1. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review
- Author
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Jamal Al-Saleh, Blerina Kola, Takahiko Horiuchi, Lisa Marshall, Leonor A Barile-Fabris, Charles Hawes, Tsutomu Takeuchi, Sadiq Lula, Vibeke Strand, and Alejandro Balsa
- Subjects
musculoskeletal diseases ,medicine.medical_specialty ,complex mixtures ,Gastroenterology ,Etanercept ,Abatacept ,Arthritis, Rheumatoid ,03 medical and health sciences ,Psoriatic arthritis ,0302 clinical medicine ,Crohn Disease ,Internal medicine ,Ustekinumab ,medicine ,Adalimumab ,Humans ,Pharmacology (medical) ,Spondylitis, Ankylosing ,skin and connective tissue diseases ,Biosimilar Pharmaceuticals ,030203 arthritis & rheumatology ,Pharmacology ,business.industry ,Anti-Inflammatory Agents, Non-Steroidal ,Arthritis, Psoriatic ,Antibodies, Monoclonal ,General Medicine ,medicine.disease ,Infliximab ,Golimumab ,Arthritis, Juvenile ,Antirheumatic Agents ,Immunology ,030211 gastroenterology & hepatology ,Secukinumab ,Colitis, Ulcerative ,Systematic Review ,business ,Biotechnology ,medicine.drug - Abstract
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. Electronic supplementary material The online version of this article (doi:10.1007/s40259-017-0231-8) contains supplementary material, which is available to authorized users.
- Published
- 2017