ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2520

Multi-Biomarker Disease Activity (MBDA) Score and Prediction of Radiographic Progression in a Randomized Study of Patients with Early RA Treated with Methotrexate Alone or with Adalimumab

Cecilie Heegaard Brahe1, Mikkel Østergaard2, Julia Sidenius Johansen3, Nadine A. Defranoux4, Ching Chang Hwang5, Xingbin Wang4, Rebecca J. Bolce4, Eric H. Sasso4, Kim Hørslev-Petersen6, Kristian Stengaard-Pedersen7, Lykke Midtbøll Ørnbjerg8, Peter Junker9, Torkell Ellingsen10, Palle Ahlquist11, Hanne Lindegaard12, Asta Linauskas13, Annette Schlemmer14, Mette Yde Dam15, Ib Tønder Hansen16, Tine Lottenburger11, Christian G. Ammitzbøll17, Anette Jørgensen17, Sophine B. Krintel8, Johnny Lillelund Raun18 and Merete Lund Hetland3,19, 1Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Denmark, Glostrup, Denmark, 2Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Denmark, Copenhagen, Denmark, 3Danish Rheumatologic Biobank and DANBIO registry, Rigshospitalet, Glostrup, Gentofte and Herlev University Hospital, Copenhagen, Denmark, 4Crescendo Bioscience Inc., South San Francisco, CA, 5Biostatistics, Crescendo Bioscience Inc., South San Francisco, CA, 6King Christian X Hospital for Rheumatic Diseases, Graasten, Denmark, 7Rigshospitalet (Glostrup and Blegdamsvej), Århus University Hospital, Odense University Hospital, Herlev/Gentofte Hospital, Slagelse Sygehus, Chr X hospital (University of South Denmark) and Zitelab Aps, DANBIO Registry and Departments of Rheumatology, Copenhagen, Denmark, 8Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, 9Department of Rheumatology C, Odense University Hospital, Odense, Denmark, 10Department of Rheumatology, Odense University Hospital, Odense, DK, Odense, Denmark, 11Department of Medicine, Vejle Regional Hospital, Vejle, Denmark, 12The DANBIO registry and the Danish Departments of Rheumatology, Odense, Denmark, 13The DANBIO registry and the Danish Departments of Rheumatology, Copenhagen, Denmark, 149Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark, 15Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark, 16Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark, 17Department of Rheumatology, Institute of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark, 18King Christian X Hospital for Rheumatic Diseases, South Jutland Hospital, Graasten, Denmark, 19Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Denmark,, Copenhagen, Denmark

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: , , ,

Session Information

Date: Tuesday, November 15, 2016

Title: Rheumatoid Arthritis – Clinical Aspects - Poster III: Treatment – Monitoring, Outcomes, Adverse Events

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: The multi-biomarker disease activity (MBDA) score, which combines 12 serum biomarkers to measure RA disease activity on a scale of 1−100, has been found to be predictive of risk for radiographic progression.1 The objectives of this study were to evaluate early RA patients from the randomized double-blinded OPERA trial for: 1) associations between baseline (BL) MBDA score and 12-month radiographic outcomes; 2) the value of adding MBDA score to anti-CCP for predicting radiographic progression.

Methods: In the OPERA trial, treatment-naive early RA patients (N=180) with moderate or high DAS28 were randomized to treatment with oral methotrexate and either adalimumab (ADA) (n=89) or placebo (n=91). Glucocorticoids were injected into up to 4 swollen joints per visit.2 X-rays of hands and feet (n=164) from months 0 and 12 were assessed with the Sharp van der Heijde Total Sharp Score (TSS). The smallest detectable change (1.8 TSS units) defined radiographic progression (DTSS≥2). Anti-CCP status was dichotomized. MBDA score was determined at 0 and 3 months. Correlations between BL or change (D) MBDA score and radiographic progression were analyzed by Spearman´s rank correlation coefficient (r). Chi-Square test was used for comparisons. A logistic regression model, adjusted for BL demographics and disease activity measures, assessed association between MBDA score and radiographic progression.  

Results: Patients had median (range) age 55 (19-86) years, disease duration 84 (42-214) days; 66% were female; 72% were positive for RF and 65% for anti-CCP.  Median values at BL were DAS28-CRP 5.6 (3.3-8.6), MBDA score 59 (12-90) and TSS 2 (0-31). 42 patients had DTSS ≥ 2, median DTSS = 3 (2-22)/mean DTSS = 4.52 (3.84). BL MBDA score correlated with DTSS in the placebo (r=0.23, p=0.04) but not the ADA group (r=0.10, P=0.35). ΔMBDA score0-3months was not correlated with DTSS. Patients with high BL MBDA score (>44) were more likely to progress radiographically (31%), while only 1/31 (3%) patients with MBDA score ≤44 progressed (p<0.01), and this was significant also for each treatment group. Moderate/high BL DAS28-CRP was not associated with radiographic progression (Figure 1A, B). BL MBDA score (OR=1.03 per unit increase [1.01-1.06]), and anti-CCP (OR=4.45 if positive [1.66-11.95]) were significantly associated with RP in multivariate analyses. 34% of anti-CCP positive and 12% of anti-CCP negative patients had RP (p<0.002). No anti-CCP+ patients with MBDA score ≤44 progressed radiographically, whereas stratifying by DAS28-CRP had no added value to anti-CCP alone (Figure 1C, D)

Conclusion: High BL MBDA score (>44) was a strong, independent predictor of radiographic progression and added value to anti-CCP status. Only 3% of patients with low or moderate BL MBDA score (≤44) progressed radiographically.  (1) Hirata et al. Current Biomarker Findings 2015, 5:69-78 (2) Hørslev-Petersen K, et al., Ann Rheum Dis 2014; 73:654-661  

 

Disclosure: C. H. Brahe, None; M. Østergaard, Abbott Immunology Pharmaceuticals, 2,Bristol-Myers Squibb, 2,Boehringer Ingelheim, 2,Eli Lilly and Company, 2,Merck Pharmaceuticals, 2,Pfizer Inc, 2,Roche Pharmaceuticals, 2,UCB, 2,Celgene, 2,Sanofi-Aventis Pharmaceutical, 2,Regeneron, 2,Novartis Pharmaceutical Corporation, 2; J. S. Johansen, None; N. A. Defranoux, Crescendo Bioscience Inc., 1,Crescendo Bioscience Inc., 3; C. C. Hwang, Crescendo Bioscience Inc., 1,Crescendo Bioscience Inc., 3; X. Wang, Crescendo Bioscience Inc., 3; R. J. Bolce, Crescendo Bioscience Inc., 3; E. H. Sasso, Crescendo Bioscience, 9; K. Hørslev-Petersen, None; K. Stengaard-Pedersen, None; L. M. Ørnbjerg, None; P. Junker, None; T. Ellingsen, None; P. Ahlquist, None; H. Lindegaard, Novartis, Eli Lilly DK, Boehringer Ingelheim Danmark, MSD Denmark, 5; A. Linauskas, None; A. Schlemmer, None; M. Yde Dam, None; I. Tønder Hansen, None; T. Lottenburger, None; C. G. Ammitzbøll, None; A. Jørgensen, None; S. B. Krintel, None; J. L. Raun, None; M. Lund Hetland, AbbVie, BMS, MSD, Roche, Pfizer, UCB, Crescendo, 2.

To cite this abstract in AMA style:

Brahe CH, Østergaard M, Johansen JS, Defranoux NA, Hwang CC, Wang X, Bolce RJ, Sasso EH, Hørslev-Petersen K, Stengaard-Pedersen K, Ørnbjerg LM, Junker P, Ellingsen T, Ahlquist P, Lindegaard H, Linauskas A, Schlemmer A, Yde Dam M, Tønder Hansen I, Lottenburger T, Ammitzbøll CG, Jørgensen A, Krintel SB, Raun JL, Lund Hetland M. Multi-Biomarker Disease Activity (MBDA) Score and Prediction of Radiographic Progression in a Randomized Study of Patients with Early RA Treated with Methotrexate Alone or with Adalimumab [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/multi-biomarker-disease-activity-mbda-score-and-prediction-of-radiographic-progression-in-a-randomized-study-of-patients-with-early-ra-treated-with-methotrexate-alone-or-with-adalimumab/. Accessed .

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