Belimumab

(Benlysta®)

Benlysta®

Drug updated on 11/1/2024

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

Indication

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

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Summary
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  • This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
  • Belimumab showed significant efficacy in achieving complete renal remission in lupus nephritis patients (OR (odds ratio) = 2.78, 95% CI (confidence interval) = 1.81-4.26), surpassing standard therapy and comparable to multitarget therapy, obinutuzumab, and voclosporin. Combined with standard therapy, belimumab improved total renal response rates (RR (relative risk) = 1.31, 95% CI = 1.11-1.53) and complete renal response rates (RR = 1.47, 95% CI = 1.07-2.02).
  • Belimumab effectively reduced SLE (systemic lupus erythematosus) Disease Activity Index (SLEDAI) scores (RR = 1.28; 95% CI = 1.16-1.40; P < 0.00001) and lowered SLE flare rates and prednisone-equivalent dosing requirements. Superior disease control was observed in extrarenal SLE and lupus nephritis relative to standard care.
  • Belimumab efficacy was comparable to obinutuzumab and multitarget therapy in lupus nephritis, with slightly lower efficacy than obinutuzumab in some analyses. It showed more consistent primary endpoint achievement in trials compared to rituximab.
  • Higher efficacy was noted in patients with elevated baseline disease activity, serologically active individuals, and younger patients (≤18 years). Real-world data confirmed consistent efficacy across gender and age demographics.
  • No significant difference in the incidence of adverse events (AEs) or serious adverse events (SAEs) between belimumab and placebo; SAEs were lower in the belimumab group.
  • Belimumab plus standard therapy significantly reduced the risk of renal flare (RR = 0.51; 95% CI = 0.37-0.69) and progression to ESRD (end-stage renal disease) (RR = 0.56; 95% CI = 0.40-0.79).
  • Belimumab demonstrated a comparable safety profile to other biologics, with no significant differences in serious infections or withdrawals due to adverse events compared to placebo.
  • Higher efficacy was observed in younger patients (≤18 years), those with elevated baseline disease activity, and serologically active individuals; efficacy and safety findings were consistent across patient demographics, including gender and age, with further study recommended for non-Asian populations in multitarget therapy effectiveness.

Product Monograph / Prescribing Information

Document TitleYearSource
Benlysta (belimumab) Prescribing Information.2024GlaxoSmithKline LLC, Philadelphia, PA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Biologicals for the treatment of lupus nephritis: a Bayesian network meta-regression analysis2024 Frontiers in Immunology
Efficacy and safety of biologics, multitarget therapy, and standard therapy for lupus nephritis: a systematic review and network meta-analysis2024 Renal Failure
Disruption of memory B-cell trafficking by belimumab in patients with systemic lupus erythematosus2024 Rheumatology (Oxford, England)
Usefulness of Belimumab in Adult Patients With Systemic Lupus Erythematosus Evaluated Using Single Indexes: A Meta-Analysis and Systematic Review2024 Current Therapeutic Research
Efficacy and Safety of New B Cell-Targeted Biologic Agent for the Treatment of Systemic Lupus Erythematosus: A Systematic Review and Meta-Analysis2023 Journal of Clinical Medicine
The Safety and Efficacy of Rituximab and Belimumab in Systemic Lupus Erythematosus: A Systematic Review2023 Cureus
Efficacy and safety of belimumab therapy in lupus nephritis: a systematic review and meta-analysis2023 Renal Failure
Comparative Efficacy and Safety of Biological Agents in the Treatment of Lupus Nephritis: A Network Meta-Analysis2023 Pharmacology
Use of belimumab in real-world in Spain: a scoping review about characteristics of SLE patients2022 Clinical Rheumatology
The Role of Belimumab in Systemic Lupus Erythematosis: A Systematic Review2022 Cureus
Real-World Effectiveness of Belimumab in Systemic Lupus Erythematosus: A Systematic Literature Review2022 Rheumatology and Therapy
A Systematic Review of the Economic Evaluations of Belimumab in Systemic Lupus Erythematosus2022 Value in Health Regional Issues
Belimumab for systemic lupus erythematosus2021Cochrane Database of Systematic Reviews
Systematic review of safety and efficacy of belimumab in treating immune-mediated disorders2021 Allergy
Rituximab use as induction therapy for lupus nephritis: a systematic review2020 Lupus
The role of baseline BLyS levels and type 1 interferon-inducible gene signature status in determining belimumab response in systemic lupus erythematosus: a post hoc meta-analysis2020 Arthritis Research & Therapy
Management of cutaneous manifestations of lupus erythematosus: A systematic review2020 Seminars in Arthritis and Rheumatism

Clinical Practice Guidelines