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Abstract Number: 2664

A Multi-Biomarker Disease Activity (VECTRA™ DA Algorithm) Score Reflects Clinical Disease Activity and Tracks Responses in Patients with Rheumatoid Arthritis Treated with Either Adalimumab, Etanercept, and Infliximab

Shintaro Hirata1, Douglas J. Haney2, Guy Cavet2, Rebecca Bolce2, Wanying Li2, Nadine Defranoux2, David Chernoff2, Kunihiro Yamaoka1, Kazuyoshi Saito1 and Yoshiya Tanaka1, 1The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, 2Crescendo Bioscience Inc., South San Francisco, CA

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Activity score, anti-TNF therapy, biomarkers and rheumatoid arthritis (RA)

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Session Information

Title: Rheumatoid Arthritis - Clinical Aspects VII: Prediction of Outcome in Rheumatoid Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose : Anti-TNF therapy has become a standard therapeutic strategy for treatment of patients with rheumatoid arthritis (RA).  A validated multi-biomarker disease activity algorithm (MBDA) blood test was used to provide objective biological information about RA.  We studied the relationship between the MBDA score and disease activity measures including DAS28, SDAI, and CDAI in patients treated with anti-TNF therapy. 

Methods: 147 patients who started anti-TNF therapy (49 adalimumab (ADA), 49 etanercept (ETN), 49 infliximab (IFX)) were enrolled.  Twelve biomarkers were measured and combined in a pre-specified algorithm to generate a MBDA score between 1 and 100 at 0 (baseline) and 52 weeks after induction of anti-TNF therapy.  Associations between MBDA score and DAS28/SDAI/CDAI were evaluated by Spearman correlation and by area under the receiver operating characteristic curve (AUROC).  MBDA score changes in patients with EULAR responses were compared by t-test. Differences in the MBDA/DAS28 relationship between TNF inhibitors were evaluated by fitting linear models for DAS28 as a function of MBDA score, therapy and an MBDA/therapy interaction term.

Results: At baseline, patients’ median age was 60 (interquartile range (IQR) 50-68), DAS28- 5.7 (5.0-6.5), MBDA- 64 (IQR 49-76) and disease duration 60 months (18-168). Methotrexate was used in 86% of patients, at a median dose of 8.0 (8.0-10) mg/week. There was a mean decrease + SD in DAS28 of 2.6 + 1.4 and in MBDA of 25 + 20 respectively.  MBDA scores correlated with DAS28, SDAI and CDAI (ρ=0.64, 0.57, 0.50 respectively, all p<0.001) and distinguished low and moderate/high disease activity for all three clinical indices (AUROC=0.80, 0.76, 0.76 respectively, all p<0.001). No differences were found in the relationship between the MBDA score and DAS28 in patients treated with either ADA, ETN and IFX (p>0.05 for all comparisons).  The mean decrease in the MBDA score was greater for patients with moderate EULAR response versus non response (-22 vs. 1, p<0.002) and greater for patients in good response versus moderate response (-30 vs. -22, p=0.009).

Conclusion: The MBDA score correlates with clinical disease activity measures in a cohort receiving anti-TNF therapy.  The MBDA score tracks response in clinical disease activity in patients treated with different anti-TNF therapies, ADA, ETN or IFX. 

ADA ETN IFX all
n at Baseline 49 49 49 147
n at 52 weeks 49 49 49 147
Mean (±SD) MBDA at Baseline 61 ± 18 63 ± 17 59 ± 21
Mean (±SD) MBDA at 52 Weeks 33 ± 15 37 ± 16 39 ± 18
Mean (±SD) DAS28 at Baseline 5.4 ± 1.2 6.0 ± 1.1 5.9 ± 1.0
Mean (±SD) DAS28 at 52 Weeks 2.8 ± 1.0 3.4 ± 1.2 3.1 ± 1.2
Mean Change in MBDA (±SD): BL to 52 Weeks -29 ± 20 -26 ± 17 -20 ± 22
Mean Change in DAS28 (±SD): BL to 52 Weeks -2.5 ± 1.4 -2.6 ± 1.4 -2.7 ± 1.3

Disclosure:

S. Hirata,
None;

D. J. Haney,

Crescendo Bioscience Inc.,

3;

G. Cavet,

Crescendo Bioscience Inc.,

3;

R. Bolce,

Crescendo Bioscience Inc.,

3;

W. Li,

Crescendo Bioscience Inc.,

3;

N. Defranoux,

Crescendo Bioscience Inc.,

3;

D. Chernoff,

Crescendo Bioscience Inc.,

3;

K. Yamaoka,
None;

K. Saito,
None;

Y. Tanaka,

Mitsubishi-Tanabe Pharma Corporation, Abbott Japan Co., Ltd., Eisai Co., Ltd., Chugai Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Santen Pharmaceutical Co., Ltd., Pfizer Japan Inc., Astellas Pharma Inc., Daiichi-Sankyo Co., Ltd., GlaxoSmithKlin,

8,

Bristol-Myers Squibb, MSD K.K., Chugai Pharmaceutical Co., Ltd., Mitsubishi-Tanabe Pharma Corporation, Astellas Pharma Inc., Abbott Japan Co., Ltd., Eisai Co., Ltd. and Janssen Pharmaceutical K.K,

2.

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