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
| Autor: | Oliver Hendricks, Ole Rintek Madsen, Mikkel Østergaard, Henrik S. Thomsen, Sabrina Mai Nielsen, Ellen Margrethe Hauge, Anne Grethe Jurik, Robin Christensen, Hanne Merete Lindegaard, Bo Ejbjerg, Signe Møller-Bisgaard, Torkell Ellingsen, Philip Bennett, Bente Jensen, Kristian Stengaard-Pedersen, Niels Steen Krogh, Merete Lund Hetland, Lone Balding, Karsten Asmussen, Kim Hørslev-Petersen, Lykke Midtbøll Ørnbjerg, Mikael Boesen, Jakob M Møller, A. H. Nielsen, Jan Alexander Villadsen, Daniel Glinatsi, Marcin Ryszard Kowalski, Henning Bliddal |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Edema/diagnostic imaging Osteitis/diagnostic imaging Arthritis Antirheumatic Agents/adverse effects 01 natural sciences law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Joints/diagnostic imaging Interquartile range law Internal medicine Multicenter trial medicine Humans 030212 general & internal medicine 0101 mathematics Adverse effect Aged biology Surrogate endpoint business.industry 010102 general mathematics C-reactive protein Remission Induction General Medicine Middle Aged medicine.disease Outcome and Process Assessment (Health Care) Magnetic Resonance Imaging Radiography Rheumatoid arthritis Bone Marrow/diagnostic imaging biology.protein Disease Progression Female business Arthritis Rheumatoid/diagnostic imaging |
| Zdroj: | Møller-Bisgaard, S, Hørslev-Petersen, K, Ejbjerg, B, Hetland, M L, Ørnbjerg, L M, Glinatsi, D, Møller, J, Boesen, M, Christensen, R, Stengaard-Pedersen, K, Madsen, O R, Jensen, B, Villadsen, J A, Hauge, E-M, Bennett, P, Hendricks, O, Asmussen, K, Kowalski, M, Lindegaard, H, Nielsen, S M, Bliddal, H, Krogh, N S, Ellingsen, T, Nielsen, A H, Balding, L, Jurik, A G, Thomsen, H S & Østergaard, M 2019, ' 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 ', JAMA: The Journal of the American Medical Association, vol. 321, no. 5, pp. 461-472 . https://doi.org/10.1001/jama.2018.21362 Møller-Bisgaard, S, Hørslev-Petersen, K, Ejbjerg, B, Hetland, M L, Ørnbjerg, L M, Glinatsi, D, Møller, J, Boesen, M, Christensen, R, Stengaard-Pedersen, K, Madsen, O R, Jensen, B, Villadsen, J A, Hauge, E M, Bennett, P, Hendricks, O, Asmussen, K, Kowalski, M, Lindegaard, H, Nielsen, S M, Bliddal, H, Krogh, N S, Ellingsen, T, Nielsen, A H, Balding, L, Jurik, A G, Thomsen, H S & Østergaard, M 2019, ' 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 ', JAMA-Journal of the American Medical Association, vol. 321, no. 5, pp. 461-472 . https://doi.org/10.1001/jama.2018.21362 Møller-Bisgaard, S, Hørslev-Petersen, K, Ejbjerg, B, Hetland, M L, Ørnbjerg, L M, Glinatsi, D, Møller, J, Boesen, M, Christensen, R, Stengaard-Pedersen, K, Madsen, O R, Jensen, B, Villadsen, J A, Hauge, E M, Bennett, P, Hendricks, O, Asmussen, K, Kowalski, M, Lindegaard, H, Nielsen, S M, Bliddal, H, Krogh, N S, Ellingsen, T, Nielsen, A H, Balding, L, Jurik, A G, Thomsen, H S & Østergaard, M 2019, ' 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 ', JAMA-Journal of the American Medical Association, vol. 321, no. 5, pp. 461-472 . https://doi.org/10.1001/jama.2018.21362 |
| DOI: | 10.1001/jama.2018.21362 |
| Popis: | Importance: 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.Objective: 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.Design, Setting, and Participants: 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] Interventions: 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.Main Outcomes and Measures: Co-primary outcomes were proportions of patients achieving DAS28-CRP remission (DAS28-CRP Results: 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.Conclusions and Relevance: 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.Trial Registration: ClinicalTrials.gov Identifier: NCT01656278. |
| Databáze: | OpenAIRE |
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