Drug updated on 11/16/2023

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


  • 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.

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
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
Belimumab for treating active autoantibody-positive systemic lupus erythematosus.2021NICE
Belimumab and voclosporin for lupus nephritis: effectiveness and value.2021ICER
Assessment report: Benlysta.2021EMA
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 review report: belimumab.2020CADTH
Clinical review report: belimumab.2020CADTH
Belimumab Treatment for Adults with Systemic Lupus Erythematosus: A Review of Clinical Effectiveness, Cost Effectiveness, and Guidelines.2018CADTH

Clinical Practice Guidelines