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Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review
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Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review
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Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review
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Journal Article
Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review
2017
Overview
Objectives
A systematic review was conducted to explore the immunogenicity of biologic agents across inflammatory diseases and its potential impact on efficacy/safety.
Methods
Literature searches were conducted through November 2016 to identify controlled and observational studies of biologics/biosimilars administered for treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), psoriasis (Ps), Crohn’s disease, and ulcerative colitis.
Results
Of >21,000 screened publications, 443 were included. Anti-drug antibody (ADAb) rates varied widely among biologics across diseases (and are not directly comparable because of immunoassay heterogeneity); the highest overall rates were reported with infliximab (0–83%), adalimumab (0–54%), and infliximab biosimilar CT-P13 (21–52%), and the lowest with secukinumab (0–1%), ustekinumab (1–11%), etanercept (0–13%), and golimumab (0–19%). Most ADAbs were neutralizing, except those to abatacept and etanercept. ADAb+ versus ADAb− patients had lower rates of clinical response to adalimumab (RA, PsA, JIA, AS, Ps), golimumab (RA), infliximab (RA, PsA, AS, Ps), rituximab (RA), ustekinumab (Ps), and CT-P13 (RA, AS). Higher rates of infusion-related reactions were reported in infliximab- and CT-P13-treated ADAb+ patients. Background immunosuppressives/anti-proliferatives reduced biologic immunogenicity across diseases.
Conclusions
Based on reviewed reports, biologic/biosimilar immunogenicity differs among agents, with the highest rates observed with infliximab and adalimumab. As ADAb formation in biologic-/biosimilar-treated patients may increase the risk of lost response, the immunogenicity of these agents is an important (albeit not the only) consideration in the treatment decision-making process.
Publisher
Springer International Publishing,Springer Nature B.V
Subject
/ Anti-Inflammatory Agents, Non-Steroidal - immunology
/ Anti-Inflammatory Agents, Non-Steroidal - therapeutic use
/ Antibodies, Monoclonal - immunology
/ Antibodies, Monoclonal - therapeutic use
/ Antirheumatic Agents - therapeutic use
/ Arthritis, Juvenile - drug therapy
/ Arthritis, Psoriatic - drug therapy
/ Arthritis, Rheumatoid - drug therapy
/ Biomedical and Life Sciences
/ Biosimilar Pharmaceuticals - therapeutic use
/ Colitis, Ulcerative - drug therapy
/ Crohn Disease - drug therapy
/ Etanercept - therapeutic use
/ Humans
/ Infliximab - therapeutic use
/ Proteins
/ Spondylitis, Ankylosing - drug therapy
/ Studies
