Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.


Association of Serum Markers with Clinical Response Measures in Rheumatoid Arthritis Patients Treated with Golimumab, a Human Anti-TNF Monoclonal Antibody

Wagner1,  C., Rahman2,  M. U., Genovese3,  M.C., Matteson4,  E. L., Kay5,  Jonathan, Keystone6,  Edward C., Hsia2,  E. C.

Centocor R&D, Inc, Malvern, PA,
Centocor R&D, Inc/U of Penn School of Med, Malvern, PA,
Stanford U, Palo Alto, CA,
Mayo Clinic, Rochester, MN,
University of Massachusetts Memorial Medical Center, Worcester, MA,
Professor of Medicine/University of Toronto, Toronto, ON,
Elashoff Consulting, Redwood City, CA

Purpose:

To examine changes in markers associated with clinical response in 1) active rheumatoid arthritis (RA) patients despite methotrexate (MTX) treated with golimumab (GLM), and 2) RA patients previously treated with TNFa inhibitors.

Methods:

Sera were collected at wks 0, 4 and 14 from a subset of the GO-FORWARD (active RA patients despite MTX) and GO-AFTER (active RA patients previously treated with TNF inhibitors) studies. Samples were tested for select markers. The change from baseline in markers was compared between GLM + MTX and PBO + MTX using ANOVA on the van der Waerden normal scores and t-tests. Logistic regression models were used to test for marker associations with clinical endpoints.

Results:

Select inflammatory markers were decreased at wks 4 and 14 after treatment with GLM±MTX as compared to PBO+MTX (p<0.05). In a regression analysis including data from both studies, baseline levels of CRP, IL-6, MMP-3, ENRAGE, a2 macroglobulin, insulin, vWF, leptin, apolipoprotein CIII, and bone alkaline phosphatase were associated (OR from 0.59 to 1.19,p<0.05) with ACR 20 and ACR 50 response at wk 14 in the GLM ±MTX group. Changes from baseline to wk4 in CRP, IL-6, MMP-3, and ENRAGE plus ICAM-1,VEGF, TIMP-1, TNFRII, IL-1Ra, a1anti trypsin, apolipoprotein C III, serum amyloid P, IL-16, hyaluronic acid and haptoglobin were associated with the same clinical measures at wk14. In GLM ± MTX patients, baseline levels of a2 macroglobulin, apolipoprotein CIII, CRP and MMP-3 were significantly different between ACR 20 and ACR 50 responders and non-responders at wk14(p<0.05).

Conclusion:

GLM impacts multiple proteins associated with the TNFa pathway and RA disease processes. The measurement of select markers in patients with active RA despite MTX and those previously treated with anti-TNF therapy could be used to predict response to GLM.

To cite this abstract, please use the following information:
Wagner, C., Rahman, M. U., Genovese, M.C., Matteson, E. L., Kay, Jonathan, Keystone, Edward C., et al; Association of Serum Markers with Clinical Response Measures in Rheumatoid Arthritis Patients Treated with Golimumab, a Human Anti-TNF Monoclonal Antibody [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1674
DOI: 10.1002/art.26748

Abstract Supplement

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