Background/Purpose: The multi-biomarker disease activity (MBDA) (Vectra^® DA) score has been reported to predict disease relapses in patients with rheumatoid arthritis (RA) in sustained remission who tapered disease modifying anti-rheumatic drug in prospective randomized controlled trial.⁽¹⁾ The purpose of the present study was to evaluate MBDA score as predictor of flare or sustained clinical remission after discontinuation of adalimumab (ADA) in patients with established RA from the HONOR cohort^.(2,3)It was previously shown that sustained biologic-free remission was possible and associated with deep clinical remission.

Methods: This retrospective sub-group analysis was conducted on 42/51 RA patients from the HONOR study with serum samples available at time of discontinuation. The study enrolled patients receiving ADA and methotrexate who maintained DAS28-ESR remission (<2.6) for ≥24 weeks and who subsequently agreed to discontinue ADA. Clinical disease activity, functional status, and joint damage were recorded at ADA discontinuation (baseline), and after 24 and 52 weeks. MBDA scores, a validated disease activity measure for patients with RA calculated based on serum concentration of 12 biomarkers (remission, ≤25; low, 26-29; moderate, 30-44; high, >44), were determined at baseline.⁽⁴⁾ The ability of MBDA scores and patient characteristics to predict flare (DAS28-ESR ≥3.2) or sustained clinical remission (SC-REM) (absence of flare with DAS28-ESR <2.6 at all visits) at 6 months and 1 year were evaluated by the area under receiver operator curves as well as Kaplan-Meier estimates, Wilcoxon rank sum test and Cochran-Armitage trend test. Any p-value <0.05 was considered statistically significant and p-value <0.1 marginally significant.

Results: At ADA discontinuation, all patients had DAS28-ESR <2.6 with 81% female, 69% RF+, 81% ACPA+ and 30- month mean disease duration. The median MBDA score was 24.5 [interquartile range: 14.3, 30.8] with 22 (52.4%) patients in remission, and 6 (14.3%) low, 9 (21.4%) moderate and 5 (11.9%) high MBDA score. At 52 weeks, flare and SC-REM were observed in 12/42 (28.6%) and 19/42 (45.2%) patients, respectively. Rate of flare and percentage of SC-REM by MBDA category (remission/low/moderate/high) were 13.6%/50.0%/33.3% and 60.0% (p=0.033) and 63.6%/33.3%/33.3% and 0% (p=0.0066), respectively. Univariate regression analyses identified MBDA score, DAS28-ESR and disease duration as predictors of flare at 52 weeks (p≤0.05). In a multivariate linear logistic regression model, MBDA scores were marginally associated with flare and SC-REM after adjusting for disease duration.

Conclusion: These findings suggest that the MBDA score could predict flare and biologic-free SC-REM in RA patients in stable clinical remission, undergoing ADA withdrawal while maintaining MTX treatment in a clinical setting and point-out to the potential utility of the MBDA score for guiding treatment decisions in patients receiving biologics. References: 1. Rech J, et al, Ann Rheum Dis 2015;0:1–8. 2. Hirata S, et al, Arthritis Res Ther. 2013;15:R135 3. Tanaka Y, et al, Ann Rheum Dis. 2015;74:389–395 4. Hirata S, et al, Current Biomarker Findings 2015;5:69-78

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/predicting-flare-and-sustained-clinical-remission-after-adalimumab-withdrawal-using-the-multi-biomarker-disease-activity-mbda-score/