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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

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@article{8f36db93bbbb4f129f784a39ce1b392f,
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",
abstract = "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] <3.2 and no swollen joints) were enrolled between April 2012 and June 2015. The final follow-up visit was April 2017.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 <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.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.",
keywords = "Aged, Antirheumatic Agents/adverse effects, Arthritis, Rheumatoid/diagnostic imaging, Bone Marrow/diagnostic imaging, Disease Progression, Edema/diagnostic imaging, Female, Humans, Joints/diagnostic imaging, Magnetic Resonance Imaging, Male, Middle Aged, Osteitis/diagnostic imaging, Outcome and Process Assessment, Health Care, Radiography, Remission Induction",
author = "Signe M{\o}ller-Bisgaard and Kim H{\o}rslev-Petersen and Bo Ejbjerg and Hetland, {Merete Lund} and {\O}rnbjerg, {Lykke Midtb{\o}ll} and Daniel Glinatsi and Jakob M{\o}ller and Mikael Boesen and Robin Christensen and Kristian Stengaard-Pedersen and Madsen, {Ole Rintek} and Bente Jensen and Villadsen, {Jan Alexander} and Ellen-Margrethe Hauge and Philip Bennett and Oliver Hendricks and Karsten Asmussen and Marcin Kowalski and Hanne Lindegaard and Nielsen, {Sabrina Mai} and Henning Bliddal and Krogh, {Niels Steen} and Torkell Ellingsen and Nielsen, {Agnete H} and Lone Balding and Jurik, {Anne Grethe} and Thomsen, {Henrik S} and Mikkel {\O}stergaard",
note = "COPECARE",
year = "2019",
month = "2",
day = "5",
doi = "10.1001/jama.2018.21362",
language = "English",
volume = "321",
pages = "461--472",
journal = "JAMA - Journal of the American Medical Association",
issn = "0002-9955",
publisher = "American Medical Association",
number = "5",

}

RIS

TY - JOUR

T1 - Effect of Magnetic Resonance Imaging vs Conventional Treat-to-Target Strategies on Disease Activity Remission and Radiographic Progression in Rheumatoid Arthritis

T2 - The IMAGINE-RA Randomized Clinical Trial

AU - Møller-Bisgaard, Signe

AU - Hørslev-Petersen, Kim

AU - Ejbjerg, Bo

AU - Hetland, Merete Lund

AU - Ørnbjerg, Lykke Midtbøll

AU - Glinatsi, Daniel

AU - Møller, Jakob

AU - Boesen, Mikael

AU - Christensen, Robin

AU - Stengaard-Pedersen, Kristian

AU - Madsen, Ole Rintek

AU - Jensen, Bente

AU - Villadsen, Jan Alexander

AU - Hauge, Ellen-Margrethe

AU - Bennett, Philip

AU - Hendricks, Oliver

AU - Asmussen, Karsten

AU - Kowalski, Marcin

AU - Lindegaard, Hanne

AU - Nielsen, Sabrina Mai

AU - Bliddal, Henning

AU - Krogh, Niels Steen

AU - Ellingsen, Torkell

AU - Nielsen, Agnete H

AU - Balding, Lone

AU - Jurik, Anne Grethe

AU - Thomsen, Henrik S

AU - Østergaard, Mikkel

N1 - COPECARE

PY - 2019/2/5

Y1 - 2019/2/5

N2 - 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] <3.2 and no swollen joints) were enrolled between April 2012 and June 2015. The final follow-up visit was April 2017.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 <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.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.

AB - 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] <3.2 and no swollen joints) were enrolled between April 2012 and June 2015. The final follow-up visit was April 2017.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 <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.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.

KW - Aged

KW - Antirheumatic Agents/adverse effects

KW - Arthritis, Rheumatoid/diagnostic imaging

KW - Bone Marrow/diagnostic imaging

KW - Disease Progression

KW - Edema/diagnostic imaging

KW - Female

KW - Humans

KW - Joints/diagnostic imaging

KW - Magnetic Resonance Imaging

KW - Male

KW - Middle Aged

KW - Osteitis/diagnostic imaging

KW - Outcome and Process Assessment, Health Care

KW - Radiography

KW - Remission Induction

U2 - 10.1001/jama.2018.21362

DO - 10.1001/jama.2018.21362

M3 - Journal article

VL - 321

SP - 461

EP - 472

JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0002-9955

IS - 5

ER -

ID: 58905393