1. 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
- Author
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Kristian Stengaard-Pedersen, Torkell Ellingsen, Hanne Merete Lindegaard, Peter Junker, Anette Jørgensen, Julia S. Johansen, Lykke Midtbøll Ørnbjerg, Tine Lottenburger, Rebecca Bolce, Cecilie Heegaard Brahe, Asta Linauskas, X Wang, Nadine Defranoux, Eric H. Sasso, Palle Ahlquist, Johnny Lillelund Raun, Mikkel Østergaard, Sophine B. Krintel, Ib Hansen, Christian Gytz Ammitzbøll, Kim Hørslev-Petersen, Annette Schlemmer, Merete Lund Hetland, and Mette Yde Dam
- Subjects
Male ,Radiography ,Arthritis ,Antirheumatic Agents/therapeutic use ,Disease ,Severity of Illness Index ,law.invention ,Arthritis, Rheumatoid ,0302 clinical medicine ,Randomized controlled trial ,law ,Immunology and Allergy ,030212 general & internal medicine ,Young adult ,skin and connective tissue diseases ,Aged, 80 and over ,Remission Induction ,General Medicine ,Middle Aged ,C-Reactive Protein ,Treatment Outcome ,Antirheumatic Agents ,Disease Progression ,Biomarker (medicine) ,Drug Therapy, Combination ,Female ,Immunosuppressive Agents ,musculoskeletal diseases ,Adult ,medicine.medical_specialty ,Methotrexate/therapeutic use ,Arthritis, Rheumatoid/blood ,Immunology ,03 medical and health sciences ,Young Adult ,Pharmacotherapy ,Rheumatology ,Double-Blind Method ,Adalimumab/therapeutic use ,Internal medicine ,Severity of illness ,medicine ,Humans ,Aged ,030203 arthritis & rheumatology ,business.industry ,C-Reactive Protein/metabolism ,Remission Induction/methods ,Adalimumab ,medicine.disease ,Methotrexate ,business ,Biomarkers/blood ,Biomarkers ,Follow-Up Studies - Abstract
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.
- Published
- 2018