Course of Magnetic Resonance Imaging-Detected Inflammation and Structural Lesions in the Sacroiliac Joints of Patients in the Randomized, Double-Blind, Placebo-Controlled Danish Multicenter Study of Adalimumab in Spondyloarthritis, as Assessed by the Berlin and Spondyloarthritis Research Consortium of Canada Methods.

Susanne J Pedersen; Denis Poddubnyy; Inge J Sørensen; Anne-Gitte Loft; Jens Hindrup; Gorm Thamsborg; Karsten Asmussen; Oliver Hendricks; Jesper Nørregaard; Anne-Dorthe Piil; Jakob M Møller; Anne-Grethe Jurik; Lone Balding; Robert G Lambert; Joachim Sieper; Mikkel Østergaard

doi:10.1002/art.39434

Course of Magnetic Resonance Imaging-Detected Inflammation and Structural Lesions in the Sacroiliac Joints of Patients in the Randomized, Double-Blind, Placebo-Controlled Danish Multicenter Study of Adalimumab in Spondyloarthritis, as Assessed by the Berlin and Spondyloarthritis Research Consortium of Canada Methods.

Susanne J Pedersen, Denis Poddubnyy, Inge J Sørensen, Anne-Gitte Loft, Jens Hindrup, Gorm Thamsborg, Karsten Asmussen, Oliver Hendricks, Jesper Nørregaard, Anne-Dorthe Piil, Jakob M Møller, Anne-Grethe Jurik, Lone Balding, Robert G Lambert, Joachim Sieper, Mikkel Østergaard

44 Citationer (Scopus)

Abstract

OBJECTIVES: To investigate changes in MRI inflammation and structural lesions in the sacroiliac joints (SIJ) during treatment with adalimumab (ADA) vs. placebo (PLA).

METHODS: In a 48-week double-blind placebo-controlled trial, 52 SpA patients were randomized to sc. ADA 40 mg (n=25) or PLA for 12 weeks, followed by ADA (n=27) eow. SIJ MRIs obtained at weeks 0, 12, 24 and 48 were assessed independently and blindly by use of the modified Berlin and Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ MRI Inflammation and Structural Scores.

RESULTS: No baseline inflammation was observed in 44% of the ADA-group and 26-30% of the PLA-group. In patients having baseline inflammation, larger mean percentage reductions in MRI inflammation from week 0 to 12 were seen in ADA-group than PLA-group (Berlin/SPARCC: -52%/-58% vs -5%/-12%, both p<0.05). Furthermore, SPARCC erosion score decreased (mean -0.6) and SPARCC backfill score increased (+0.8) in ADA-group. From week 12 to 24, larger absolute reductions in Berlin/SPARCC inflammation scores and SPARCC erosion score, and larger increases in Berlin/SPARCC fat scores were seen in PLA-group than ADA-group. In univariate regression analyses (ANCOVA) and multivariate stepwise regression analyses treatment with adalimumab was independently associated with regression of SPARCC erosion score from week 0 to 12, but not with changes in the other types of MRI lesions.

CONCLUSION: Significant changes in Berlin and SPARCC MRI inflammation scores and in SPARCC erosion score occurred within 12 weeks after initiation of adalimumab. TNFα-inhibitor treatment was associated with resolution of erosion and development of backfill. This article is protected by copyright. All rights reserved.

Originalsprog	Engelsk
Tidsskrift	Arthritis & rheumatology
Vol/bind	68
Udgave nummer	2
Sider (fra-til)	418-29
DOI	https://doi.org/10.1002/art.39434
Status	Udgivet - 2016

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10.1002/art.39434

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Citationsformater

Pedersen, S. J., Poddubnyy, D., Sørensen, I. J., Loft, A.-G., Hindrup, J., Thamsborg, G., Asmussen, K., Hendricks, O., Nørregaard, J., Piil, A.-D., Møller, J. M., Jurik, A.-G., Balding, L., Lambert, R. G., Sieper, J., & Østergaard, M. (2016). Course of Magnetic Resonance Imaging-Detected Inflammation and Structural Lesions in the Sacroiliac Joints of Patients in the Randomized, Double-Blind, Placebo-Controlled Danish Multicenter Study of Adalimumab in Spondyloarthritis, as Assessed by the Berlin and Spondyloarthritis Research Consortium of Canada Methods. Arthritis & rheumatology, 68(2), 418-29. https://doi.org/10.1002/art.39434

Course of Magnetic Resonance Imaging-Detected Inflammation and Structural Lesions in the Sacroiliac Joints of Patients in the Randomized, Double-Blind, Placebo-Controlled Danish Multicenter Study of Adalimumab in Spondyloarthritis, as Assessed by the Berlin and Spondyloarthritis Research Consortium of Canada Methods. / Pedersen, Susanne J; Poddubnyy, Denis; Sørensen, Inge J et al.
I: Arthritis & rheumatology, Bind 68, Nr. 2, 2016, s. 418-29.

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

Pedersen, SJ, Poddubnyy, D, Sørensen, IJ, Loft, A-G, Hindrup, J, Thamsborg, G, Asmussen, K, Hendricks, O, Nørregaard, J, Piil, A-D, Møller, JM, Jurik, A-G, Balding, L, Lambert, RG, Sieper, J & Østergaard, M 2016, 'Course of Magnetic Resonance Imaging-Detected Inflammation and Structural Lesions in the Sacroiliac Joints of Patients in the Randomized, Double-Blind, Placebo-Controlled Danish Multicenter Study of Adalimumab in Spondyloarthritis, as Assessed by the Berlin and Spondyloarthritis Research Consortium of Canada Methods.', Arthritis & rheumatology, bind 68, nr. 2, s. 418-29. https://doi.org/10.1002/art.39434

Pedersen SJ, Poddubnyy D, Sørensen IJ, Loft AG, Hindrup J, Thamsborg G et al. Course of Magnetic Resonance Imaging-Detected Inflammation and Structural Lesions in the Sacroiliac Joints of Patients in the Randomized, Double-Blind, Placebo-Controlled Danish Multicenter Study of Adalimumab in Spondyloarthritis, as Assessed by the Berlin and Spondyloarthritis Research Consortium of Canada Methods. Arthritis & rheumatology. 2016;68(2):418-29. doi: 10.1002/art.39434

Pedersen, Susanne J ; Poddubnyy, Denis ; Sørensen, Inge J et al. / Course of Magnetic Resonance Imaging-Detected Inflammation and Structural Lesions in the Sacroiliac Joints of Patients in the Randomized, Double-Blind, Placebo-Controlled Danish Multicenter Study of Adalimumab in Spondyloarthritis, as Assessed by the Berlin and Spondyloarthritis Research Consortium of Canada Methods. I: Arthritis & rheumatology. 2016 ; Bind 68, Nr. 2. s. 418-29.

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title = "Course of Magnetic Resonance Imaging-Detected Inflammation and Structural Lesions in the Sacroiliac Joints of Patients in the Randomized, Double-Blind, Placebo-Controlled Danish Multicenter Study of Adalimumab in Spondyloarthritis, as Assessed by the Berlin and Spondyloarthritis Research Consortium of Canada Methods.",

abstract = "OBJECTIVES: To investigate changes in MRI inflammation and structural lesions in the sacroiliac joints (SIJ) during treatment with adalimumab (ADA) vs. placebo (PLA).METHODS: In a 48-week double-blind placebo-controlled trial, 52 SpA patients were randomized to sc. ADA 40 mg (n=25) or PLA for 12 weeks, followed by ADA (n=27) eow. SIJ MRIs obtained at weeks 0, 12, 24 and 48 were assessed independently and blindly by use of the modified Berlin and Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ MRI Inflammation and Structural Scores.RESULTS: No baseline inflammation was observed in 44% of the ADA-group and 26-30% of the PLA-group. In patients having baseline inflammation, larger mean percentage reductions in MRI inflammation from week 0 to 12 were seen in ADA-group than PLA-group (Berlin/SPARCC: -52%/-58% vs -5%/-12%, both p<0.05). Furthermore, SPARCC erosion score decreased (mean -0.6) and SPARCC backfill score increased (+0.8) in ADA-group. From week 12 to 24, larger absolute reductions in Berlin/SPARCC inflammation scores and SPARCC erosion score, and larger increases in Berlin/SPARCC fat scores were seen in PLA-group than ADA-group. In univariate regression analyses (ANCOVA) and multivariate stepwise regression analyses treatment with adalimumab was independently associated with regression of SPARCC erosion score from week 0 to 12, but not with changes in the other types of MRI lesions.CONCLUSION: Significant changes in Berlin and SPARCC MRI inflammation scores and in SPARCC erosion score occurred within 12 weeks after initiation of adalimumab. TNFα-inhibitor treatment was associated with resolution of erosion and development of backfill. This article is protected by copyright. All rights reserved.",

author = "Pedersen, {Susanne J} and Denis Poddubnyy and S{\o}rensen, {Inge J} and Anne-Gitte Loft and Jens Hindrup and Gorm Thamsborg and Karsten Asmussen and Oliver Hendricks and Jesper N{\o}rregaard and Anne-Dorthe Piil and M{\o}ller, {Jakob M} and Anne-Grethe Jurik and Lone Balding and Lambert, {Robert G} and Joachim Sieper and Mikkel {\O}stergaard",

note = "COPECARE",

year = "2016",

doi = "10.1002/art.39434",

language = "English",

volume = "68",

pages = "418--29",

journal = "Arthritis & rheumatology",

issn = "2326-5205",

publisher = "John Wiley and Sons Ltd",

number = "2",

}

TY - JOUR

T1 - Course of Magnetic Resonance Imaging-Detected Inflammation and Structural Lesions in the Sacroiliac Joints of Patients in the Randomized, Double-Blind, Placebo-Controlled Danish Multicenter Study of Adalimumab in Spondyloarthritis, as Assessed by the Berlin and Spondyloarthritis Research Consortium of Canada Methods.

AU - Pedersen, Susanne J

AU - Poddubnyy, Denis

AU - Sørensen, Inge J

AU - Loft, Anne-Gitte

AU - Hindrup, Jens

AU - Thamsborg, Gorm

AU - Asmussen, Karsten

AU - Hendricks, Oliver

AU - Nørregaard, Jesper

AU - Piil, Anne-Dorthe

AU - Møller, Jakob M

AU - Jurik, Anne-Grethe

AU - Balding, Lone

AU - Lambert, Robert G

AU - Sieper, Joachim

AU - Østergaard, Mikkel

N1 - COPECARE

PY - 2016

Y1 - 2016

N2 - OBJECTIVES: To investigate changes in MRI inflammation and structural lesions in the sacroiliac joints (SIJ) during treatment with adalimumab (ADA) vs. placebo (PLA).METHODS: In a 48-week double-blind placebo-controlled trial, 52 SpA patients were randomized to sc. ADA 40 mg (n=25) or PLA for 12 weeks, followed by ADA (n=27) eow. SIJ MRIs obtained at weeks 0, 12, 24 and 48 were assessed independently and blindly by use of the modified Berlin and Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ MRI Inflammation and Structural Scores.RESULTS: No baseline inflammation was observed in 44% of the ADA-group and 26-30% of the PLA-group. In patients having baseline inflammation, larger mean percentage reductions in MRI inflammation from week 0 to 12 were seen in ADA-group than PLA-group (Berlin/SPARCC: -52%/-58% vs -5%/-12%, both p<0.05). Furthermore, SPARCC erosion score decreased (mean -0.6) and SPARCC backfill score increased (+0.8) in ADA-group. From week 12 to 24, larger absolute reductions in Berlin/SPARCC inflammation scores and SPARCC erosion score, and larger increases in Berlin/SPARCC fat scores were seen in PLA-group than ADA-group. In univariate regression analyses (ANCOVA) and multivariate stepwise regression analyses treatment with adalimumab was independently associated with regression of SPARCC erosion score from week 0 to 12, but not with changes in the other types of MRI lesions.CONCLUSION: Significant changes in Berlin and SPARCC MRI inflammation scores and in SPARCC erosion score occurred within 12 weeks after initiation of adalimumab. TNFα-inhibitor treatment was associated with resolution of erosion and development of backfill. This article is protected by copyright. All rights reserved.

AB - OBJECTIVES: To investigate changes in MRI inflammation and structural lesions in the sacroiliac joints (SIJ) during treatment with adalimumab (ADA) vs. placebo (PLA).METHODS: In a 48-week double-blind placebo-controlled trial, 52 SpA patients were randomized to sc. ADA 40 mg (n=25) or PLA for 12 weeks, followed by ADA (n=27) eow. SIJ MRIs obtained at weeks 0, 12, 24 and 48 were assessed independently and blindly by use of the modified Berlin and Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ MRI Inflammation and Structural Scores.RESULTS: No baseline inflammation was observed in 44% of the ADA-group and 26-30% of the PLA-group. In patients having baseline inflammation, larger mean percentage reductions in MRI inflammation from week 0 to 12 were seen in ADA-group than PLA-group (Berlin/SPARCC: -52%/-58% vs -5%/-12%, both p<0.05). Furthermore, SPARCC erosion score decreased (mean -0.6) and SPARCC backfill score increased (+0.8) in ADA-group. From week 12 to 24, larger absolute reductions in Berlin/SPARCC inflammation scores and SPARCC erosion score, and larger increases in Berlin/SPARCC fat scores were seen in PLA-group than ADA-group. In univariate regression analyses (ANCOVA) and multivariate stepwise regression analyses treatment with adalimumab was independently associated with regression of SPARCC erosion score from week 0 to 12, but not with changes in the other types of MRI lesions.CONCLUSION: Significant changes in Berlin and SPARCC MRI inflammation scores and in SPARCC erosion score occurred within 12 weeks after initiation of adalimumab. TNFα-inhibitor treatment was associated with resolution of erosion and development of backfill. This article is protected by copyright. All rights reserved.

U2 - 10.1002/art.39434

DO - 10.1002/art.39434

M3 - Journal article

C2 - 26414004

SN - 2326-5205

VL - 68

SP - 418

EP - 429

JO - Arthritis & rheumatology

JF - Arthritis & rheumatology

IS - 2

ER -