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.

Neutrophils contribute to elevated BAFF levels to modulate adaptive immunity in patients with primary immune thrombocytopenia by CD62P and PSGL1 interaction

“…31 Moreover, BAFF blockade therapy such as belimumab has shown prominent therapeutic effect in systemic lupus erythematosus and other autoimmune diseases such as rheumatic arthritis and sjögren's syndrome. 32 , 33 , 34 , 35 Therefore, multicentre and large‐scale trails are anticipated to investigate the therapeutic application of belimumab in ITP.…”

“…A prospective phase IIb trial in ITP reported notable efficacy and safety of a combined rituximab and belimumab regimen in persistent or chronic adults ITP patients, for that 80% patients achieved an overall response without serious complications after 5 weeks of treatment 31 . Moreover, BAFF blockade therapy such as belimumab has shown prominent therapeutic effect in systemic lupus erythematosus and other autoimmune diseases such as rheumatic arthritis and sjögren's syndrome 32–35 . Therefore, multicentre and large‐scale trails are anticipated to investigate the therapeutic application of belimumab in ITP.…”

Systematic Review of Safety and Efficacy of IL-1-Targeted Biologics in Treating Immune-Mediated Disorders

“…As established in our previous studies (11)(12)(13)(14), we included randomized controlled trials (RCTs), their extension trials and their substudies with predefined endpoints. If there were no RCTs, we included prospective case series including at least three patients and non-randomized clinical studies with at least five patients per intervention group.…”

Pathophysiologische Mechanismen und Behandlung von Dermatomyositis und immunvermittelten nekrotisierenden Myopathien: Ein fokussiertes Review

“…Belimumab ist ein humanisierter monoklonaler Antikörper gegen das Zytokin BAFF, der zur Behandlung von systemischem Lupus erythematosus (SLE) zugelassen ist [190]. Eine doppelblinde, placebokontrollierte Studie zur Untersuchung der Wirksamkeit und Sicherheit von Belimumab bei Patienten mit IIM, die in der Vorgeschichte unzureichend auf eine 3-monatige Behandlung mit Glukokortikoiden und/oder einem anderen Immunsuppressivum angesprochen haben, wird derzeit durchgeführt (ClinicalTrials.gov-Kennung: NCT02347891).…”