We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Effect of Magnetic Resonance Imaging vs Conventional Treat-to-Target Strategies on Disease Activity Remission and Radiographic Progression in Rheumatoid Arthritis: The IMAGINE-RA Randomized Clinical Trial.
- Authors
Møller-Bisgaard, Signe; Hørslev-Petersen, Kim; Ejbjerg, Bo; Hetland, Merete Lund; Ørnbjerg, Lykke Midtbøll; Glinatsi, Daniel; Møller, Jakob; Boesen, Mikael; Christensen, Robin; Stengaard-Pedersen, Kristian; Madsen, Ole Rintek; Jensen, Bente; Villadsen, Jan Alexander; Hauge, Ellen-Margrethe; Bennett, Philip; Hendricks, Oliver; Asmussen, Karsten; Kowalski, Marcin; Lindegaard, Hanne; Nielsen, Sabrina Mai
- Abstract
<bold>Importance: </bold>Whether using magnetic resonance imaging (MRI) to guide treatment in patients with rheumatoid arthritis (RA) improves disease activity and slows joint damage progression is unknown.<bold>Objective: </bold>To determine whether an MRI-guided treat-to-target strategy vs a conventional clinical treat-to-target strategy improves outcomes in patients with RA in clinical remission.<bold>Design, Setting, and Participants: </bold>Two-year, randomized, multicenter trial conducted at 9 hospitals in Denmark. Two hundred patients with RA in clinical remission (disease activity score in 28 joints-C-reactive protein [DAS28-CRP] <3.2 and no swollen joints) were enrolled between April 2012 and June 2015. The final follow-up visit was April 2017.<bold>Interventions: </bold>Patients were randomly allocated (1:1) to an MRI-guided vs a conventional treat-to-target strategy. In the MRI-guided group, the treatment goal was absence of MRI bone marrow edema combined with clinical remission, defined as DAS28-CRP of 3.2 or less and no swollen joints. In the conventional group, the treatment goal was clinical remission.<bold>Main Outcomes and Measures: </bold>Co-primary outcomes were proportions of patients achieving DAS28-CRP remission (DAS28-CRP <2.6) and with no radiographic progression (no increase in total van der Heijde-modified Sharp score) at 24 months. Significance testing for the primary outcome was based on 1-sided testing. Secondary outcomes were clinical and MRI measures of disease activity, physical function, and quality of life.<bold>Results: </bold>Of 200 patients randomized (133 women [67%]; mean [SD] age, 61.6 [10.5] years; median baseline DAS28-CRP, 1.9 [interquartile range, 1.7-2.2]; van der Heijde-modified Sharp score, 18.0 [interquartile range, 7.0-42.5]), 76 patients (76%) in the MRI-guided group and 95 (95%) in the conventional group completed the study. Of these, 64 (85%) vs 83 (88%), respectively, reached the primary clinical end point (risk difference, -4.8% [1-sided 95% CI, -13.6% to + ∞; 1-sided P = .19]) and 49 (66%) vs 58 (62%), respectively, reached the primary radiographic end point (risk difference, 4.7% [1-sided 95% CI, -7.0% to + ∞; 1-sided P = .25). Of 10 key secondary end points, 8 were null and 2 showed statistically significant benefit for the MRI treat-to-target group. Seventeen patients (17%) in the MRI-guided treat-to-target group and 6 patients (6%) in the conventional treat-to-target group experienced serious adverse events.<bold>Conclusions and Relevance: </bold>Among patients with RA in clinical remission, an MRI-guided treat-to-target strategy compared with a conventional treat-to-target strategy did not result in improved disease activity remission rates or reduce radiographic progression. These findings do not support the use of an MRI-guided strategy for treating patients with RA.<bold>Trial Registration: </bold>ClinicalTrials.gov Identifier: NCT01656278.
- Subjects
ANTIRHEUMATIC agents; BONE marrow; COMPARATIVE studies; EDEMA; JOINTS (Anatomy); MAGNETIC resonance imaging; RESEARCH methodology; EVALUATION of medical care; MEDICAL cooperation; OSTEITIS; RADIOGRAPHY; RESEARCH; RHEUMATOID arthritis; EVALUATION research; RANDOMIZED controlled trials; DISEASE remission; DISEASE progression
- Publication
JAMA: Journal of the American Medical Association, 2019, Vol 321, Issue 5, p461
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2018.21362