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Predictive value of a multi-biomarker disease activity score for clinical remission and radiographic progression in patients with early rheumatoid arthritis: a post-hoc study of the OPERA trial.
- Source :
- Scandinavian Journal of Rheumatology; Jan2019, Vol. 48 Issue 1, p9-16, 8p, 4 Charts, 2 Graphs
- Publication Year :
- 2019
-
Abstract
- <bold>Objectives: </bold>Measurement of serum biomarkers at disease onset may improve prediction of disease course in patients with early rheumatoid arthritis (RA). We evaluated the multi-biomarker disease activity (MBDA) score and early changes in MBDA score for prediction of 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP) remission and radiographic progression in the double-blinded OPERA trial.<bold>Method: </bold>Treatment-naïve RA patients (N = 180) with moderate or high DAS28 were randomized to methotrexate (MTX) + adalimumab (n = 89) or MTX + placebo (n = 91) in combination with glucocorticoid injection into swollen joints. X-rays of hands and feet were evaluated at months 0 and 12 (n = 164) by the total Sharp van der Heijde score (TSS). The smallest detectable change (1.8 TSS units) defined radiographic progression (∆TSS ≥ 2). Clinical remission (DAS28-CRP < 2.6) was assessed at baseline and 6 months. MBDA score was determined at 0 and 3 months and tested in a multivariable logistic regression model for predicting DAS28 remission at 6 months and radiographic progression at 1 year.<bold>Results: </bold>Baseline MBDA score was independently associated with radiographic progression at 1 year [odds ratio (OR) = 1.03/unit, 95% confidence interval (CI) = 1.01-1.06], and changes in MBDA score from baseline to 3 months with clinical remission at 6 months [OR = 0.98/unit, 95% CI 0.96-1.00). In anti-cyclic citrullinated peptide antibody (anti-CCP)-positive patients, 35 of 89 with high MBDA score (> 44) showed radiographic progression (PPV = 39%), compared with 0 of 15 patients (NPV = 100%) with low/moderate MBDA score (≤ 44) (p = 0.003).<bold>Conclusion: </bold>Early changes in MBDA score were associated with clinical remission based on DAS28-CRP at 6 months. In anti-CCP-positive patients, a non-high baseline MBDA score (≤ 44) had a clinical value by predicting very low risk of radiographic progression at 12 months. [ABSTRACT FROM AUTHOR]
- Subjects :
- RHEUMATOID arthritis
METHOTREXATE
ADALIMUMAB
PLACEBOS
GLUCOCORTICOIDS
RHEUMATOID arthritis diagnosis
ANTIRHEUMATIC agents
C-reactive protein
COMBINATION drug therapy
COMPARATIVE studies
IMMUNOSUPPRESSIVE agents
LONGITUDINAL method
RESEARCH methodology
MEDICAL cooperation
RADIOGRAPHY
RESEARCH
STATISTICAL sampling
EVALUATION research
RANDOMIZED controlled trials
TREATMENT effectiveness
DISEASE remission
BLIND experiment
SEVERITY of illness index
DISEASE progression
Subjects
Details
- Language :
- English
- ISSN :
- 03009742
- Volume :
- 48
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- Scandinavian Journal of Rheumatology
- Publication Type :
- Academic Journal
- Accession number :
- 133803684
- Full Text :
- https://doi.org/10.1080/03009742.2018.1464206