Immunogenicity of Biologics in Chronic Inflammatory Diseases

A Systematic Review

Vibeke Strand, Alejandro Balsa, Jamal Al-Saleh, Leonor Barile-Fabris, Takahiko Horiuchi, Tsutomu Takeuchi, Sadiq Lula, Charles Hawes, Blerina Kola, Lisa Marshall

Research output: Contribution to journalReview article

42 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)299-316
Number of pages18
JournalBioDrugs
Volume31
Issue number4
DOIs
Publication statusPublished - 2017 Aug 1

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Biosimilar Pharmaceuticals
Biological Products
Ankylosing Spondylitis
Anti-Idiotypic Antibodies
Rheumatoid Arthritis
Chronic Disease
Psoriasis
Psoriatic Arthritis
Pharmaceutical Preparations
Juvenile Arthritis
Biological Factors
Immunosuppressive Agents
Ulcerative Colitis
Immunoassay
Crohn Disease
Antibody Formation
Observational Studies
Publications
Decision Making
Infliximab

ASJC Scopus subject areas

  • Biotechnology
  • Pharmacology
  • Pharmacology (medical)

Cite this

Strand, V., Balsa, A., Al-Saleh, J., Barile-Fabris, L., Horiuchi, T., Takeuchi, T., ... Marshall, L. (2017). Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review. BioDrugs, 31(4), 299-316. https://doi.org/10.1007/s40259-017-0231-8

Immunogenicity of Biologics in Chronic Inflammatory Diseases : A Systematic Review. / Strand, Vibeke; Balsa, Alejandro; Al-Saleh, Jamal; Barile-Fabris, Leonor; Horiuchi, Takahiko; Takeuchi, Tsutomu; Lula, Sadiq; Hawes, Charles; Kola, Blerina; Marshall, Lisa.

In: BioDrugs, Vol. 31, No. 4, 01.08.2017, p. 299-316.

Research output: Contribution to journalReview article

Strand, V, Balsa, A, Al-Saleh, J, Barile-Fabris, L, Horiuchi, T, Takeuchi, T, Lula, S, Hawes, C, Kola, B & Marshall, L 2017, 'Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review', BioDrugs, vol. 31, no. 4, pp. 299-316. https://doi.org/10.1007/s40259-017-0231-8
Strand V, Balsa A, Al-Saleh J, Barile-Fabris L, Horiuchi T, Takeuchi T et al. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review. BioDrugs. 2017 Aug 1;31(4):299-316. https://doi.org/10.1007/s40259-017-0231-8
Strand, Vibeke ; Balsa, Alejandro ; Al-Saleh, Jamal ; Barile-Fabris, Leonor ; Horiuchi, Takahiko ; Takeuchi, Tsutomu ; Lula, Sadiq ; Hawes, Charles ; Kola, Blerina ; Marshall, Lisa. / Immunogenicity of Biologics in Chronic Inflammatory Diseases : A Systematic Review. In: BioDrugs. 2017 ; Vol. 31, No. 4. pp. 299-316.
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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.",
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AU - Barile-Fabris, Leonor

AU - Horiuchi, Takahiko

AU - Takeuchi, Tsutomu

AU - Lula, Sadiq

AU - Hawes, Charles

AU - Kola, Blerina

AU - Marshall, Lisa

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