Whole-body magnetic resonance imaging in axial spondyloarthritis: Reduction of sacroiliac, spinal, and entheseal inflammation in a placebo-controlled trial of adalimumab

Simon Krabbe; Mikkel Østergaard; Iris Eshed; Inge J. Sørensen; Bente Jensen; Jakob M. Møller; Lone Balding; Ole R. Madsen; Karsten Asmussen; Grith Eng; Niklas R. Jørgensen; Susanne J. Pedersen

doi:10.3899/jrheum.170408

Whole-body magnetic resonance imaging in axial spondyloarthritis: Reduction of sacroiliac, spinal, and entheseal inflammation in a placebo-controlled trial of adalimumab

Simon Krabbe^*, Mikkel Østergaard, Iris Eshed, Inge J. Sørensen, Bente Jensen, Jakob M. Møller, Lone Balding, Ole R. Madsen, Karsten Asmussen, Grith Eng, Niklas R. Jørgensen, Susanne J. Pedersen

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin

17 Citationer (Scopus)

Abstract

Objective. To investigate whether adalimumab (ADA) reduces whole-body (WB-) magnetic resonance imaging (MRI) indices for inflammation in the entheses, peripheral joints, sacroiliac joints, spine, and the entire body in patients with axial spondyloarthritis (axSpA). Methods. An investigator-initiated, randomized, placebo-controlled, double-blinded 48-week followup trial included 49 patients with axSpA, who had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4.0 despite treatment with nonsteroidal antiinflammatory drugs and a clinical indication for tumor necrosis factor inhibitor treatment. Patients were randomized to subcutaneous ADA 40 mg or placebo every other week for 6 weeks; thereafter, all patients received ADA. Conventional MRI and WBMRI were performed at weeks 0, 6, 24, and 48. The primary WBMRI endpoint was the proportion of patients with an improvement in WBMRI total inflammation index above the smallest detectable change (SDC) at Week 6. Results. The primary WBMRI endpoint (improvement of SDC > 2.3) was met in 11 (44%) patients in the ADA group and 3 (13%) patients in the placebo group (p = 0.025, Fisher’s exact test). The primary conventional MRI endpoint, the minimally important change in Spondyloarthritis Research Consortium of Canada Spine MRI Inflammation Index at Week 6, was achieved by 9 (36%) patients in the ADA group and 4 (17%) patients in the placebo group (p = 0.20). The primary clinical endpoint, BASDAI reduction > 50% or 2.0 at Week 24, was attained by 32 (65%) patients. Conclusion. ADA provided significant reductions in WBMRI indices of peripheral, axial, and whole-body inflammation in patients with axSpA. WBMRI is promising for objective assessment and monitoring of peripheral and axial disease activity in future clinical trials.

Originalsprog	Engelsk
Tidsskrift	Journal of Rheumatology
Vol/bind	45
Udgave nummer	5
Sider (fra-til)	621-629
Antal sider	9
ISSN	0315-162X
DOI	https://doi.org/10.3899/jrheum.170408
Status	Udgivet - 2018

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10.3899/jrheum.170408

Citationsformater

Krabbe, S., Østergaard, M., Eshed, I., Sørensen, I. J., Jensen, B., Møller, J. M., Balding, L., Madsen, O. R., Asmussen, K., Eng, G., Jørgensen, N. R., & Pedersen, S. J. (2018). Whole-body magnetic resonance imaging in axial spondyloarthritis: Reduction of sacroiliac, spinal, and entheseal inflammation in a placebo-controlled trial of adalimumab. Journal of Rheumatology, 45(5), 621-629. https://doi.org/10.3899/jrheum.170408

Whole-body magnetic resonance imaging in axial spondyloarthritis: Reduction of sacroiliac, spinal, and entheseal inflammation in a placebo-controlled trial of adalimumab. / Krabbe, Simon; Østergaard, Mikkel; Eshed, Iris et al.
I: Journal of Rheumatology, Bind 45, Nr. 5, 2018, s. 621-629.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Krabbe, S, Østergaard, M, Eshed, I, Sørensen, IJ, Jensen, B, Møller, JM, Balding, L, Madsen, OR, Asmussen, K, Eng, G, Jørgensen, NR & Pedersen, SJ 2018, 'Whole-body magnetic resonance imaging in axial spondyloarthritis: Reduction of sacroiliac, spinal, and entheseal inflammation in a placebo-controlled trial of adalimumab', Journal of Rheumatology, bind 45, nr. 5, s. 621-629. https://doi.org/10.3899/jrheum.170408

@article{26742fc2291c40de86a721ebac438194,

title = "Whole-body magnetic resonance imaging in axial spondyloarthritis: Reduction of sacroiliac, spinal, and entheseal inflammation in a placebo-controlled trial of adalimumab",

abstract = "Objective. To investigate whether adalimumab (ADA) reduces whole-body (WB-) magnetic resonance imaging (MRI) indices for inflammation in the entheses, peripheral joints, sacroiliac joints, spine, and the entire body in patients with axial spondyloarthritis (axSpA). Methods. An investigator-initiated, randomized, placebo-controlled, double-blinded 48-week followup trial included 49 patients with axSpA, who had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4.0 despite treatment with nonsteroidal antiinflammatory drugs and a clinical indication for tumor necrosis factor inhibitor treatment. Patients were randomized to subcutaneous ADA 40 mg or placebo every other week for 6 weeks; thereafter, all patients received ADA. Conventional MRI and WBMRI were performed at weeks 0, 6, 24, and 48. The primary WBMRI endpoint was the proportion of patients with an improvement in WBMRI total inflammation index above the smallest detectable change (SDC) at Week 6. Results. The primary WBMRI endpoint (improvement of SDC > 2.3) was met in 11 (44%) patients in the ADA group and 3 (13%) patients in the placebo group (p = 0.025, Fisher{\textquoteright}s exact test). The primary conventional MRI endpoint, the minimally important change in Spondyloarthritis Research Consortium of Canada Spine MRI Inflammation Index at Week 6, was achieved by 9 (36%) patients in the ADA group and 4 (17%) patients in the placebo group (p = 0.20). The primary clinical endpoint, BASDAI reduction > 50% or 2.0 at Week 24, was attained by 32 (65%) patients. Conclusion. ADA provided significant reductions in WBMRI indices of peripheral, axial, and whole-body inflammation in patients with axSpA. WBMRI is promising for objective assessment and monitoring of peripheral and axial disease activity in future clinical trials.",

keywords = "Inflammation, Magnetic Resonance Imaging, Outcome assessment, Spondyloarthritis, Whole-body Imaging",

author = "Simon Krabbe and Mikkel {\O}stergaard and Iris Eshed and S{\o}rensen, {Inge J.} and Bente Jensen and M{\o}ller, {Jakob M.} and Lone Balding and Madsen, {Ole R.} and Karsten Asmussen and Grith Eng and J{\o}rgensen, {Niklas R.} and Pedersen, {Susanne J.}",

year = "2018",

doi = "10.3899/jrheum.170408",

language = "English",

volume = "45",

pages = "621--629",

journal = "Journal of Rheumatology",

issn = "0315-162X",

publisher = "Journal of Rheumatology Publishing Co. Ltd.",

number = "5",

}

TY - JOUR

T1 - Whole-body magnetic resonance imaging in axial spondyloarthritis

T2 - Reduction of sacroiliac, spinal, and entheseal inflammation in a placebo-controlled trial of adalimumab

AU - Krabbe, Simon

AU - Østergaard, Mikkel

AU - Eshed, Iris

AU - Sørensen, Inge J.

AU - Jensen, Bente

AU - Møller, Jakob M.

AU - Balding, Lone

AU - Madsen, Ole R.

AU - Asmussen, Karsten

AU - Eng, Grith

AU - Jørgensen, Niklas R.

AU - Pedersen, Susanne J.

PY - 2018

Y1 - 2018

N2 - Objective. To investigate whether adalimumab (ADA) reduces whole-body (WB-) magnetic resonance imaging (MRI) indices for inflammation in the entheses, peripheral joints, sacroiliac joints, spine, and the entire body in patients with axial spondyloarthritis (axSpA). Methods. An investigator-initiated, randomized, placebo-controlled, double-blinded 48-week followup trial included 49 patients with axSpA, who had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4.0 despite treatment with nonsteroidal antiinflammatory drugs and a clinical indication for tumor necrosis factor inhibitor treatment. Patients were randomized to subcutaneous ADA 40 mg or placebo every other week for 6 weeks; thereafter, all patients received ADA. Conventional MRI and WBMRI were performed at weeks 0, 6, 24, and 48. The primary WBMRI endpoint was the proportion of patients with an improvement in WBMRI total inflammation index above the smallest detectable change (SDC) at Week 6. Results. The primary WBMRI endpoint (improvement of SDC > 2.3) was met in 11 (44%) patients in the ADA group and 3 (13%) patients in the placebo group (p = 0.025, Fisher’s exact test). The primary conventional MRI endpoint, the minimally important change in Spondyloarthritis Research Consortium of Canada Spine MRI Inflammation Index at Week 6, was achieved by 9 (36%) patients in the ADA group and 4 (17%) patients in the placebo group (p = 0.20). The primary clinical endpoint, BASDAI reduction > 50% or 2.0 at Week 24, was attained by 32 (65%) patients. Conclusion. ADA provided significant reductions in WBMRI indices of peripheral, axial, and whole-body inflammation in patients with axSpA. WBMRI is promising for objective assessment and monitoring of peripheral and axial disease activity in future clinical trials.

AB - Objective. To investigate whether adalimumab (ADA) reduces whole-body (WB-) magnetic resonance imaging (MRI) indices for inflammation in the entheses, peripheral joints, sacroiliac joints, spine, and the entire body in patients with axial spondyloarthritis (axSpA). Methods. An investigator-initiated, randomized, placebo-controlled, double-blinded 48-week followup trial included 49 patients with axSpA, who had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4.0 despite treatment with nonsteroidal antiinflammatory drugs and a clinical indication for tumor necrosis factor inhibitor treatment. Patients were randomized to subcutaneous ADA 40 mg or placebo every other week for 6 weeks; thereafter, all patients received ADA. Conventional MRI and WBMRI were performed at weeks 0, 6, 24, and 48. The primary WBMRI endpoint was the proportion of patients with an improvement in WBMRI total inflammation index above the smallest detectable change (SDC) at Week 6. Results. The primary WBMRI endpoint (improvement of SDC > 2.3) was met in 11 (44%) patients in the ADA group and 3 (13%) patients in the placebo group (p = 0.025, Fisher’s exact test). The primary conventional MRI endpoint, the minimally important change in Spondyloarthritis Research Consortium of Canada Spine MRI Inflammation Index at Week 6, was achieved by 9 (36%) patients in the ADA group and 4 (17%) patients in the placebo group (p = 0.20). The primary clinical endpoint, BASDAI reduction > 50% or 2.0 at Week 24, was attained by 32 (65%) patients. Conclusion. ADA provided significant reductions in WBMRI indices of peripheral, axial, and whole-body inflammation in patients with axSpA. WBMRI is promising for objective assessment and monitoring of peripheral and axial disease activity in future clinical trials.

KW - Inflammation

KW - Magnetic Resonance Imaging

KW - Outcome assessment

KW - Spondyloarthritis

KW - Whole-body Imaging

U2 - 10.3899/jrheum.170408

DO - 10.3899/jrheum.170408

M3 - Journal article

C2 - 29449506

AN - SCOPUS:85046374687

SN - 0315-162X

VL - 45

SP - 621

EP - 629

JO - Journal of Rheumatology

JF - Journal of Rheumatology

IS - 5

ER -

Whole-body magnetic resonance imaging in axial spondyloarthritis: Reduction of sacroiliac, spinal, and entheseal inflammation in a placebo-controlled trial of adalimumab

Abstract

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