Sirolimus versus tacrolimus for systemic lupus erythematosus treatment: results from a real-world CSTAR cohort study

ObjectiveThe effectiveness and safety of sirolimus for SLE treatment have been shown in some uncontrolled studies. However, a comparison of sirolimus with other classic immunosuppressants has not been reported. We conducted the study to compare the effectiveness and safety of sirolimus versus tacrolimus for SLE treatment.MethodsA real-world cohort study was conducted. Patients with clinically active SLE who were prescribed sirolimus or tacrolimus were enrolled. Propensity score matching was used to ensure equivalent disease conditions and background medications. SLE disease activity indices, serological parameters, steroid doses, modification of other immunosuppressants, renal effectiveness and adverse events were compared between the two groups at 3-month, 6-month, 9-month and 12-month follow-up visits.ResultsData from 52 patients in each of the sirolimus and tacrolimus groups were analysed. Indices regarding the effectiveness of sirolimus, including Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores, physician’s global assessment (PhGA) scores, and proportion of patients with SLEDAI-2K reduction of ≥4 and PhGA increase of <0.3, were equivalent to those of tacrolimus at all follow-up timepoints (all p≥0.05). Greater improvements in complement levels were observed in the sirolimus group at 3 and 6 months. Higher percentages of patients with prednisone doses ≤7.5 mg/day were observed in the sirolimus group at all timepoints. Seventeen adverse events in the sirolimus group were recorded. None was severe or led to drug discontinuation.ConclusionsOverall, sirolimus was as effective as tacrolimus in the treatment of SLE. Sirolimus had better effects on serological improvement and glucocorticoid tapering. Sirolimus was well tolerated in patients with SLE.

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Autoantibodies’ titre modulation by anti-BlyS treatment in systemic lupus erythematosus

Lupus ◽

10.1177/0961203319860191 ◽

2019 ◽

Vol 28 (9) ◽

pp. 1074-1081 ◽

Cited By ~ 2

Author(s):

I Cavazzana ◽

R Kumar ◽

C Pozzari ◽

R Ottaviani ◽

M Fredi ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Disease Activity ◽

Lupus Erythematosus ◽

Activity Index ◽

Disease Activity Index ◽

High Avidity ◽

Systemic Lupus ◽

Glycoprotein I ◽

Cardiolipin Antibodies

Objective The objective of this study was to analyse autoantibodies’ titres modulation during belimumab treatment in 50 patients with systemic lupus erythematosus (SLE). Methods Sera were collected at belimumab start (T0) and every six months until the 24th month. Disease activity index (SLEDAI-2K) was analysed at every timepoint. High avidity anti-dsDNA was detected by radioimmunological method, anti-ENA, anti-cardiolipin antibodies (aCL), anti-β2 glycoprotein I (anti-β2GPI) were analysed by ELISA. Results Fifty patients with SLE (mean SLEDAI-2K: 7.18 ± :3), mean age of 39 ± 11 years and mean follow-up of 13 ± 7.8 years were enrolled. A significant decrease of anti-dsDNA and anti-β2GPI IgM titres was observed at all timepoints. IgG aCL titre showed significant decrease only at T18. Anti-dsDNA negativization was detected in 21%, anti-β2GPI IgG in 33% and aCL IgG in 30% of sera, mostly at T6. Anti-ribosomal showed a significant titre decrease at T6 and T12, with negative seroconversion at T18. Anti-Sm titre significantly dropped down at T6, then remained stable during the time. Significant correlations were found between anti-dsDNA and anti-ribosomal titre and between SLEDAI ratio (SLEDAI value/SLEDAI T0) and anti-ribosomal titre ratio (value/value T0). Conclusions Belimumab treatment induced a significant reduction of SLE-specific autoantibodies titre and IgM anti-β2GPI. Anti-ribosomal titre decrease correlates with anti-dsDNA titre and disease activity improvement.

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Prognostic Factors for Clinical Response in Systemic Lupus Erythematosus Patients Treated by Allogeneic Mesenchymal Stem Cells

Stem Cells International ◽

10.1155/2019/7061408 ◽

2019 ◽

Vol 2019 ◽

pp. 1-7 ◽

Cited By ~ 2

Author(s):

Lihui Wen ◽

Myriam Labopin ◽

Manuela Badoglio ◽

Dandan Wang ◽

Lingyun Sun ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Disease Activity ◽

Clinical Response ◽

Lupus Erythematosus ◽

Activity Index ◽

Clinical Manifestations ◽

Older Age ◽

Allogeneic Bone ◽

Systemic Lupus

Systemic lupus erythematosus (SLE) is an autoimmune disease with a broad range of clinical manifestations and a heterogeneous disease course. There is no cure for SLE, but current standard pharmacotherapies can improve disease prognosis in most patients. However, some patients are refractory to conventional treatments and require alternative treatment options. The present study is aimed at identifying predictors of clinical response to allogeneic bone marrow-derived or umbilical cord-derived mesenchymal stem cell (BM-/UC-MSC) transplant in SLE. All adult patients identified in the Nanjing database with an SLE Disease Activity Index (SLEDAI) score≥8 at baseline that had undergone MSC transplant and who had at least 1 year of follow-up after one or two successive intravenous injections of allogeneic BM-/UC-MSCs (1 million/kg) were analyzed. SLE symptoms and SLEDAI were assessed at baseline and during follow-up to determine low disease activity (LDA) and clinical remission (CR) at 1, 3, 6, and 12 months. Sixty-nine patients were included in the study, with a median (range) SLEDAI of 13 (8-34) at baseline. Among the 69 patients, 40 (58%) achieved LDA and 16 (23%) achieved CR with a SLEDAI of 9 (4–20), 8 (0-16), 6 (0-18), and 5 (0-18) after 1, 3, 6, and 12 months, respectively. Older age (p=0.006) and no arthralgia/arthritis at baseline (p=0.03) were associated with a higher rate of LDA. Achieving CR was associated with older age (p=0.033), no arthralgia/arthritis at baseline (p=0.001), and no prior use of cyclophosphamide (p=0.003) or hydroxychloroquine (p=0.016). Future studies using unique immunosuppressive regimens and allogeneic MSC sources will further elucidate determinants of clinical response to MSC transplant in SLE.

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Systemic lupus erythematosus and pregnancy: the challenge of improving antenatal care and outcomes

Lupus ◽

10.1177/0961203319877247 ◽

2019 ◽

Vol 28 (12) ◽

pp. 1417-1426 ◽

Cited By ~ 2

Author(s):

D E A Pastore ◽

M L Costa ◽

F G Surita

Keyword(s):

Systemic Lupus Erythematosus ◽

Disease Activity ◽

Pregnant Women ◽

Lupus Erythematosus ◽

Activity Index ◽

Perinatal Outcomes ◽

Disease Activity Index ◽

Systemic Lupus ◽

The Mean

Objectives The objective of this article is to describe maternal and perinatal outcomes in women with systemic lupus erythematosus (SLE) followed in a high-risk prenatal outpatient clinic at a referral center. Methods This observational study included pregnant women with SLE who underwent prenatal follow-up and childbirth at the Women’s Hospital, University of Campinas, from January 2012 to January 2018. All women were followed according to the institution’s protocol for pregnant women with SLE. They were subdivided into two groups according to the presence of disease activity during the preconception and gestation periods, and evaluated according to the Systemic Lupus Erythematosus Disease Activity Index and Systemic Lupus Erythematosus Pregnancy Disease Activity Index scales. Data were retrieved from patients’ medical records. Chi-square, Fisher exact and Mann-Whitney tests and multivariable analyses were performed. Statistical significance level was 5% ( p < .05). Results A total of 125 cases were initially included; those who were lost to follow-up or gave birth at another hospital were further excluded, with 102 pregnancies (of 95 women) remaining. The mean age of the women was 27.7 years (SD 5.44), and 48% were in their first gestation. The average duration of disease was 6.79 years (SD 5.38), with 92.1% receiving SLE-specific therapy. SLE flare occurred in 8.9% during the preconception period and 23.5% during gestation. Preterm premature rupture of membranes (16.6%), preeclampsia or eclampsia (15.6%) and preterm labor (12.7%) were the most frequent complications. The mean gestational age at birth was 34.4 weeks (SD 5.9); the preterm birth rate was 46.8%, the low birth weight rate was 35.1%, and intensive neonatal care admission was 40.4%. Four fetal deaths and one maternal death occurred, all of them in the group with SLE flares. Multivariable logistic regression analysis showed that preconception lupus activity had a six-fold increased rate of gestational loss (odds ratio (OR): 6.14 (95% confidence interval (CI) 1.26–29.99)), and lupus activity during pregnancy had a five-fold increased rate of prematurity at less than 34 weeks (OR: 5.02 (95% CI: 1.90–13.30)). Conclusions Despite the low percentages of women with pregestational and pregnancy-active disease, we found high incidences of maternal and perinatal complications. Preconception SLE activity increased gestational loss, and SLE activity during pregnancy increased prematurity. Effective immunosuppressive therapy was able to decrease clinical and laboratory activity of SLE; however, unfavorable perinatal outcomes still occurred, even when lupus activity was under control. Pregnancy in women with SLE is always a challenge.

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Fatores Determinantes de Morbilidade nos Doentes com Lúpus Eritematoso Sistémico

Acta Médica Portuguesa ◽

10.20344/amp.8082 ◽

2017 ◽

Vol 30 (5) ◽

pp. 368

Author(s):

Margarida Jacinto ◽

Eliana Silva ◽

Nuno Riso ◽

Maria Francisca Moraes-Fontes

Keyword(s):

Systemic Lupus Erythematosus ◽

Disease Activity ◽

Lupus Erythematosus ◽

Activity Index ◽

Damage Index ◽

Disease Activity Index ◽

Systemic Lupus Erythematosus Disease ◽

Systemic Lupus ◽

American College Of Rheumatology

Introduction: Severity in systemic lupus erythematosus may vary from mild to even fatal consequences. There are no biomarkers to predict the disease’s prognosis. The Systemic Lupus International Collaborating Clinics/ Systemic Damage Index defines systemic lupus erythematosus disease severity and is found to predict prognosis.Objective: To test damage determinants in a single-centre systemic lupus erythematosus cohort.Material and Methods: Retrospectively followed systemic lupus erythematosus female patients (defined by the identification of at least four systemic lupus erythematosus American College of Rheumatology criteria – fulfillment 100%, n = 76) over the past five years. Age of onset, ethnicity, disease duration, number of American College of Rheumatology criteria at the end of follow-up, cumulative: renal, neuropsychiatric and articular phenotypes, hypertension, dyslipidaemia, smoking and Systemic Lupus Erythematosus Disease Activity Index 2K were correlated to the presence and degree of irreversible damage (Systemic Lupus International Collaborating Clinics Damage Index). Accumulation of American College of Rheumatology criteria was measured in a sub-group of patients followed from disease onset (within a year of the first symptom ascribed to systemic lupus erythematosus) (n = 39 – 51%); Systemic Lupus Erythematosus Disease Activity Index and Systemic Lupus International Collaborating Clinics Damage Index were performed. Statistical analysis was performed using Chi-square, Wilcoxon Mann-Whitney tests and Spearman correlation rho (Sig. 2-tailed p < 0.05).Results: Systemic Lupus International Collaborating Clinics/Systemic Damage Index > 0 was present in 56.6% and significantly associated to a longer duration, a higher number of American College of Rheumatology criteria and a neuropsychiatric phenotype when compared with those with no damage. The final number of American College of Rheumatology criteria accrued was positively correlated to a higher disease activity over the past five years of follow-up (Spearman´s rho 0.02 and p < 0.05). There was no effect from other features.Discussion and Conclusion: Disease duration and number of American College of Rheumatology criteria predict Systemic Lupus International Collaborating Clinics/ Systemic Damage Index. neuropsychiatric disease has an impact on damage accrual.

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POS0105 PREDICTORS OF FLARE IN SLE PATIENTS ATTAINING LUPUS LOW DISEASE ACTIVITY STATE: A REAL-LIFE COHORT STUDY OF 292 PATIENTS WITH 36-MONTH FOLLOW-UP

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.478 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 263.2-263

Author(s):

A. R. Cunha ◽

L. Saraiva ◽

J. A. P. Da Silva ◽

L. Inês

Keyword(s):

Systemic Lupus Erythematosus ◽

Cohort Study ◽

Disease Activity ◽

Lupus Erythematosus ◽

Cox Regression ◽

Systemic Lupus ◽

Low Disease Activity ◽

Ongoing Treatment ◽

Activity State

Background:Lupus Low Disease Activity State (LLDAS) is a target for management of patients with SLE, that should be maintained in the long-term by preventing flares. Stratification of flare risk would be useful to optimize management.Objectives:To identify predictors of flare in SLE patients attaining LLDAS.Methods:Patients with SLE fulfilling classification criteria [ACR (1997) and/or SLICC and/or EULAR/ACR], followed at an academic lupus clinic from January 2017 to March 2020 were eligible. Baseline for each patient was the first visit with LLDAS within the study period. Patients never fulfilling LLDAS were excluded. Flares were identified as change from baseline by 3 instruments: revised SELENA flare index (r-SFI); SLEDAI-2K; Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS). Time to first flare up to 36 months was identified separately for each instrument. Predictors of flare were sought through survival analysis, with distinct models for each of the three definitions of flare. Univariate analysis was performed using Kaplan-Meir curves and Log-Rank tests. Tested variables at baseline were: gender; age at time of SLE diagnosis; disease duration; cumulative SLE organ involvement (arthritis; mucocutaneous; renal; neurologic; haematological; anti-phospholipid syndrome); cumulative immunological features (anti-dsDNA; anti-Sm; anti-RNP, anti-phospholipid antibodies; hypocomplementemia); ongoing treatment (hydroxychloroquine; prednisone; immunosuppressants). Variables with p<0.1 were further tested in multivariate Cox regression models. Hazard ratios (HR) were determined with 95% confidence intervals (95%CI).Results:From 322 patients in this SLE cohort, 292 (90.7%) fulfilled LLDAS and were included in the analyses (female: 87.3%; mean age: 46.2±14.5 years; previous lupus nephritis: 36.0%; receiving ongoing antimalarials, immunosuppressants, glucocorticoids: 92.8%, 34.6% and 29.8%, respectively. Over follow-up, the proportion of patients with flares according to each definition were: 28.4% (r-SFI), 24.7% (SLE-DAS) and 13.4% (SLEDAI-2K). The r-SFI flares were moderate in 28.9% and severe in 9.6% of the cases. From all patients, 54.1% maintained stable glucocorticoid-free control of the disease, without flares during follow-up. In the multivariate models, the following parameters were independent predictors of flare, as defined by any of the definitions (Table 1): anti-RNP+; oral glucocorticoids; immunosuppressants.Conclusion:Patients attaining LLDAS but requiring ongoing treatment with immunosuppressants and/or glucocorticoids present a higher risk of flare and thus might need a tighter clinical monitoring. Anti-RNP+ was newly identified as a potential biomarker for higher risk of flares. Glucocorticoid-free, stable low disease activity is an achievable target.References:[1]Mathian A, Pha M, Haroche J, Cohen-Aubart F, Hié M, Pineton de Chambrun M, et al. Withdrawal of low-dose prednisone in SLE patients with a clinically quiescent disease for more than 1 year: a randomised clinical trial. Ann Rheum Dis. 2020;79(3):339-46.[2]Inês L, Duarte C, Silva RS, Teixeira AS, Fonseca FP, da Silva JA. Identification of clinical predictors of flare in systemic lupus erythematosus patients: a 24-month prospective cohort study. Rheumatology (Oxford). 2014;53(1):85-9.Table 1.Predictors of flare in multivariate Cox regression according to each of the flare definitions (r-SFI; SLE-DAS; SLEDAI-2K)r-SFISLE-DASSLEDAI-2KAnti-RNP+2.11 (1.30-3.42)2.39 (1.44-3.95)2.22 (1.11-4.42)Immunosuppressants1.96 (1.22-3.15)2.32 (1.38-3.88)2.26 (1.12-4.54)Prednisone*1.93 (1.19-3.14)1.99 (1.18-3.35)2.17 (1.07-4.38)Blood cytopenias§2.08 (1.03-4.17)n.s.n.s.Arthritis§n.s.n.s.2.23 (1.12-4.44)* Prednisone ≤7.5 mg/day as required by LLDAS. § Blood cytopenias; arthritis: cumulative SLE features up to baseline. Risk for each predictor reported as Hazard Ratio (95% Confidence Interval); n.s.: non-significantDisclosure of Interests:None declared

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Impact of markers of endothelial injury and hypercoagulability on systemic lupus erythematosus

Lupus ◽

10.1177/0961203319899478 ◽

2020 ◽

Vol 29 (2) ◽

pp. 182-190

Author(s):

W Batista Cicarini ◽

R C Figueiredo Duarte ◽

K Silvestre Ferreira ◽

C de Mello Gomes Loures ◽

R Vargas Consoli ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Disease Activity ◽

Lupus Erythematosus ◽

Activity Index ◽

Disease Activity Index ◽

Endothelial Injury ◽

Control Group ◽

Systemic Lupus ◽

Low Concentrations ◽

The Relationship

We have explored the relationship between possible hemostatic changes and clinical manifestation of the systemic lupus erythematosus (SLE) as a function of greater or lesser disease activity according to Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) criteria. Endothelial injury and hypercoagulability were investigated in patients with SLE by measuring thrombomodulin (TM), D-dimer (DDi) and thrombin generation (TG) potential. A total of 90 participants were distributed into three groups: 1) women with SLE presenting with low disease activity (laSLE) (SLEDAI-2K ≤ 4), 2) women with SLE presenting with moderate to high disease activity (mhaSLE) (SLEDAI-2K > 4), and 3) a control group comprising healthy women. Levels of TM and DDi were higher both in the laSLE and mhaSLE groups compared to controls and in mhaSLE compared to the laSLE group. With respect to TG assay, lagtime and endogen thrombin potential, low concentrations of tissue factor provided the best results for discrimination among groups. Analysis of these data allow us to conclude that TM, DDi and TG are potentially useful markers for discriminating patients with very active from those with lower active disease. Higher SLE activity may cause endothelial injury, resulting in higher TG and consequently a hypercoagulability state underlying the picture of thrombosis common in this inflammatory disease.

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Disease activity index is associated with subclinical atherosclerosis in childhood-onset systemic lupus erythematosus

Pediatric Rheumatology ◽

10.1186/s12969-021-00513-5 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Priscila B. S. Medeiros ◽

Roberta G. Salomão ◽

Sara R. Teixeira ◽

Diane M. Rassi ◽

Luciana Rodrigues ◽

...

Keyword(s):

Risk Factors ◽

Systemic Lupus Erythematosus ◽

Disease Activity ◽

Lupus Erythematosus ◽

Activity Index ◽

Subclinical Atherosclerosis ◽

Disease Activity Index ◽

Uncontrolled Hypertension ◽

Childhood Onset ◽

Systemic Lupus

Abstract Background Systemic lupus erythematosus (SLE) is an independent risk factor for cardiovascular events. The present study determined the prevalence of subclinical atherosclerosis in childhood-onset SLE using the carotid intima-media thickness (CIMT) measurement and investigated associations between traditional and nontraditional risk factors for atherosclerosis, such as medications, SLE Disease Activity Index - SLEDAI-2 K and SLICC-ACR damage index and CIMT. Methods Cross-sectional prospective study between 2017 and 2018. CIMT was assessed by ultrasonography. Data were collected by chart review, nutritional evaluation and laboratory tests and analyzed by Fisher, Wilcoxon-Mann-Whitney tests, multiple linear and log binomial regression. Results Twenty-eight patients (mean age 13.9 years, SD 3) were enrolled. The prevalence of subclinical atherosclerosis was 32% (95% CI 14.8, 49.4). The mean CIMT was 0.43 ± 0.035 mm. The most common traditional risk factors observed were dyslipidemia (82.1%), uncontrolled hypertension (14.2%), obesity (14.3%), and poor diet (78.6%). Uncontrolled hypertension (p = 0.04), proteinuria (p = 0.02), estimated glomerular filtration rate < 75 ml /min/1.73 m2 (p = 0.02) and SLEDAI-2 K > 5 (P = 0.04) were associated with subclinical atherosclerosis. SLEDAI-2 K > 5 maintained association with CIMT after adjusting for control variables. Conclusion Subclinical atherosclerosis is frequently observed in cSLE, mainly in patients with moderate to severe disease activity.

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Elevated levels of IL-24 in systemic lupus erythematosus patients

Lupus ◽

10.1177/0961203319845476 ◽

2019 ◽

Vol 28 (6) ◽

pp. 748-754 ◽

Cited By ~ 1

Author(s):

R C Li ◽

J Guo ◽

L C Su ◽

A F Huang

Keyword(s):

Systemic Lupus Erythematosus ◽

Disease Activity ◽

Lupus Erythematosus ◽

Inflammatory Cytokine ◽

Activity Index ◽

Clinical Manifestations ◽

Mrna Levels ◽

Healthy Controls ◽

Systemic Lupus ◽

Good Ability

Objective This study aimed to assess IL-24 levels and their association with clinical manifestations in patients with systemic lupus erythematosus (SLE). Methods There were 75 patients with SLE and 58 healthy controls recruited in this study. Serum levels of IL-24 were measured by enzyme-linked immunosorbent assays, and mRNA levels of IL-24 were tested by quantitative real-time polymerase chain reaction . The area under the curve of the receiver operating characteristic (ROC) curve was used for diagnostic ability of the inflammatory cytokine. Results Serum IL-24 levels were significantly higher in SLE patients than that in healthy controls. SLE patients with nephritis had higher IL-24 levels than those without nephritis. Active SLE patients showed higher expression of IL-24 as compared to less active disease patients. The mRNA levels of IL-24 were much higher in SLE patients. Correlation analysis showed significant correlation between serum IL-24 levels and SLE disease activity index. In addition, ROC analysis may suggest good ability of serum IL-24 in differentiating SLE. Conclusion The inflammatory cytokine correlated with SLE disease activity, and may be involved in this disease pathogenesis.

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A Comparison of the Correlation of Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) with Health-Related Quality of Life

Journal of Clinical Medicine ◽

10.3390/jcm10102137 ◽

2021 ◽

Vol 10 (10) ◽

pp. 2137

Author(s):

Ning-Sheng Lai ◽

Ming-Chi Lu ◽

Hsiu-Hua Chang ◽

Hui-Chin Lo ◽

Chia-Wen Hsu ◽

...

Keyword(s):

Quality Of Life ◽

Systemic Lupus Erythematosus ◽

Disease Activity ◽

Lupus Erythematosus ◽

Activity Index ◽

Disease Activity Index ◽

Information Criterion ◽

Systemic Lupus Erythematosus Disease ◽

Systemic Lupus

Background and Aim: The aim of this study was to compare the correlation of a recently developed systemic lupus erythematosus disease activity score (SLE-DAS) with the SLE disease activity index 2000 (SLEDAI-2K) with the Lupus Quality of Life questionnaire (LupusQoL) in Taiwanese patients with SLE. Methods: A cross-sectional study was conducted in a regional teaching hospital in Taiwan from April to August 2019. Adult patients with a clinician-confirmed diagnosis of SLE based on the 1997 American College of Rheumatology revised criteria or the 2012 Systemic Lupus International Collaborating Clinics Classification Criteria were recruited. SLE disease activity was measured with both SLEDAI-2K and SLE-DAS. Disease-specific quality of life was assessed using the LupusQoL. Results: Of the 333 patients with SLE in this study, 90.4% were female and 40% were between the ages of 20 and 39 years. The median SLEDAI-2K score was 4.00 (interquartile range [IQR] 2.00–7.50) and the median SLE-DAS score was 2.08 (IQR 1.12–8.24) in our patients with SLE. After adjusting for sex and age intervals, both SLEDAI-2k and SLE-DAS were significantly and inversely associated with all eight domains of LupusQoL. The magnitudes of the mean absolute error, root mean square error, Akaike Information Criterion, Bayesian Information Criterion, and coefficient of determination were comparable between SLEDAI-2K and SLE-DAS. Conclusions: There were no clear differences in the use of SLE-DAS over SLEDAI-2K in assessing HRQoL in patients with SLE. We suggest that, in this aspect, both SLEDAI-2K and SLE-DAS are effective tools for measuring disease activity in patients with SLE.

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Systemic Lupus Erythematosus Disease Activity Index 2000 Responder Index-50 Enhances the Ability of SLE Responder Index to Identify Responders in Clinical Trials

The Journal of Rheumatology ◽

10.3899/jrheum.110550 ◽

2011 ◽

Vol 38 (11) ◽

pp. 2395-2399 ◽

Cited By ~ 31

Author(s):

ZAHI TOUMA ◽

DAFNA D. GLADMAN ◽

DOMINIQUE IBAÑEZ ◽

SHAHRZAD TAGHAVI-ZADEH ◽

MURRAY B. UROWITZ

Keyword(s):

Systemic Lupus Erythematosus ◽

Clinical Trials ◽

Disease Activity ◽

Lupus Erythematosus ◽

Activity Index ◽

Disease Activity Index ◽

Systemic Lupus ◽

Original Definition ◽

Definition Of

Objective.To evaluate the performance of the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) when the SLE Disease Activity Index 2000 (SLEDAI-2K) is substituted with SLEDAI-2K Responder Index-50 (SRI-50), a valid and reliable index of disease activity improvement. Also, to determine whether the SRI-50 will enhance the ability of SRI in detecting responders.Methods.Our study was conducted on patients who attended the Lupus Clinic from September 2009 to September 2010. SLEDAI-2K, SRI-50, the British Isles Lupus Assessment Group measure, and the Physician’s Global Assessment were determined initially and at followup. SRI was determined at the followup visit according to its original definition using the SLEDAI-2K score and by substituting SLEDAI-2K with SRI-50.Results.A total of 117 patients with SLEDAI-2K ≥ 4 at baseline were studied. Patients had 1 followup visit over a 3-month period. Twenty-nine percent of patients met the original definition of SRI and 35% of patients met the definition of SRI when SLEDAI-2K was substituted with SRI-50. The use of SRI-50 allowed determination of significant improvement in 7 additional patients. This improvement could not be discerned with the use of SLEDAI-2K as a component of SRI. At followup visits that showed improvement, SRI-50 scores decreased to a greater extent than SLEDAI-2K scores (p < 0.0001).Conclusion.SRI-50 enhances the ability of SRI to identify patients with clinically important improvement in disease activity. SRI-50 was superior to SLEDAI-2K in detecting partial clinical improvement, ≥ 50%, between visits. These properties of the SRI-50 enable it to be used as an independent outcome measure of improvement or as a component of SRI in clinical trials.

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