The impact of tabalumab on the kidney in systemic lupus erythematosus: results from two phase 3 randomized, clinical trials

Lupus ◽  
2016 ◽  
Vol 25 (14) ◽  
pp. 1597-1601 ◽  
Author(s):  
B H Rovin ◽  
M A Dooley ◽  
J Radhakrishnan ◽  
E M Ginzler ◽  
T D Forrester ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Glomerular Filtration Rate ◽  
Serum Creatinine ◽  
Lupus Erythematosus ◽  
Filtration Rate ◽  
Creatinine Ratio ◽  
Systemic Lupus ◽  
Urine Protein ◽  
Creatinine Concentration ◽  
Intent To Treat

Introduction Tabalumab is a monoclonal antibody that neutralizes membrane and soluble B-cell activating factor. Two 52-week, randomized, double-blind, placebo controlled phase 3 trials evaluated the safety and efficacy of tabalumab in systemic lupus erythematosus. Methods Patients with moderate to severe active systemic lupus erythematosus (without severe active lupus nephritis) were randomly assigned 1:1:1 to receive tabalumab (120 mg subcutaneously every 2 or 4 weeks) or placebo for 52 weeks. Serum creatinine concentration, estimated glomerular filtration rate, urine protein/creatinine ratio, renal flares and renal adverse events were determined monthly. Data were analyzed for the intent-to-treat population and for intent-to-treat patients with baseline urine protein/creatinine ratio >20 mg/mmol (intent-to-treat plus urine protein/creatinine ratio). Results The trials enrolled 2262 patients. At baseline, demographics, systemic lupus erythematosus disease activity, serum creatinine concentration, estimated glomerular filtration rate and urine protein/creatinine ratio were similar among the treatment arms (with the exception of disease duration). In the intent-to-treat and intent-to-treat plus urine protein/creatinine ratio populations, there were no differences between the arms in the baseline-to-endpoint change in serum creatinine concentration, glomerular filtration rate, urine protein/creatinine ratio, or renal flare rates. Tabalumab resulted in a significant B-cell reduction and decreased immunoglobulin G levels at both doses. Conclusions Compared to placebo, tabalumab did not significantly affect the serum creatinine concentration, glomerular filtration rate, urine protein/creatinine ratio, or renal flare rates over 1 year in intent-to-treat or intent-to-treat plus urine protein/creatinine ratio patients. There were no significant renal safety signals. ClinicalTrials.gov identifiers: NCT01205438 and NCT01196091 Lupus (2016) 25, 1597–1601.

Estimation of glomerular filtration rate in patients with systemic lupus erythematosus

Lupus ◽  
2006 ◽  
Vol 15 (5) ◽  
pp. 276-281 ◽  
Author(s):  
Y Y Leung ◽  
K M Lo ◽  
L S Tam ◽  
C C Szeto ◽  
E K Li ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Glomerular Filtration Rate ◽  
Glomerular Filtration ◽  
Lupus Erythematosus ◽  
Filtration Rate ◽  
Systemic Lupus

scholarly journals Predictors of the start of declining eGFR in patients with systemic lupus erythematosus

Lupus ◽  
2020 ◽  
Vol 30 (1) ◽  
pp. 15-24
Author(s):  
Terry Cheuk-Fung Yip ◽  
Suchi Saria ◽  
Michelle Petri ◽  
Laurence S Magder
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Blood Pressure ◽  
High Blood Pressure ◽  
Lupus Erythematosus ◽  
Stable State ◽  
State Transitions ◽  
Creatinine Ratio ◽  
Systemic Lupus ◽  
Urine Protein ◽  
The Impact

Objective To characterize the longitudinal trajectory of estimated glomerular filtration rate (eGFR) in patients with systemic lupus erythematosus (SLE) and identify predictors of the change in eGFR trajectory. Methods The longitudinal eGFR levels of patients in the Hopkins Lupus Cohort were modelled by piecewise linear regression to evaluate the slope of different line segments. The slopes were classified into declining (≤−4 mL/min/1.73 m2 per year), stable (−4 to 4 mL/min/1.73 m2 per year), and increasing (≥4 mL/min/1.73 m2 per year) states. The transition rate between states and the impact of clinical parameters were estimated by a Markov model. Results The analysis was based on 494 SLE patients. At a mean follow-up of 8.8 years, 347 (70.2%), 107 (21.7%), 33 (6.7%), and 7 (1.4%) patients had zero, one, two, and three state transitions, respectively. In patients with no transition, 37 (10.7%), 308 (88.8%), and 2 (0.6%) were in declining, stable, and increasing state, respectively. In patients with one transition, 43 (40.2%) changed from declining to stable state while 29 (27.1%) changed from stable to declining state. When patients were in a non-declining GFR state, those who were younger and African Americans were more likely to transition to a declining GFR state. In adjusted analyses, high blood pressure, C4 and low hematocrit were associated with change from non-declining to declining state. High urine protein-to-creatinine ratio also tended to be associated with change from non-declining to declining state. African American patients were less likely to move from declining to non-declining state. Use of prednisone was associated with change from declining to non-declining state. Conclusions Patients with high blood pressure, low complement C4, low haematocrit, and high urine protein-to-creatinine ratio are more likely to have a declining eGFR trajectory, while the use of prednisone stabilizes the declining eGFR trajectory.

scholarly journals Glomerular filtration rate predicts arterial events in women with systemic lupus erythematosus

Rheumatology ◽  
2010 ◽  
Vol 50 (4) ◽  
pp. 799-805 ◽  
Author(s):  
W. Zhang ◽  
E. Aghdassi ◽  
H. N. Reich ◽  
J. Su ◽  
W. Lou ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Glomerular Filtration Rate ◽  
Glomerular Filtration ◽  
Lupus Erythematosus ◽  
Filtration Rate ◽  
Systemic Lupus

scholarly journals AB0299 QUANTITATIVE EVALUATION OF PROTEINURIA WITH URINALYSIS TEST AND COMPARING ITS CORRELATION WITH RANDOM SPOT URINE PROTEIN-CREATININE RATIO AND 24 HOUR URINE PROTEIN IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS –A SINGLE CENTRE EXPERIENCE IN MALAYSIA

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1176.1-1176
Author(s):  
C. R. Ng ◽  
Y. L. Loh
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Nephritis ◽  
Lupus Erythematosus ◽  
Standard Test ◽  
Protein Quantification ◽  
Nephrol Dial Transplant ◽  
Creatinine Ratio ◽  
Systemic Lupus ◽  
Urine Protein ◽  
Spot Urine

Background:Lupus nephritis is an important concern among Systemic Lupus Erythematosus (SLE) patients in Asia and its mortality rate was reported to be 6 times higher compared to the general population [1]. Without prompt treatment it can lead to end stage renal failure and affect quality of life. 24 hour urine protein collection has long been used as the gold standard test to assess proteinuria. However due to its cumbersome process random spot urine protein-creatinine ratio is used as an alternative to replace the former in some centres before subjecting patients to renal biopsy. In a study done by Matar HE et al in 2012, he showed that there was a significant correlation between 24 hour urine protein and urine protein creatinine ratio in his 95 subjects [2].Urinalysis is a semi-quantitative screening tool for early detection of potential kidney disorders. A survey done by Siedner MJ et al on practice preferences among American Rheumatologists in 2005 reported that 64.6% of them preferred to use urinalysis as the primary tool to screen for proteinuria [3].Objectives:To assess the correlation of urinalysis test with random spot urine protein-creatinine ratio PCR) compared with 24 hour urine protein.Methods:This was a retrospective study. The electronic medical records of all SLE patients seen in the rheumatology clinic of Hospital Sultan Ismail from 1/1/2017 to 31/12/2020 were reviewed. Patients who had urinalysis, urine protein creatinine ratio and 24 hour urine protein tests done were identified. Data on demography, urinalysis, random spot urine protein creatinine ratio and 24 hour urine protein were obtained and analysed.Results:There were a total of 131 patients and 124 were females. The majority were Malays (75/131) followed by the Chinese (45/131),Indians (9/141) and others (2/131). The mean age group for the studied subjects was 34 (13-67). The urinalysis test showed that 34 of them had negative results, 37 of them had urine protein of 1 +, 18 of them had urine protein of 2+ followed by 23 patients with urine protein of 3 + and the rest had urine protein of 4+. The correlation between urinalysis and 24 hour urine protein was strong (r = 0.702), whereas the correlation between urinalysis and urine PCR ratio was stronger (r = 0.797).Conclusion:We conclude that urinalysis correlates well with both random spot urine protein creatinine ratio and 24 hour urine protein and the correlation is stronger with urine PCR.References:[1]Yap DY, Tang CS, Ma MK, Lam MF, Chan TM. Survival analysis and causes of mortality in patients with lupus nephritis. Nephrol Dial Transplant. 2012;27:3248–3254. [PubMed][2]Matar HE, Peterson P, Sangle S, D’Cruz DP. Correlation of 24-hour urinary protein quantification with spot urine protein: creatinine ratio in lupus nephritis. Lupus 2012 Jul;21(8): 836-9. doi:10.1177/0961203312437438. Epub 2012 Feb 13.[3]Siedner MJ, Christopher-Stine L, Astor BC, Gelber AC, Fine DM. Screening for proteinuria in patients with lupus: a survey of practice preferences among American rheumatologists. J Rheumatol. 2007;34:973–977. [PubMed].Disclosure of Interests:None declared

scholarly journals Mortality in a cohort of Egyptian systemic lupus erythematosus patients: retrospective two-center study

2021 ◽  
Vol 48 (1) ◽  
Author(s):  
Abdelkawy Moghazy ◽  
Amira M. Ibrahim
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Glomerular Filtration Rate ◽  
Lupus Erythematosus ◽  
End Stage Renal Disease ◽  
Filtration Rate ◽  
Causes Of Death ◽  
Systemic Lupus ◽  
Cardiopulmonary Complications ◽  
Stage Renal Disease ◽  
End Stage

Abstract Background Systemic lupus erythematosus is a debilitating autoimmune disease with major contribution to the worldwide morbidity and mortality. This study aimed to investigate the causes of mortality in systemic lupus erythematosus (SLE) patients and the relation between clinical activity, disease-associated end-organ damage, laboratory markers and mortality. Results Among the 771 patients who were successfully followed up, 34 patients (4.4%) died. The leading causes of death were infectious causes (35.29%), cardiopulmonary causes (26.48%), renal causes (14.7%), unknown causes (14.7%), neuropsychiatric causes (5.88%), and lastly gastrointestinal causes (2.94%). Subjects who died had lower complement 3 level, more anemia, lymphopenia, neutropenia, leukocytosis, thrombocytopenia, decreased glomerular filtration rate, higher incidence of infection, end-stage renal disease, and cardiopulmonary complications. Higher glucocorticoid dosage with more immunosuppressant (mofetil and cyclophosphamide) treatment was observed in patients who died. SLE disease Activity Index and Systemic Lupus International Collaborating Clinics damage index were both significantly higher in deceased persons. Multivariable hazards regression analysis revealed that lymphopenia (p = 0.017), decreased glomerular filtration rate < 50% (p = 0.002) with end-stage renal disease (p = 0.001), and high steroid daily use of > 40 mg (p = 0.016) were independent risk factors for the mortality of SLE patients. Conclusion Infections and cardiopulmonary complications are the leading causes of death in two centers caring for Egyptian SLE patients. Lymphopenia, end-stage renal failure, and high steroid daily use were associated with poor outcomes.

scholarly journals Cistatina C: Um Marcador de Função Renal Promissor em Doentes com Lúpus Eritematoso Sistémico?

2015 ◽  
Vol 28 (3) ◽  
pp. 333 ◽  
Author(s):  
Lígia Peixoto ◽  
Patrício Aguiar ◽  
Raquel De Bragança ◽  
Joana Rosa Martins ◽  
Alba Janeiro Acabado ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Chronic Kidney Disease ◽  
Glomerular Filtration Rate ◽  
Kidney Disease ◽  
Glomerular Filtration ◽  
Cystatin C ◽  
Lupus Erythematosus ◽  
Filtration Rate ◽  
Systemic Lupus ◽  
Disease Epidemiology

<strong>Purpose:</strong> Cystatin C has a higher correlation with glomerular filtration rate and a more significant clinical prognosis than creatinine. We sought to determine whether it is a marker of renal function different from creatinine (cystatin C potentially superior to creatinine), in patients with systemic lupus erythematosus.<br /><strong>Material and Methods:</strong> 37 patients with systemic lupus erythematosus were evaluated. Serum cystatin C was determined by nephelometry and creatinine by modified Jaffe method. We compared five formulas: Chronic Kidney Disease – Epidemiology Collaboration cystiatin; Chronic Kidney Disease – Epidemiology Collaboration creatinine-cystatin; Cockcroft-Gault; Modification of Diet in Renal Disease and Chronic Kidney Disease – Epidemiology Collaboration creatinine, using the latter as a reference. We analyzed the influence of clinical and laboratory factors in cystatin C variation, using multivariate linear regression.<br /><strong>Results:</strong> Cystatin C was singly elevated in ten participants, versus none isolated creatinine elevation, and this difference was significant (p = 0.002). There was a difference between the estimated glomerular filtration rate by Chronic Kidney Disease – Epidemiology Collaboration cystatin and by Chronic Kidney Disease – Epidemiology Collaboration creatinine (-6.0541 mL/min/1.73 m2, p = 0.07), more pronounced for lower glomerular filtration rate. Consequently, Chronic Kidney Disease – Epidemiology Collaboration cystatin reclassified 4 patients as having chronic kidney disease de novo and 1 patient as not having chronic kidney disease (p = 0.375).<br />Cystatin C was only significantly influenced by age (p &lt; 0.001).<br /><strong>Discussion:</strong> Several reports showed cystatin C as a better marker to define chronic kidney disease, allowing more accurate classification and risk stratification, compared with creatinine. In this study, Cystatin C revealed as a promisor marker of renal function in patient with lupus, mainly in patients with lower glomerular filtration rates. The correlation between age and cystatin C seems to be a confounding<br />factor, as glomerular filtration rate physiologically declines with ageing.<br /><strong>Conclusion:</strong> Cystatin C was potentially superior to creatinine and in this study and cystatin C seems to detect changes in glomerular filtration rate earlier than creatinine and may be a better screening method for chronic kidney disease in systemic lupus erythematosus.

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