Belimumab

(Benlysta®)

Belimumab

Drug updated on 4/10/2024

Dosage FormInjection (subcutaneous; 200 mg/mL); Injection (intravenous; 120 mg, 400 mg)
Drug ClassB-lymphocyte stimulator-specific inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For the treatment of patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.
  • For the treatment of adult patients with active lupus nephritis who are receiving standard therapy.

Latest News

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Summary
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  • Belimumab (Benlysta) is indicated for the treatment of patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE), who are receiving standard therapy. It is also used in adult patients with active lupus nephritis.
  • A comprehensive review of 19 systematic reviews/meta-analyses concerning Belimumab was conducted. The drug offers a novel therapeutic approach in managing SLE and Lupus Nephritis where conventional therapies often fall short.
  • In terms of efficacy, belimumab showed superior results in improving total and complete renal response rates compared to conventional therapy alone for Lupus Nephritis. It significantly reduced the risk of renal flares without a significant increase in the incidence of adverse events.
  • For Cutaneous Lupus Erythematosum, both with or without systemic involvement, belimumab users exhibited a 44% increased odds of clinical response at 52 weeks compared to non-users. This supports its efficacy in managing symptoms related to this condition.
  • When compared against other biologic agents like Rituximab and newer agents such as anifrolumab for LN management, belimumab ranked highly, indicating competitive effectiveness among available treatments.
  • In treatment scenarios including pediatric populations, randomized controlled trials demonstrated that long-term use resulted in low incidences of organ damage, thereby improving patient outcomes more effectively than placebo or standard therapy alone.
  • Across all studies reviewed, the safety profile was highlighted by a comparable incidence rate between control groups, suggesting a favorable safety profile despite concerns over specific domains like serious infections and infusion-related reactions.
  • Belimumab's potential has been underscored across various subgroups including children and those suffering from refractory disease due to significant improvement shown during trials, which suggests broad applicability across diverse racial groups based on clinical trial data from the North-East Asia region.

Product Monograph / Prescribing Information

Document TitleYearSource
Benlysta (belimumab) Prescribing Information.2023GlaxoSmithKline LLC, Philadelphia, PA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of belimumab therapy in lupus nephritis: a systematic review and meta-analysis.2023Renal Failure
Improvement in Cutaneous Lupus Erythematosus After Twenty Weeks of Belimumab Use: A Systematic Review and Meta-Analysis.2023Arthritis Care & Research
The Safety and Efficacy of Rituximab and Belimumab in Systemic Lupus Erythematosus: A Systematic Review.2023Cureus
Efficacy and safety of novel biologics in the treatment of lupus nephritis based on registered clinical trials: a systematic review and network meta-analysis.2023Clinical and Experimental Medicine
Efficacy and Safety of New B Cell-Targeted Biologic Agent for the Treatment of Systemic Lupus Erythematosus: A Systematic Review and Meta-Analysis.2023Journal of Clinical Medicine
Efficacy and Safety of Biologic Agents for Lupus Nephritis.2023JCR: Journal of Clinical Rheumatology
Comparative Efficacy and Safety of Biological Agents in the Treatment of Lupus Nephritis: A Network Meta-Analysis.2023Pharmacology
Efficacy and safety of belimumab therapy for patients with lupus nephritis: A meta-analysis and a propensity score-matched case-control study2023Immunity, Inflammation and Disease
Belimumab combined with standard therapy does not increase adverse effects compared with a control treatment: a systematic review and meta-analysis of randomised controlled trials.2022International Immunopharmacology
Efficacy and safety of belimumab therapy in systemic lupus erythematosus: a systematic review and meta-analysis.2022Lupus
A Systematic Review of the Economic Evaluations of Belimumab in Systemic Lupus Erythematosus.2022Value in Health Regional Issues
Biological drugs for systemic lupus erythematosus or active lupus nephritis and rates of infectious complications. Evidence from large clinical trials.2022Frontiers in Immunology
The role of belimumab in systemic lupus erythematosis: a systematic review.2022Cureus
Real-world effectiveness of belimumab in systemic lupus erythematosus: a systematic literature review.2022Rheumatology and Therapy
The role of belimumab in systemic lupus erythematosis: A systematic review.2022Cureus
Multitarget therapy versus monotherapy as induction treatment for lupus nephritis: A meta-analysis of randomized controlled trials.2022Lupus
Belimumab in lupus nephritis: a systematic review and meta-analysis.2021Cureus
Risk of psychiatric disorders and all-cause mortality with belimumab therapy in patients with systemic lupus erythematosus: a meta-analysis of randomised controlled trials.2021Lupus Science & Medicine
Belimumab for systemic lupus erythematosus.2021Cochrane Database of Systematic Reviews
Systematic review of safety and efficacy of belimumab in treating immune-mediated disorders.2021Allergy

Clinical Practice Guidelines