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Belimumab Treatment for Adults with Systemic Lupus Erythematosus: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines

Last updated: May 23, 2018
Project Number: RC0989-000
Product Line: Rapid Response
Research Type: Drug
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical effectiveness of belimumab for the treatment of adults with systemic lupus erythematosus?
  2. What is the cost-effectiveness of belimumab for the treatment of adults with systemic lupus erythematosus?
  3. What are the evidence-based guidelines associated with belimumab for the treatment of adults with systemic lupus erythematosus?

Key Message

Belimumab administered intravenously or subcutaneously in addition to standard of care was effective in improving SLE severity measures among patients with moderate to severe SLE based on three fair- to good- quality RCTs and three low-quality SRs that followed patients for a maximum of 76 weeks. The affected measures included better SRI4 response, musculoskeletal and immunological manifestation, decreasing autoantibodies, and higher serum complement levels based on the SRs. To avoid the adverse effects of corticosteroid treatment, patients with SLE treated with belimumab intravenously or subcutaneously might be able to reduce the dosage of corticosteroid. Certain patient groups might benefit from adjuvant belimumab treatment more than others, such as those with more severe SLE, low serum complement levels, positive ds-DNA antibodies, or active steroid treatment. Belimumab administered intravenously or subcutaneously was well tolerated with the incidence of adverse effects or serious adverse effects similar to placebo. There were no relevant cost-effectiveness studies or evidence-based guidelines identified.The limitations of this review include publication bias, limited lengths of follow-up in the trials, limited numbers of trials, and applicability of the existing evidence to patients with SELENA-SLEDAI scores less than eight.