Drug updated on 4/10/2024
| Dosage Form | Injection (subcutaneous; 200 mg/mL); Injection (intravenous; 120 mg, 400 mg) |
| Drug Class | B-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.
Summary
- 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 Title | Year | Source |
|---|---|---|
| Benlysta (belimumab) Prescribing Information. | 2023 | GlaxoSmithKline LLC, Philadelphia, PA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| 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 |
| SER recommendations on the use of biological drugs in primary Sjögren's syndrome. | 2019 | Reumatologia Clinica |
| Clinical practice guidelines for the treatment of systemic lupus erythematosus by the Mexican College of Rheumatology. | 2019 | Sociedad Espa nolada Reumatologıa y Colegio Mexicano de Reumatologıa |
| 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus. | 2019 | BMJ |