and anti,C-reactive protein (anti-CRP) autoantibodies. We undertook this study to examine whether levels of these antibodies rise in association with increased SLE disease activity. Methods IgG anti,Apo A-I, anti-HDL, and anti-CRP levels were measured in serum from the following groups: 39 patients with persistently high disease activity (British Isles Lupus Assessment Group [BILAG] A or B score) over the previous 2 years, 42 patients with persistently low disease activity (no BILAG A or B scores) over the previous 2 years, 34 healthy controls, 25 individual patients from whom paired samples (at time of disease flare and quiescence) were obtained and compared, 16 patients with newly diagnosed lupus nephritis from whom multiple samples were obtained and who were followed up prospectively for up to 2 years, and 24 patients with SLE who had experienced CVD events. Results Serum levels of IgG anti,Apo A-I, anti-HDL, and anti-CRP were higher in patients with SLE than in controls. Anti,Apo A-I and anti-HDL levels, but not anti-CRP levels, were higher in patients with persistently high disease activity than in those with low disease activity. Mean levels of the 3 autoantibodies in patients who had experienced CVD events lay between the mean levels in the high and low disease activity groups. Only levels of anti,Apo A-I were significantly higher in samples obtained from individual patients during disease flares than in samples obtained during disease quiescence. In the lupus nephritis patients, anti,Apo A-I and anti-HDL levels correlated with serum levels of high avidity IgG anti,double-stranded DNA. Conclusion Persistent disease activity is associated with a significant increase in IgG anti,Apo A-I and anti-HDL in patients with SLE. [source]

Nonrenal disease activity following mycophenolate mofetil or intravenous cyclophosphamide as induction treatment for lupus nephritis: Findings in a multicenter, prospective, randomized, open-label, parallel-group clinical trial,

ARTHRITIS & RHEUMATISM, Issue 1 2010
Ellen M. Ginzler
Objective To assess the effect of mycophenolate mofetil compared with intravenous pulses of cyclophosphamide on the nonrenal manifestations of lupus nephritis. Methods Patients with active lupus nephritis (renal biopsy class III, IV, or V) were recruited for the study (n = 370) and treated with mycophenolate mofetil (target dosage 3 gm/day) or intravenous cyclophosphamide (0.5,1.0 gm/m2/month), plus tapered prednisone, for 24 weeks. Nonrenal outcomes were determined using measures of whole body disease activity, including the British Isles Lupus Assessment Group (BILAG) disease activity index, the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) version of the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), and immunologic variables. Results Both treatments were effective on whole body disease activity in the systems examined, as indicated by changes in the classic BILAG index. With either treatment, remission was induced, notably in the mucocutaneous, musculoskeletal, cardiovascular/respiratory, and vasculitis systems, and flares were rare, as measured by the SELENA,SLEDAI. Levels of complement C3, C4, and CH50 and titers of anti,double-stranded DNA antibodies were normalized after treatment with either mycophenolate mofetil or intravenous cyclophosphamide. Conclusion In addition to the efficacy of both treatments on the renal system, this analysis showed that remission could also be induced in other systems. There was no clear difference in efficacy between mycophenolate mofetil and intravenous cyclophosphamide in ameliorating either the renal or nonrenal manifestations. Mycophenolate mofetil is, therefore, a suitable alternative to cyclophosphamide for the treatment of renal and nonrenal disease manifestations in patients with biopsy-proven lupus nephritis. [source]

Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: The randomized, double-blind, phase ii/iii systemic lupus erythematosus evaluation of rituximab trial,

ARTHRITIS & RHEUMATISM, Issue 1 2010
Joan T. Merrill
Objective B cells are likely to contribute to the pathogenesis of systemic lupus erythematosus (SLE), and rituximab induces depletion of B cells. The Exploratory Phase II/III SLE Evaluation of Rituximab (EXPLORER) trial tested the efficacy and safety of rituximab versus placebo in patients with moderately-to-severely active extrarenal SLE. Methods Patients entered with ,1 British Isles Lupus Assessment Group (BILAG) A score or ,2 BILAG B scores despite background immunosuppressant therapy, which was continued during the trial. Prednisone was added and subsequently tapered. Patients were randomized at a ratio of 2:1 to receive rituximab (1,000 mg) or placebo on days 1, 15, 168, and 182. Results In the intent-to-treat analysis of 257 patients, background treatment was evenly distributed among azathioprine, mycophenolate mofetil, and methotrexate. Fifty-three percent of the patients had ,1 BILAG A score at entry, and 57% of the patients were categorized as being steroid dependent. No differences were observed between placebo and rituximab in the primary and secondary efficacy end points, including the BILAG-defined response, in terms of both area under the curve and landmark analyses. A beneficial effect of rituximab on the primary end point was observed in the African American and Hispanic subgroups. Safety and tolerability were similar in patients receiving placebo and those receiving rituximab. Conclusion The EXPLORER trial enrolled patients with moderately-to-severely active SLE and used aggressive background treatment and sensitive cutoffs for nonresponse. No differences were noted between placebo and rituximab in the primary and secondary end points. Further evaluation of patient subsets, biomarkers, and exploratory outcome models may improve the design of future SLE clinical trials. [source]

Neutrophil gelatinase,associated lipocalin is a predictor of the course of global and renal childhood-onset systemic lupus erythematosus disease activity

ARTHRITIS & RHEUMATISM, Issue 9 2009
Claas H. Hinze
Objective To determine whether neutrophil gelatinase,associated lipocalin (NGAL) can predict worsening of global and renal disease activity in childhood-onset systemic lupus erythematosus (SLE). Methods One hundred eleven patients with childhood-onset SLE were enrolled in a longitudinal, prospective study with quarterly study visits and had at least 3 study visits. At each visit, global disease activity was measured using 3 external standards: the numerically converted British Isles Lupus Assessment Group (BILAG) index, the SLE Disease Activity Index 2000 update score, and the physician's assessment of global disease activity. Renal and extrarenal disease activity were measured by the respective domain scores. The disease course over time was categorized at the most recent visit (persistently active, persistently inactive, improved, or worsening). Plasma and urinary NGAL levels were measured by enzyme-linked immunosorbent assay, and urinary NGAL levels were standardized to the urinary creatinine concentration. The longitudinal changes in NGAL levels were compared with the changes in SLE disease activity using mixed-effect models. Results Significant increases in standardized urinary NGAL levels of up to 104% were detected up to 3 months before worsening of lupus nephritis (as measured by all 3 external standards). Plasma NGAL levels increased significantly by as much as 26% up to 3 months before worsening of global SLE disease activity as measured by all 3 external standards. Plasma NGAL levels increased significantly by 26% as early as 3 months prior to worsening of lupus nephritis as measured by the BILAG renal score. Conclusion Serial measurement of urinary and plasma NGAL levels may be valuable in predicting impending worsening of global and renal childhood-onset SLE disease activity. [source]

British isles lupus assessment group 2004 index is valid for assessment of disease activity in systemic lupus erythematosus

ARTHRITIS & RHEUMATISM, Issue 12 2007
Chee-Seng Yee
Objective To determine the construct and criterion validity of the British Isles Lupus Assessment Group 2004 (BILAG-2004) index for assessing disease activity in systemic lupus erythematosus (SLE). Methods Patients with SLE were recruited into a multicenter cross-sectional study. Data on SLE disease activity (scores on the BILAG-2004 index, Classic BILAG index, and Systemic Lupus Erythematosus Disease Activity Index 2000 [SLEDAI-2K]), investigations, and therapy were collected. Overall BILAG-2004 and overall Classic BILAG scores were determined by the highest score achieved in any of the individual systems in the respective index. Erythrocyte sedimentation rates (ESRs), C3 levels, C4 levels, anti,double-stranded DNA (anti-dsDNA) levels, and SLEDAI-2K scores were used in the analysis of construct validity, and increase in therapy was used as the criterion for active disease in the analysis of criterion validity. Statistical analyses were performed using ordinal logistic regression for construct validity and logistic regression for criterion validity. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. Results Of the 369 patients with SLE, 92.7% were women, 59.9% were white, 18.4% were Afro-Caribbean and 18.4% were South Asian. Their mean ± SD age was 41.6 ± 13.2 years and mean disease duration was 8.8 ± 7.7 years. More than 1 assessment was obtained on 88.6% of the patients, and a total of 1,510 assessments were obtained. Increasing overall scores on the BILAG-2004 index were associated with increasing ESRs, decreasing C3 levels, decreasing C4 levels, elevated anti-dsDNA levels, and increasing SLEDAI-2K scores (all P < 0.01). Increase in therapy was observed more frequently in patients with overall BILAG-2004 scores reflecting higher disease activity. Scores indicating active disease (overall BILAG-2004 scores of A and B) were significantly associated with increase in therapy (odds ratio [OR] 19.3, P < 0.01). The BILAG-2004 and Classic BILAG indices had comparable sensitivity, specificity, PPV, and NPV. Conclusion These findings show that the BILAG-2004 index has construct and criterion validity. [source]

Reactivity to alcohol assessment measures: an experimental test

ADDICTION, Issue 8 2009
Scott T. Walters
ABSTRACT Aims Previous research has suggested that alcohol screening and assessment may affect drinking. Design This study was a randomized test of reactivity to alcohol assessment questionnaires among a group of heavy drinking college students. Setting and participants A total of 147 university students completed a screening questionnaire and were randomized to either immediate assessment or delayed assessment. The immediate assessment group completed a set of drinking questionnaires at baseline, 3, 6 and 12 months, while the delayed assessment group completed questionnaires only at 12 months. Measurements Primary outcomes included overall volume of drinking, risky drinking and use of risk reduction behaviors. Findings We found a significant effect of assessment on measures of risky drinking and risk reduction behaviors, but not on overall volume of drinking. Specifically, at 12 months, participants who had previously completed drinking assessments had a lower peak blood alcohol concentration (BAC) (d = ,0.373), were more likely to report a low score on the Alcohol Use Disorders Identification Test (AUDIT; odds ratio = 2.55) and tended to use more strategies to moderate their alcohol consumption (d = 0.352). Risk reduction behaviors that were affected tended to be those that limited alcohol consumption, rather than those that minimized consequences. Conclusions These results may have implications for the development of brief interventions. [source]

British isles lupus assessment group 2004 index is valid for assessment of disease activity in systemic lupus erythematosus

Home safety assessment in the prevention of falls among older people

AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 5 2000
Nancye Peel
Objective:Home safety assessment was examined as part of a randomised trial of falls prevention interventions among older community dwellers. Method:Falls prevention strategies, including education and awareness-raising, exercise, home modifications and medical assessment, were trialled with 252 members of the National Seniors Association. Falls outcomes were monitored using a daily calendar diary during intervention and follow-up periods. Results:The home assessment group was significantly more likely to modify their home environment than the controls (p<0.0001). Participants, regardless of group allocation, reported a significant reduction in concern about falling (p<0.0001). During the intervention, the home assessment group had lower incidence rates for falls and injuries than the control group, although differences were not significant. The lowered rates were sustained post-intervention. Conclusions:While the effect on falls incidence of a home safety intervention on its own could not be demonstrated, other benefits, including improved confidence attributable to awareness of such falls prevention measures, were recorded. Implication:The null effects of home modifications on falls prevention in this study may indicate that the program is more appropriate for the frail aged. [source]