Article Text

PDF
AB1031 Anti-drug antibodies: assay performance in patients treated with ANTI-TNF biodrugs
  1. B Hock1,
  2. JL O'donnell2,
  3. J Liu2,
  4. P Keating2,
  5. M Spellerberg2,
  6. L Stamp3,
  7. M Barclay3
  1. 1Haematolgy Research Group, University of Otago
  2. 2Immunology Section, Canterbury Health Labs
  3. 3Medicine, University of Otago, Christchurch, New Zealand

Abstract

Background Minimum biodrug concentrations of ∼7mg/l are predictive of disease remission1. Very low/absent biodrug concentrations associate with loss of benefit which may be due to ADA2 however the clinical utility of ADA is assay dependant. In rheumatoid arthritis the combination of low/absent drug concentration and the presence of ADA appears to have the greatest utility3. Canterbury Health Laboratories, New Zealand (CHL) has developed a competitive binding ELISA to detect neutralising antibodies whereas most commercial assays utilise a bridging methodology

Objectives Compare performance of a competitive binding assay with two commercial bridging assays in the detection of ADA to anti-TNFα biodrugs in serum samples with low/absent biodrug concentration

Methods Serum samples referred for anti TNF biodrug concentrations found to have very low/undetectable concentrations (<1mg/l) were tested for ADA using the competitive-bind assay and two bridging assays (TANI Medikal and GRIFOLS)

Results Over a 22 month period (Jan 2014 – Oct 2016), 67% (331/497) of referred samples had biodrug concentrations below 7mg/l and 15% (n=79) had low/undetectable biodrug concentrations (adalimumab n=36 or infliximab n=43). ADAs were detected in 53% (42/79) of this latter group. The competitive binding assay detected ADAs in all samples testing positive for ADA by binding assay. In addition a further 8 samples were positive for ADA by the competitive assay: 53% (42/79) positive for ADA by the competitive assay and 33% positive by one or other of the commercial assays

Conclusions The competitive binding ELISA was more sensitive in detecting biodrug ADAs in serum samples with very low/undetectable biodrug concentrations

References

  1. Felice C, Marco M, Pugliese D,et al. Expert Opin Biol Ther 2015;15:1107–1117.

  2. Schaeverbeke T, Truchetet M, Kostine M, Barnetche T et al. Rheumatology 2016;55:210–220.

  3. Jani M,Chinoy, Warren R, et al. Arthritis and Rheumatology 2015;67:2011–2019.

References

Disclosure of Interest None declared

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.