A5076651506- Systemic Lupus Erythematosus Research
- Monoclonal and Polyclonal Antibodies Research
- T-cell and B-cell Immunology
- Renal Diseases and Glomerulopathies
- Cytokine Signaling Pathways and Interactions
- Chronic Lymphocytic Leukemia Research
- Atherosclerosis and Cardiovascular Diseases
- Rheumatoid Arthritis Research and Therapies
- Liver Diseases and Immunity
- Lymphoma Diagnosis and Treatment
- Immune Cell Function and Interaction
- Complement system in diseases
- Autoimmune and Inflammatory Disorders Research
- Peripheral Neuropathies and Disorders
- Systemic Sclerosis and Related Diseases
- Osteoarthritis Treatment and Mechanisms
- Adrenal Hormones and Disorders
- Inflammatory Bowel Disease
- Immunodeficiency and Autoimmune Disorders
- Platelet Disorders and Treatments
- CAR-T cell therapy research
- Pharmacological Effects of Natural Compounds
- Autoimmune Bullous Skin Diseases
- Eosinophilic Disorders and Syndromes
- Immunotherapy and Immune Responses
Hofstra University
2016-2025
Northwell Health
2016-2025
Donald & Barbara Zucker School of Medicine at Hofstra/Northwell
2017-2025
American College of Rheumatology
2020-2024
Feinstein Institute for Medical Research
2009-2024
Center for Rheumatology
2021-2022
Yale University
2021
Institute of Molecular Medicine
2021
Women's Hospital
2020
AID Atlanta
2020
Abstract Objective To determine the efficacy and safety of treatment with rituximab plus methotrexate (MTX) in patients active rheumatoid arthritis (RA) who had an inadequate response to anti–tumor necrosis factor (anti‐TNF) therapies explore pharmacokinetics pharmacodynamics this population. Methods We evaluated primary at 24 weeks enrolled Randomized Evaluation Long‐Term Efficacy Rituximab RA (REFLEX) Trial, a 2‐year, multicenter, randomized, double‐blind, placebo‐controlled, phase III...
To assess the efficacy/safety of B lymphocyte stimulator inhibitor belimumab plus standard therapy compared with placebo in active systemic lupus erythematosus (SLE).In a phase III, multicenter, randomized, placebo-controlled trial, 819 antinuclear antibody-positive or anti-double-stranded DNA-positive SLE patients scores ≥6 on Safety Estrogens Lupus Erythematosus National Assessment (SELENA) version Disease Activity Index (SLEDAI) were randomized 1:1:1 ratio to receive 1 mg/kg belimumab, 10...
To evaluate the efficacy and safety of rituximab in a randomized, double-blind, placebo-controlled phase III trial patients with lupus nephritis treated concomitantly mycophenolate mofetil (MMF) corticosteroids.Patients (n = 144) class or IV were randomized 1:1 to receive (1,000 mg) placebo on days 1, 15, 168, 182. The primary end point was renal response status at week 52.Rituximab depleted peripheral CD19+ B cells 71 72 patients. overall (complete partial) rates 45.8% among receiving 56.9%...
Anifrolumab, a human monoclonal antibody to type I interferon receptor subunit 1 investigated for the treatment of systemic lupus erythematosus (SLE), did not have significant effect on primary end point in previous phase 3 trial. The current trial used secondary from that as point.
To assess the efficacy and safety of anifrolumab, a type I interferon (IFN) receptor antagonist, in phase IIb, randomized, double-blind, placebo-controlled study adults with moderate-to-severe systemic lupus erythematosus (SLE).Patients (n = 305) were randomized to receive intravenous anifrolumab (300 mg or 1,000 mg) placebo, addition standard therapy, every 4 weeks for 48 weeks. Randomization was stratified by SLE Disease Activity Index 2000 score (<10 ≥10), oral corticosteroid dosage ≥10...
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.
Abstract Objective CD40–CD40 ligand (CD40L) interactions play a significant role in the production of autoantibodies and tissue injury lupus nephritis. We performed an open‐label, multiple‐dose study to evaluate safety, efficacy, pharmacokinetics BG9588, humanized anti‐CD40L antibody, patients with proliferative The primary outcome measure was 50% reduction proteinuria without worsening renal function. Methods Twenty‐eight active nephritis were scheduled receive 20 mg/kg BG9588 at biweekly...
Abstract Objective To assess the safety, tolerability, biologic activity, and efficacy of belimumab in combination with standard care therapy (SOC) patients active systemic lupus erythematosus (SLE). Methods Patients a Safety Estrogens Lupus Erythematosus: National Assessment (SELENA) version Systemic Erythematosus Disease Activity Index (SLEDAI) score ≥4 (n = 449) were randomly assigned to (1, 4, or 10 mg/kg) placebo 52‐week study. Coprimary end points percent change SELENA–SLEDAI at week...
Abstract Objective To describe a new systemic lupus erythematosus (SLE) responder index (SRI) based on belimumab phase II SLE trial and demonstrate its potential utility in clinical trials. Methods Data from randomized, double‐blind, placebo‐controlled study 449 patients of 3 doses (1, 4, 10 mg/kg) or placebo plus standard care therapy (SOC) over 56‐week period were analyzed. The Safety Estrogens Lupus Erythematosus: National Assessment (SELENA) version the Systemic Erythematosus Disease...
Objectives The efficacy and safety of sifalimumab were assessed in a phase IIb, randomised, double-blind, placebo-controlled study ( NCT01283139 ) adults with moderate to severe active systemic lupus erythematosus (SLE). Methods 431 patients randomised received monthly intravenous (200 mg, 600 mg or 1200 mg) placebo addition standard-of-care medications. Patients stratified by disease activity, interferon gene-signature test (high vs low based on the expression four genes) geographical...
Objectives To update the EULAR recommendations for management of systemic lupus erythematosus (SLE) based on emerging new evidence. Methods An international Task Force formed questions systematic literature reviews (January 2018–December 2022), followed by formulation and finalisation statements after a series meetings. A predefined voting process was applied to each overarching principle recommendation. Levels evidence strengths recommendation were assigned, participants finally provided...
To evaluate the effects of belimumab versus placebo, plus standard systemic lupus erythematosus (SLE) therapy, on organ domain-specific SLE disease activity.Data obtained after 52 weeks treatment from two phase III trials (BLISS-52 and BLISS-76) comparing 1 10 mg/kg in 1684 autoantibody-positive patients were analysed post hoc for changes British Isles Lupus Assessment Group (BILAG) Safety Estrogens National Assessment-Systemic Erythematosus Disease Activity Index (SELENA-SLEDAI) domain...
Objective To investigate the efficacy and safety of ocrelizumab in patients with class III/IV lupus nephritis (LN). Methods Patients were randomized 1:1:1 to receive placebo, 400 mg ocrelizumab, or 1,000 given as an intravenous infusion on days 1 15, followed by a single at week 16 every weeks thereafter, accompanied background glucocorticoids plus either mycophenolate mofetil (MMF) Euro‐Lupus Nephritis Trial (ELNT) regimen (cyclophosphamide azathioprine). The study was terminated early due...
To compare the efficacy and safety of intravenous (IV) abatacept, a selective T cell costimulation modulator, versus placebo for treatment active class III or IV lupus nephritis, when used on background mycophenolate mofetil glucocorticoids.This was 12-month, randomized, phase II/III, multicenter, international, double-blind study. A total 298 patients were treated in 1 3 arms: placebo, abatacept at standard weight-tiered dose (approximating 10 mg/kg), 30 mg/kg months, followed by (abatacept...
Randomised trials of type I anti-CD20 antibodies rituximab and ocrelizumab failed to show benefit in proliferative lupus nephritis (LN). We compared obinutuzumab, a humanised II monoclonal antibody that induces potent B-cell depletion, with placebo for the treatment LN combination standard therapies.Patients receiving mycophenolate corticosteroids were randomised obinutuzumab 1000 mg or on day 1 weeks 2, 24 26, followed through week 104. The primary endpoint was complete renal response (CRR)...
BACKGROUND. Plasmacytoid DCs (pDC) produce large amounts of type I IFN (IFN-I), cytokines convincingly linked to systemic lupus erythematosus (SLE) pathogenesis. BIIB059 is a humanized mAb that binds blood DC antigen 2 (BDCA2), pDC-specific receptor inhibits the production IFN-I and other inflammatory mediators when ligated. A first-in-human study was conducted assess safety, tolerability, pharmacokinetic (PK) pharmacodynamic (PD) effects single doses in healthy volunteers (HV) patients with...
<h3>Objectives</h3> To evaluate the efficacy and safety of tabalumab, a human IgG4 monoclonal antibody that neutralises membrane soluble B-cell activating factor (BAFF). <h3>Methods</h3> This randomised, placebo-controlled study enrolled 1124 patients with moderate-to-severe systemic lupus erythematosus (SLE) (Safety Estrogens in Lupus Erythematosus National Assessment- SLE Disease Activity Index ≥6 at baseline). Patients received standard care plus subcutaneous drug, starting loading dose...
Objective Epratuzumab, a monoclonal antibody that targets CD22, modulates B cell signaling without substantial reductions in the number of cells. The aim this study was to report results 2 phase III multicenter randomized, double‐blind, placebo‐controlled trials, EMBODY 1 and assessing efficacy safety epratuzumab patients with moderately severely active systemic lupus erythematosus (SLE). Methods Patients met ≥4 American College Rheumatology revised classification criteria for SLE, were...
To assess the efficacy and safety of type I interferon receptor antibody, anifrolumab, in patients with active, biopsy-proven, Class III/IV lupus nephritis.
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....