Comprehensive disease control in systemic lupus erythematosus

2021 ◽  
Vol 51 (2) ◽  
pp. 404-408
Author(s):  
Fulvia Ceccarelli ◽  
Giulio Olivieri ◽  
Alessio Sortino ◽  
Lorenzo Dominici ◽  
Filmon Arefayne ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Control ◽  
Lupus Erythematosus ◽  
Systemic Lupus

Restrictive Use of Oral Glucocorticoids in Systemic Lupus Erythematosus and Prevention of Damage Without Worsening Long-Term Disease Control: An Observational Study

2018 ◽  
Vol 70 (4) ◽  
pp. 582-591 ◽  
Author(s):  
Ioana Ruiz-Arruza ◽  
Jesús Lozano ◽  
Ivan Cabezas-Rodriguez ◽  
Jose-Alejandro Medina ◽  
Amaia Ugarte ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Observational Study ◽  
Disease Control ◽  
Lupus Erythematosus ◽  
Systemic Lupus ◽  
Oral Glucocorticoids

scholarly journals Phase III, multicentre, randomised, double-blind, placebo-controlled, 104-week study of subcutaneous belimumab administered in combination with rituximab in adults with systemic lupus erythematosus (SLE): BLISS-BELIEVE study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e025687 ◽  
Author(s):  
Y K Onno Teng ◽  
Ian N Bruce ◽  
Betty Diamond ◽  
Richard A Furie ◽  
Ronald F van Vollenhoven ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Control ◽  
Lupus Erythematosus ◽  
B Lymphocyte ◽  
Activity Index ◽  
Phase Iii ◽  
Systemic Lupus ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Link Type

IntroductionBelimumab, an anti-B-lymphocyte-stimulator antibody, is approved for the treatment of active, autoantibody-positive systemic lupus erythematosus (SLE). Rituximab, a B cell-depleting anti-CD20 antibody, remains in the SLE treatment armamentarium despite failed trials in lupus nephritis and extrarenal lupus. These biologics, which operate through complementary mechanisms, might result in an enhanced depletion of circulating and tissue-resident autoreactive B lymphocytes when administered together. Thus, belimumab and rituximab combination may be a highly effective treatment of SLE. This study aims to evaluate and compare the efficacy, safety and tolerability of subcutaneous (SC) belimumab and a single cycle of rituximab in patients with SLE with belimumab alone.Methods and analysisBLISS-BELIEVE is a three-arm, randomised, double-blind, placebo-controlled, 104-week superiority study. Two hundred adults with SLE will be randomised 1:2:1 to arm A, belimumab SC 200 mg/week for 52 weeks plus placebo at weeks 4 and 6; arm B, belimumab SC 200 mg/week for 52 weeks plus rituximab 1000 mg at weeks 4 and 6; arm C, belimumab SC 200 mg/week plus standard of care for 104 weeks. The 52-week treatment period (arms A and B) is followed by a 52-week observational phase. The primary efficacy endpoint is the proportion of patients with disease control (SLE Disease Activity Index (SLEDAI)−2K≤2, without immunosuppressants and with a prednisone-equivalent dose of ≤5 mg/day) at week 52. Major secondary efficacy endpoints are the proportion of patients in clinical remission (defined as SLEDAI-2K=0, without immunosuppressants and corticosteroids) at week 64, and the proportion of patients with disease control at week 104. Safety endpoints include the incidence of adverse events (AEs), serious AEs and AEs of special interest.Ethics and disseminationWithin 6 months of the study’s primary manuscript publication, anonymised individual participant data and study documents can be requested for further research fromwww.clinicalstudydatarequest.com.Trial registration numberNCT03312907; Pre-results.

scholarly journals Disease Control and Safety of Belimumab Plus Standard Therapy Over 7 Years in Patients with Systemic Lupus Erythematosus

2013 ◽  
Vol 41 (2) ◽  
pp. 300-309 ◽  
Author(s):  
Ellen M. Ginzler ◽  
Daniel J. Wallace ◽  
Joan T. Merrill ◽  
Richard A. Furie ◽  
William Stohl ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Control ◽  
Lupus Erythematosus ◽  
Standard Therapy ◽  
Initial Study ◽  
Systemic Lupus ◽  
Open Label ◽  
Double Blind ◽  
Link Type ◽  
Auto Antibody

Objective.To evaluate the efficacy/safety of belimumab plus standard therapy in patients (n = 449) with active systemic lupus erythematosus (SLE) treated up to 7 years (n = 177 currently ongoing).Methods.Patients (n = 345) who completed a double-blind, placebo-controlled, 52-week study of belimumab 1, 4, or 10 mg/kg and 24-week extension of belimumab (placebo switched to 10 mg/kg; belimumab same dose or switched to 10 mg/kg) could receive belimumab 10 mg/kg in an open-label continuation study (n = 296). Disease activity was analyzed in patients with active SLE at baseline of the initial study. Biomarker and SLE medication changes were evaluated, and adverse events (AE) were monitored throughout the study.Results.Total belimumab exposure over 7 years (double-blind and open-label periods): 1746 patient-years. SLE Responder Index (SRI) response rates at Week 52 in autoantibody-positive patients: placebo, 29%; belimumab, 46% (p < 0.05). In the continuation study, 57% of auto-antibody-positive patients had an SRI response by Year 2 and 65% by Year 7; severe flares occurred in 19% with placebo and 17% with belimumab during the first year, with the annual rate declining to 2%–9% during years 2–7. Anti-dsDNA autoantibodies in patients positive for them at baseline had a progressive decline of 40%–60% from baseline over 2–7 years with belimumab. Corticosteroid use decreased over time with ≥ 50–55% reduction in median dose during years 5–7. Serious and overall annual AE rates, including infections, were generally stable or decreased during 7-year treatment.Conclusion.Disease control and safety profile were maintained in patients with active SLE taking belimumab plus standard therapy for up to 7 years. [ClinicalTrials.gov numbers: NCT00071487 and NCT00583362]

Organized Intraglomerular Deposits in NZB Mouse Disease

1971 ◽  
Vol 29 ◽  
pp. 544-545
Author(s):  
Francis R. Comerford ◽  
Alan S. Cohen
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Antinuclear Antibodies ◽  
Human Systemic Lupus Erythematosus ◽  
Systemic Lupus ◽  
Glomerular Lesion ◽  
Ultrastructural Studies ◽  
Dense Deposits ◽  
Experimental Nephritis ◽  
Glomerular Lesions

Mice of the inbred NZB strain develop a spontaneous disease characterized by autoimmune hemolytic anemia, positive lupus erythematosus cell tests and antinuclear antibodies and nephritis. This disease is analogous to human systemic lupus erythematosus. In ultrastructural studies of the glomerular lesion in NZB mice, intraglomerular dense deposits in mesangial, subepithelial and subendothelial locations were described. In common with the findings in many examples of human and experimental nephritis, including many cases of human lupus nephritis, these deposits were amorphous or slightly granular in appearance with no definable substructure.We have recently observed structured deposits in the glomeruli of NZB mice. They were uncommon and were found in older animals with severe glomerular lesions by morphologic criteria. They were seen most commonly as extracellular elements in subendothelial and mesangial regions. The deposits ranged up to 3 microns in greatest dimension and were often adjacent to deposits of lipid-like round particles of 30 to 250 millimicrons in diameter and with amorphous dense deposits.

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