Drug updated on 11/1/2024
Dosage Form | Injection (subcutaneous; 200 mg/mL); Injection (intravenous; 120 mg, 400 mg) |
Drug Class | B-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.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Benlysta (belimumab) Prescribing Information. | 2024 | GlaxoSmithKline LLC, Philadelphia, PA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
II Brazilian Society of Rheumatology consensus for lupus nephritis diagnosis and treatment | 2024 | Advances in Rheumatology (London, England) |
Management of systemic lupus erythematosus: a systematic literature review informing the 2023 update of the EULAR recommendations | 2024 | Annals of the Rheumatic Diseases |
EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. | 2023 | Annals of Rheumatic Diseases |
Guideline for the diagnosis, treatment and long-term management of cutaneous lupus erythematosus. | 2021 | Journal of Autoimmunity |
BSR guideline on the management of adults with systemic lupus erythematosus (SLE) 2018: baseline multi-centre audit in the UK. | 2020 | Rheumatology |
EULAR recommendations for the management of Sjögren’s syndrome with topical and systemic therapies. | 2020 | Annals of Rheumatic Diseases |