title: Immunogenicity of anti-TNF biologic agents in the treatment of rheumatoid arthritis.
abstract: BACKGROUND
  The use of biologic disease-modifying anti-rheumatic drugs (DMARDs), including therapeutic antibodies, antibody fragments and protein constructs that target key mediators in the pathophysiology of rheumatoid arthritis (RA), has improved the chance of achieving low disease activity and clinical remission. However, individual patients respond differently to biologic DMARD therapy, particularly the tumor necrosis factor (TNF) inhibitors.
  
  
  METHODS
  While the variation of clinical response may be related to pharmacogenetic and other unknown factors, immunogenicity associated with some of these agents may contribute in part to a lack of efficacy and immune-mediated side effects. Timely detection of immunogenicity may avoid continued administration of ineffective treatment, and reduce unnecessary risks and costs. Access to and appropriate implementation of clinically validated drug level assays is required.
  
  
  CONCLUSIONS
  There are currently no evidence-based recommendations to guide biologic therapy on the basis of drug level and immunogenicity testing but as more data become available and better tests are developed, a strategy of immunopharmacologic guidance to individualize treatment of RA will emerge. The potential benefits of this approach must be balanced against the costs of monitoring, and further research is required.
authors.affiliation: a Department of Medicine , Tuen Mun Hospital , Hong Kong , China.
authors.forename: Chi Chiu
authors.initials: CC
authors.lastname: Mok
authors.affiliation: b Kaohsiung Medical University Hospital , Kaohsiung City , Taiwan.
authors.forename: Wen Chan
authors.initials: WC
authors.lastname: Tsai
authors.affiliation: c Department of Medical Education and Research, Division of Allergy, Immunology and Rheumatology , Taichung Veterans General Hospital , Taichung , Taiwan.|d Faculty of Medicine, National Yang Ming University, Taiwan and Institute of Biomedical Science , National Chung Hsing University , Taichung , Taiwan.
authors.forename: Der Yuan
authors.initials: DY
authors.lastname: Chen
authors.affiliation: e Institute of Medicine, Chung Shan Medical University; Division of Allergy, Immunology and Rheumatology , Chung Shan Medical University Hospital , Taichung , Taiwan.|f Institute of Integrative Medicine , China Medical University , Taichung , Taiwan.
authors.forename: James Cheng Chung
authors.initials: JC
authors.lastname: Wei
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000494:pharmacology / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000235:genetics / Q000276:immunology*; D001685:Biological Factors / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D055261:Immunogenetic Phenomena / Q000187:drug effects / Q000235:genetics / Q000276:immunology*; D007155:Immunologic Factors / Q000494:pharmacology / Q000627:therapeutic use; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors* / Q000235:genetics / Q000276:immunology
chemical_list: D000970:Antineoplastic Agents; D018501:Antirheumatic Agents; D001685:Biological Factors; D007155:Immunologic Factors; D014409:Tumor Necrosis Factor-alpha
keywords: Antidrug antibodies; anti-TNF therapies; immunogenicity; rheumatoid arthritis