PMID- 29325166
OWN - NLM
STAT- MEDLINE
DCOM- 20190521
LR  - 20220129
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Print)
IS  - 1462-0324 (Linking)
VI  - 57
IP  - 11
DP  - 2018 Nov 1
TI  - Drug safety and immunogenicity of tumour necrosis factor inhibitors: the story so 
      far.
PG  - 1896-1907
LID - 10.1093/rheumatology/kex434 [doi]
AB  - TNF-alpha inhibitor (TNFi) therapies have transformed the treatment of several 
      rheumatic musculoskeletal diseases. However, the majority of TNFi's are 
      immunogenic and consequent anti-drug antibodies formation can impact on both 
      treatment efficacy and safety. Several controversies exist in the area of 
      immunogenicity of TNFis and drug safety. While anti-drug antibodies to TNFis have 
      been described in association with infusion reactions; serious adverse events 
      (AEs) such as thromboembolic events, lupus-like syndrome, paradoxical AEs, for 
      example, vasculitis-like events and other autoimmune manifestations have also 
      been reported. The expansion of the biologic armamentarium, new treatment 
      strategies such as introduction/switching to biosimilars and cost-saving 
      approaches such as TNFi tapering, may all have a potential impact on 
      immunogenicity and clinical sequelae. In this review we evaluate how evolution of 
      biologics relates to drug safety and immunogenicity, appraise relevant evidence 
      from trials, spontaneous pharmacovigilance and observational studies and outline 
      the areas of uncertainty that still exist.
FAU - Jani, Meghna
AU  - Jani M
AD  - Arthritis Research UK Centre for Epidemiology, The University of Manchester, 
      Manchester, UK.
AD  - Centre for Musculoskeletal Research, Manchester Academic Health Science Centre, 
      The University of Manchester, Manchester, UK.
FAU - Dixon, William G
AU  - Dixon WG
AD  - Arthritis Research UK Centre for Epidemiology, The University of Manchester, 
      Manchester, UK.
AD  - Centre for Musculoskeletal Research, Manchester Academic Health Science Centre, 
      The University of Manchester, Manchester, UK.
AD  - NIHR Manchester Musculoskeletal Biomedical Research Centre, Manchester University 
      Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, 
      Manchester, UK.
AD  - Health eResearch Centre, Farr Institute for Health Informatics Research, 
      University of Manchester, Manchester, UK.
FAU - Chinoy, Hector
AU  - Chinoy H
AD  - Centre for Musculoskeletal Research, Manchester Academic Health Science Centre, 
      The University of Manchester, Manchester, UK.
AD  - NIHR Manchester Musculoskeletal Biomedical Research Centre, Manchester University 
      Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, 
      Manchester, UK.
LA  - eng
GR  - G1000417/MRC_/Medical Research Council/United Kingdom
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biological Products)
RN  - 0 (Tumor Necrosis Factor-alpha)
SB  - IM
MH  - Antirheumatic Agents/adverse effects/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Autoimmune Diseases/*drug therapy
MH  - Biological Products/adverse effects/*therapeutic use
MH  - Humans
MH  - Tumor Necrosis Factor-alpha/*antagonists & inhibitors
PMC - PMC6199532
EDAT- 2018/01/13 06:00
MHDA- 2019/05/22 06:00
PMCR- 2018/01/08
CRDT- 2018/01/12 06:00
PHST- 2017/07/27 00:00 [received]
PHST- 2018/01/13 06:00 [pubmed]
PHST- 2019/05/22 06:00 [medline]
PHST- 2018/01/12 06:00 [entrez]
PHST- 2018/01/08 00:00 [pmc-release]
AID - 4792969 [pii]
AID - kex434 [pii]
AID - 10.1093/rheumatology/kex434 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2018 Nov 1;57(11):1896-1907. doi: 
      10.1093/rheumatology/kex434.