Abstract Number: 0321 • ACR Convergence 2021
Sequential Administration of Belimumab and Rituximab in Primary Sjögren’s Syndrome Reduces Minor Salivary Gland–Resident B Cells and Delays B-Cell Repopulation in Circulation
Background/Purpose: Primary Sjögren’s syndrome (pSS) is characterized by B-cell hyperactivity and elevated serum and saliva B-lymphocyte stimulator (BLyS) levels.1 Sequential administration of belimumab (BEL; anti-BLyS)…Abstract Number: 0443 • ACR Convergence 2021
Safety and Efficacy of Belimumab in the Treatment of Adult Idiopathic Inflammatory Myositis (Polymyositis and Dermatomyositis)
Background/Purpose: Treatment of Idiopathic Inflammatory Myositis (IIM) includes steroids and immunosuppressive agents. Targeting IL6, IL1, TNF for treatment of IIM has not been successful, and…Abstract Number: 1302 • ACR Convergence 2021
Year-3 Observational Follow-up of Belimumab Safety (Mortality and Malignancies) in Patients with SLE Who Completed a Phase 4, 52-Week, Randomized, Double-Blind Placebo-Controlled Safety Study
Background/Purpose: Belimumab (BEL) is a recombinant IgG1λ monoclonal antibody that is approved for treatment of systemic lupus erythematosus (SLE). Although clinical studies of BEL have…Abstract Number: 1757 • ACR Convergence 2021
Clinical Use of Belimumab for Systemic Lupus Erythematosus in the Setting of Advanced Chronic Kidney Disease and End-Stage Renal Disease on Dialysis: A Case Series
Background/Purpose: Belimumab is FDA approved for treatment of SLE and Lupus Nephritis. Patients with an eGFR < 30 ml/min/1.73m2 were excluded from clinical trials, thus…Abstract Number: 860 • 2019 ACR/ARP Annual Meeting
Efficacy of Belimumab in Patients of Black Race with Systemic Lupus Erythematosus and High Disease Activity or Renal Manifestations
Background/Purpose: Black patients have more severe SLE and more frequent lupus nephritis vs other racial groups. Efficacy and safety of intravenous (IV) belimumab was demonstrated…Abstract Number: 2544 • 2019 ACR/ARP Annual Meeting
Results of the Open-label, Non-randomized 52-Week Study to Evaluate Treatment Holidays and Rebound Phenomenon After Treatment with Belimumab in Patients with SLE
Background/Purpose: Belimumab is approved as add-on therapy in active, autoantibody-positive SLE. Safety and efficacy up to 13 years has been reported in adults, but potential…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: 2865 • 2019 ACR/ARP Annual Meeting
Application of Bayesian Statistics to Support Approval of Intravenous Belimumab in Children with Systemic Lupus Erythematosus in the United States
Background/Purpose: In April 2019, FDA approved the first treatment, intravenous (IV) belimumab (BEL), specifically for children 5 to 17 years of age with active, seropositive…Abstract Number: 1711 • 2018 ACR/ARHP Annual Meeting
Utility of the Lupus Low Disease Activity State (LLDAS) in Discriminating Responders in the BLISS-52 and BLISS-76 Phase 3 Trials of Intravenous Belimumab in Systemic Lupus Erythematosus
Background/Purpose: Measurement of treatment response in SLE clinical trials has been based on measurement of change from baseline; however a treat-to-target analysis has seldom been…Abstract Number: 2627 • 2018 ACR/ARHP Annual Meeting
Not All Clinical Responders in SLE Are Equal: Comparison of Subcutaneous Belimumab + Standard of Care Responders to Placebo + Standard of Care Responders
Background/Purpose: To determine whether degree of response among responders to subcutaneous (SC) belimumab (BEL) + standard of care (SoC) is greater than that for responders…Abstract Number: 2676 • 2018 ACR/ARHP Annual Meeting
SLE Patients with No Organ Damage Might Benefit More from Belimumab Treatment
Background/Purpose: In systemic lupus erythematosus (SLE), organ damage is associated with unfavourable disease courses and premature mortality. We aimed at investigating the impact of organ…Abstract Number: 2867 • 2018 ACR/ARHP Annual Meeting
Efficacy and Safety of Intravenous Belimumab in Children with Systemic Lupus Erythematosus
Background/Purpose: Belimumab (BEL) is approved in adults with active systemic lupus erythematosus (SLE). There are no approved biologic therapies for pediatric patients with childhood-onset SLE…Abstract Number: 291 • 2018 ACR/ARHP Annual Meeting
Factors Associated with High-Dose Corticosteroid Use in SLE Patients Post Initiation of SLE Therapy
Background/Purpose: Systemic lupus erythematosus (SLE) therapies include non-steroidal anti-inflammatory drugs, antimalarials, systemic immunosuppressants, and biologics with corticosteroids as necessary. The majority of these current therapies…Abstract Number: 1704 • 2018 ACR/ARHP Annual Meeting
Clinical SLE Disease Activity Index Score of Zero May be a More Pragmatic Outcome Measure in SLE Studies
Background/Purpose: Drug development in systemic lupus erythematosus (SLE) has been challenging. One of the reasons can be traced in the choice of outcome measures. In…Abstract Number: 890 • 2017 ACR/ARHP Annual Meeting
Synergetic B-Cell Immunomodulation with Rituximab and Belimumab Combination Treatment in Severe, Refractory SLE
Background/Purpose: Neutrophil extracellular traps (NETs) are auto-antigenic DNA strands and potentially give rise to SLE-specific autoantibodies that can deposit in glomeruli. It has been shown…