scholarly journals Spliceosomal peptide P140 for immunotherapy of systemic lupus erythematosus: Results of an early phase II clinical trial

2008 ◽  
Vol 58 (12) ◽  
pp. 3873-3883 ◽  
Author(s):  
Sylviane Muller ◽  
Fanny Monneaux ◽  
Nicolas Schall ◽  
Rasho K. Rashkov ◽  
Boycho A. Oparanov ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trial ◽  
Phase Ii ◽  
Lupus Erythematosus ◽  
Early Phase ◽  
Phase Ii Clinical Trial ◽  
Systemic Lupus

scholarly journals Belimumab after B cell depletion therapy in patients with systemic lupus erythematosus (BEAT Lupus) protocol: a prospective multicentre, double-blind, randomised, placebo-controlled, 52-week phase II clinical trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032569 ◽  
Author(s):  
Alexis Jones ◽  
Patrick Muller ◽  
Caroline J Dore ◽  
Felicia Ikeji ◽  
Emilia Caverly ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trial ◽  
B Cell ◽  
Phase Ii ◽  
Lupus Erythematosus ◽  
Phase Ii Clinical Trial ◽  
Cell Depletion ◽  
B Cell Depletion ◽  
Systemic Lupus ◽  
Double Blind

IntroductionFew treatment options exist for patients with systemic lupus erythematosus (SLE) who fail conventional therapy. Although widely used to treat lupus, the efficacy of B cell depletion therapy using rituximab has not been demonstrated in randomised clinical trials. Following rituximab, elevated levels of serum B cell activating factor (BAFF) have been associated with failure to remit or subsequent lupus relapse. The administration of belimumab, a monoclonal antibody specific for BAFF and approved for lupus therapy, could potentiate the efficacy of rituximab and enable longer periods of disease remission. The aim of this trial is to assess the safety and efficacy of belimumab following rituximab in patients with SLE.Methods and analysisBEAT Lupus is a double-blind, randomised, placebo controlled, phase II clinical trial. Patients with SLE commencing a treatment cycle of rituximab (two 1g infusions, 2 weeks apart) as standard of care will be randomised to receive belimumab or placebo, 4 to 8 weeks following the first rituximab infusion. Belimumab or placebo infusions are administered for 52 weeks. The primary outcome measure is anti-double stranded DNA (anti-dsDNA) antibody levels at 52 weeks. Secondary outcomes include measures of adverse events, lupus disease activity and cumulative steroid dose. The kinetics of B cell repopulation will be assessed in a subgroup of participants. Belimumab administration after rituximab may provide a novel therapeutic pathway for patients with active lupus if safety is demonstrated in this proof of concept study, and lower anti-dsDNA antibodies levels are achieved in those patients treated with belimumab compared with placebo.Ethics and disseminationThe protocol has been reviewed and approved by the Hampstead Research Ethics Committee - London (reference 16/LO/1024). Trial information is available athttps://www.isrctn.com/ISRCTN47873003, and the results of this trial will be submitted for publication in relevant peer-reviewed journals. Key findings will also be presented at national and international conferences.Trial registration numberISRCTN47873; date assigned to the registry: 28 November 2016. The stage is pre-results.

scholarly journals Effect of vitamin D supplementation on disease activity (SLEDAI) and fatigue in Systemic Lupus Erythematosus patients with hipovitamin D: An Open Clinical Trial

2018 ◽  
Vol 8 (2) ◽  
Author(s):  
Achmad Rifa’i ◽  
Handono Kalim ◽  
Kusworini Kusworini ◽  
Cesarius Singgih Wahono
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trial ◽  
Vitamin D ◽  
Placebo Group ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Vitamin D Supplementation ◽  
Control Group ◽  
Systemic Lupus ◽  
Significant Difference

Background : Low level of vitamin D impact the disease activity and the degree of fatigue in SLE patients. This study aims to determine the effect of vitamin D supplementation on disease activity and fatigue condition in Systemic Lupus Erythematosus (SLE) patients with hipovitamin D.Methods: We performed an open clinical trial. Subjects were randomized into two different groups (supplementation or placebo) using simple random sampling. The treatment group got vitamin D3 softgel/ cholecalciferol 1200 IU/day or 30 mg/day, while the control group gotplacebo for 3 months. SLEDAI scores and FSS scores were calculated at pre and posttreatment.Results: There were 20 subjectsfor supplementation group and 19 subjects in the placebo group. From this study, before and after treatment, we found a significant difference of mean level of vitamin D in supplementation group (p=0.000), and no significant difference inpatients with placebo (p=0.427). Moreover, from the SLEDAI score analysis, observed a significant difference bothin the supplemented group (p=0.000) and the placebo group (p=0.006). FSS scores significantly different in the supplemented group (p=0.000). Incorrelation test,there was a negative correlation (r=-0763) between vitamin D level and disease activity (SLEDAI), and both showing stastistical significance between thepre supplementation (p=0.000) and post supplementation (r=-0846; p=0.000). Similarly to theFSS scores, there was a meaningfulnegative correlation (r=-0.931, p=0.000) between the level of vitamin D with FSS scores pre and post supplementation (r=-0.911; p= 0.000). Furthermore, there was a significant correlation between disease activity (SLEDAI) pre supplementation with fatigue condition pre supplementation (r=0.846; p = 0.000) and postsupplementation (r=0.913; p= 0.000).Conclusion: The supplementation of vitamin D 1200 IU per day in patients with SLE improve disease activity and degree of fatigue. Keywords: vitamin D, disease activity, fatigue, SLE

scholarly journals A randomized clinical trial of a psychoeducational intervention to improve outcomes in systemic lupus erythematosus

2004 ◽  
Vol 50 (6) ◽  
pp. 1832-1841 ◽  
Author(s):  
Elizabeth W. Karlson ◽  
Matthew H. Liang ◽  
Holley Eaton ◽  
Jie Huang ◽  
Lisa Fitzgerald ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Lupus Erythematosus ◽  
Psychoeducational Intervention ◽  
Systemic Lupus

scholarly journals Correction: Initial clinical trial of epratuzumab (humanized anti-CD22 antibody) for immunotherapy of systemic lupus erythematosus

2008 ◽  
Vol 10 (5) ◽  
pp. 406 ◽  
Author(s):  
Thomas Dörner ◽  
Joerg Kaufmann ◽  
William A Wegener ◽  
Nick Teoh ◽  
David M Goldenberg ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trial ◽  
Lupus Erythematosus ◽  
Systemic Lupus ◽  
Initial Clinical Trial

Impaired Health Status and the Effect of Pain and Fatigue on Functioning in Clinical Trial Patients with Systemic Lupus Erythematosus

2013 ◽  
Vol 40 (11) ◽  
pp. 1865-1874 ◽  
Author(s):  
Michelle Petri ◽  
Ariane K. Kawata ◽  
Ancilla W. Fernandes ◽  
Kavita Gajria ◽  
Warren Greth ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trial ◽  
Health Status ◽  
General Population ◽  
Lupus Erythematosus ◽  
Health Assessment ◽  
Systemic Lupus ◽  
Patient Reported ◽  
The Us ◽  
Impaired Health

Objective.Our study evaluated the impaired health status of clinical trial patients with systemic lupus erythematosus (SLE) and explored the relationship between changes in fatigue and pain and their effect on overall health status.Methods.Pooled treatment and placebo data from a phase Ib clinical trial of adults with moderate/severe SLE were analyzed. Measures included patient-reported Medical Outcome Study Short Form-36 Survey, Version 2 (SF-36v2), Fatigue Severity Scale, and numeric rating scales (NRS) for pain and global health assessment and clinician-reported global assessment of disease activity (MDGA). Disease burden was compared to the US general population. Health status of responders and nonresponders on pain or fatigue were compared.Results.The sample included 161 patients with SLE, predominantly female (96%) and white (72%), with average age of 43 ± 11 years. Mean SF-36v2 component summary scores reflected overall problems with physical [physical component summary (PCS); 35.2 ± 9.7] and mental health (mental component summary; 40.9 ± 12.9). Patients with SLE had worse health status on all SF-36v2 subscales than the US general population and comparable age and sex norms (effect size −0.51 to −2.15). Pain and fatigue responders had greater improvements on SF-36v2 scores (bodily pain, physical functioning, social functioning, PCS), patient global health assessment NRS, and MDGA than nonresponders. There was moderate agreement in responder status, based on global assessments by patients and clinicians (68.1%), with some discrepancy between patients who were MDGA responders but patient assessment nonresponders (27.7%).Conclusion.Improvements in patient-reported pain or fatigue correlated with improvements in overall health. Patient assessments offer a unique perspective on treatment outcomes. Patient-reported outcomes add value in understanding clinical trial treatment benefits.

Assessments of fatigue and disease activity in patients with systemic lupus erythematosus enrolled in the Phase 2 clinical trial with blisibimod

Lupus ◽  
2016 ◽  
Vol 26 (1) ◽  
pp. 27-37 ◽  
Author(s):  
M A Petri ◽  
R S Martin ◽  
M A Scheinberg ◽  
R A Furie
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trial ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Activity Index ◽  
Disease Activity Index ◽  
Poor Correlation ◽  
Systemic Lupus ◽  
Fatigue Score ◽  
Patient Reported

This report evaluates the effects of blisibimod (A-623, AMG 623), a potent and selective inhibitor of B-cell activating factor (BAFF), on patient-reported fatigue and disease activity in the Phase 2b PEARL-SC clinical trial in patients with systemic lupus erythematosus (SLE). A total of 547 individuals who met the American College of Rheumatology (ACR) classification criteria for SLE, were positive for anti-double-stranded DNA or antinuclear antibodies, and had a Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score ≥6 at baseline, were randomized to receive placebo or blisibimod for at least 24 weeks. Patient self-reported fatigue was evaluated using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale, and disease activity was evaluated using Physician’s Global Assessment, SELENA-SLEDAI, and British Isles Lupus Assessment Group Score. Statistically significant improvements in FACIT-Fatigue score were observed among individuals randomized to blisibimod, especially in the 200 mg QW group where favorable effects on disease activity with blisibimod compared to placebo were observed as early as Week 8. The mean improvement from baseline of 6.9 points at Week 24, compared with 4.4 points with placebo, met the criteria for minimal clinically important improvement difference defined for patients with SLE. Despite concomitant improvements in FACIT-Fatigue, SLE Responder Index (SRI) and SLE biomarkers (reported previously), FACIT-Fatigue score correlated only weakly with disease activity. While poor correlation between fatigue and disease activity is not new, the observation that correlation remains poor despite concurrent population improvements in disease and fatigue brings a new facet to our understanding of SLE.

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