A5047601269- Systemic Lupus Erythematosus Research
- Monoclonal and Polyclonal Antibodies Research
- T-cell and B-cell Immunology
- Liver Diseases and Immunity
- Immunodeficiency and Autoimmune Disorders
- Atherosclerosis and Cardiovascular Diseases
- Adrenal Hormones and Disorders
- Lymphoma Diagnosis and Treatment
- Renal Diseases and Glomerulopathies
- Pharmacological Effects of Natural Compounds
- Autoimmune and Inflammatory Disorders Research
- Systemic Sclerosis and Related Diseases
- Immune Cell Function and Interaction
- Inflammatory Bowel Disease
- Computational Drug Discovery Methods
- Medical Malpractice and Liability Issues
- Inflammatory mediators and NSAID effects
- Heparin-Induced Thrombocytopenia and Thrombosis
- Long-Term Effects of COVID-19
- SARS-CoV-2 and COVID-19 Research
- Brain Metastases and Treatment
- Cytokine Signaling Pathways and Interactions
- Acute Lymphoblastic Leukemia research
- Lung Cancer Research Studies
- Multiple Sclerosis Research Studies
Providence College
2024
GlaxoSmithKline (United States)
2011-2022
Research Triangle Park Foundation
2022
GlaxoSmithKline (Japan)
2021
GlaxoSmithKline (Netherlands)
2018
Kalamazoo College
2017
GlaxoSmithKline (United Kingdom)
2013
To assess the efficacy and safety of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE).Patients moderate-to-severe SLE (score ≥8 on Safety Estrogens Lupus Erythematosus National Assessment [SELENA] version Disease Activity Index [SLEDAI]) were randomized 2:1 to receive weekly SC 200 mg or placebo by prefilled syringe addition standard therapy for 52 weeks. The primary end point was Responder (SRI4) at week 52. Secondary points reduction corticosteroid dosage...
Intravenous belimumab plus standard of care (SoC) is approved in the USA and Europe for treatment active, autoantibody-positive systemic lupus erythematosus (SLE).This phase III, multicentre, randomised, double-blind, placebo-controlled study (BEL113750; NCT01345253) was conducted 49 centres across China, Japan South Korea (May 2011-September 2015). Patients with SLE were randomised 2:1 to intravenous 10 mg/kg or placebo, SoC, every 4 weeks until Week 48. The primary endpoint Responder Index...
Objectives This ongoing Phase-2, randomised, placebo-controlled, double-blind study evaluated the efficacy, safety and pharmacokinetics of intravenous belimumab in childhood-onset systemic lupus erythematosus (cSLE). Methods Patients (5 to 17 years) were randomised 10 mg/kg or placebo every 4 weeks, plus standard SLE therapy. Primary endpoint: Responder Index (SRI4) response rate (Week 52). Key major secondary endpoints: proportion patients achieving Paediatric Rheumatology International...
We performed a post hoc analysis of the Belimumab International Study in Lupus Nephritis (BLISS-LN), Phase 3, multinational, double-blind, 104-week trial, which 448 patients with lupus nephritis were randomized to receive intravenous belimumab 10 mg/kg or placebo standard therapy (cyclophosphamide/azathioprine mycophenolate mofetil). Add-on was found be most effective improving primary efficacy kidney response and complete proliferative baseline urine protein/creatinine ratio under 3 g/g....
Objective Enrollment of patients Black African ancestry with systemic lupus erythematosus (SLE) in phase II and III the belimumab trials was not reflective racial distribution observed population. This study undertaken to assess efficacy safety intravenous (IV) plus standard therapy self‐identified race. Methods EMBRACE (GSK Study BEL115471; ClinicalTrials.gov identifier: NCT01632241) a 52‐week multicenter, double‐blind, placebo‐controlled trial adults race active SLE who received monthly 10...
Granulocyte-macrophage colony-stimulating factor (GM-CSF) and dysregulated myeloid cell responses are implicated in the pathophysiology severity of COVID-19.
To assess healthcare resource utilization and costs in a cohort of US managed care patients with systemic lupus erythematosus (SLE).Claims data from large plan were used to identify 18-64 years old SLE-related claims 2004-2005. Algorithms developed retrospectively categorize by disease severity flare episodes severity. Descriptive multivariate analyses performed estimate over 2-year period for the overall severity.Among 2990 study cohort, was mild 789 (26.4%), moderate 1558 (52.1%), severe...
To investigate the efficacy and safety of belimumab, a human immunoglobulin monoclonal antibody against B lymphocyte stimulator, in subset patients with systemic lupus erythematosus (SLE) who were hypocomplementemic (C3 <90 mg/dl and/or C4 <10 mg/dl) anti-double-stranded DNA (anti-dsDNA) positive (≥30 IU/ml) at baseline.
Objective Intravenous belimumab 10 mg/kg is approved as an add-on therapy in patients with active, autoantibody-positive systemic lupus erythematosus. This study aimed to assess the impact of on immune response pneumococcal vaccination Methods was a Phase 4, open-label (GSK BEL115470; NCT01597492) conducted United States. Patients were randomized (7:9) receive 23-valent four weeks prior (pre-belimumab cohort) or 24 after (belimumab-concurrent commencing four-weekly intravenous treatment plus...
Objective To evaluate the safety, tolerability and efficacy of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE) beyond 1 year. Methods This was a 24-week, open-label extension following 52-week, double-blind, placebo-controlled trial SC. Patients who completed double-blind phase were eligible to enter phase. All received weekly 200 mg SC plus standard SLE therapy. Outcome measures included safety (SLE Response Index (SRI) Flare (SFI) rates), changes biomarker B...
Objective To assess the efficacy and safety of belimumab in paediatric versus adult patients with systemic lupus erythematosus (SLE). Methods We performed across-study comparisons active SLE who received or placebo, plus standard therapy, PLUTO (paediatric phase II) BLISS-52, BLISS-76, BLISS-NEA EMBRACE (adult III). Analysed data included Week 52 Responder Index (SRI)-4 response rate (EMBRACE: SRI modified Systemic Lupus Erythematosus Disease Activity (SLEDAI) proteinuria scoring (SRI-S2K));...
Objectives To evaluate the long-term safety and efficacy of belimumab in patients with systemic lupus erythematosus (SLE) China. Methods In this phase 3, open-label extension period, eligible completers study BEL113750 ( NCT01345253 ) received intravenous 10 mg/kg monthly for ≤6 years. The primary endpoint was safety. Secondary endpoints included SLE Responder Index (SRI)-4 response rate, severe flares changes prednisone use. Analyses were based on observed data from first dose through to...
Objectives To evaluate the long-term safety and efficacy of belimumab in patients with systemic lupus erythematosus (SLE) from Japan South Korea. Methods In this phase III, open-label continuation study (BEL114333; NCT01597622 ), eligible completers BEL113750 ( NCT01345253 ) or BEL112341 NCT01484496 received intravenous 10 mg/kg every 28 days for ≤7 years. Primary endpoint was safety. Secondary endpoints: SLE Responder Index (SRI)4 response rate, proportion meeting individual SRI4 criteria,...
To assess the efficacy and safety of intravenous (IV) belimumab plus standard systemic lupus erythematosus (SLE) therapy care (SoC) in Japanese patients with SLE.A Phase 3, multicenter, double-blind, placebo-controlled, 52-week study (BEL 113750; NCT01345253) SLE, randomized 2:1 to 10 mg/kg SoC or placebo Week 48.Sixty 707 were enrolled from centers Japan (belimumab, n = 39; placebo, 21). In this cohort, more achieved SLE Responder Index 4 response at 52 group compared (46.2% [18/39] vs....
<h3>Background</h3> Black patients have an increased prevalence and severity of systemic lupus erythematosus (SLE), alongside higher mortality rates. The efficacy safety intravenous (IV) belimumab has been demonstrated in several Phase 2/3 studies; however, the small number black within these trials, conflicting results, limited conclusions regarding this population. objective study was to specifically assess IV plus standard care (SoC) with active, auto antibody-positive SLE....
Objective To assess the appropriateness of expanded serological activity eligibility criteria for belimumab use in UK systemic lupus erythematosus (SLE) population (and possibly other countries), which includes patients with either anti-double-stranded DNA (anti-dsDNA) positivity or hypocomplementaemia rather than both criteria. Methods This post-hoc analysis used data from three randomised, double-blind, placebo-controlled phase III trials: BLISS-52 (BEL110752; NCT00424476 ), BLISS-76...
Abstract Background Treatment goals for patients with systemic lupus erythematosus (SLE) include minimising disease activity and reducing the risk of flares. Although belimumab is effective at severe flares, it was previously unknown what clinical effects were upon treatment discontinuation. The objective this study to assess impact temporary withdrawal intravenous (IV) in SLE. Methods This multicentre, open-label, non-randomised, 52-week (GSK Study BEL116027; NCT02119156) recruited SLE...
The Systemic Lupus Erythematosus (SLE) Responder Index (SRI), developed as a primary outcome measure for use in clinical trials, captures improvement SLE disease activity without concomitant worsening manifestations. This study investigated the relationships between SRI and clinical/laboratory correlates of response patients with SLE.
Objectives: To assess the effects of belimumab on disease activity across multiple organ domains in Japanese patients from Phase 3 randomized, double-blind, North-East Asia study, BEL113750 (NCT01345253). Methods: Patients, aged ≥18 years, with American College Rheumatology-defined systemic lupus erythematosus (SLE) and a Safety Estrogen Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score ≥8 at screening, stable SLE treatment, were randomized 2:1 to...
The objective of this study was to evaluate efficacy, safety and tolerability the first-in-class, anti-CCL17 monoclonal antibody, GSK3858279, in treating knee osteoarthritis (OA) pain.