Abstract
BackgroundThe objective of this study was to evaluate early changes in magnetic resonance imaging (MRI) and clinical disease activity measures as predictors of later structural progression in early rheumatoid arthritis (RA).MethodsThis was a post hoc analysis of data pooled across treatments from a three-arm (tofacitinib monotherapy, tofacitinib with methotrexate [MTX], or MTX monotherapy) trial of MTX-naïve patients with early, active RA. Synovitis, osteitis and erosions were assessed with the Outcome Measures in Rheumatology (OMERACT) RA MRI scoring system (RAMRIS) and RAMRIQ (automated quantitative RA MRI assessment system; automated RAMRIS) at months 0, 1, 3, 6 and 12. Radiographs were assessed at months 0, 6 and 12, and clinical endpoints were assessed at all timepoints. Univariate and multivariate analyses explored the predictive value of early changes in RAMRIS/RAMRIQ parameters and disease activity measures, with respect to subsequent radiographic progression.ResultsData from 109 patients with a mean RA duration of 0.7 years were included. In univariate analyses, changes in RAMRIS erosions at months 1 and 3 significantly predicted radiographic progression at month 12 (both p < 0.01); changes in RAMRIQ synovitis and osteitis at months 1 and 3 were significant predictors of RAMRIS erosions and radiographic progression at month 12 (all p < 0.01). In subsequent multivariate analyses, RAMRIS erosion change at month 1 (p < 0.05) and RAMRIQ osteitis changes at months 1 and 3 (both p < 0.01) were significant independent predictors of radiographic progression at month 12. Univariate analyses demonstrated that changes in Clinical Disease Activity Index (CDAI) and Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4[ESR]) at months 1 and 3 were not predictive of month 12 radiographic progression.ConclusionsMRI changes seen as early as 1 month after RA treatment initiation have the potential to better predict long-term radiographic progression than changes in disease activity measures.Trial registrationClinicalTrials.gov, NCT01164579.
Highlights
The objective of this study was to evaluate early changes in magnetic resonance imaging (MRI) and clinical disease activity measures as predictors of later structural progression in early rheumatoid arthritis (RA)
In a phase 2 study of tofacitinib 10 mg twice daily (BID) with and without concomitant methotrexate (MTX), tofacitinib reduced inflammation and inhibited progression of structural damage from baseline to month 12 compared with treatment with MTX alone, as assessed using RA MRI scoring system (RAMRIS) and Automated quantitative RA MRI assessment system (RAMRIQ) [8]
RAMRIQ osteitis values were reported as normalised volume (%) calculated as × 100, and RAMRIQ erosions values were reported as normalised volume (%), calculated as × 100
Summary
The objective of this study was to evaluate early changes in magnetic resonance imaging (MRI) and clinical disease activity measures as predictors of later structural progression in early rheumatoid arthritis (RA). Magnetic resonance imaging (MRI) can assess inflammation (synovitis and bone marrow edema/osteitis) as well as damage (erosions) in joints, using the semiquantitative Outcome Measures in Rheumatology (OMERACT) RA MRI scoring system (RAMRIS) [7, 8] and, more recently, the automated quantitative RA MRI assessment system (RAMRIQ; automated RAMRIS) [8, 9]. This sensitivity for pathology detection may provide a tool for accurate early detection of an objective treatment response. In a phase 2 study of tofacitinib 10 mg twice daily (BID) with and without concomitant methotrexate (MTX), tofacitinib reduced inflammation and inhibited progression of structural damage from baseline to month 12 compared with treatment with MTX alone, as assessed using RAMRIS and RAMRIQ [8]
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