FRI0346 Evaluating Differences in The Enrolled Populations of Randomized Clinical Trials of Systemic Lupus Erythematosus

2016 ◽  
Vol 75 (Suppl 2) ◽  
pp. 560.1-560
Author(s):  
N. Goel ◽  
B. Barrett ◽  
A. Duncan ◽  
M.-B. Gallagher ◽  
M. Mackey
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trials ◽  
Lupus Erythematosus ◽  
Randomized Clinical Trials ◽  
Systemic Lupus

Next stop in the treatment of refractory systemic lupus erythematosus: B-cell targeted combined therapy

Lupus ◽  
2020 ◽  
Vol 30 (1) ◽  
pp. 134-140
Author(s):  
Margarida Matos Bela ◽  
Gerard Espinosa ◽  
Ricard Cervera
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trials ◽  
B Cell ◽  
Lupus Erythematosus ◽  
Randomized Clinical Trials ◽  
Wide Spectrum ◽  
Combined Therapy ◽  
Clinical Manifestations ◽  
Drug Regimen ◽  
Systemic Lupus

Background: Systemic lupus erythematosus (SLE) is an autoimmune condition with a wide spectrum of clinical manifestations encompassing most organs and systems. Its treatment approach includes different immunomodulatory treatments, of which B-cell targeted therapies are part of. Rituximab (an anti-CD20 antibody) had encouraging results in observational studies but failed when tested in clinical trials. It is theorized that this could have been partially due to BAFF upregulation, leading to rituximab failure. Therefore, targeting BAFF with belimumab after rituximab therapy, may have a synergic effect in SLE. Objective: We review the available observational data regarding sequential rituximab/belimumab therapy in SLE patients. Results: Twenty-four patients from 6 studies were included. The results suggest a benefit with this combined therapy, with reduction of the mean SLEDAI. However, there was significant drug regimen and patient selection heterogeneity. Conclusion: Further randomized clinical trials are needed to examine this drug sequencing protocol in SLE patients.

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.

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.

scholarly journals Fatigue Measurements in Systemic Lupus Erythematosus

2019 ◽  
Vol 46 (11) ◽  
pp. 1470-1477 ◽  
Author(s):  
Ariane Barbacki ◽  
Michelle Petri ◽  
Antonio Aviña-Zubieta ◽  
Graciela S. Alarcón ◽  
Sasha Bernatsky
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trials ◽  
Lupus Erythematosus ◽  
Observational Studies ◽  
Ad Hoc ◽  
Inclusion Criteria ◽  
Systemic Lupus ◽  
French Studies ◽  
Chronic Illness Therapy ◽  
Fatigue Severity

Objective.Fatigue is a frequent, disabling issue in systemic lupus erythematosus (SLE). It is, however, difficult to quantify. The Ad Hoc Committee on SLE Response Criteria for Fatigue in 2007 recommended using the Krupp Fatigue Severity Scale (FSS). Since then, the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale has also been validated in SLE. We performed a review of instruments used to measure fatigue in adult SLE patients from 2007 onward.Methods.We searched PubMed, Medline, and Embase (January 2008–October 2017), identifying clinical trials and observational studies in adult SLE, where fatigue was a specifically measured outcome. All English and French studies were reviewed to determine fatigue measures and results.Results.Thirty-seven studies met inclusion criteria. Eight scales were used. The visual analog scale (VAS), FSS, and FACIT-Fatigue Scale were most frequent. FSS was the most often used instrument in both clinical trials and observational studies. Twenty-five of the 37 studies demonstrated a difference in fatigue that was statistically significant and clinically meaningful. Of the 12 studies that did not, 6 used FSS, 3 used VAS, 2 used the Multidimensional Assessment of Fatigue, and 1 used the Brief Fatigue Index. All 6 studies using the FACIT-Fatigue Scale detected clinically meaningful and statistically significant differences.Conclusion.VAS, FSS, and FACIT-Fatigue Scale were the most frequently used instruments in adult SLE studies from 2008 to 2017. Many studies detected clinically important changes in fatigue. Fatigue remains a key measure in both clinical trials and observational SLE studies.

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