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BioDrugs. 2017 Aug;31(4):299-316. doi: 10.1007/s40259-017-0231-8.

Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.

Author information

1
Division of Immunology/Rheumatology, Stanford University School of Medicine, 306 Ramona Road, Portola Valley, CA, 94028, USA. vibekestrand@me.com.
2
Rheumatology Unit, Instituto de Investigación Sanitaria del Hospital Universitario La Paz (IdiPAZ), Madrid, Spain.
3
Rheumatology Section, Dubai Hospital, Dubai, United Arab Emirates.
4
Hospital de Especialidades Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, México City, Mexico.
5
Department of Internal Medicine, Kyushu University Beppu Hospital, Beppu, Japan.
6
Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
7
Market Access Solutions, Envision Pharma Group, London, UK.
8
Pfizer Ltd, Surrey, UK.
9
Medical Affairs, Pfizer, Collegeville, PA, USA.

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.

PMID:
28612180
PMCID:
PMC5548814
DOI:
10.1007/s40259-017-0231-8
[Indexed for MEDLINE]
Free PMC Article

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