Systematic review of safety and efficacy of belimumab in treating immune‐mediated disorders

Abstract Background Biologic agents (also termed biologics or biologicals) are becoming increasingly important in the treatment of immune‐mediated diseases. However, the diversity of clinical trials along with the fast pace of publication makes it difficult to determine the level of evidence for the use of a biologic for a given disorder. To address this challenge, we are publishing a series of systematic reviews evaluating the safety and efficacy of B cell–targeting biologics for the treatment of immune‐mediated diseases. In this article, we have assessed the safety and efficacy of belimumab, a fully human IgG1 monoclonal antibody targeting the cytokine B cell–activating factor (BAFF). Objective To evaluate belimumab's safety and efficacy for the treatment of immune‐mediated disorders compared to placebo, conventional treatment or other biologics. Methods The Preferred Reporting Items for Systematic reviews and Meta‐Analyses (PRISMA) checklist guided the reporting of the data. We searched the PubMed database between October 4, 2016, and June 23, 2019, concentrating on immune‐mediated disorders. Results The literature search identified 583 articles. After screening titles and abstracts against the inclusion and exclusion criteria and assessing full texts, 17 articles were finally included in a narrative synthesis. Conclusions Belimumab is both safe and effective for the treatment of systemic lupus erythematosus. Results were further promising for the use of belimumab in patients with rheumatoid arthritis and Sjögren’s syndrome. Conversely, results using belimumab in patients with anti‐neutrophil cytoplasmic antibody (ANCA)‐associated vasculitis and myasthenia gravis were rather disappointing.