ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2530

PRE.MARK-TNF Test Based on Iga-Specific Autoantigens Predicts Therapy Response in Rheumatoid Arthritis Patients Treated with TNFα Inhibitors

Karl Skriner1, Jörg Hollidt2, Gerd Burmester3 and Zoltan Konthur4, 1Department of Rheumatology and Clinical Immunology, Germany, Charité - Universitätsmedizin Berlin, Berlin, Germany, 2Drug Response DX GmbH, Berlin, Germany, 3Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany, 4Drug Response DX GmbH, Hennigsdorf, Germany

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: , , ,

Session Information

Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy: Therapeutic Strategies, Biomarkers and Predictors of Outcomes in Rheumatoid Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose

One third of rheumatoid arthritis patients treated with biologicals targeting TNFα are therapy non-responders. We have earlier investigated the difference in seroreactivity of patients being responder and non-responder to anti-TNFα therapies prior and after therapy and identified a set IgA-specific autoantigens. So far no mechanism for non-response has been described. Here we present a fist study on the diagnostic applicability of the found autoantigenic biomarkers.

Methods

Screening with >200 well defined patient sera on 5 different autoantigenic biomarker candidates, which were expressed recombinantly in E. coli by ELISA.

Results

Pretreatment sera from patients with diagnosis of RA based on the ACR classification criteria who were initiated on therapy with TNFα inhibitors were analyzed for the presence of autoantibodies against a set of 5 biomarker proteins (RAB11B, PPP2R1A, KPNB1, COG4, FTFT1) using ELISA assays. In total, analyses of 203 patients were carried out, of which 162 were clearly defined as Responder and 41 were clearly defined as Non-Responder after 6 month treatment. 81% of Non-responder could be clearly identified with the pre.markTNF Test. The assay has currently a specificity 94%.

Moreover, of the 203 samples, 57 samples were baseline sera from an early intervention study with Humira. In this subset, all 3 non-responder were identified and the specificity of the assay was 98 %. Only one – an intermediate responder after 6 months of treatment with Humira – gave any signal in the assay on IgA-level.

Conclusion These data suggests that IgA-autoantibodies against a set of protein biomarkers (pre.markTNF test) might be diagnostically applied for the identification of anti-TNFα therapy non-responders prior treatment.

Disclosure:

K. Skriner,
None;

J. Hollidt,
None;

G. Burmester,

AbbVie, Pfizer, Roche, UCB,

2,

AbbVie, BMS, MSD, Medimmune, Novartis, Pfizer, Roche, Sandoz, UCB,

5,

AbbVie, BMS, MSD, Pfizer, Roche, Sandoz, UCB,

8;

Z. Konthur,
None.

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