Abstract

Belimumab is a recombinant human IgG-1λ monoclonal antibody. It inhibits the B-cell activating factor (BAFF) and is approved for patients with systemic lupus erythematosus (SLE) older than five years with positive autoantibody. We aimed to evaluate the role of belimumab in the maintenance phase of treatment for lupus nephritis (LN). PubMed, PubMed Central (PMC), Cochrane Library, and Embase were searched using appropriate keywords. The screening of title and abstract was done in Covidence, followed by data extraction of the relevant studies based on inclusion criteria. Review manager (RevMan 5.4) was used for data analysis with random or fixed effects model based on heterogeneities. Two randomized controlled trials were included in the quantitative analysis. There were 1.71 times higher odds of complete renal response in the belimumab group than in the control group (odds ratio (OR), 1.71; 95% confidence interval (CI), 1.12-2.60; I-square (I2) ​​​​= 0%). Similarly, there was 34% lower odds for having no response among the belimumab group (OR, 0.66; 95% CI, 0.45-0.96; I2 = 0%). No significant differences between the two groups were observed for the occurrence of treatment-related adverse events (TRAEs) (OR, 1.07; 95% CI, 0.74-1.56; I2 = 0%), treatment-related serious adverse events (OR, 0.54; 95% CI, 0.15-1.96; I2 = 68%), and treatment-related infections (OR, 0.65; 95% CI, 0.27-1.55; I2 = 21%).Therefore, belimumab and standard treatment were instrumental for beneficial renal response in patients with lupus nephritis and were not associated with increased odds of adverse effect compared with the standard treatment alone.

Highlights

  • BackgroundSystemic lupus erythematosus (SLE) is a chronic inflammatory disease with variable clinical manifestations

  • We aimed to evaluate the role of belimumab in the maintenance phase of treatment for lupus nephritis (LN)

  • No significant differences between the two groups were observed for the occurrence of treatment-related adverse events (TRAEs) (OR, 1.07; 95% confidence interval (CI), 0.74-1.56; I2 = 0%), treatment-related serious adverse events (OR, 0.54; 95% CI, 0.15-1.96; I2 = 68%), and treatmentrelated infections (OR, 0.65; 95% CI, 0.27-1.55; I2 = 21%).belimumab and standard treatment were instrumental for beneficial renal response in patients with lupus nephritis and were not associated with increased odds of adverse effect compared with the standard treatment alone

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Summary

Introduction

BackgroundSystemic lupus erythematosus (SLE) is a chronic inflammatory disease with variable clinical manifestations. LN of clinical relevance is diagnosed when the creatinine clearance decrease by 30%, with proteinuria of >500 mg/dL, and renal biopsy histological findings support active LN [1]. It occurs in nearly 50% of patients with SLE but is not the only cause of kidney injury in SLE [2]. The present treatment regimens for LN are associated with high drug-associated toxicity and low treatment efficacy and adherence [3] In this context, belimumab has emerged as one of the emerging drugs for treating lupus nephritis. We conducted this study to assess the efficacy and safety of belimumab in patients with lupus nephritis

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