Search results for "Belimumab"
showing 8 items of 8 documents
Advances in the treatment of cutaneous lupus erythematosus.
2016
Lupus erythematosus (LE) is a multifactorial autoimmune disease with clinical manifestations of differing severity which may present with skin manifestations as primary sign of the disease (cutaneous lupus erythematosus, CLE) or as part of a disease spectrum (systemic lupus erythematosus, SLE). To date, no drugs are approved specifically for the treatment of CLE and only single agents have been applied in randomized controlled trials. Therefore, topical and systemic agents are used “off-label”, primarily based on open-label studies, case series, retrospective analyses, and expert opinions. In contrast, several agents, such as hydroxychloroquine, chloroquine, cyclophosphamide, azathioprine,…
Renal tubular epithelial cell-derived BAFF expression mediates kidney damage and correlates with activity of proliferative lupus nephritis in mouse a…
2017
B-cell activating factor of the tumour necrosis factor family (BAFF) is a cytokine, mainly produced by hematopoietic cells (e.g. monocytes/macrophages, dendritic cells), indispensable for B-cell maturation. The BLISS studies have demonstrated that blocking BAFF by the human monoclonal antibody belimumab is a valuable therapeutic approach in patients with clinically and serologically active systemic lupus erythematosus (SLE). However, the defined sources of BAFF, which contributes to SLE, are still unclear. Recent findings show that BAFF expression is not restricted to myeloid cells. Since lupus nephritis is the main cause of morbidity and mortality for SLE patients, the aim of this study wa…
Fatigue in SLE: diagnostic and pathogenic impact of anti-N-methyl-D-aspartate receptor (NMDAR) autoantibodies.
2019
ObjectivesWe explored the impact of circulating anti-N-methyl-D-aspartate receptor (NMDAR) antibodies on the severity of fatigue in patients with systemic lupus erythematosus (SLE).MethodsSerum samples of 426 patients with SLE were analysed for the presence of antibodies to the NR2 subunit of the NMDAR. In parallel, the severity of fatigue was determined according to the Fatigue Scale for Motor and Cognitive functions questionnaire. In a subgroup of patients with SLE, the hippocampal volume was correlated with the levels of anti-NR2 antibodies. Isolated immunoglobulin G from patients with anti-NR2 antibodies were used for murine immunohistochemical experiments and functional assays on neuro…
Efficacy and Safety of Subcutaneous Belimumab in Anti–Double-Stranded DNA–Positive, Hypocomplementemic Patients With Systemic Lupus Erythematosus
2018
Objective: To investigate the efficacy and safety of belimumab, a human immunoglobulin monoclonal antibody against B lymphocyte stimulator, in a subset of patients with systemic lupus erythematosus (SLE) who were hypocomplementemic (C3 <90 mg/dl and/or C4 <10 mg/dl) and anti–double-stranded DNA (anti-dsDNA) positive (≥30 IU/ml) at baseline. Methods: In this phase III, double-blind, placebo-controlled study (BEL112341; ClinicalTrials.gov identifier: NCT01484496), patients with moderate to severe SLE (Safety of Estrogens in Lupus Erythematosus National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index [SELENA–SLEDAI] score ≥8) were randomized (2:1) to receive weekl…
B cell activating factor (BAFF): Structure, functions, autoimmunity and clinical implications in Systemic Lupus Erythematosus (SLE)
2020
The B cell activating factor (BAFF), or B lymphocyte stimulator (BLyS), is a B cell survival factor which supports autoreactive B cells and prevents their deletion. BAFF expression is closely linked with autoimmunity and is enhanced by genetic alterations and viral infections. Furthermore, BAFF seems to be involved in adipogenesis, atherosclerosis, neuro-inflammatory processes and ischemia reperfusion (I/R) injury. BAFF is commonly overexpressed in Systemic Lupus Erythematosus (SLE) and strongly involved in the pathogenesis of the disease. The relationship between BAFF levels, disease activity and damage accrual in SLE is controversial, but growing evidence is emerging on its role in renal …
The skin in autoimmune diseases-Unmet needs.
2016
Treatment of skin manifestations in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and dermatomyositis (DM) is based on the results of only few randomized controlled trials. The first-line treatment for disfiguring and widespread cutaneous involvement in SLE is antimalarials, but some patients are therapy resistant. Recently, the monoclonal antibody belimumab was approved for SLE as an adjunct therapy for patients with autoantibody-positive disease who despite standard therapy show high disease activity, intolerance of other treatments, or an unacceptably high need for corticosteroids. However, a validated skin score has not been used to confirm the efficacy of belimumab on m…
FRI0189 POOLED ANALYSIS OF THE REAL-WORLD EFFECTIVENESS OF BELIMUMAB IN TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS USING MULTI-COUNTRY DATA FROM THE O…
2019
Background: Real-world evidence of belimumab effectiveness in patients with systemic lupus erythematosus (SLE) has been reported separately for several countries through the OBSErve (evaluation Of use of Belimumab in clinical practice SEttings) programme. Objectives: To evaluate the effectiveness of belimumab in patients with SLE using pooled data from the individual OBSErve studies. Methods: This was a post hoc meta-analysis (GSK study 206351) of patient level data pooled from six retrospective observational cohort studies (Argentina, Canada, Germany, Spain, Switzerland, United States of America). Physicians provided data for adults (≥18 years; clinical diagnosis of SLE) who had initiated …
OP0048 Outcomes in Systemic Lupus Erythematous (SLE) Patients Treated with Belimumab in Clinical Practice Settings: Results from the Observe Study in…
2014
Background Large-scale clinical trials have demonstrated clinical efficacy of belimumab in SLE patients. Objectives This study examined the clinical outcomes associated with belimumab in clinical practice settings in Germany. Methods OBSErve (GSK 117214) is a multi-center retrospective medical chart review study. Twenty-one rheumatologists from Germany treating >10 SLE-patients annually and with at least >5 yrs of practice experience were selected for data reporting. Adult SLE patients meeting the ACR classification criteria who received belimumab (10mg/kg) as part of usual care were identified for chart abstraction. Index date was the date of belimumab initiation. The primary outcome measu…