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Abstract Number: 2973

The Multi-Biomarker Disease Activity Score As a Predictor of Radiographic Progression in a Registry of Patients with Rheumatoid Arthritis

Eric H. Sasso1, George Wu2, CC Hwang2, Michael E. Weinblatt3, Nancy A. Shadick4, Claire Alexander5 and Oscar Segurado1, 1Crescendo Bioscience Inc., South San Francisco, CA, 2Biostatistics, Crescendo Bioscience Inc., South San Francisco, CA, 3Division of Rheumatology & Immunology, Brigham and Women's Hospital, Boston, MA, 4Rheumatology/Immunology, Brigham and Women's Hospital, Boston, MA, 5Clinical Operations, Crescendo Bioscience Inc., South San Francisco, CA

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Biomarkers, Disease Activity, DMARDs, radiography and rheumatoid arthritis (RA)

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Session Information

Session Title: Rheumatoid Arthritis - Clinical Aspects VII: New Aspects of Monitoring Disease

Session Type: Abstract Submissions (ACR)

Background/Purpose

This study evaluated the association between baseline disease activity, as assessed with the multi-biomarker disease activity (MBDA) blood test, CRP or clinical measures, and the rate of radiographic progression over 2 years for patients with rheumatoid arthritis (RA) receiving stable therapy in the Brigham and Women’s Hospital Rheumatoid Arthritis Sequential Study (BRASS) Registry.

Methods

MBDA scores, CRP, DAS28-CRP, CDAI, RAPID3, and radiographic progression were analyzed at baseline (defined as the initial visit in the BRASS registry), for 143 patients with RA who had received a stable treatment, i.e., with no addition or removal of DMARDs and irrespective of dosing, over 2 years.  Radiographs of hands and wrists only, taken within 3 months of baseline in BRASS and 2 years later, were evaluated to determine the change per year in total Sharp score (DTSS).  Radiographic progression (RP) was defined as DTSS >3 per year over 2 years.  Predictive performance was assessed using AUROC.  Associations with RP were evaluated using univariate and multivariate logistic regression adjusted for potential confounders. 

Results

For 143 patients, mean age and disease duration were 59 and 18 years, respectively, with 84% female, 80% seropositive (RF+ and/or anti-CCP+), and 52% receiving MTX/non-biologic DMARD monotherapy, 19% a TNF inhibitor alone, 27% both in combination, and 2% not on any DMARD therapy. Mean baseline values were MBDA score=39, CRP=0.86 mg/dL, DAS28-CRP=4.1, CDAI=24.8, RAPID3=8.1 and TSS=68.  RP was observed in 18% (26/143) of patients. Better predictive accuracy for RP was observed for baseline MBDA score (AUROC=0.75), compared with baseline clinical CRP (AUROC=0.71), DAS28-CRP (AUROC=0.62), CDAI (AUROC=0.59) or RAPID3 (AUROC=0.50). Adjusting for BMI and baseline TSS, the significant independent predictors for RP were MBDA score (OR1SD=2.90, 95% CI=1.69-4.97), CRP (OR1SD=2.36, 95% CI=1.46-3.82), and DAS28-CRP (OR1SD=1.74, 95% CI=1.04-2.93), but not CDAI (OR1SD=1.46, 95% CI=0.89-2.41) and RAPID3 (OR1SD=0.97, 95% CI=0.61-1.55). For patients with low CRP (≤1 mg/dL) at baseline, RP was observed in 34.8% (8/23) with high MBDA score (>44) versus 8.1% (7/86) with low/moderate MBDA score (≤44) (p=0.003).

Conclusion

Baseline MBDA score was a better predictor of radiographic progression over 2 years than CRP, DAS28-CRP, CDAI or RAPID3 in patients with RA on stable therapy from the BRASS registry.


Disclosure:

E. H. Sasso,

Crescendo Bioscience,

3;

G. Wu,

Crescendo Bioscience,

3;

C. Hwang,

Crescendo Bioscience,

3;

M. E. Weinblatt,

UCB,

2,

Bristol-Myers Squibb,

2,

Crescendo,

2,

UCB,

5,

Bristol-Myers Squibb,

5,

Crescendo,

5;

N. A. Shadick,

Crescendo Bioscience,

2,

Amgen,

2,

UCB,

2,

Abbvie,

2,

Bristol Myers Squibb,

2,

Genentech ,

2;

C. Alexander,

Crescendo Bioscience,

3;

O. Segurado,

Crescendo Bioscience,

3.

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