Summary

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• Benlysta (belimumab) 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, and for the treatment of adults with active lupus nephritis who are receiving standard therapy.
• This summary is based on the review of 20 systematic review(s)/meta-analysis(es). ^[1-20]
• Lupus Nephritis (LN): Belimumab combined with standard therapy improved total renal response rates (RR 1.31; 95% CI, 1.11-1.53; p=0.001) and complete renal response rates (RR 1.47; 95% CI, 1.07-2.02; p=0.02). It reduced the risk of renal flare (RR 0.51; 95% CI, 0.37-0.69; p<0.001) and progression to ESRD (RR 0.56; 95% CI, 0.40-0.79; p=0.001).
• Cutaneous Lupus Erythematosus (CLE) with/without SLE: Belimumab increased the odds of clinical response at 52 weeks by 44% compared to non-users (OR 1.44; 95% CI, 1.20-1.74). Clinical response was observed starting from 20 weeks (OR 1.35; 95% CI, 1.01-1.81).
• Systemic Lupus Erythematosus (SLE): Belimumab significantly reduced SLEDAI scores (RR 1.32; 95% CI, 1.21-1.44; p<0.001) and prednisone dose by 50% or more (RR 1.59; 95% CI, 1.17-2.15; p=0.003), and improved the 36 Physical Component Summary score (MD 1.60; 95% CI, 0.30-2.90; p=0.02).
• Comparative Effectiveness: Belimumab was more effective than placebo and anifrolumab 300 mg in achieving complete renal remission and showed consistent effectiveness over rituximab and combined therapies in achieving primary endpoints in systemic lupus.
• There were no significant differences in the incidence of treatment-related adverse events between belimumab plus standard therapy and standard therapy alone (RR 1.04; 95% CI, 0.99-1.09; p=0.12).
• The risk of serious organ-specific adverse events was not significantly different between belimumab and control groups, except for a lower incidence in 'infections and infestations' (RR 0.82; 95% CI, 0.70-0.97; p=0.02) and 'musculoskeletal and connective tissue disorders' (RR 0.46; 95% CI, 0.32-0.67; p<0.0001).
• No increased risk was identified for psychiatric disorders or all-cause mortality (OR 1.10; 95% CI, 0.64-1.89). Subgroup analysis also showed no elevated risks for serious psychiatric disorders, suicidal ideation, or depression.
• Belimumab demonstrated effectiveness across various subgroups, including those at higher risk for organ dysfunction, children, and different racial groups, with a consistent safety profile showing no significant increase in adverse events among these populations.