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

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  • C H Brahe, Københavns Universitet, The DANBIO Registry, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup
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  • M Østergaard, Københavns Universitet, The DANBIO Registry, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup
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  • J S Johansen, Departments of Oncology and Medicine, Copenhagen University Hospital, Herlev, Denmark.
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  • N Defranoux, e Crescendo Bioscience Inc ., San Francisco , CA , USA.
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  • X Wang, e Crescendo Bioscience Inc ., San Francisco , CA , USA.
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  • R Bolce, e Crescendo Bioscience Inc ., San Francisco , CA , USA.
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  • E H Sasso, e Crescendo Bioscience Inc ., San Francisco , CA , USA.
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  • L M Ørnbjerg, The DANBIO Registry, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Københavns Universitet
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  • K Hørslev-Petersen, King Christian X’s Hospital for Rheumatic Diseases, Graasten
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  • K Stengaard-Pedersen
  • P Junker, Reumatologisk Afdeling, Odense Universitetshospital
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  • T Ellingsen
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  • P Ahlquist, Medicinsk Afdeling, Sygehus Lillebælt, Vejle
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  • H Lindegaard, Reumatologisk Afdeling, Odense Universitetshospital
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  • A Linauskas
  • A Schlemmer
  • M Y Dam
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  • I Hansen
  • T Lottenburger, Medicinsk Afdeling, Sygehus Lillebælt, Vejle
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  • C Ammitzbøll
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  • A Jørgensen
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  • S B Krintel, Københavns Universitet, The DANBIO Registry, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup
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  • J Raun, King Christian X’s Hospital for Rheumatic Diseases, Graasten
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  • M L Hetland, The DANBIO Registry, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Københavns Universitet

OBJECTIVES: 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.

METHOD: 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.

RESULTS: 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).

CONCLUSION: 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.

OriginalsprogEngelsk
TidsskriftScandinavian Journal of Rheumatology
Vol/bind48
Nummer1
Sider (fra-til)9-16
Antal sider8
ISSN0300-9742
DOI
StatusUdgivet - 2019

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