Clinical trials in systemic lupus erythematosus (SLE): lessons from the past as we proceed to the future – the EULAR recommendations for the management of SLE and the use of end-points in clinical trials

Lupus ◽  
2008 ◽  
Vol 17 (5) ◽  
pp. 437-442 ◽  
Author(s):  
G Bertsias ◽  
C Gordon ◽  
DT Boumpas
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trials ◽  
Lupus Erythematosus ◽  
Systemic Lupus ◽  
End Points ◽  
The Past ◽  
Eular Recommendations ◽  
The Future

The Kidney Biopsy in Systemic Lupus Erythematosus: A View of the Past and a Vision of the Future

2019 ◽  
Vol 26 (5) ◽  
pp. 360-368 ◽  
Author(s):  
Isabelle Ayoub ◽  
Clarissa Cassol ◽  
Salem Almaani ◽  
Brad Rovin ◽  
Samir V. Parikh
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Kidney Biopsy ◽  
Systemic Lupus ◽  
The Past ◽  
The Future

EULAR points to consider for conducting clinical trials in systemic lupus erythematosus: literature based evidence for the selection of endpoints: Table 1

2008 ◽  
Vol 68 (4) ◽  
pp. 477-483 ◽  
Author(s):  
G K Bertsias ◽  
J P A Ioannidis ◽  
J Boletis ◽  
S Bombardieri ◽  
R Cervera ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trials ◽  
Literature Review ◽  
Outcome Measures ◽  
Lupus Erythematosus ◽  
Task Force ◽  
Evidence Base ◽  
Cochrane Library ◽  
Systemic Lupus ◽  
End Points

Objective:To assess available evidence on the use of end-points (outcome measures) in clinical trials in systemic lupus erythematosus (SLE), as a part of the development of evidence-based recommendations for points to consider in clinical trials in SLE.Methods:The European League Against Rheumatism (EULAR) Task Force on SLE comprised 19 specialists, a clinical epidemiologist and a research fellow. Key questions addressing the evidence for clinical trial end-points in SLE were compiled using the Delphi technique. A systematic search of the PubMed and Cochrane Library databases was performed using McMaster/Hedges clinical query strategies and an array of relevant terms. Evidence was categorised based on sample size and type of design, and the categories of available evidence were identified for each recommendation. The strength of recommendation was assessed based on the category of available evidence and agreement on the statements was measured across the 19 specialists.Results:Eight questions were generated regarding end-points for clinical trials. The evidence to support each proposition was evaluated. The literature review revealed that most outcome measures used in phase 2/3 trials in SLE have not been formally validated in clinical trials, although some indirect validation has been undertaken.Conclusion:This systematic literature review forms the evidence base considered in the development of the EULAR recommendations for end-points in clinical trials in SLE.

scholarly journals The Wolf’(s)-B(r)ain- The Past, Present, Future of CNS Lupus

2019 ◽  
Vol 16 (3) ◽  
pp. 6-14
Author(s):  
Murali Suhas ◽  
Srikanteshwara Parveen-Kumar
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Review Article ◽  
Future Research ◽  
Systemic Lupus ◽  
Research Directions ◽  
Cns Lupus ◽  
The Past ◽  
The Future ◽  
Future Research Directions

Systemic Lupus Erythematosus is a long-studied condition with protean manifestations, yet, with so much known about the pathogenesis and treatment aspects still in the dark. In this review article, we try to sum up all the knowledge we have till date, the practice essentials used to date and the future research directions, all of which ultimately lead to a better understanding of the disease and its management.

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

2011 ◽  
Vol 38 (11) ◽  
pp. 2395-2399 ◽  
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.

Stem cell transplantation: progress in Asia

Lupus ◽  
2010 ◽  
Vol 19 (12) ◽  
pp. 1468-1473 ◽  
Author(s):  
L. Sun
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Stem Cell ◽  
Lupus Erythematosus ◽  
Systemic Lupus ◽  
Hematopoietic Stem ◽  
The Past ◽  
Complex Autoimmune Disease ◽  
Significant Mortality

Systemic lupus erythematosus (SLE) is a complex autoimmune disease with multiorgan involvement and high mortality, which was reduced because of the most widely and classically used immunosuppressive therapies. However, some patients continue to have significant mortality. So a shift in the approach to the treatment of SLE is needed. In the past decade, most transplants have been performed in the treatment of SLE with allogeneic or autologous hematopoietic stem cells and currently emerging mesenchymal stem cells. There are some important differences between the two procedures.

scholarly journals Machine learning applied to whole-blood RNA-sequencing data uncovers distinct subsets of patients with systemic lupus erythematosus

2019 ◽  
Author(s):  
William A Figgett ◽  
Katherine Monaghan ◽  
Milica Ng ◽  
Monther Alhamdoosh ◽  
Eugene Maraskovsky ◽  
...  
Keyword(s):  
Gene Expression ◽  
Machine Learning ◽  
Systemic Lupus Erythematosus ◽  
Clinical Trials ◽  
Lupus Erythematosus ◽  
Whole Blood ◽  
Rna Seq ◽  
Systemic Lupus ◽  
Disease Heterogeneity ◽  
Healthy Donors

ABSTRACTObjectiveSystemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease that is difficult to treat. There is currently no optimal stratification of patients with SLE, and thus responses to available treatments are unpredictable. Here, we developed a new stratification scheme for patients with SLE, based on the whole-blood transcriptomes of patients with SLE.MethodsWe applied machine learning approaches to RNA-sequencing (RNA-seq) datasets to stratify patients with SLE into four distinct clusters based on their gene expression profiles. A meta-analysis on two recently published whole-blood RNA-seq datasets was carried out and an additional similar dataset of 30 patients with SLE and 29 healthy donors was contributed in this research; 141 patients with SLE and 51 healthy donors were analysed in total.ResultsExamination of SLE clusters, as opposed to unstratified SLE patients, revealed underappreciated differences in the pattern of expression of disease-related genes relative to clinical presentation. Moreover, gene signatures correlated to flare activity were successfully identified.ConclusionGiven that disease heterogeneity has confounded research studies and clinical trials, our approach addresses current unmet medical needs and provides a greater understanding of SLE heterogeneity in humans. Stratification of patients based on gene expression signatures may be a valuable strategy to harness disease heterogeneity and identify patient populations that may be at an increased risk of disease symptoms. Further, this approach can be used to understand the variability in responsiveness to therapeutics, thereby improving the design of clinical trials and advancing personalised therapy.

scholarly journals Telerheumatology: A Narrative Review

2021 ◽  
Vol 2 (3) ◽  
pp. 139-145
Author(s):  
Wei Tang ◽  
Leila Khalili ◽  
Anca Askanase
Keyword(s):  
Rheumatoid Arthritis ◽  
Systemic Lupus Erythematosus ◽  
Health Care ◽  
Clinical Trials ◽  
Lupus Erythematosus ◽  
Delivery Of Health Care ◽  
Healthcare Professionals ◽  
Direct Consequence ◽  
Systemic Lupus ◽  
Rheumatology Practice

Abstract Telemedicine (TM), the delivery of health care using telecommunication technologies, has been in use in rheumatology practice for over two decades to maximize access and optimize care. As a direct consequence of the Coronavirus disease 2019 (COVID-19) pandemic in March 2020, rheumatology practice shifted from traditional in-person encounters to TM to ensure the safety of both healthcare professionals and patients. However, there is limited literature on the acceptance, feasibility, and effectiveness of TM in the management of rheumatic diseases. Additionally, there is limited guidance on the implementation of telerheumatology (TR) for both patient care and clinical trials. Here we reviewed the most recent publications related to the application of TR, in the management of Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE), assessed the perceptions of patients and physicians on TM in rheumatology, and identified several key barriers to TR.

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