Belimumab (Benlysta) is a human recombinant monoclonal antibody that targets and inhibits soluble B-lymphocyte stimulator, also known as B-cell activating factor, a proliferation and survival factor for B cells. The published clinical trials data showed that in patients with active systemic lupus erythematosus (SLE), belimumab effectively reduced peripheral B-cell levels and improved disease activity. This article reviews the belimumab clinical trials and the post-marketing experience with belimumab in the treatment of those lupus patients with persistent active disease despite current standard of care (SOC) therapy.
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Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis.
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Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Objective: The present study aimed to provide a comprehensive evaluation of the postmarketing safety of belimumab based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Methods: Adverse event (AE) reports in the FAERS database from January 2021 to December 2023 were extracted to perform the disproportionality analysis by calculating the reporting OR. The clinical characteristics and onset times of AEs were investigated.
Real-world effectiveness of intravenous belimumab in adults with systemic lupus erythematosus: results of the observational OBSErve study in the Russian Federation.
BMC Rheumatol
January 2025
GSK Saudi Arabia, Value Evidence and Outcomes, Jeddah, Saudi Arabia.
Background: The real-world effectiveness of intravenous (IV) belimumab in treating systemic lupus erythematosus (SLE) has been demonstrated in various countries through the OBSErve (evaluation Of use of Belimumab in clinical practice SEttings) program. Here we describe the clinical effectiveness of IV belimumab for treating SLE in real-world clinical practice in the Russian Federation.
Methods: In the retrospective, observational OBSErve Russia study (GSK Study 215349), eligible physicians enrolled adults with SLE receiving IV belimumab as part of their standard care.
The beneficial effect of adding belimumab in severe and refractory IgA nephropathy: a case report.
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Department of Nephrology, Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai, China.
IgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide and is the most common cause of chronic kidney disease (CKD) in China. It lacks recommended treatment in refractory IgAN after conventional therapy. Belimumab, a recombinant human IgG-1λ monoclonal antibody that inhibits the B lymphocyte stimulator, is recommended to treat active lupus nephritis.
View Article and Find Full Text PDFBelimumab versus telitacicept in sequential treatment after rituximab for refractory lupus nephritis: a real-world multicentre study.
Lupus Sci Med
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Kidney Disease Center, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Objective: Both belimumab and telitacicept are recognised blockers for B lymphocyte activation, both of which have been approved as add-on therapies for SLE in China. The aim of this study is to compare the efficacy of rituximab (RTX) followed by belimumab or telitacicept in a real-world cohort.
Methods: A total of 49 refractory lupus nephritis patients were enrolled from four independent centres, subsequently categorised into two treatment groups: belimumab group (n=35) and telitacicept group (n=14) based on their treatment following RTX.
Evolving Treatment Strategies for Systemic Lupus Erythematosus in Clinical Practice: A Narrative Review.
Cureus
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Pain Medicine, Fondazione Paolo Procacci, Rome, ITA.
Systemic lupus erythematosus (SLE) is an autoimmune disease that more commonly affects African American people, although it is seen in people of all racial backgrounds. This condition is characterized by a dysregulated immune response resulting in widespread inflammation. Clinical manifestations caused by this inflammation include arthritis, anemia, cutaneous rashes, pleuritis, and nephritis.
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