Dataset Information

Detection of anti-drug antibodies using a bridging ELISA compared with radioimmunoassay in adalimumab-treated rheumatoid arthritis patients with random drug levels.

ABSTRACT:

Objective

To determine the concordance between RIA and bridging ELISA at detecting anti-drug antibodies (ADAbs) in the context of random adalimumab levels and investigate the additional clinical utility of detecting ADAbs in RA patients who test ADAb positive by RIA and negative by ELISA.

Methods

ADAb levels were determined using RIA and bridging ELISA in 63 adalimumab-treated RA patients (159 samples). Immunogenicity concordance was determined using receiver operating characteristic curves. To determine the additional clinical value provided by a positive RIA in the presence of negative ELISA, association between treatment response (?DAS28), adalimumab drug levels and ADAbs was evaluated longitudinally using generalized estimating equation.

Results

Of the 60 RIA⁺?samples (n?=?31 patients), 19 (n?=?10 patients) were also ELISA⁺, corresponding to 31.7% of samples. Area under the curve for detecting ADAbs using ELISA (compared with RIA) using receiver operating characteristic curves was 0.65 (95% CI: 0.59, 0.71); this increased to 0.91 (95% CI: 0.81, 0.99) if ADAbs were??100?AU/ml using RIA. In RIA⁺/ELISA^- patients, adalimumab levels were associated with ?DAS28 over 12 months [regression coefficient: 0.098 (95% CI: 0.043, 0.15), P?ConclusionADAbs were detected using ELISA more frequently when present in high titres as measured by RIA. In RIA⁺/ELISA^- patients, only drug levels were significantly associated with treatment response. Although ADAbs were not independently associated with treatment response, they may be helpful in determining the aetiology of low drug levels.

SUBMITTER: Jani M

PROVIDER: S-EPMC5088626 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Publications

Detection of anti-drug antibodies using a bridging ELISA compared with radioimmunoassay in adalimumab-treated rheumatoid arthritis patients with random drug levels.

Jani Meghna M Isaacs John D JD Morgan Ann W AW Wilson Anthony G AG Plant Darren D Hyrich Kimme L KL Chinoy Hector H Barton Anne A

Rheumatology (Oxford, England) 20160825 11

<h4>Objective</h4>To determine the concordance between RIA and bridging ELISA at detecting anti-drug antibodies (ADAbs) in the context of random adalimumab levels and investigate the additional clinical utility of detecting ADAbs in RA patients who test ADAb positive by RIA and negative by ELISA.<h4>Methods</h4>ADAb levels were determined using RIA and bridging ELISA in 63 adalimumab-treated RA patients (159 samples). Immunogenicity concordance was determined using receiver operating characteris ...[more]

PMID: 27565176

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Dataset Information

Detection of anti-drug antibodies using a bridging ELISA compared with radioimmunoassay in adalimumab-treated rheumatoid arthritis patients with random drug levels.

Objective

Methods

Results

Publications

Detection of anti-drug antibodies using a bridging ELISA compared with radioimmunoassay in adalimumab-treated rheumatoid arthritis patients with random drug levels.

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