Abstract Number: L18 • 2019 ACR/ARP Annual Meeting
A Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), Telitacicept (RC18), in Systemic Lupus Erythematosus (SLE): Results of a Phase 2b Study
Background/Purpose: Telitacicept, also named RC18, is a novel recombinant fusion protein constructed with the extracellular domain of the human transmembrane activator and calcium modulator and…Abstract Number: 2572 • 2019 ACR/ARP Annual Meeting
Efficacy Analysis of Patients with Systemic Lupus Erythematosus Treated with Belimumab or Placebo Plus Standard Therapy in Phase 3 Trials by Baseline Levels of BLyS mRNA and Type 1 Interferon Inducible Gene Signature Status
Background/Purpose: Belimumab (BEL) is a B-lymphocyte stimulator (BLyS) inhibitor approved as an add-on to standard of care (SoC) for patients with autoantibody-positive SLE with active…Abstract Number: 1 • 2018 ACR/ARHP Annual Meeting
Profiling of B-Cell Related Factors and Its Decoy Receptors in Rheumatoid Arthritis: Potential Clues for Patient Stratification
Background/Purpose: B-cell over-activation plays a key role in the pathogenesis of rheumatoid arthritis (RA), thus being recognized as a therapeutic target. However, the activation of…Abstract Number: 2642 • 2018 ACR/ARHP Annual Meeting
Atacicept Dose Rationale for a Phase 3 Study in Patients with High Disease Activity and Auto-Antibody Positive SLE
Background/Purpose: Atacicept targets the B-cell-stimulators BLyS and APRIL, and is in development for the treatment of patients (pts) with SLE. Here, we integrated non-clinical and…Abstract Number: 2678 • 2018 ACR/ARHP Annual Meeting
Integrated Safety Profile of Atacicept from All Clinical Studies to Date
Background/Purpose: We conducted an integrated analysis of pooled safety data from all 17 atacicept clinical studies to date, across multiple indications, to further define atacicept’s…Abstract Number: 889 • 2017 ACR/ARHP Annual Meeting
Attainment of Low Disease Activity By Patients with Systemic Lupus Erythematosus Starting with High Disease Activity in a 24-Week, Randomized, Placebo-Controlled, Phase IIb Study of Atacicept (ADDRESS II)
Background/Purpose: Low disease activity (LDA) in lupus patients is increasingly a goal of treatment. For instance, Lupus Low Disease Activity State (LLDAS) attainment is associated…Abstract Number: 2585 • 2017 ACR/ARHP Annual Meeting
Safety Profile in SLE Patients Treated with Atacicept in a Phase IIb Study (ADDRESS II) and Its Extension Study
Background/Purpose: Atacicept targets the B-cell stimulating factors, BLyS and APRIL, and has demonstrated a clinical response in SLE patients (pts) with high disease activity (HDA;…Abstract Number: 756 • 2016 ACR/ARHP Annual Meeting
Pharmacokinetics and Exposure-Response Relationship of Belimumab Administered Subcutaneously to SLE Patients
Background/Purpose: Monthly (q4w) intravenously (IV) administered belimumab 10 mg/kg is approved for the treatment of adults with active, autoantibody-positive SLE receiving standard therapy. The present…Abstract Number: 742 • 2016 ACR/ARHP Annual Meeting
A Pivotal Phase III, Randomized, Placebo-Controlled Study of Belimumab in Patients with Systemic Lupus Erythematosus Located in China, Japan, and South Korea
Background/Purpose: SLE is an autoimmune disease associated with elevated levels of B Lymphocyte Stimulator (BLyS). This study assessed the efficacy and safety of belimumab (BLyS-specific…Abstract Number: 745 • 2016 ACR/ARHP Annual Meeting
Clinical and Laboratory Correlates of Response in a Phase 3 Clinical Trial of Belimumab or Placebo Administered Subcutaneously Plus Standard Care to Patients with Systemic Lupus Erythematosus (SLE)
Background/Purpose: The SRI (SLE responder index) is a composite measure established as a primary endpoint in SLE clinical trials. However, it has been questioned whether…Abstract Number: 626 • 2015 ACR/ARHP Annual Meeting
Efficacy of Belimumab and Targeting of Rheumatoid Factor Positive B-Cells in Sjögren’s Syndrome: Follow-up of the Open-Label Phase II Study
Background/Purpose: Belimumab, a monoclonal anti-B lymphocyte Stimulator (BLyS) antibody is preliminary found to be effective in Sjögren’s syndrome (SS) patients with moderate to high systemic…Abstract Number: 2836 • 2014 ACR/ARHP Annual Meeting
Effects of Blisibimod, an Inhibitor of B Cell Activating Factor, on Patient Reported Outcomes and Disease Activity in Patients with Systemic Lupus Erythematosus
Background/Purpose: To conduct secondary endpoint analyses of the effects of subcutaneously-administered blisibimod (A-623, AMG 623), an inhibitor of B-cell activating factor (BAFF), on patient-reported outcomes and…Abstract Number: 2838 • 2014 ACR/ARHP Annual Meeting
Exploratory Analysis of Pharmacokinetic Effects of Atacicept in Patients with Moderate to Severe Systemic Lupus Erythematosus
Background/Purpose: Atacicept is a fusion protein that inhibits B-cell stimulating factors BLyS and APRIL. We previously reported the clinical effects of atacicept in lupus patients…Abstract Number: 2694 • 2014 ACR/ARHP Annual Meeting
B Lymphocyte Stimulator (BLyS) Promotes Dysregulated Monocyte Function in Systemic Lupus Erythematosus(SLE)
Background/Purpose SLE involves complex interactions between the innate and adaptive immune systems. Monocytes are increasingly recognised to play a key role in the dysregulated immune…Abstract Number: 1976 • 2014 ACR/ARHP Annual Meeting
Elevation and Functional Activity of Interferon Omega in Human Systemic Lupus Erythematosus
Background/Purpose IFNα is emerging as a clinically validated target in SLE yet it is currently unclear if other type I IFNs are contributing to the…