A5034488510- Systemic Lupus Erythematosus Research
- Monoclonal and Polyclonal Antibodies Research
- T-cell and B-cell Immunology
- Renal Transplantation Outcomes and Treatments
- Renal Diseases and Glomerulopathies
- Hemophilia Treatment and Research
- Organ Transplantation Techniques and Outcomes
- Acute Myeloid Leukemia Research
- Blood Coagulation and Thrombosis Mechanisms
- Liver Diseases and Immunity
- Virus-based gene therapy research
- Receptor Mechanisms and Signaling
- Chronic Myeloid Leukemia Treatments
- Adipose Tissue and Metabolism
- Coagulation, Bradykinin, Polyphosphates, and Angioedema
- Organ Donation and Transplantation
- Cardiac electrophysiology and arrhythmias
- Atherosclerosis and Cardiovascular Diseases
- Protein Degradation and Inhibitors
- Renal and Vascular Pathologies
- Advanced Breast Cancer Therapies
- Muscle metabolism and nutrition
- Vasculitis and related conditions
- Hepatitis C virus research
- Immunodeficiency and Autoimmune Disorders
University of Miami
1996-2024
GlaxoSmithKline (United States)
2015-2024
University of Wisconsin–Madison
1945-2024
University of Pennsylvania
1991-2024
Baylor College of Medicine
2023
University of North Carolina at Chapel Hill
2022
GlaxoSmithKline (Japan)
2021
GlaxoSmithKline (United Kingdom)
2011-2018
GlaxoSmithKline (Netherlands)
2018
GlaxoSmithKline (India)
2015-2018
Background: Serum creatinine concentration is widely used as an index of renal function, but this affected by factors other than glomerular filtration rate (GFR). Objective: To develop equation to predict GFR from serum and factors. Design: Cross-sectional study GFR, clearance, concentration, demographic clinical characteristics in patients with chronic disease. Patients: 1628 enrolled the baseline period Modification Diet Renal Disease (MDRD) Study, whom 1070 were randomly selected training...
Long-term therapy with cyclophosphamide enhances renal survival in patients proliferative lupus nephritis; however, the beneficial effect of must be weighed against its considerable toxic effects.Fifty-nine nephritis (12 World Health Organization class III, 46 IV, and 1 Vb) received induction consisting a maximum seven monthly boluses intravenous (0.5 to 1.0 g per square meter body-surface area) plus corticosteroids. Subsequently, were randomly assigned one three maintenance therapies:...
In adults with active lupus nephritis, the efficacy and safety of intravenous belimumab as compared placebo, when added to standard therapy (mycophenolate mofetil or cyclophosphamide–azathioprine), are unknown.
To identify factors that predict response to belimumab treatment in the phase 3 BLISS trials of autoantibody-positive systemic lupus erythematosus (SLE) and further analyse clinical efficacy various patient subsets.The compared 1 10 mg/kg versus placebo, all plus standard SLE therapy, over 52 or 76 weeks. Pooled subgroup analyses week responder index rates (the primary endpoint both trials) were performed based on demographic characteristics baseline disease activity indicators. multivariate...
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....
Disease activity control in patients with systemic lupus erythematosus (SLE) corticosteroid and immunosuppressant withdrawal is a treatment goal. We evaluated whether this could be attained sequential subcutaneous belimumab (BEL) one cycle of rituximab (RTX).
We tested the safety of a nonviral somatic-cell gene-therapy system in patients with severe hemophilia A.
Exercise training produces a vast array of physiological adaptations, ranging from changes in metabolism to muscle mitochondrial biogenesis. Researchers studying the effects exercise often use animal models that employ forced regimens include aversive motivation, which could activate stress response. This study examined effect treadmill running (8 wk) on several systems are sensitive and stress. Forced produced both positive negative adaptations. Indicative exercised male Sprague-Dawley rats...
Brooks, G. A. FACSM; Slainsby, W. N. Shulman, I.; Wasserman, D. H. Stanley, C.; Roth, A.; Lehman, S. L.
The incidence of posttransplant diabetes mellitus (PTDM) was compared in two groups renal allograft recipients. These were all nondiabetic patients who had been transplanted between 1979 and 1987 received either azathioprine-methylprednisolone (group 1) or cyclosporine-methylprednisolone 2) therapy as maintenance immunosuppression. PTDM group 1 9.1% vs. 18.6% 2 (P less than .05). mean daily dose methylprednisolone during the initial months not greater among 2. Cyclosporine levels CsA doses...
Objective To evaluate the safety and efficacy of belimumab as adjunctive therapy to maintain remission in antineutrophil cytoplasmic antibody ( ANCA )–associated vasculitis AAV ). Methods In this multicenter, double‐blind, placebo‐controlled study, patients with (ages ≥18 years) were randomized 1:1 receive azathioprine (2 mg/kg/day), low‐dose oral glucocorticoids (≤10 mg/day), either intravenous (10 mg/kg) or placebo, following induction rituximab cyclophosphamide along glucocorticoids. The...
To investigate the long-term safety and efficacy of intravenous (IV) belimumab plus standard care (SOC) therapy for systemic lupus erythematosus (SLE) in patients with active, autoantibody-positive SLE.The study was designed as a multicenter, open-label, continuation IV given every 4 weeks conjunction SOC SLE who completed phase II, double-blind study. Adverse events (AEs) laboratory data were monitored from first dose (in either study) until 24 after final dose. Efficacy assessments...
Objective To examine long-term organ damage and safety following treatment with belimumab plus standard of care (SoC) in patients systemic lupus erythematosus (SLE). Methods Pooled data were examined from two ongoing open-label studies that enrolled who completed BLISS-52 or BLISS-76. Patients received every four weeks SoC. SLICC Damage Index (SDI) values assessed 48 (study years) initiation (baseline). The primary endpoint was change SDI baseline at study years 5–6. Incidences adverse...
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...
BACKGROUNDPrimary Sjögren's syndrome (pSS) is characterized by B cell hyperactivity and elevated B-lymphocyte stimulator (BLyS). Anti-BLyS treatment (e.g., belimumab) increases peripheral memory cells; decreases naive, activated, plasma subsets; stringency on selection during reconstitution. Anti-CD20 therapeutics rituximab) bind deplete CD20-expressing cells in circulation but are less effective depleting tissue-resident CD20+ cells. Combined, these 2 mechanisms may achieve synergistic...
In the BLISS-LN study, belimumab improved kidney outcomes in adult patients with active lupus nephritis. This 28-week open-label extension of assessed belimumab's safety and efficacy.Eligible completing received monthly intravenous 10 mg/kg plus standard therapy. End points included safety, week 28 primary efficacy renal response (urine protein-creatinine ratio [UPCR] ≤0.7, eGFR no more than 20% below baseline value or ≥60 ml/min per 1.73 m2, prohibited medications) complete (UPCR <0.5, 10%...