Assessment Of Systemic Lupus Erythematosus Research Articles

Development and psychometric properties of the Reproductive Health Assessment in Systemic Lupus Erythematosus: Mixed-Methods study.

Systemic lupus erythematosus (SLE) with a high morbidity rate (7% in general and 325/100.000 in reproductive period) was known as "the mother of autoimmune diseases." But healthcare providers hadn't reliable scales to measure the effectiveness of interventions to improve reproductive health. Women with systemic lupus erythematosus (SLE) express concern about a significant gap in their reproductive and sexual health during medical care due to the lack of a specific scale to measure this concept. This study developed psychometrically specific scale to evaluate this concept in Iranian women. The study utilized a sequential-exploratory mixed-methods design, wherein the concept of reproductive health was clarified during the qualitative phase using conventional content analysis (inductive-deductive) to create a pool of RHASLE (Reproductive Health Assessment in SLE) items. During the psychometric process, the face, content, and construct validities of the RHASLE were checked with 650 individuals (320 using exploratory factor analysis [EFA] and 330 using confirmatory factor analysis [CFA]) through interviews and completion of the questionnaire. Convergent and divergent validities were then checked, and the reliability was assessed through stability and internal consistency. Finally, the measurement error, responsiveness, and interpretability of the scale were evaluated and confirmed. The study's findings revealed that the RHASLE consisted of 5 factors (33 items): physical-psychological disorder (13 items), relaxing feeling (6 items), spirituality (3 items), high-risk pregnancies (5 items), and sexual satisfaction (6 items). These factors explained a total of 99.97% of the variance in the concept of reproductive health. Confirmatory factor analysis confirmed the good model fit, and its validity and reliability were deemed acceptable. The RHASLE consisted of 27 items with high internal consistency, stability, responsiveness, and interpretability. That was able to get approval of Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist. Based on the results, RHASLE is a valid and reliable multidimensional scale that encompasses various aspects of reproductive health (physical, sexual, psychological, social, and spiritual).

Adaptation of the Russian version of the activity index of systemic lupus erythematosus EASY-BILAG

Assessment of systemic lupus erythematosus (SLE) activity is important to determine the efficacy of treatment and to decide on further therapy. Russian-language versions of activity indices are needed to meet the needs of Russian-speaking patients and clinicians and to facilitate the use of these tools in clinical practice. An important step in this direction is the adaptation of the EASY-BILAG index, which is used to more accurately assess disease activity and select appropriate therapy in patients with SLE.

Could systemic immune inflammation index be a new parameter for diagnosis and disease activity assessment in systemic lupus erythematosus?

Systemic immune inflammation index (SII) has been used as a marker of inflammatory status in various diseases, but its role in systemic lupus erythematosus (SLE) is unknown. We aimed to investigate the role of SII in SLE and its association with disease activity and renal involvement. In this retrospective study, 76 patients with SLE were compared with 76 age- and gender-matched healthy control group in terms of SII, neutrophil-lymphocyte ratio (NLR), and platelet-lymphocyte ratio (PLR). SLE Disease Activity Index 2000 system (SLEDAI-2K) was used to divide the SLE patients into an inactive group (SLEDAI-2K < 9) and an active group (SLEDAI-2K ≥ 9). Correlations between the ratios and both disease activity and renal involvement were analyzed. SLE patients had a higher level of SII compared with controls. The ability of SII in predicting SLE (AUC = 0.626) was lower than NLR (AUC = 0.723) and PLR (AUC = 0.666). SII was positively correlated with C-reactive protein (r = 0.288. p = 0.01), but no association between SII and SLEDAI-2K scores was found. Significantly higher values of NLR, but not SII, were detected in patients with nephritis (p = 0.04). The best NLR cut-off value to predict SLE patients with nephritis was 2.32, with 78.5% sensitivity and 56.2% specificity. For the first, we demonstrated that SII level was elevated in patients with SLE. However, NLR is a better marker than SII in predicting SLE and could serve as an indicator of nephritis. Larger-scale studies should be carried out to confirm our results.

Cognitive Problems and Their Clinical Assessment in Systemic Lupus Erythematosus: Contrasting Patient and Provider Views.

Systemic lupus erythematosus (SLE) is a complex chronic disease associated with reduced cognitive functioning. Patients with SLE report cognitive symptoms, but cognitive assessment is not routine in SLE and little is known about day-to-day cognitive problems and their effect on disease management. As part of a pilot exploring the use of a cognitive functioning report prototype for shared decision-making in clinical encounters (the Approaches to Positive Patient-Centered Experiences of Aging in Lupus [APPEAL] Study), we investigated the relevance of cognitive assessments performed using the National Institutes of Health (NIH) Toolbox among patients with SLE. We conducted 4 focus groups, 2 with SLE patients (n=18) and 2 with lupus providers (physicians and nurses; n=9), addressing cognitive issues and interest in communicating about cognition. We compared how NIH Toolbox cognitive domains (episodic memory, working memory, processing speed, attention and inhibitory control, cognitive flexibility) matched with patient- and provider-identified cognitive problems and needs. Patients identified all NIH domains with rich experiential examples; providers identified fewer domains and offered less detail. An unanticipated additional domain was prospective memory (i.e., problems with remembering future actions). Use of technologic aids (e.g., smart phone alerts) was mentioned by some patients, but not providers, and represent a potential opportunity for medical care. All participants expressed interest in discussing cognition in clinic. Cognitive assessment using the NIH Cognitive Toolbox is relevant to this population, with the possible addition of a prospective memory assessment. Cognitive problems and indications of communication gaps suggest the appropriateness of more clinical communication about cognition in the SLE population.

Serum Interleukin-26 Is a New Biomarker for Disease Activity Assessment in Systemic Lupus Erythematosus.

ObjectiveInterleukin-26 (IL-26) has a unique ability to activate innate immune cells due to its binding to circulating double-stranded DNA. High levels of IL-26 have been reported in patients with chronic inflammation. We aimed to investigate IL-26 levels in patients with systemic lupus erythematosus (SLE).MethodsIL-26 serum levels were quantified by ELISA for 47 healthy controls and 109 SLE patients previously enrolled in the PLUS study. Performance of IL-26 levels and classical markers (autoantibodies or complement consumption) to identify an active SLE disease (SLE disease activity index (SLEDAI) score > 4) were compared.ResultsIL-26 levels were significantly higher in SLE patients than in controls (4.04 ± 11.66 and 0.74 ± 2.02 ng/mL; p = 0.005). IL-26 levels were also significantly higher in patients with active disease than those with inactive disease (33.08 ± 21.06 vs 1.10 ± 3.80 ng/mL, p < 0.0001). IL-26 levels correlated with SLEDAI score and the urine protein to creatinine ratio (uPCR) (p < 0.001). Patients with high IL-26 levels had higher SLEDAI score, anti-DNA antibodies levels, and uPCR (p < 0.05). They presented more frequently with C3 or C4 complement consumption. Lastly, IL-26 showed stronger performance than classical markers (complement consumption or autoantibodies) for active disease identification.ConclusionsOur results suggest that, in addition to classical SLE serological markers, the measurement of IL-26 levels may be a useful biomarker for active disease identification in SLE patients.

Use of Physician Global Assessment in systemic lupus erythematosus: a systematic review of its psychometric properties.

The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients' age. Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. The literature search identified 91 studies. Face validity was reported in all the articles retrieved in which the PGA was used alone or as part of composite indices (Systemic Responder Index, Safety of Estrogen in Lupus Erythematosus National Assessment Flare Index, Lupus Low Disease Activity State, Definitions of Remission in Systemic Lupus Erythematosus criteria). Content validity was reported in 89 studies. Construct validity was demonstrated by a good correlation (r ≥ 0.50) between the PGA with the SLEDAI (12 studies), SLAM (4 studies), LAI, BILAG and ECLAM (2 studies each). Criterion validity was assessed exploring the PGA correlation with quality of life measurements, biomarker levels and treatment changes in 28 studies, while no study has evaluated correlation with damage. A good responsiveness for PGA was shown in eight studies. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). PGA is a valid, responsive and feasible instrument, though its reliability was impacted by the scale adopted, suggesting the major need for standardization of its scoring.

Assessment of Systemic Lupus Erythematosus in Term of Serum Anti-nucleosome and Interleukin 12 Markers in Relation to Epstein–Barr virus and Cytomegalovirus

Background: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease, more dominant in female, associated with high risk of life threating complication and increase morbidity and mortality. the exact cause of SLE is not yet known with many suggestions about a possible role of viral infection in the development of the disease. Epstein –Barr virus is the most commonly studied virus in an attempt to prove its presumed association with development of SLE.The objectives of this study are the measurement of the effect of CMV and EBV seropositivity in the auto immune status and severity of disease SLE measured by estimating the level of immunological markers anti-nucleosome and IL-12 with viral marker. Materials and Method: Forty newly diagnosed female with SLE were randomly selected from patient attended rheumatology clinic at medical city in Baghdad during the period between December 2018 to May In addition, with 40 apparently healthy females, as, a control groups. Both group were investigated for IL12, anti-nucleosome, EA, VCA, EBNA and CMV by ELISA and the results were statistically evaluated. Results: The studied viral markers in the current study which included EBV markers EA, VCA, EBNA, have shown significantly higher level compared to the control group. Similarly, anti-nucleosome and IL12 have shown significantly higher level compared to the control group. Conclusions: The possible defect in controlling viral infection and increased number of latent infected cell in SLE may enhance production of auto-antibodies

Patient experience in systemic lupus erythematosus: development of novel patient-reported symptom and patient-reported impact measures

BackgroundComprehensive assessment of systemic lupus erythematosus (SLE) and its treatment requires patient-reported outcome (PRO) measures to capture impacts and fluctuating symptoms. The objective of this study was to develop PROs, in accordance with the Food and Drug Administration (FDA) PRO Guidance, to assess fluctuations in SLE symptoms and its impact.MethodsFollowing independent review board approval, six US rheumatology practices recruited patients with SLE to participate in concept elicitation (CE) interviews, in order to identify important SLE symptoms and their impacts. The SLE Symptom Severity Diary (SSD) and SLE Impact Questionnaire (SIQ) were drafted based on CE interview results and clinician input. The PROs were revised based on patient feedback from cognitive debriefing (CD) interviews, clinician feedback, and a translatability assessment.ResultsForty-one patients completed CE interviews. Commonly-reported symptoms included fatigue (98%), joint pain (93%), and rash (88%). The most frequently reported impact was difficulty with chores/housework (61%). Eighteen patients completed CD interviews. The PROs were considered comprehensive, clear, and relevant.The SSD contains 17 items assessing energy/vitality, joint and muscle pain/stiffness/swelling, flu-like symptoms, cognition, numbness/tingling, skin symptoms and hair loss using an 11-point numeric response scale and a 24-h recall period (with the exception of hair loss). It also evaluates steroid status and dose. The SIQ contains 50 items, uses a 5-point Likert scale and a 7-day recall period, to assess disease impacts including patients’ ability to make plans, work, and physical/social/emotional functioning.ConclusionThe SSD and SIQ are comprehensive SLE-specific PROs developed in accordance with the FDA PRO Guidance. Following assessment of their measurement properties, they may be useful in clinical studies and clinical practice to measure fluctuations in, and the impact of, symptoms in patients with SLE.

Study of Flare Assessment in Systemic Lupus Erythematosus Based on Paper Patients

Study of Flare Assessment in Systemic Lupus Erythematosus Based on Paper Patients

Thrombotic Risk Assessment in Systemic Lupus Erythematosus: Validation of the Global Antiphospholipid Syndrome Score in a Prospective Cohort

This study was performed to prospectively and independently validate the Global Antiphospholipid Syndrome Score (GAPSS), a system derived from the combination of independent risk factors for thrombosis, including antiphospholipid antibodies (aPL) and conventional cardiovascular risk factors. The GAPSS was applied to 51 consecutive systemic lupus erythematosus patients, all positive for aPL and prospectively followed up for mean ± SD 32.94 ± 12.06 months. Of them, 48 were women with a mean ± SD age of 37.35 ± 12.15 years at entry. The GAPSS was calculated yearly for each patient by adding together the points corresponding to the risk factors. An increase in the GAPSS (entry versus last visit) was seen in patients who experienced vascular events (n = 4, mean ± SD 7.5 ± 4.36 versus 10.0 ± 5.4; P = 0.032). No changes were observed in those without thrombosis (n = 47, mean ± SD 8.28 ± 4.88 versus 7.13 ± 5.75; P = 0.24). An increase in the GAPSS during the followup was associated with a higher risk of vascular events (relative risk 12.30 [95% confidence interval (95% CI) 1.43-106.13], P = 0.004), and an increase of more than 3 points showed the best risk accuracy for vascular events (hazard ratio 48 [95% CI 6.90-333.85], P = 0.0001). The cumulative proportion of thrombosis-free individuals was lower in patients whose GAPSS was increased by 3 or more points (P = 0.0027). We have prospectively demonstrated that GAPSS is a valid tool for accurate prediction of vascular events in SLE patients with aPL.

Comparison of the Farr radioimmunoassay, 3 commercial enzyme immunoassays and Crithidia luciliae immunofluorescence test for diagnosis and activity assessment of systemic lupus erythematosus

Backgrounds Among anti-double-strand (ds)DNA antibody assays, Farr radioimmunoassay is decreasingly used because it requires radioactive material and is labor intensive. We evaluated the performance of Farr, three commercial enzyme immunoassays (EIAs) and the Crithidia luciliae immunofluorescence test (CLIFT) in systemic lupus erythematosus (SLE). Methods Anti-dsDNA antibodies were determined in 99 SLE patients, 101 healthy subjects, and 53 patients with autoimmune rheumatic diseases. Results Farr performed better than the 3 EIAs and CLIFT for the diagnosis of SLE at the manufacturer's cut off and at the cut off set to achieve a specificity of 95%. To achieve a similar level of specificity, some EIAs had a decrease in sensitivity which was dramatic for some tests. Farr was also the best at distinguishing patients with quiescent to mildly active disease from patients with more active disease at the cut off value of 93 IU/ml. Using manufacturer's cut off did not allow distinguishing between patients with quiescent and active SLE. Conclusions Farr was the best global test to assess the level of anti-dsDNA antibodies for both diagnosis and disease activity evaluation in SLE with adequately determined cut off values. Some EIA had low performances limiting their use in decision-making regarding diagnosis and/or treatment.

Measurement of autoantibodies using multiplex methodology in patients with systemic lupus erythematosus

Autoantibodies are central to the diagnosis and assessment of systemic lupus erythematosus (SLE). A recent technique for the measurement of autoantibodies utilizes addressable laser bead immunoassay technology (BioPlex 2200) which permits the simultaneous detection of multiple autoantibodies and improved efficiency due to the shorter time to perform the assay and low volume of test samples and reagents. In the current study we have compared this technique to more traditional measures of autoantibody detection. The clinical and laboratory data and stored serum samples from the enrollment visit into a long-term lupus registry at a single academic medical center were used. Sera were examined for a panel of autoantibodies using the BioPlex ANA screen. The results were compared to the historical data on autoantibody profiles using indirect immunofluorescence (IIF) and ELISA. The association with global and organ specific SLE disease activity (nephritis) was also examined. The study consisted of 192 patients who were predominantly female (87%) and Caucasian (91%) with mean disease duration of 8.8 years. The frequency of ANA and anti-dsDNA by IIF and ELISA was 81.3% and 46.6% respectively and was higher than that found with BioPlex (75.5% and 31.8%). The latter detected a higher proportion of patients with autoantibodies to Sm (7.5% vs 16.7%), RNP (21.8% vs 24.0%), Ro (37.4% vs 41.7) and La (13.9% vs 23.4%). Overall agreement between assays varied between 71.4% and 92.5%. Additional autoantibodies identified by BioPlex were anti-chromatin antibodies which were similar in frequency to anti-dsDNA antibodies (33.9% and 31.8% respectively). There was a low frequency of anti-ribosomal P (6.8%), anti-Scl-70 (5.2%), anti-centromere B (3.7%) and anti-Jo-1 (0.5%). Several autoantibodies revealed significant associations with SLEDAI scores but in a multivariate analysis the only autoantibodies that approached statistical significance were anti-Sm ( p = 0.094) measured by ELISA and anti-dsDNA ( p = 0.082) measured by BioPlex. There was no association between any of the autoantibodies regardless of the method of detection and cumulative organ damage scores. Fifty-three patients (27.6%) had lupus nephritis of which 17 (32%) had active nephritis at the time of autoantibody determination. There was no significant association between a positive ANA (IIF) and any autoantibodies detected by ELISA with either the cumulative occurrence of lupus nephritis or active nephritis. In contrast, there was an association between BioPlex detected anti-dsDNA with the cumulative occurrence of nephritis ( p = 0.074) which reached statistical significance with active nephritis at the time of antibody testing ( p = 0.012). This was confirmed by multivariate analysis ( p = 0.047). These results suggest reasonable agreement between the detection of lupus autoantibodies by ELISA and BioPlex. The latter demonstrated a better correlation with lupus nephritis.

Revised British Isles Lupus Assessment Group 2004 index: A reliable tool for assessment of systemic lupus erythematosus activity

To test the interrater reliability of the revised British Isles Lupus Assessment Group 2004 (BILAG-2004) index for the assessment of systemic lupus erythematosus (SLE) activity. Patients with SLE were recruited from 11 centers. Two physician raters separately assessed the patients' disease activity using the BILAG-2004 index in routine clinical practice. Scores ranged from A (for very active disease) to E (for inactivity). Two reliability exercises were performed. Changes were made to the index after the first exercise (E1), and additional training was provided to the raters before the second exercise (E2). E1 and E2 involved 12 and 14 raters, respectively. Interrater reliability was assessed using kappa statistics and intraclass correlation coefficients. Levels of agreement and the extent of major disagreement were also examined. Major disagreement was defined as a score difference between raters of A versus C, D, or E or B versus D or E. For each exercise, 97 patients were recruited. In E1, the mean age of the patients was 42.3 years (range 18.5-82.2 years), 89.7% were women, and 74.2% were white, 8.2% were Afro-Caribbean, and 13.4% were South Asian, and in E2, the mean age was 43.7 years (range 17.7-75 years), 90.7% were women, and 68% were white, 15.5% were Afro-Caribbean, and 11.3% were South Asian. The mean disease duration was 9.4 years (range 0-32.1 years) for patients in E1 and 10 years (range 0-34.8 years) in E2. There was improvement in the interrater reliability and the level of agreement from E1 to E2. Further improvement was achieved after removal of poorly performing items. The BILAG-2004 index is a reliable tool to assess SLE activity. The use of a well-defined glossary and training of raters are essential to ensure the optimal performance of the index.

Validity of retrospective disease activity assessment in systemic lupus erythematosus

Validity of retrospective disease activity assessment in systemic lupus erythematosus