André van Maurik

A randomised study of rituximab and belimumab sequential therapy in PR3 ANCA-associated vasculitis

Rachel Jones, Mark McClure, Kim Mynard, Matthew Coates et autres

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Insights from the BLISS-LN Phase 3 study of biomarker associations with kidney response to belimumab in lupus nephritis

Brad H. Rovin, Richard Alan Furie, Ana Malvar, Cynthia B. Aranow et autres

Introduction This study evaluated the effects of belimumab versus placebo on biomarker responses and identified predictive biomarkers for kidney response to belimumab in patients with lupus nephritis (LN) receiving different standard therapies. Methods BLISS-LN was a Phase 3 study (NCT01639339) of adults …

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Sjögren’s disease metabolome reveals biomarker signatures to characterise patients and assess disease activity

Madeleine Suffiotti, Lukas Bahati Tanner, Łukasz Kozera, Agata Sebastian et autres

OBJECTIVE: Sjögren's disease (SjD) is a chronic systemic autoimmune disease with heterogeneous glandular and extraglandular manifestations. Although aetiology and pathogenesis of SjD remains elusive, emergence of autoreactive T and B lymphocytes is crucial in disease development. In this study, the metabolome of …

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Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Belimumab in Pediatric Patients With Systemic Lupus Erythematosus: A Multicenter, Open‐Label Trial

Hermine I. Brunner, Jordi Antón, Inmaculada Calvo‐Penadés, Richard J. Dimelow et autres

OBJECTIVE: This study aimed to characterize the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of subcutaneous belimumab in pediatric patients with active systemic lupus erythematosus (SLE) receiving standard therapy. METHODS: This single-arm, multicenter, open-label trial (GSK study 200908; ClinicalTrials.gov identifier: NCT04179032) used three-weight-band …

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Primary Sjögren’s Disease: a review of unmet need, outcome measures, therapeutic advances and health economic impacts. Lessons from the NEw Clinical Endpoints in primary Sjögren’s Syndrome: an Interventional Trial based on stratifYing patients (NECESSITY) Innovative Health Initiative (IHI)

Simon Bowman, Raphaèle Séror, Raphaël Porcher, Suzanne Arends et autres

Primary Sjögren's disease (pSjD) is an autoimmune rheumatic disease involving exocrine glands and associated with high symptom burden (dryness, fatigue, pain), systemic features and salivary gland dysfunction. B-cell hyperactivity is common, with an increased risk of mucosa-associated lymphoid tissue lymphoma. This review …

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Efficacy and safety of sequential therapy with subcutaneous belimumab and one cycle of rituximab in patients with systemic lupus erythematosus: the phase 3, randomised, placebo-controlled BLISS-BELIEVE study

Cynthia B. Aranow, Cornelia F Allaart, Zahir Amoura, Ian N Bruce et autres

OBJECTIVES: Disease activity control in patients with systemic lupus erythematosus (SLE) with corticosteroid and immunosuppressant withdrawal is a treatment goal. We evaluated whether this could be attained with sequential subcutaneous belimumab (BEL) and one cycle of rituximab (RTX). METHODS: In this phase …

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Disruption of memory B-cell trafficking by belimumab in patients with systemic lupus erythematosus

Eline J. Arends, Mihaela Zlei, Christopher M. Tipton, J. Cotic et autres

OBJECTIVES: Autoreactive memory B cells (MBCs) contribute to chronic and progressive courses in autoimmune diseases like SLE. The efficacy of belimumab (BEL), the first approved biologic treatment for SLE and LN, is generally attributed to depletion of activated naïve B cells and …

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Post Hoc Analyses of Biomarkers Predictive of a Renal Response to Intravenous (IV) Belimumab (BEL) Plus Standard Therapy (ST) in Patients with Lupus Nephritis (LN)

Brad H. Rovin, Richard Alan Furie, Ana Malvar, Cynthia B. Aranow et autres

Background: In BLISS-LN (GSK BEL114054), a Phase 3 trial of adults with LN treated with BEL 10 mg/kg/month IV or placebo (PBO), + ST, BEL resulted in significantly more kidney responses (Primary Efficacy Renal Response [PERR] and Complete Renal Response [CRR]), and …

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AB0904 BELIMUMAB FOR THE TREATMENT OF INTERSTITIAL LUNG DISEASE ASSOCIATED WITH SYSTEMIC SCLEROSIS: A PHASE 2/3, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Christopher P. Denton, Robert Spiera, David J. Jörg, Dinesh Khanna et autres

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POS0814 UNTARGETED METABOLOMICS ANALYSIS OF SEBUM: A NON-INVASIVE STRATEGY THAT SHOWS POTENTIAL TO IDENTIFY NEW BIOMARKERS IN PRIMARY SJÖGREN’S SYNDROME AND SYSTEMIC SCLEROSIS

Anneline C. Hinrichs, Sofie L. M. Blokland, Johanna Vappiani, André van Maurik et autres

Background Saliva and tears are easy accessible fluids for biomarker analyses but a major drawback is that a substantial proportion of patients with primary Sjogren’s syndrome (pSS) suffers from severe dryness, with limited or no saliva or tear to donate. Thus, novel …

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A randomised study of rituximab and belimumab sequential therapy in PR3 ANCA-associated vasculitis (COMBIVAS): design of the study protocol

Mark McClure, Seerapani Gopaluni, James M. S. Wason, Robert B. Henderson et autres

BACKGROUND: Sequential B cell-targeted immunotherapy with BAFF antagonism (belimumab) and B cell depletion (rituximab) may enhance B cell targeting in ANCA-associated vasculitis (AAV) through several mechanisms. METHODS: Study design: COMBIVAS is a randomised, double-blind, placebo-controlled trial designed to assess the mechanistic effects …

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Population model‐based analysis of the memory B‐cell response following belimumab therapy in the treatment of systemic lupus erythematosus

Richard J. Dimelow, William R. Gillespie, André van Maurik

Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by B-cell hyperactivity and breach of tolerance. Autoreactive memory B cells, which have a decreased activation threshold and the ability to survive in absence of antigen, are believed to contribute to chronicity in …

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