62 results on '"Sørensen IJ"'
Search Results
2. Comparing patient-reported outcomes entered at home versus at hospital, and testing touch screens for initial recruitment to scientific trials in arthritis patients
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Secher, AE, primary, Glintborg, B, additional, Gudbergsen, H, additional, Krogh, NS, additional, Sørensen, IJ, additional, Jensen, DV, additional, Christensen, R, additional, Skougaard, M, additional, Pedersen, PL, additional, and Hetland, ML, additional
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- 2018
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3. Structural progression rate decreases over time on serial radiography and magnetic resonance imaging of sacroiliac joints and spine in a five-year follow-up study of patients with ankylosing spondylitis treated with tumour necrosis factor inhibitor
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Pedersen, SJ, primary, Weber, U, additional, Said-Nahal, R, additional, Sørensen, IJ, additional, Loft, AG, additional, Kollerup, G, additional, Juul, L, additional, Frandsen, PB, additional, Thamsborg, G, additional, Madsen, OR, additional, Møller, J, additional, Balding, L, additional, Jurik, AG, additional, and Østergaard, M, additional
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- 2018
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4. Scoring magnetic resonance imaging (MRI) inflammation and structural lesions in sacroiliac joints of patients with axial spondyloarthritis: assessment of all MRI slices of the cartilaginous compartment versus standardized six or five slices.
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Krabbe, S, Kröber, G, Pedersen, SJ, Østergaard, M, Møller, JM, Sørensen, IJ, Jensen, B, Madsen, OR, Klarlund, M, Weber, U, Pedersen, S J, Møller, J M, Sørensen, I J, and Madsen, O R
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SACROILIAC joint ,MAGNETIC resonance imaging ,INFLAMMATION ,DRUG therapy for arthritis ,THERAPEUTIC use of monoclonal antibodies ,ANKYLOSIS ,SPONDYLOARTHROPATHIES ,METAPLASIA ,ARTHRITIS ,BONE marrow ,RESEARCH bias ,ARTICULAR cartilage ,EDEMA ,ADIPOSE tissues - Abstract
Objectives: The Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joint (SIJ) scoring system assesses six or five (6/5) semicoronal magnetic resonance imaging (MRI) slices for inflammation/structural lesions in patients with axial spondyloarthritis (axSpA). However, the cartilaginous SIJ compartment may be visible in a few additional slices. The objective was to investigate interreader reliability, sensitivity to change, and classification of MRI scans as positive or negative for various lesion types using an 'all slices' approach versus standard SPARCC scoring of 6/5 slices.Method: Fifty-three axSpA patients were treated with the tumour necrosis factor inhibitor golimumab and followed with serial MRI scans at weeks 0, 4, 16, and 52. The most anterior and posterior slices covering the cartilaginous compartment and the transitional slice were identified. Scores for inflammation, fat metaplasia, erosion, backfill, and ankylosis in the cartilaginous SIJ compartment were calculated for the 'all slices' approach and the 6/5 slices standard.Results: By the 'all slices' approach, three readers scored mean 7.2, 7.7, and 7.0 slices per MRI scan. Baseline and change scores for the various lesion types closely correlated between the two approaches (Pearson's rho ≥ 0.95). Inflammation score was median 13 (interquartile range 6-21, range 0-49) for 6/5 slices versus 14 (interquartile range 6-23, range 0-69) for all slices at baseline. Interreader reliability, sensitivity to change, and classification of MRI scans as positive or negative for various lesion types were similar.Conclusion: The standardized 6/5 slices approach showed no relevant differences from the 'all slices' approach and, therefore, is equally suited for monitoring purposes. [ABSTRACT FROM AUTHOR]
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- 2020
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5. Drug concentrations and anti-drug antibodies during treatment with biosimilar infliximab (CT-P13) in routine care
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Glintborg, B, primary, Kringelbach, T, additional, Bolstad, N, additional, Warren, DJ, additional, Eng, G, additional, Sørensen, IJ, additional, Loft, AG, additional, Hendricks, O, additional, Hansen, IMJ, additional, Linauskas, A, additional, Nordin, H, additional, Kristensen, S, additional, Lindegaard, H, additional, Jensen, DV, additional, Goll, GL, additional, Høgdall, E, additional, Gehin, J, additional, Enevold, C, additional, Nielsen, CH, additional, Krogh, NS, additional, Johansen, JS, additional, and Hetland, ML, additional
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- 2018
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6. Clinical outcomes from a nationwide non-medical switch from originator to biosimilar etanercept in patients with inflammatory arthritis after 5 months follow-up. results from the danbio registry
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Glintborg, B, Sørensen, IJ, Loft, AG, Esbesen, J, Lindegaard, H, Jensen, DV, Danebod, K, Dieperink, S, Hendricks, O, Hansen, IMJ, Linauskas, A, Kristensen, S, Andersen, LS, Hossein, M, Nordin, H, Andersen, BL, Chrysidis, S, Raun, JL, Manilo, N, Grydehøj, J, Dalgaard, EB, Pedersen, DD, Krogh, NS, Hetland, ML, Glintborg, B, Sørensen, IJ, Loft, AG, Esbesen, J, Lindegaard, H, Jensen, DV, Danebod, K, Dieperink, S, Hendricks, O, Hansen, IMJ, Linauskas, A, Kristensen, S, Andersen, LS, Hossein, M, Nordin, H, Andersen, BL, Chrysidis, S, Raun, JL, Manilo, N, Grydehøj, J, Dalgaard, EB, Pedersen, DD, Krogh, NS, and Hetland, ML
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- 2017
7. OP0287 Ultrasonography-detected peripheral enthesitis in patients with axial spondyloarthritis:anatomical distribution, morphology and response to anti-tnf therapy
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Seven, S, Pedersen, SJ, Østergaard, M, Sørensen, IJ, Døhn, UM, Krabbe, S, Terslev, L, Seven, S, Pedersen, SJ, Østergaard, M, Sørensen, IJ, Døhn, UM, Krabbe, S, and Terslev, L
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- 2017
8. THU0662 Comparing electronic collection of patient reported outcomes at home versus touch-screens in the waiting area among patients with arthritis in clinical practice:a randomised agreement study with online recruitment using danbio
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Secher, AE, Glintborg, B, Gudbergsen, H, Krogh, NS, Jensen, DV, Sørensen, IJ, Christensen, R, Skougaard, M, Hetland, ML, Secher, AE, Glintborg, B, Gudbergsen, H, Krogh, NS, Jensen, DV, Sørensen, IJ, Christensen, R, Skougaard, M, and Hetland, ML
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- 2017
9. FRI0674 Using higher image resolution of magnetic resonance imaging of the cervical spine identifies more inflammatory and structural lesions in patients with axial spondyloarthritis
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Krabbe, S, Østergaard, M, Møller, J, Sørensen, IJ, Jensen, B, Madsen, OR, Pedersen, SJ, Krabbe, S, Østergaard, M, Møller, J, Sørensen, IJ, Jensen, B, Madsen, OR, and Pedersen, SJ
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- 2017
10. FRI0674 Using higher image resolution of magnetic resonance imaging of the cervical spine identifies more inflammatory and structural lesions in patients with axial spondyloarthritis
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Krabbe, S, primary, Østergaard, M, additional, Møller, J, additional, Sørensen, IJ, additional, Jensen, B, additional, Madsen, OR, additional, and Pedersen, SJ, additional
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- 2017
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11. OP0287 Ultrasonography-detected peripheral enthesitis in patients with axial spondyloarthritis – anatomical distribution, morphology and response to anti-tnf therapy
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Seven, S, primary, Pedersen, SJ, additional, Østergaard, M, additional, Sørensen, IJ, additional, Døhn, UM, additional, Krabbe, S, additional, and Terslev, L, additional
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- 2017
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12. THU0662 Comparing electronic collection of patient reported outcomes at home versus touch-screens in the waiting area among patients with arthritis in clinical practice: a randomised agreement study with online recruitment using danbio
- Author
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Secher, AE, primary, Glintborg, B, additional, Gudbergsen, H, additional, Krogh, NS, additional, Jensen, DV, additional, Sørensen, IJ, additional, Christensen, R, additional, Skougaard, M, additional, and Hetland, ML, additional
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- 2017
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13. FRI0190 Clinical outcomes from a nationwide non-medical switch from originator to biosimilar etanercept in patients with inflammatory arthritis after 5 months follow-up. results from the danbio registry
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Glintborg, B, primary, Sørensen, IJ, additional, Loft, AG, additional, Esbesen, J, additional, Lindegaard, H, additional, Jensen, DV, additional, Danebod, K, additional, Dieperink, S, additional, Hendricks, O, additional, Hansen, IMJ, additional, Linauskas, A, additional, Kristensen, S, additional, Andersen, LS, additional, Hossein, M, additional, Nordin, H, additional, Andersen, BL, additional, Chrysidis, S, additional, Raun, JL, additional, Manilo, N, additional, Grydehøj, J, additional, Dalgaard, EB, additional, Pedersen, DD, additional, Krogh, NS, additional, and Hetland, ML, additional
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- 2017
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14. Comparing patient-reported outcomes entered at home versus at hospital, and testing touch screens for initial recruitment to scientific trials in arthritis patients.
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Secher, AE, Glintborg, B, Gudbergsen, H, Krogh, NS, Sørensen, IJ, Jensen, DV, Christensen, R, Skougaard, M, Pedersen, PL, Hetland, ML, Secher, A E, Krogh, N S, Sørensen, I J, Jensen, D V, Pedersen, P L, and Hetland, M L
- Subjects
TOUCH screens ,PATIENT selection ,INTRACLASS correlation ,ANKYLOSING spondylitis ,DATA entry - Abstract
Objectives: Touch screens for entering patient-reported outcomes (PROs) are available at all Danish departments of rheumatology reporting to the nationwide DANBIO registry. This project comprises two substudies in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (AxSpA), aiming to (A) investigate the feasibility of first line patient recruitment for research via touch screens, and (B) compare PROs collected at hospital versus at home, including patient preferences.Method: Substudy A: using a touch screen, patients answered whether we could contact them about a clinical research project (yes/no). Characteristics of patients who accepted/declined were explored using chi-squared and Mann-Whitney U-tests. Substudy B (randomized crossover agreement study): a random sample of patients from the accepting group in substudy A was contacted by telephone. According to prespecified power and sample size estimation, 56 patients were included. After randomization, 50% of patients entered PROs and information on comorbidities and lifestyle from home and then at hospital, and 50% first from hospital and then at home. Finally, they stated their preference for data entry (hospital/home/equally good). Differences in PROs entered from home and in the hospital were compared (limits of agreement, 95% confidence intervals, and intraclass correlation coefficients).Results: The touch-screen invitation was accepted by 428/952 patients (45%). Patients who accepted and those who declined had similar PROs and demographics. Substudy B was completed by 42 patients (22 RA, 20 AxSpA). They had no significant differences between PROs and lifestyle/comorbidity data entered from home and hospital, except for AxSpA patients on the Bath Ankylosing Spondylitis Functional Index and Bath Ankylosing Spondylitis Disease Activity Index item 5. The preferred method of data entry was hospital (10%), home (50%), and equally good (40%).Conclusion: Touch screens seem feasible for first line research recruitment. PROs collected from home were similar to the touch-screen solution. Patients preferred data entry from home. [ABSTRACT FROM AUTHOR]- Published
- 2019
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15. Structural progression rate decreases over time on serial radiography and magnetic resonance imaging of sacroiliac joints and spine in a five-year follow-up study of patients with ankylosing spondylitis treated with tumour necrosis factor inhibitor.
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Pedersen, SJ, Weber, U, Said-Nahal, R, Sørensen, IJ, Loft, AG, Kollerup, G, Juul, L, Frandsen, PB, Thamsborg, G, Madsen, OR, Møller, J, Balding, L, Jurik, AG, Østergaard, M, Pedersen, S J, Sørensen, I J, Loft, A G, Frandsen, P B, Madsen, O R, and Jurik, A G
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ANKYLOSING spondylitis ,SACROILIAC joint ,MAGNETIC resonance imaging ,SPONDYLITIS ,SPINE ,HLA-B27 antigen ,GOLIMUMAB - Abstract
Objective: To investigate temporal changes in structural progression assessed by serial conventional radiography and magnetic resonance imaging (MRI) of the sacroiliac joints (SIJs) and spine in patients with ankylosing spondylitis (AS) treated with tumour necrosis factor (TNF) inhibitor for 5 years.Method: Forty-two patients were included and 33 patients were followed for 5 years in a prospective investigator-initiated study. Conventional radiographs were required four times and MRI seven times. The modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS); Spondyloarthritis Research Consortium of Canada (SPARCC) MRI SIJ and Spine Inflammation, and SPARCC MRI SIJ Structural Score (SSS) for Fat, Erosion, Backfill, and Ankylosis; and the Canada-Denmark MRI scores for Spine Inflammation, Fat, Erosion, and New Bone Formation (NBF) were applied.Results: Compared with baseline, MRI Inflammation had decreased significantly at week 22 (spine)/week 46 (SIJ) and thereafter. MRI SIJ Fat (from week 22), SIJ Ankylosis, Spine NBF, and mSASSS had increased significantly at week 46 and thereafter. SIJ Erosion had decreased from year 2. The annual progression rate in mSASSS was significantly higher during weeks 0-46 compared to week 46 to year 3. In multivariate regression analyses, baseline SIJ Inflammation and Backfill were independent predictors of 5 year progression in SIJ Ankylosis. Spine Erosion predicted progression in Spine NBF. Longitudinally, Ankylosing Spondylitis Disease Activity Score, Bath Ankylosing Spondylitis Disease Activity Index, MRI Spine Inflammation, Fat, and Erosion scores were significantly associated with mSASSS. SIJ Inflammation, Fat, Erosion, and Backfill scores were longitudinally associated with SIJ Ankylosis. Structural progression was not associated with body mass index, smoking, or Assessment of SpondyloArthritis international Society Non-Steroidal Anti-Inflammatory Drug Index.Conclusion: In a 5 year follow-up study of patients with AS treated with TNF inhibitor, structural progression decreased over time. [ABSTRACT FROM AUTHOR]- Published
- 2019
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16. Identification of patient endotypes and adalimumab treatment responders in axial spondyloarthritis using blood-derived extracellular matrix biomarkers.
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Port H, Christiansen F, Nielsen SH, Frederiksen P, Bay-Jensen AC, Karsdal MA, Seven S, Sørensen IJ, Loft AG, Madsen OR, Ostergaard M, and Pedersen SJ
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- Humans, Adalimumab therapeutic use, Cross-Sectional Studies, Extracellular Matrix, Inflammation, Biomarkers, Spondylitis, Ankylosing, Axial Spondyloarthritis
- Abstract
Objective: To explore the potential of a panel of ECM remodelling markers as endotyping tools for axial spondyloarthritis (axSpA) by separating patients into subtypes and investigate how they differ among each other in disease activity scores and response to treatment with adalimumab., Methods: In three axSpA studies, a panel of 14 blood-based ECM biomarkers related to formation of collagen (PRO-C2, PRO-C3, PRO-C6), degradation of collagen by metalloproteinases (C1M, C2M, T2CM, C3M, C4M, C6M, C10C), matrix metalloproteinase (MMP)-degraded prolargin (PROM), MMP-degraded and citrullinated vimentin (VICM), basement membrane turnover (PRO-C4) and neutrophil activity (CPa9-HNE) were assessed to enable patient clustering (endotyping). MASH (n=41) was a cross-sectional study, while Adalimumab in Axial Spondyloarthritis study (ASIM,n=45) and Danish Multicenter Study of Adalimumab in Spondyloarthritis (DANISH, n=49) were randomised, double-blind placebo-controlled trials of adalimumab versus placebo every other week for 6 or 12 weeks, respectively, followed by active treatment. Biomarker data were log-transformed, standardised by mean centering and scaled by the SD prior to principal component analysis and K-means clustering., Results: Based on all three studies, we identified two orthogonal dimensions reflecting: (1) inflammation and neutrophil activity (driven by C1M and CPa9-HNE) and (2) collagen turnover (driven by PRO-C2). Three endotypes were identified: high inflammation endotype (Endotype1), low inflammation endotype (Endotype 2) and high collagen turnover endotype (Endotype3). Endotype1 showed higher disease activity (Ankylosing Spondylitis Disease Activity Score (ASDAS)) at baseline compared with Endotype2 and Endotype3 and higher percentage of patients responding to adalimumab based on ASDAS clinical improvement at week 24. Endotype3 showed higher percentage of patients with 50% improvement in Bath Ankylosing Spondylitis Disease Activity Index response at week 24 compared with Endotype2., Conclusion: These endotypes differ in their tissue remodelling profile and may in the future have utility for patient stratification and treatment tailoring., Competing Interests: Competing interests: MØ: research grants from AbbVie, BMS, Merck, Novartis and UCB, and speaker and/or consultancy fees from AbbVie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Galapagos, Gilead, Hospira, Janssen, MEDAC, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB. SJP: speaker’s bureau MSD, Pfizer, AbbVie, UCB, Novartis. Consulting fees and/or honoraria: AbbVie, UCB, Novartis. Grant/research support: AbbVie, MSD and Novartis. HP: none. Frederik Christiansen: Employed at Nordic Bioscience A/S. SHN: employed and shareholder of Nordic Bioscience A/S. PF: none. A-CB-J: employed and shareholder of Nordic Bioscience A/S. MK Shareholder of: employed and shareholder of Nordic Bioscience A/S. SS: None. IJS: none. AGL: speaking and/or consulting fees from AbbVie, Janssen, Lilly, MSD, Novartis, Pfizer, and UCB. Research grant from Novartis. ORM: none., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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17. Complement Proteins L-Ficolin and M-Ficolin Are Increased in Patients With Axial Spondyloarthritis and Decrease After Tumor Necrosis Factor Inhibitor Treatment.
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Mistegaard CE, Troldborg A, Hansen A, Thiel S, Jurik AG, Kiil RM, Christiansen AA, Schiøttz-Christensen B, Hendricks O, Pedersen SJ, Sørensen IJ, Østergaard M, and Loft AG
- Abstract
Objective: We have previously reported elevated levels of the complement lectin pathway proteins L-ficolin and H-ficolin in patients with axial spondyloarthritis (axSpA) compared with healthy controls. The aim of the present study was to investigate these biomarkers in a cross-sectional cohort of patients suffering from low back pain (LBP). Further, we aimed to investigate changes in lectin pathway protein levels after initiation of adalimumab (ADA; a tumor necrosis factor inhibitor) in a longitudinal cohort of patients with axSpA., Methods: Lectin pathway protein levels (mannan-binding lectin [MBL], collectin liver 1, H-ficolin, L-ficolin, M-ficolin, MBL-associated serine protease [MASP]-1, MASP-2, MASP-3, MBL-associated protein 19 [MAp19], and MAp44) in EDTA plasma were determined in 2 well-characterized cohorts: (1) a clinical cross-sectional cohort of patients with LBP, including patients with axSpA (n = 23), patients with unspecific LBP (uLBP) with ≥ 1 SpA features (n = 55), and patients with uLBP without SpA features or magnetic resonance imaging findings suggestive of axSpA (n = 64); and (2) a randomized double-blinded, placebo-controlled trial cohort of patients with axSpA (n = 49) initiating ADA therapy. Lectin pathway protein levels were determined using immunoassays., Results: Plasma levels of L-ficolin and M-ficolin were significantly increased in the cross-sectional cohort of newly diagnosed patients with axSpA compared with clinically relevant controls with uLBP (all P < 0.05). Both L-ficolin and M-ficolin decreased significantly after ADA therapy ( P < 0.05)., Conclusion: L-ficolin and M-ficolin levels are elevated in newly diagnosed patients with axSpA compared with clinically relevant controls. Both L-ficolin and M-ficolin levels decrease significantly after initiating ADA therapy. These findings provide new insights into the inflammatory processes in axSpA and support the involvement of complement in axSpA pathogenesis.
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- 2023
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18. Extracellular matrix turnover biomarkers reflect pharmacodynamic effects and treatment response of adalimumab in patients with axial spondyloarthritis-results from two randomized controlled trials.
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Port H, Holm Nielsen S, Frederiksen P, Madsen SF, Bay-Jensen AC, Sørensen IJ, Jensen B, Loft AG, Madsen OR, Østergaard M, and Pedersen SJ
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- Humans, Adalimumab therapeutic use, Tumor Necrosis Factor-alpha, Randomized Controlled Trials as Topic, Biomarkers, Complement C4, Extracellular Matrix, Tumor Necrosis Factor Inhibitors, C-Reactive Protein, Axial Spondyloarthritis
- Abstract
Objective: To investigate if extracellular matrix (ECM) blood-based biomarkers reflect the pharmacodynamic effect and response to TNF-α inhibitor therapy (adalimumab, ADA), in patients with axial spondyloarthritis (axSpA)., Methods: We investigated ECM biomarkers in two randomized, double-blind, placebo-controlled trials of axSpA patients (DANISH and ASIM, n = 52 and n = 49, respectively) receiving ADA 40 mg or placebo every other week for 12 and 6 weeks, respectively, and thereafter ADA to week 48. Serum concentrations of degraded type I (C1M), II (C2M, T2CM), III (C3M), IV (C4M), VI (C6M), type X (C10C) collagen; metabolite of C-reactive protein (CRPM), prolargin (PROM), citrullinated vimentin (VICM), calprotectin (CPa9-HNE); and formation of type II (PRO‑C2), III (PRO‑C3), and VI (PRO‑C6) turnover of type IV collagen (PRO-C4) were measured at baseline and weeks 6 or 12, 24, and 48. The pharmacodynamic effect and treatment response to ADA was evaluated by linear mixed models, and correlations between biomarkers and clinical scores were assessed by Spearman's correlation., Results: C1M, C3M, C4M, C6M, CRP, PRO-C4, and CPa9-HNE levels declined after 6 or 12 weeks in patients receiving ADA compared to placebo (all p < 0.05). Patients with AS Disease Activity Score C-reactive protein (ASDAS CRP) major improvement and/or clinically important improvement had significantly higher C1M, C3M, C4M, C6M, and PRO-C4 levels than patients with no/low improvement at baseline (all p < 0.05). Baseline levels of biomarkers showed weak to moderate correlations with ASDAS and structural damage scores., Conclusion: ECM metabolites showed a pharmacodynamic effect and were associated with ASDAS response during TNF-α inhibitor treatment in patients with axSpA., (© 2023. BioMed Central Ltd., part of Springer Nature.)
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- 2023
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19. Levels of extracellular matrix metabolites are associated with changes in Ankylosing Spondylitis Disease Activity Score and MRI inflammation scores in patients with axial spondyloarthritis during TNF inhibitor therapy.
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Holm Nielsen S, Sun S, Bay-Jensen AC, Karsdal M, Sørensen IJ, Weber U, Loft AG, Kollerup G, Thamsborg G, Madsen OR, Møller J, Østergaard M, and Pedersen SJ
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- Male, Humans, Adult, Middle Aged, Female, Tumor Necrosis Factor Inhibitors therapeutic use, Prospective Studies, Complement C3 therapeutic use, Inflammation, Magnetic Resonance Imaging, Extracellular Matrix metabolism, Collagen, Severity of Illness Index, Complement C4 therapeutic use, Spondylitis, Ankylosing diagnostic imaging, Spondylitis, Ankylosing drug therapy, Spondylarthritis diagnostic imaging, Spondylarthritis drug therapy, Spondylarthritis metabolism
- Abstract
Background/purpose: In axial spondyloarthritis (axSpA) inflammation of the sacroiliac joints and spine is associated with local extracellular matrix (ECM) remodeling of affected tissues. We aimed to investigate the association of ECM metabolites with treatment response in axSpA patients treated with TNF-α inhibitory therapy for 46 weeks., Methods: In a prospective clinical study of axSpA patients (n=55) initiating a TNF inhibitor (infliximab, etanercept, or adalimumab), serum concentrations of formation of type I (PRO-C1), type III (PRO-C3), and type VI (PRO-C6) collagen; turnover of type IV collagen (PRO-C4), and matrix-metalloproteinase (MMP)-degraded type III (C3M) collagen, MMP-degraded type IV (C4M), type VI (C6M), and type VII (C7M) collagen, and cathepsin-degraded type X collagen (C10C), MMP-mediated metabolite of C-reactive protein (CRPM), citrullinated vimentin (VICM), and neutrophil elastase-degraded elastin (EL-NE) were measured at baseline, week 2, week 22, and week 46., Results: Patients were mostly males (82%), HLA-B27 positive (84%), with a median age of 40 years (IQR: 32-48), disease duration of 5.5 years (IQR: 2-10), and a baseline Ankylosing Spondylitis Disease Activity Score (ASDAS) of 3.9 (IQR: 3.0-4.5). Compared to baseline, PRO-C1 levels were significantly increased after two weeks of treatment, C6M levels were significantly decreased after two and 22 weeks (repeated measures ANOVA, p=0.0014 and p=0.0015, respectively), EL-NE levels were significantly decreased after 2 weeks (p=0.0008), VICM levels were significantly decreased after two and 22 weeks (p=0.0163 and p=0.0374, respectively), and CRP were significantly decreased after two and 22 weeks (both p=0.0001). Baseline levels of PRO-C1, PRO-C3, C6M, VICM, and CRP were all associated with ASDAS clinically important and major improvement after 22 weeks (ΔASDAS ≥1.1) (Mann-Whitney test, p=0.006, p=0.008, p<0.001, <0.001, <0.001, respectively), while C6M, VICM and CRP levels were associated with ASDAS clinically important and major improvement after 46 weeks (ΔASDAS ≥2.0) (p=0.002, p=0.044, and p<0.001, respectively). PRO-C1 and C6M levels were associated with a Bath AS Disease Activity Score (BASDAI) response to TNF-inhibitory therapy after 22 weeks (Mann-Whitney test, p=0.020 and p=0.049, respectively). Baseline levels of PRO-C4 and C6M were correlated with the total SPARCC MRI Spine and Sacroiliac Joint Inflammation score (Spearman's Rho ρ=0.279, p=0.043 and ρ=0.496, p=0.0002, respectively)., Conclusions: Extracellular matrix metabolites were associated with ASDAS response, MRI inflammation, and clinical treatment response during TNF-inhibitory treatment in patients with axSpA., (© 2022. The Author(s).)
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- 2022
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20. Multiomics analysis of rheumatoid arthritis yields sequence variants that have large effects on risk of the seropositive subset.
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Saevarsdottir S, Stefansdottir L, Sulem P, Thorleifsson G, Ferkingstad E, Rutsdottir G, Glintborg B, Westerlind H, Grondal G, Loft IC, Sorensen SB, Lie BA, Brink M, Ärlestig L, Arnthorsson AO, Baecklund E, Banasik K, Bank S, Bjorkman LI, Ellingsen T, Erikstrup C, Frei O, Gjertsson I, Gudbjartsson DF, Gudjonsson SA, Halldorsson GH, Hendricks O, Hillert J, Hogdall E, Jacobsen S, Jensen DV, Jonsson H, Kastbom A, Kockum I, Kristensen S, Kristjansdottir H, Larsen MH, Linauskas A, Hauge EM, Loft AG, Ludviksson BR, Lund SH, Markusson T, Masson G, Melsted P, Moore KHS, Munk H, Nielsen KR, Norddahl GL, Oddsson A, Olafsdottir TA, Olason PI, Olsson T, Ostrowski SR, Hørslev-Petersen K, Rognvaldsson S, Sanner H, Silberberg GN, Stefansson H, Sørensen E, Sørensen IJ, Turesson C, Bergman T, Alfredsson L, Kvien TK, Brunak S, Steinsson K, Andersen V, Andreassen OA, Rantapää-Dahlqvist S, Hetland ML, Klareskog L, Askling J, Padyukov L, Pedersen OB, Thorsteinsdottir U, Jonsdottir I, and Stefansson K
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- Genetic Predisposition to Disease genetics, Humans, Interferon-alpha, Janus Kinases genetics, Protein Tyrosine Phosphatase, Non-Receptor Type 22 genetics, Proteomics, STAT Transcription Factors genetics, Signal Transduction genetics, Arthritis, Rheumatoid genetics, Genome-Wide Association Study
- Abstract
Objectives: To find causal genes for rheumatoid arthritis (RA) and its seropositive (RF and/or ACPA positive) and seronegative subsets., Methods: We performed a genome-wide association study (GWAS) of 31 313 RA cases (68% seropositive) and ~1 million controls from Northwestern Europe. We searched for causal genes outside the HLA-locus through effect on coding, mRNA expression in several tissues and/or levels of plasma proteins (SomaScan) and did network analysis (Qiagen)., Results: We found 25 sequence variants for RA overall, 33 for seropositive and 2 for seronegative RA, altogether 37 sequence variants at 34 non-HLA loci, of which 15 are novel. Genomic, transcriptomic and proteomic analysis of these yielded 25 causal genes in seropositive RA and additional two overall. Most encode proteins in the network of interferon-alpha/beta and IL-12/23 that signal through the JAK/STAT-pathway. Highlighting those with largest effect on seropositive RA, a rare missense variant in STAT4 (rs140675301-A) that is independent of reported non-coding STAT4 -variants, increases the risk of seropositive RA 2.27-fold (p=2.1×10
-9 ), more than the rs2476601-A missense variant in PTPN22 (OR=1.59, p=1.3×10-160 ). STAT4 rs140675301-A replaces hydrophilic glutamic acid with hydrophobic valine (Glu128Val) in a conserved, surface-exposed loop. A stop-mutation (rs76428106-C) in FLT3 increases seropositive RA risk (OR=1.35, p=6.6×10-11 ). Independent missense variants in TYK2 (rs34536443-C, rs12720356-C, rs35018800-A, latter two novel) associate with decreased risk of seropositive RA (ORs=0.63-0.87, p=10-9 -10-27 ) and decreased plasma levels of interferon-alpha/beta receptor 1 that signals through TYK2/JAK1/STAT4., Conclusion: Sequence variants pointing to causal genes in the JAK/STAT pathway have largest effect on seropositive RA, while associations with seronegative RA remain scarce., Competing Interests: Competing interests: Authors affiliated with deCODE Genetics/Amgen declare competing financial interests as employees. OAA is a consultant to HealthLytix. The following coauthors report the following but unrelated to the current report: Karolinska Institutet, with JA as principal investigator, has entered into agreements with the following entities, mainly but not exclusively for safety monitoring of rheumatology immunomodulators: Abbvie, BMS, Eli Lilly, Janssen, MSD, Pfizer, Roche, Samsung Bioepis and Sanofi, unrelated to the present study. SB has ownerships in Intomics A/S, Hoba Therapeutics Aps, Novo Nordisk A/S, Lundbeck A/S and managing board memberships in Proscion A/S and Intomics A/S. BG has received research grants from AbbVie, Bristol Myers-Squibb and Pfizer; OH has received research grants from AbbVie, Novartis and Pfizer, DVJ has received speaker and consultation fees from AbbVie, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, AGL has received speaking and/or consulting fees from AbbVie, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB; and CT has received consulting fees from Roche, speaker fees from Abbvie, Bristol Myers-Squibb, Nordic Drugs, Pfizer and Roche, and an unrestricted grant from Bristol Myers-Squibb., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)- Published
- 2022
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21. Extracellular matrix protein turnover markers are associated with axial spondyloarthritis-a comparison with postpartum women and other non-axial spondyloarthritis controls with or without back pain.
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Port H, Nielsen SH, Madsen SF, Bay-Jensen AC, Karsdal M, Seven S, Sørensen IJ, Morsel-Carlsen L, Østergaard M, and Pedersen SJ
- Subjects
- Back Pain, Biomarkers, Collagen metabolism, Complement C3, Complement C4, Cross-Sectional Studies, Female, Humans, Inflammation, Male, Pelvic Pain, Postpartum Period, Axial Spondyloarthritis, Extracellular Matrix Proteins
- Abstract
Background: Axial spondyloarthritis (axSpA) is a common chronic inflammatory disease, associated with extracellular matrix (ECM) remodeling of the cartilage, bone, and connective tissues. The primary symptom of axSpA is back pain, caused by inflammation. However, there is a medical need to truly identify patients with axSpA from other subjects with buttock or low back pain attributable to other reasons. We aimed to investigate circulating biomarkers of ECM/inflammation (MMP-degraded type I (C1M), II (C2M, T2CM), III (C3M), IV (C4M), VI (C6M), and X (C10C, COL10NC) collagens, CRPM, PROM and VICM) and ECM formation of type II (PRO-C2), III (PRO-C3), IV (PRO-C4), and VI (PRO-C6) collagens as potential biomarkers to identify patients with axSpA., Methods: We measured biomarkers from a cross-sectional study with 204 participants by enzyme-linked immunosorbent assay (ELISA). The study included axSpA patients (N = 41), women with postpartum buttock/pelvic pain (N = 46), disc herniation (N = 25), and a group of healthy subjects (including women without postpartum pelvic pain (N = 14), subjects with various types of physical strain (cleaning staff (N = 26) long-distance runners (N = 23)), and healthy men (N = 29)). Differences between the groups were calculated by ANCOVA and AUC, while Spearman's correlations were performed with ECM biomarkers and clinical scores., Results: Patients with axSpA expressed significantly higher levels of C1M, C4M, and VICM (p < 0.05-p < 0.0001) compared to all the non-axSpA control groups. Further, C6M and PRO-C4 were significantly higher in patients with axSpA (both p < 0.0001) compared to women with postpartum pelvic pain and healthy subjects, whereas PRO-C3 was significantly lower compared to healthy subjects (p = 0.01). The best ECM common biomarker to differentiate between axSpA and the non-axSpA control groups was PRO-C4 (AUC ≥ 0.75; specificity ≥ 0.79, sensitivity = 0.65). Mild correlations were observed between collagen turnover and inflammation biomarkers and CRP and MRI (ρ ≥ 0.3; p < 0.05-p < 0.001)., Conclusions: Biomarkers of type I, IV, and VI collagen and biomarkers of inflammation showed an altered turnover in patients with axSpA compared with the non-axSpA control groups. Such biomarkers may be useful in combination with MRI or independently to separate patients with axSpA from other back pain conditions., (© 2022. The Author(s).)
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- 2022
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22. Tapering of TNF inhibitors in axial spondyloarthritis in routine care - 2-year clinical and MRI outcomes and predictors of successful tapering.
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Wetterslev M, Georgiadis S, Sørensen IJ, Pedersen SJ, Christiansen SN, Hetland ML, Brahe CH, Bakkegaard M, Duer A, Boesen M, Gosvig KK, Møller JM, Krogh NS, Jensen B, Madsen OR, Christensen J, Hansen A, Nørregaard J, Røgind H, and Østergaard M
- Subjects
- Follow-Up Studies, Humans, Magnetic Resonance Imaging methods, Treatment Outcome, Tumor Necrosis Factor Inhibitors therapeutic use, Antirheumatic Agents therapeutic use, Axial Spondyloarthritis, Spondylarthritis diagnostic imaging, Spondylarthritis drug therapy
- Abstract
Objectives: In a 2-year follow-up study of patients with axial spondyloarthritis (axSpA) in clinical remission who tapered TNF inhibitor (TNFi) treatment according to a clinical guideline, we aimed to investigate the proportion who successfully tapered/discontinued therapy and baseline predictors thereof. The proportion regaining clinical remission after flare and the progression on MRI/radiography were also assessed., Methods: One-hundred-and-nine patients (78 [72%]/31 [28%] receiving standard and reduced dose, respectively) in clinical remission (BASDAI < 40, physician global score < 40) and no signs of disease activity the previous year tapered TNFi as follows: to two-thirds of standard dose at baseline, half at week 16, one-third at week 32 and discontinuation at week 48. Patients experiencing clinical, BASDAI or MRI flare (predefined criteria) stopped tapering and escalated to previous dose. Prediction analyses were performed by multivariable regression., Results: One hundred and six patients (97%) completed 2 years' follow-up; 55 patients (52%) had successfully tapered: 23 (22%) receiving two-thirds, 15 (14%) half, 16 (15%) one-third dose and 1 (1%) discontinued. In patients at standard dose at baseline (n = 78), lower physician global score was the only independent predictor of successful tapering (odds ratio [OR] = 0.79 [95% CI: 0.64, 0.93]; P = 0.003). In the entire patient group lower physician global score (OR = 0.86 [0.75, 0.98]; P = 0.017), lower Spondyloarthritis Research Consortium of Canada (SPARCC) Sacroiliac Joint Erosion score (OR = 0.78 [0.57, 0.98]; P = 0.029) and current smoker (OR = 3.28 [1.15, 10.57]; P = 0.026) were independent predictors of successful tapering. At 2 years, 97% of patients were in clinical remission. Minimal changes in imaging findings were observed., Conclusion: After 2 years following a clinical guideline, 52% of patients with axSpA in clinical remission had successfully tapered TNFi, only 1% discontinued. Baseline physician global score was an independent predictor of successful tapering., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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23. Ultrasound of the Heel Improves Diagnosis-Tender Entheses in the Heel Region Rarely Corresponds to Inflammatory Enthesitis in Patients with Peripheral Spondyloarthritis.
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Felbo SK, Østergaard M, Sørensen IJ, and Terslev L
- Abstract
Enthesitis is a key pathology in spondyloarthritis (SpA), but diagnosis may be clinically challenging. The objective of this study was to investigate the prevalence of ultrasound enthesitis lesions in tender entheses in the heel region in patients with peripheral SpA. In 27 patients with tenderness upon palpation at the Achilles tendon or the plantar fascia insertion, ultrasound assessment of the affected enthesis was performed using greyscale and color Doppler mode. Images were evaluated using the Outcome Measures in Rheumatology (OMERACT) scoring system for enthesitis, scoring presence/absence of hypoechogenicity, thickening, calcifications/enthesophytes, and erosions, and color Doppler activity semi quantitatively from 0 to 3. A total enthesitis sum score was calculated. A second examiner scanned 10 patients for inter-reader reliability. Ultrasound signs of inflammatory enthesitis (thickening/hypoechogenicity and/or Doppler activity) were found in 48%, and 19% showed Doppler activity-all in the Achilles enthesis. Inflammatory pathologies other than enthesitis (e.g., tendinitis, arthritis, bursitis) were identified in 26% of tender heels. The ultrasound OMERACT scoring system for enthesitis lesions showed excellent intra- and inter-reader agreement in a clinical setting. In conclusion, less than 50% of clinically tender entheses are related to inflammatory enthesitis when assessed by ultrasound. Ultrasound is useful for diagnosing other pathologies that may explain tenderness in the area.
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- 2022
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24. Morphological characteristics of sacroiliac joint MRI lesions in axial spondyloarthritis and control subjects.
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Seven S, Østergaard M, Morsel-Carlsen L, Sørensen IJ, Bonde B, Thamsborg G, Lykkegaard JJ, and Pedersen SJ
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- Adult, Cross-Sectional Studies, Female, Humans, Male, Prospective Studies, Young Adult, Axial Spondyloarthritis diagnostic imaging, Axial Spondyloarthritis pathology, Magnetic Resonance Imaging, Sacroiliac Joint diagnostic imaging, Sacroiliac Joint pathology
- Abstract
Objectives: To investigate SI joint MRI inflammation, structural and degenerative lesion characteristics in patients with axial spondyloarthritis (axSpA) and various control groups., Methods: Patients with axSpA (n = 41) and lumbar disc herniation (n = 25), women with (n = 46) and without (n = 14) post-partum (childbirth within 4-16 months) buttock/pelvic pain, cleaning assistants (n = 26), long-distance runners (n = 23) and healthy men (n = 29) had MRI of the SI joints prospectively performed. MRI lesions were assessed on nine slices covering the cartilaginous compartment by two experienced readers according to the definitions of the Spondyloarthritis Research Consortium of Canada SI joint inflammation and structural scores, and were evaluated according to depth and extent. Other morphological characteristics were also analysed., Results: Total depth scores for bone marrow oedema (BME) and fat lesion (FAT) and total extent score for erosion were statistically significantly highest in axSpA, while scores for sclerosis were numerically highest in women with post-partum pain. Maximum BME depth >10 mm was frequently and exclusively found in axSpA and post-partum women (39% vs 14-17%) while FAT depth >5 mm was predominantly found in axSpA (76% vs 0-10%). Erosions were primarily seen in axSpA, especially when extensive (≥4 or confluent; 17% vs 0%). Capsulitis was absent in non-axSpA groups. BME and FAT in the ligamentous compartment were primarily found in axSpA (17/22% vs 0/2% in non-axSpA groups). In non-axSpA, osteophytes (axSpA vs non-axSpA: 0% vs 3-17%) and vacuum phenomenon (7% vs 30-66%) were more frequent, and the joint space was wider [mean (s.d.) 1.5 (0.9) vs 2.2 (0.5) mm]., Conclusions: FAT depth >5 mm, but not BME depth >10 mm, could almost differentiate axSpA patients from all other groups. When excluding post-partum women, BME >5 mm and erosion were highly specific for axSpA., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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25. Do tender joints in active psoriatic arthritis reflect inflammation assessed by ultrasound and magnetic resonance imaging?
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Felbo SK, Wiell C, Østergaard M, Poggenborg RP, Bøyesen P, Hammer HB, Boonen A, Pedersen SJ, Sørensen IJ, Madsen OR, Slot O, Møller JM, Szkudlarek M, and Terslev L
- Subjects
- Adult, Arthralgia pathology, Arthritis, Psoriatic pathology, Cross-Sectional Studies, Female, Humans, Joints pathology, Magnetic Resonance Imaging, Male, Middle Aged, Pain Measurement, Patient Acuity, Ultrasonography, Arthralgia diagnostic imaging, Arthritis, Psoriatic diagnostic imaging, Joints diagnostic imaging
- Abstract
Objective: To investigate the association between clinical joint tenderness and intra- and periarticular inflammation as assessed by ultrasound and MRI in patients with active PsA and to explore if the associations differ according to patient-reported outcomes (PROs) and structural damage., Methods: Forty-one patients with active PsA and hand involvement had 76/78 joints examined for swelling/tenderness and ultrasound and MRI of 24 and 12 finger joints, respectively. Synovitis, tenosynovitis, periarticular inflammation and erosions were assessed using OMERACT definitions and scoring systems. Correlation between imaging inflammation sum-scores (intra-and periarticular) and tender/swollen joint counts were calculated using Spearman's rho, agreement at joint level was examined using prevalence and bias adjusted kappa (PABAK). Subgroup analyses explored the influence of PROs and radiographic erosive disease on these associations., Results: No significant correlations were found between tender or swollen joint counts and imaging inflammation sum-scores (rho = -0.31-0.38). In patients with higher level of overall pain, disability and lower self-reported mental health, a tendency towards negative correlations were found. At joint level, intra- and periarticular imaging inflammatory lesions had slight agreement with joint tenderness (PABAK = 0.02-0.19) and slight to moderate with swelling (PABAK = 0.16-0.54). For tender joints, agreement with imaging inflammation was even weaker in patients with either high overall pain scores, high disability scores, and/or non-erosive disease., Conclusion: Joint tenderness had low association with imaging signs of inflammation in PsA patients, particularly in patients with high self-reported pain, disability and low mental health, indicating that tenderness is influenced by other parameters than local inflammation., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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26. Development and Validation of 3 Preliminary MRI Sacroiliac Joint Composite Structural Damage Scores in a 5-year Longitudinal Axial Spondyloarthritis Study.
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Wetterslev M, Østergaard M, Sørensen IJ, Weber U, Loft AG, Kollerup G, Juul L, Thamsborg G, Madsen OR, Møller JM, and Pedersen SJ
- Subjects
- Humans, Magnetic Resonance Imaging, Sacroiliac Joint diagnostic imaging, Sacroiliitis, Spondylarthritis diagnostic imaging, Spondylitis, Ankylosing
- Abstract
Objective: In axial spondyloarthritis (axSpA), sacroiliac joint (SIJ) erosion is often followed by fat metaplasia in an erosion cavity (backfill), and subsequently ankylosis. We aimed to combine the Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ structural score for erosion, backfill, and ankylosis into 3 versions of a novel preliminary axSpA magnetic resonance imaging (MRI) SIJ Composite Structural Damage Score (CSDS) and to test these., Methods: Thirty-three patients with axSpA, followed for 5 years after initiation of tumor necrosis factor inhibitor, had MRIs of the SIJs at baseline, and yearly thereafter. Three versions of CSDS were calculated based on different weightings of erosion, backfill, and ankylosis: (1) equal weighting: CSDS
equal = (erosion × 0.5) + backfill + ankylosis; (2) advanced stages weighting more: CSDSstepwise = (erosion × 1) + (backfill × 4) + (ankylosis × 6); and (3) advanced stages overruling earlier stages ("hierarchical") with "<" meaning "overruled by": CSDShierarchical = (erosion × 1) < (backfill × 4) < (ankylosis × 6)., Results: At baseline, all CSDS correlated positively with SPARCC fat and ankylosis scores and modified New York radiography grading, and negatively with the Bath Ankylosing Spondylitis Disease Index and SPARCC SIJ inflammation scores. CSDSstepwise and CSDShierarchical (not CSDSequal ) correlated positively with symptom duration and the Bath Ankylosing Spondylitis Metrology Index, and closer with SPARCC ankylosis score and modified New York radiography grading than CSDSequal . The adjusted annual progression rate for CSDSstepwise and CSDShierarchical (not CSDSequal ) was higher the first year compared with fourth year ( P = 0.04 and P = 0.01). Standardized response mean (baseline to Week 46) was moderate for CSDShierarchical (0.64) and CSDSstepwise (0.59) and small for CSDSequal (0.25)., Conclusion: Particularly CSDSstepwise and CSDShierarchical showed construct validity and responsiveness, encouraging further validation in larger clinical trials. The potential clinical implication is assessment of SIJ damage progression by 1 composite score., (Copyright © 2021 by the Journal of Rheumatology.)- Published
- 2021
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27. Musculoskeletal Pain in Patients with Psoriasis and its Influence on Health-related Quality of Life: Results from a Danish Population-based Survey.
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Felbo SK, Terslev L, Sørensen IJ, Skov L, Zachariae C, and Østergaard M
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- Denmark epidemiology, Humans, Quality of Life, Severity of Illness Index, Surveys and Questionnaires, Arthritis, Psoriatic diagnosis, Arthritis, Psoriatic epidemiology, Musculoskeletal Pain diagnosis, Musculoskeletal Pain epidemiology, Psoriasis diagnosis, Psoriasis epidemiology
- Abstract
This study used a nationwide e-based survey of patients with psoriasis to assess the pattern of musculoskeletal pain and its influence on patient-reported outcomes, including health-related quality of life and disability. A total of 561 respondents (56% of the screened psoriasis patients) reported physician-diagnosed psoriasis and completed the questionnaire. Respondents were grouped based on the presence of musculoskeletal pain and/or diagnosed psoriatic arthritis: 81% had psoriasis without arthritis (29% pain now, 23% pain previously, 39% no pain ever), and 19% had psoriatic arthritis. Patients with psoriasis with pain now had poorer quality of life compared with patients without pain and, importantly, similar to that of patients with arthritis. Furthermore, patients with pain now/previously reported higher self-assessed severity of psoriasis and lower satisfaction with current treatment than patients without pain. Two-thirds of patients with psoriasis with pain now/previously and one-third of patients with arthritis had never been examined by a rheumatologist, demonstrating an unmet need for adequate evaluation of such patients. A nationwide e-based survey of patients with psoriasis was preformed to assess the pattern of musculoskeletal pain and its influence on patient-reported outcomes, including health-related quality of life and disability. A total of 561 respondents (56% of the screened psoriasis patients) reported physician- diagnosed psoriasis and completed the questionnaire. Respondents were grouped based on the presence of musculoskeletal pain and/or diagnosed psoriatic arthritis: 81% had psoriasis without arthritis (29% pain now, 23% pain previously, 39% no pain ever), and 19% had psoriatic arthritis. Patients with psoriasis with pain now had poorer quality of life compared with patients without pain and, importantly, similar to that of patients with arthritis. Furthermore, patients with pain now/previously reported higher self-assessed severity of psoriasis and lower satisfaction with current treatment than patients without pain. Two-thirds of patients with psoriasis with pain now/previously and one-third of patients with arthritis had never been examined by a rheumatologist, demonstrating an unmet need for adequate evaluation of such patients.
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- 2021
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28. Anatomic Distribution of Sacroiliac Joint Lesions on Magnetic Resonance Imaging in Patients With Axial Spondyloarthritis and Control Subjects: A Prospective Cross-Sectional Study, Including Postpartum Women, Patients With Disc Herniation, Cleaning Staff, Runners, and Healthy Individuals.
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Seven S, Østergaard M, Morsel-Carlsen L, Sørensen IJ, Bonde B, Thamsborg G, Lykkegaard JJ, and Pedersen SJ
- Subjects
- Adult, Bone Marrow Diseases diagnostic imaging, Case-Control Studies, Cross-Sectional Studies, Diagnosis, Differential, Edema diagnostic imaging, Female, Housekeeping, Hospital, Humans, Job Description, Male, Marathon Running, Middle Aged, Physical Endurance, Postpartum Period, Predictive Value of Tests, Prospective Studies, Young Adult, Intervertebral Disc Displacement diagnostic imaging, Magnetic Resonance Imaging, Sacroiliac Joint diagnostic imaging, Sacroiliitis diagnostic imaging, Spondylarthritis diagnostic imaging
- Abstract
Objective: To investigate the anatomic location and distribution of lesions on magnetic resonance imaging (MRI) in the sacroiliac (SI) joints in patients with axial spondyloarthritis (SpA), women with and without postpartum pain (childbirth within 4-16 months), patients with disc herniation, cleaning staff, runners, and healthy persons., Methods: In a prospective cross-sectional study of 204 participants, MRI of the entire cartilaginous compartment of the SI joint was scored blindly by 2 independent, experienced readers, according to Spondyloarthritis Research Consortium of Canada definitions of SI joint inflammation and structural lesions in each SI joint quadrant or half and in each of 9 slices. The locations of the lesions (unilateral/bilateral, upper/lower, sacral/iliac, and anterior/central/posterior slices) were analyzed based on concordant reads., Results: Bone marrow edema (BME) occurred in all quadrants in nearly all participant groups, but rarely bilaterally, except in patients with axial SpA and women with postpartum pain. Fat lesions were mainly found in axial SpA and occurred in all quadrants, but mostly bilaterally in sacral quadrants. Erosion was rare, except in axial SpA, where it was mainly iliac and often bilateral. Sclerosis was exclusively iliac and most frequent in women with postpartum pain., Conclusion: The location and distribution of common SI joint lesions in axial SpA and non-axial SpA were reported, and group-specific patterns were revealed. BME distributed bilaterally or unilaterally, both locally and more widespread in the SI joint, is common in both postpartum women with pain and axial SpA patients, which limits the use of BME to differentiate these groups. This study indicates that the presence of fat lesions, especially when widespread, and/or erosion, particularly when located centrally or posteriorly, are diagnostically important and should be investigated further., (© 2020, American College of Rheumatology.)
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- 2021
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29. Which ultrasound lesions contribute to dactylitis in psoriatic arthritis and their reliability in a clinical setting.
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Felbo SK, Østergaard M, Sørensen IJ, and Terslev L
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- Humans, Reproducibility of Results, Tendons diagnostic imaging, Ultrasonography, Arthritis, Psoriatic complications, Arthritis, Psoriatic diagnostic imaging, Tenosynovitis diagnostic imaging
- Abstract
Objectives: To explore the frequency of ultrasound elementary lesions in dactylitis in psoriatic arthritis (PsA), and the reliability of scoring these lesions in a clinical setting., Methods: In 31 patients with PsA and clinical dactylitis, ultrasound assessment of the affected finger or toe was performed using greyscale and color Doppler mode. One examiner scanned all patients and a second examiner scanned 10 patients for inter-reader reliability. For each digit, the following lesions were evaluated: subcutaneous edema; soft tissue thickening; synovitis of the digital joints; tenosynovitis of the flexor tendon; enthesitis at the deep flexor tendon and the extensor tendon entheses; and paratenonitis of the extensor tendon. A dactylitis sum-score was calculated. Findings in clinically tender and non-tender digits were compared., Results: The most frequent lesions were soft tissue thickening (81%) and subcutaneous edema (74%) followed by synovitis (56-68%) and flexor tenosynovitis (52%). Color Doppler was most frequently found subcutaneously (55%) and around the flexor tendons (45%). All lesions were typically found in combinations, most commonly subcutaneous edema and synovitis (71%), subcutaneous edema and flexor tenosynovitis (52%), and all three in combination (52%). Tender digits had a higher dactylitis sum-score and numerically higher prevalence of most lesions than non-tender digits. Intra- and inter-reader agreements were moderate to excellent, though lower for few components of digital enthesitis, especially hypoechogenicity., Conclusion: Dactylitis in PsA appears to encompass several lesions, most often subcutaneous changes combined with synovitis and/or flexor tenosynovitis. Reliability of scoring established ultrasound lesions of dactylitis in a clinical setting is moderate-excellent. Key Points • Dactylitis in psoriatic arthritis consists of multiple ultrasound lesions • A dactylitis ultrasound sum-score gives an impression of severity by including all lesions • Reliability of ultrasound scoring of dactylitis components is good.
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- 2021
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30. Repeatability and reproducibility of MRI apparent diffusion coefficient applied on four different regions of interest for patients with axial spondyloarthritis and healthy volunteers scanned twice within a week.
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Møller JM, Østergaard M, Thomsen HS, Hangaard S, Sørensen IJ, Madsen OR, and Pedersen SJ
- Abstract
Objectives: The apparent diffusion coefficient (ADC) may be used as a biomarker for diagnosis and/or monitoring treatment response in patients with axial spondyloarthritis (axSpA), but this requires reliable ADC measurements. This study assessed test-retest repeatability and reproducibility of ADC measurements using four different region of interest (ROI) settings., Methods: In this prospective study, the sacroiliac joints (SIJs) of 25 patients with axSpA and 24 age- and sex-matched healthy volunteers were imaged twice at a mean interval of 6.8 days in a 1.5 T scanner using, multishot echoplanar diffusion-weighted sequences. ADCs at four ROI settings were assessed: 5 mm and 10 mm anatomic band-shaped, 15 mm linear, and 40 mm
2 circular., Results: Intraclass correlation coefficient (ICC) assessments showed that the interstudy repeatability was good for median ADC (ADCmed ) and 95th-percentile ADC (ADC95 ) measurements in patients with axSpA (0.77-0.83 and 0.75-0.83, respectively), but poor-to-moderate in healthy subjects (0.27-0.55 and 0.13-0.37, respectively). For all ROI settings, intrareader reproducibility was excellent for ADCmed -measurements (ICC:0.85-0.99) and moderate-to-excellent for ADC95 measurements (ICC:0.68-0.96). The 5 mm ROI had the least estimated bias and highest level of agreement on Bland-Altman plots. The interreader reproducibility was moderate (ICC:0.71). The 15 mm linear ROI produced significantly greater ADCmed and ADC95 measurements than all other ROI settings ( p < 0.01-0.02), except for the circular ROI ADC95 measurements., Conclusion: ROI settings influence ADC measurements. Interstudy repeatability of SIJ ADC measurements is independent of ROI settings. However, the 5 mm ROI showed the least bias and random error and seems preferable., Advances in Knowledge: ADC measurements are affected by ROI settings, and this should be taken into account when assessing ADC maps., (© 2020 The Authors. Published by the British Institute of Radiology.)- Published
- 2020
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31. Validation of assessment methods for the apparent diffusion coefficient in a clinical trial of axial spondyloarthritis patients treated with golimumab.
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Møller JM, Østergaard M, Thomsen HS, Krabbe S, Sørensen IJ, Jensen B, Madsen OR, Klarlund M, and Pedersen SJ
- Abstract
Purpose: To compare three region-of-interest (ROI) settings in the assessment of ADC in a clinical trial, and to evaluate the effectiveness of ADC in assessing therapy-induced changes and predicting clinical outcomes., Methods: In a 52-week clinical trial involving patients with axial spondyloarthritis, mean sacroiliac joint (SIJ) ADC measurements using structured, lesion-based, and index-lesion ROI-settings were assessed at baseline and weeks 4, 16, and 52. Variation among the three ROI-settings, correlations with Spondyloarthritis Research Consortium of Canada (SPARCC)-bone marrow edema (BME) SIJ inflammation indices, standardized response means (SRMs), and effectiveness in predicting clinical outcomes were analyzed., Results: Forty of the 53 patients had at least one assessable SIJ lesion on ADC at baseline. The mean of the structured ROI ADC (ADC
struc ) was 230 μmm2 /s (standard deviation [SD] = 120). This was significantly lower ( p < 0.01) than the means of the lesion-based ROI ADC (ADClesion = 420 μmm2 /s, SD = 210) and index-lesion ROI ADC (ADCindex = 471 μmm2 /s, SD = 278), which did not differ. ADC correlated with SPARCC-BME scores at baseline ( p < 0.01) as did changes over time in ADC- and SPARCC-BME ( p <0.05). At all follow-up time points, responsiveness was high for ADClesion (SRM > 0.92) and ADCindex (SRM > 0.87) while moderate for ADCstruc (SRM:0.54-0.67). Baseline ADC and changes in ADC did not predict clinical outcomes., Conclusions: Lesion-based and index-lesion ROI ADC could both be used to evaluate the effectiveness of tumor necrosis factor inhibitor therapy. None of the methods could predict clinical outcomes., (© 2020 The Author(s).)- Published
- 2020
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32. Novel whole-body magnetic resonance imaging response and remission criteria document diminished inflammation during golimumab treatment in axial spondyloarthritis.
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Krabbe S, Eshed I, Sørensen IJ, Møller J, Jensen B, Madsen OR, Klarlund M, Pedersen SJ, and Østergaard M
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- Adult, Cohort Studies, Enthesopathy, Female, Humans, Male, Remission Induction, Sacroiliac Joint diagnostic imaging, Time Factors, Treatment Outcome, Anti-Inflammatory Agents therapeutic use, Antibodies, Monoclonal therapeutic use, Joints diagnostic imaging, Magnetic Resonance Imaging methods, Spondylarthritis diagnostic imaging, Spondylarthritis drug therapy, Whole Body Imaging methods
- Abstract
Objectives: To investigate criteria for treatment response and remission in patients with axial SpA as assessed by whole-body magnetic resonance imaging (WB-MRI) of axial and peripheral joints and entheses during treatment with golimumab., Methods: We performed an investigator-initiated cohort study of 53 patients who underwent WB-MRI at weeks 0, 4, 16 and 52 after initiation of golimumab. Images were assessed according to the Spondyloarthritis Research Consortium of Canada MRI SI joint inflammation index, Canada-Denmark MRI spine inflammation score and the MRI peripheral joints and entheses inflammation index., Results: At weeks 4, 16 and 52, WB-MRI demonstrated an at least 50% reduction of MRI inflammation of the sacroiliac joints in 16, 29 and 32 (30%, 55% and 60%) patients, of the spine in 20, 30 and 31 (38%, 57% and 58%) patients and of peripheral joints and entheses in 8, 17 and 15 (15%, 32% and 28%) patients, respectively. The BASDAI50 response was achieved by 29, 31 and 31 (55%, 58% and 58%) patients, while ASDAS clinically important improvement (ASDAS-CII) was achieved by 37, 40 and 34 (70%, 75% and 64%) patients. WB-MRI remission criteria for spine, sacroiliac joints and peripheral joints and entheses were explored; total WB-MRI remission was attained by 2, 6 and 3 (4%, 11% and 6%) patients. At week 16, among 35 patients with an at least 50% reduction in the MRI Axial Inflammation Index (sacroiliac joint and spine inflammation), 29 (83%) achieved BASDAI50 and 35 (100%) achieved ASDAS-CII; among 16 patients with MRI axial inflammation non-response, 14 (88%) were BASDAI50 non-responders and 11 (69%) did not achieve ASDAS-CII., Conclusion: WB-MRI demonstrated a significant reduction of inflammation in both the spine, sacroiliac joints and peripheral joints and entheses during golimumab treatment. Few patients achieved total WB-MRI remission. Combining spinal and sacroiliac joint inflammation in an MRI Axial Inflammation Index increased the ability to capture response., Trial Registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT02011386., (© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2020
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33. Erratum to: The utility of magnetic resonance imaging lesion combinations in the sacroiliac joints for diagnosing patients with axial spondyloarthritis. A prospective study of 204 participants including post-partum women, patients with disc herniation, cleaning staff, runners and healthy persons.
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Seven S, Østergaard M, Morsel-Carlsen L, Sørensen IJ, Bonde B, Thamsborg G, Lykkegaard JJ, Hendricks O, Jørgensen NR, and Pedersen SJ
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- 2020
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34. The utility of magnetic resonance imaging lesion combinations in the sacroiliac joints for diagnosing patients with axial spondyloarthritis. A prospective study of 204 participants including post-partum women, patients with disc herniation, cleaning staff, runners and healthy persons.
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Seven S, Østergaard M, Morsel-Carlsen L, Sørensen IJ, Bonde B, Thamsborg G, Lykkegaard JJ, Hendricks O, Jørgensen NR, and Pedersen SJ
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- Adult, Cross-Sectional Studies, Diagnosis, Differential, Female, Healthy Volunteers, Housekeeping, Hospital, Humans, Intervertebral Disc Displacement, Likelihood Functions, Low Back Pain, Lumbar Vertebrae, Magnetic Resonance Imaging methods, Male, Middle Aged, Pelvic Pain, Postpartum Period, Prospective Studies, Running, Sensitivity and Specificity, Young Adult, Adipose Tissue diagnostic imaging, Bone Marrow Diseases diagnostic imaging, Connective Tissue Diseases diagnostic imaging, Edema diagnostic imaging, Sacroiliac Joint diagnostic imaging, Spondylarthritis diagnostic imaging
- Abstract
Objectives: To investigate the diagnostic utility of different combinations of SI joint MRI lesions for differentiating patients with axial SpA (axSpA) from other conditions with and without buttock/pelvic pain., Methods: A prospective cross-sectional study included patients with axSpA (n = 41), patients with lumbar disc herniation (n = 25), women with (n = 46) and without (n = 14) post-partum (birth within 4-16 months) buttock/pelvic pain and cleaning assistants (n = 26), long-distance runners (n = 23) and healthy men (n = 29) without pain. Two independent readers assessed SI joint MRI lesions according to the Spondyloarthritis Research Consortium of Canada MRI definitions and pre-defined MRI lesion combinations with bone marrow oedema (BME) and fat lesions (FAT), respectively. Statistical analyses included the proportion of participants with scores above certain thresholds, sensitivity, specificity, positive and negative predictive values and likelihood ratios., Results: BME adjacent to the joint space (BME@joint space) was most frequent in axSpA (63.4%), followed by women with post-partum pain (43.5%), but was present in nearly all groups. BME adjacent to fat lesions (BME@FAT) and BME adjacent to erosions (BME@erosion) were only present in axSpA patients and in women with post-partum pain, but scores ≥3 and ≥4, respectively, were only seen in axSpA patients. FAT@erosion was exclusively recorded in axSpA patients. FAT@joint space and FAT@sclerosis were present in most groups, but with higher scores in the axSpA group., Conclusion: BME@joint space and FAT@joint space were frequent in axSpA but also in other conditions, reducing the diagnostic utility. FAT@erosion, and BME@FAT, BME@erosion and FAT@sclerosis above certain thresholds, were exclusively seen in axSpA patients and may thus have diagnostic utility in the differentiation of axSpA from other conditions., (© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2020
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35. Peripheral Enthesitis Detected by Ultrasonography in Patients With Axial Spondyloarthritis-Anatomical Distribution, Morphology, and Response to Tumor Necrosis Factor-Inhibitor Therapy.
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Seven S, Pedersen SJ, Østergaard M, Felbo SK, Sørensen IJ, Døhn UM, and Terslev L
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Objectives: To investigate the anatomical distribution, morphological abnormalities and response to adalimumab therapy of ultrasound(US)-detected peripheral enthesitis in patients with axial spondyloarthritis (SpA). Methods: In a randomized, placebo-controlled, double-blinded, investigator-initiated trial (NCT01029847), patients with axial SpA according to the Assessment of Spondyloarthritis International Society criteria were randomized to subcutaneous adalimumab 40 mg every other week or placebo from baseline to week 6. From week 6 to 24, all patients received adalimumab 40 mg every other week. Of 49 patients enrolled, 21 patients participated in our observational US sub-study. US assessment applying the OMERACT US definitions for enthesitis of 10 peripheral entheseal regions of the upper and lower extremities and clinical examination were performed at baseline, weeks 6 and 24. US was performed by one experienced investigator. Hypo-echogenicity, increased thickness and Doppler activity of the enthesis were considered signs of active inflammation, whereas insertional bone erosions, intratendinous calcifications, and enthesophytes were regarded as signs of structural lesions. Results: Enthesitis on US was mostly present in the lower limbs, especially in the Achilles tendon (81%), the quadriceps tendon (62%), and the greater femoral trochanter (52%). Structural lesions were predominant (38 vs. 12% of examined entheses with inflammatory changes), particularly in the entheses of the lower limbs, and exhibited no change during treatment. Conclusion: US-detected structural lesions were common while inflammatory lesions were relatively rare in patients initiating adalimumab due to axial SpA. Structural lesions did not appear to change during 24 weeks follow-up, suggesting that these lesions may not be helpful outcome measures in short-term clinical trials., (Copyright © 2020 Seven, Pedersen, Østergaard, Felbo, Sørensen, Døhn and Terslev.)
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- 2020
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36. Response to ''To switch or not to switch': the missing piece in the puzzle of biosimilar literature?' by Scherlinger et al .
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Glintborg B, Loft AG, Omerovic E, Hendricks O, Linauskas A, Espesen J, Danebod K, Jensen DV, Nordin H, Dalgaard EB, Chrysidis S, Kristensen S, Raun JL, Lindegaard H, Manilo N, Jakobsen SH, Hansen IMJ, Pedersen DD, Sørensen IJ, Andersen LS, Grydehøj J, Mehnert F, Krogh NS, and Lund Hetland M
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- Etanercept, Humans, Registries, Treatment Outcome, Antirheumatic Agents, Biosimilar Pharmaceuticals
- Abstract
Competing Interests: Competing interests: BG: AbbVie, Biogen, Pfizer, MSD. MLH: Orion, BMS, AbbVie, Biogen, Pfizer, MSD, Celltrion. IMJH: Roche. AGL: AbbVie, MSD, Novartis, Pfizer, Roche, UCB. OH: AbbVie, Roche, Novartis. HN: AbbVie, Novartis, Medac. LSA: Pfizer.
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- 2020
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37. High versus standard magnetic resonance image resolution of the cervical spine in patients with axial spondyloarthritis.
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Krabbe S, Østergaard M, Sørensen IJ, Møller J, Jensen B, Madsen OR, and Pedersen SJ
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- Adult, Cervical Vertebrae diagnostic imaging, Double-Blind Method, Female, Humans, Male, Image Interpretation, Computer-Assisted methods, Magnetic Resonance Imaging methods, Spondylarthritis diagnostic imaging
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- 2020
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38. Test-retest repeatability of the apparent diffusion coefficient in sacroiliac joint MRI in patients with axial spondyloarthritis and healthy individuals.
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Møller JM, Østergaard M, Thomsen HS, Sørensen IJ, Madsen OR, and Pedersen SJ
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Background: The apparent diffusion coefficient (ADC) may be used as a biomarker to diagnose axial spondyloarthritis (axSpA) and monitor therapeutic response., Purpose: To measure the repeatability of the ADC in healthy individuals and in patients with axSpA with and without active sacroiliitis in a test-retest set-up, and to correlate ADC to conventional magnetic resonance imaging (MRI) bone marrow edema (BME) scores and clinical findings., Material and Methods: A total of 25 patients with axSpA and 24 sex- and age-matched healthy individuals were prospectively examined with MRI twice within 10 days. Short tau inversion recovery (STIR), T1-weighted and diffusion-weighted imaging sequences were performed. Mono-exponential ADC maps were based on four b-values: 0; 50; 500; and 800. Inter-study repeatability and intra-reader reproducibility were investigated in subgroups, as were associations with conventional MRI and clinical findings., Results: The inter-study repeatability for the median ADC was moderate for all individuals (intraclass correlation coefficient [ICC] 0.66); it was good in patients with axSpA (ICC 0.79) and poor in healthy individuals (ICC 0.27). Significant differences in ADC were found between women and men ( P = 0.03), and between patients with versus without BME on STIR ( P = 0.01). ADC was associated with an MRI BME score and with age in women., Conclusion: ADC seems to be a repeatable parameter in patients with axSpA but not in healthy individuals. ADC is correlated with MRI sacroiliac joint BME score and with age in women., (© The Foundation Acta Radiologica 2020.)
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- 2020
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39. Response to: 'Mandatory, cost-driven switching from originator etanercept to its biosimilar SB 4 : possible fallout on non-medical switching' by Cantini and Benucci.
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Glintborg B, Loft AG, Omerovic E, Hendricks O, Linauskas A, Espesen J, Danebod K, Jensen DV, Nordin H, Dalgaard EB, Chrysidis S, Kristensen S, Raun JL, Lindegaard H, Manilo N, Jakobsen SH, Hansen IMJ, Dalsgaard Pedersen D, Sørensen IJ, Andersen LS, Grydehøj J, Mehnert F, Krogh NS, and Hetland ML
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- Etanercept, Humans, Registries, Treatment Outcome, Antirheumatic Agents, Biosimilar Pharmaceuticals
- Abstract
Competing Interests: Competing interests: BG: AbbVie, Biogen, Pfizer, MSD. MLH: Orion, BMS, AbbVie, Biogen, Pfizer, MSD, Celltrion. IMJH: Roche. AGL: AbbVie, MSD, Novartis, Pfizer, Roche, UCB. OH: AbbVie, Roche, Novartis. HN: AbbVie, Novartis, Medac. LSA: Pfizer.
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- 2020
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40. Whole-body Magnetic Resonance Imaging Inflammation in Peripheral Joints and Entheses in Axial Spondyloarthritis: Distribution and Changes during Adalimumab Treatment.
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Krabbe S, Eshed I, Sørensen IJ, Jensen B, Møller JM, Balding L, Madsen OR, Pedersen SJ, and Østergaard M
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- Achilles Tendon diagnostic imaging, Adult, Enthesopathy complications, Female, Humans, Inflammation diagnostic imaging, Male, Middle Aged, Spondylitis, Ankylosing complications, Treatment Outcome, Adalimumab therapeutic use, Antirheumatic Agents therapeutic use, Enthesopathy diagnostic imaging, Joints diagnostic imaging, Magnetic Resonance Imaging methods, Spondylitis, Ankylosing diagnostic imaging, Spondylitis, Ankylosing drug therapy, Whole Body Imaging methods
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Objective: To investigate the distribution of whole-body magnetic resonance imaging (WB-MRI) inflammatory lesions of peripheral joints and entheses, and their response to adalimumab (ADA) treatment and agreement with clinical measures of disease activity in patients with axial spondyloarthritis (axSpA)., Methods: Explorative analysis of an investigator-initiated randomized controlled trial of ADA. WB-MRI was performed at weeks 0, 6, 24, and 48. Detailed analyses of WB-MRI lesions in peripheral joints and entheses were performed, including agreement with clinical measures of disease activity., Results: WB-MRI inflammatory lesions were most frequently observed in the acromioclavicular, metatarsophalangeal, and wrist joints (> 10% of joints), and at the greater trochanter, calcaneal insertion of the Achilles tendon, and ischial tuberosity (> 15% of entheses). Inflammation resolved in ≥ 2/3 of involved sternoclavicular, metacarpophalangeal, first carpometacarpal, hip, and tarsometatarsal joints, and pubic symphyses and medial femoral condyles. In contrast, inflammation resolved in ≤ 1/6 of involved acromioclavicular joints, knee joints, and supraspinatus tendon insertions at humerus. Tenderness of joints and entheses agreed poorly with WB-MRI inflammation (κ < 0.40). Joint tenderness resolved more frequently in MRI-positive than MRI-negative joints (8/13, 62% vs 9/34, 26%) after 6 weeks of active treatment., Conclusion: Inflammatory lesions of peripheral joints and entheses in patients with predominantly axSpA, and changes therein, can be mapped using WB-MRI, and it may contribute to differentiate between inflammatory and noninflammatory joint tenderness. (Trial registration: ClinicalTrials NCT01029847).
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- 2020
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41. Magnetic Resonance Imaging of Lesions in the Sacroiliac Joints for Differentiation of Patients With Axial Spondyloarthritis From Control Subjects With or Without Pelvic or Buttock Pain: A Prospective, Cross-Sectional Study of 204 Participants.
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Seven S, Østergaard M, Morsel-Carlsen L, Sørensen IJ, Bonde B, Thamsborg G, Lykkegaard JJ, Hendricks O, Jørgensen NR, and Pedersen SJ
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- Adult, Bone Marrow Diseases diagnostic imaging, Buttocks diagnostic imaging, Buttocks pathology, Cross-Sectional Studies, Diagnosis, Differential, Edema diagnostic imaging, Female, Humans, Intervertebral Disc Displacement diagnostic imaging, Intervertebral Disc Displacement pathology, Male, Postpartum Period, Predictive Value of Tests, Pregnancy, Prospective Studies, Reference Values, Sacroiliac Joint pathology, Sensitivity and Specificity, Severity of Illness Index, Young Adult, Magnetic Resonance Imaging statistics & numerical data, Musculoskeletal Pain diagnostic imaging, Pelvic Pain diagnostic imaging, Sacroiliac Joint diagnostic imaging, Spondylarthritis diagnostic imaging
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Objective: To evaluate whether different types of sacroiliac (SI) joint lesions identified by magnetic resonance imaging (MRI) could differentiate axial spondyloarthritis (SpA) from conditions with buttock or pelvic pain attributable to other reasons, including postpartum women and healthy subjects., Methods: The study was designed as a prospective, cross-sectional study involving 204 participants, comprising patients with axial SpA (n = 41) and control groups of subjects with or without SI joint pain, including patients with lumbar disc herniation (n = 25), women with (n = 46) or without (n = 14) postpartum buttock/pelvic pain (having given birth within the preceding 4-16 months), hospital cleaning staff (n = 26), long-distance runners (n = 23), and healthy men (n = 29). Participants underwent clinical examination and MRI, and MRIs were evaluated in a blinded manner by 2 readers according to the Spondyloarthritis Research Consortium of Canada (SPARCC) SI joint inflammation and structural lesion scores. SPARCC score cutoff levels were defined as scores above a certain threshold. Primary analyses were based on reader agreement with regard to the presence of SI joint pathologic features on MRI ("concordant reads"). Sensitivity, specificity, and positive and negative predictive values were calculated., Results: SI joint ankylosis and backfill were detected by MRI only in patients with axial SpA (32% and 37%, respectively), while bone marrow edema (BME) and fat lesions were seen in all non-axial SpA control groups (3-39% with BME and 4-14% with fat lesions). SI joint erosion was present only in patients with axial SpA and in women with postpartum buttock/pelvic pain (at erosion score cutoffs of >1 and >4, 61% and 34%, respectively, in patients with axial SpA, and 9% and 2%, respectively, in women with postpartum buttock/pelvic pain). A SPARCC BME score of ≥5 was present only in patients with axial SpA (56%) and in women with postpartum buttock/pelvic pain (24%), while fat lesions were present, albeit rarely, at high SPARCC cutoff scores in nearly all groups. Of the 38 women from the non-postpartum control groups who had given birth (mean time since birth 9.7 years), 2 (5%) had BME, whereas none had SI joint erosion or fat lesions, and none had a BME score of ≥4., Conclusion: BME and fat lesions were most pronounced in patients with axial SpA, but also occurred in other groups, particularly women with postpartum buttock/pelvic pain. Erosion above a certain SPARCC score threshold as well as backfill and ankylosis were highly specific for axial SpA., (© 2019, American College of Rheumatology.)
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- 2019
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42. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry.
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Glintborg B, Loft AG, Omerovic E, Hendricks O, Linauskas A, Espesen J, Danebod K, Jensen DV, Nordin H, Dalgaard EB, Chrysidis S, Kristensen S, Raun JL, Lindegaard H, Manilo N, Jakobsen SH, Hansen IMJ, Dalsgaard Pedersen D, Sørensen IJ, Andersen LS, Grydehøj J, Mehnert F, Krogh NS, and Hetland ML
- Subjects
- Adult, Antirheumatic Agents standards, Arthritis, Psoriatic drug therapy, Biosimilar Pharmaceuticals standards, Denmark, Drug Substitution standards, Etanercept standards, Female, Humans, Male, Middle Aged, Registries, Spondylarthritis drug therapy, Treatment Outcome, Antirheumatic Agents administration & dosage, Arthritis, Rheumatoid drug therapy, Biosimilar Pharmaceuticals administration & dosage, Drug Substitution methods, Etanercept administration & dosage
- Abstract
Objectives: Real-world evidence on effectiveness of switching to biosimila r etanercept is scarce. In Denmark, a nationwide guideline of mandatory switch from 50 mg originator (ETA) to biosimilar (SB4) etanercept was issued for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA) in 2016. Clinical characteristics and treatment outcomes were studied in ETA-treated patients, who switched to SB4 (switchers) or maintained ETA (non-switchers). Retention rates were compared with that of a historic cohort of ETA-treated patients. Switchers who resumed ETA treatment (back-switchers) were characterised., Methods: Observational cohort study based on the DANBIO registry. Treatment retention was explored by Kaplan-Meier plots and Cox regression (crude, adjusted)., Results: 1621 (79%) of 2061 ETA-treated patients switched to SB4. Disease activity was unchanged 3 months' preswitch/postswitch. Non-switchers often received 25 mg ETA (ETA 25 mg pens/syringes and powder solution were still available). One-year adjusted retention rates were: non-switchers: 77% (95% CI: 72% to 82%)/switchers: 83% (79% to 87%)/historic cohort: 90% (88% to 92%). Patients not in remission had lower retention rates than patients in remission, both in switchers (crude HR 1.7 (1.3 to 2.2)) and non-switchers (2.4 (1.7 to 3.6)). During follow-up, 120 patients (7% of switchers) back-switched to ETA. Back-switchers' clinical characteristics were similar to switchers, and reasons for SB4 withdrawal were mainly subjective., Conclusion: Seventy-nine per cent of patients switched from ETA to SB4. After 1 year, adjusted treatment retention rates were lower in switchers versus the historic ETA cohort, but higher than in non-switchers. Withdrawal was more common in patients not in remission. The results suggest that switch outcomes in routine care are affected by patient-related factors and non-specific drug effects., Competing Interests: Competing interests: BG: AbbVie, Biogen, Pfizer, MSD. MLH: Orion, BMS, AbbVie, Biogen, Pfizer, MSD, Celltrion. IMJH: Roche. AGL: AbbVie, MSD, Novartis, Pfizer, Roche, UCB OH: AbbVie, Roche, Novartis. HN: AbbVie, Novartis, Medac. LSA: Pfizer. The remaining authors: none declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2019
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43. Whole-body Magnetic Resonance Imaging in Axial Spondyloarthritis: Reduction of Sacroiliac, Spinal, and Entheseal Inflammation in a Placebo-controlled Trial of Adalimumab.
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Krabbe S, Østergaard M, Eshed I, Sørensen IJ, Jensen B, Møller JM, Balding L, Madsen OR, Asmussen K, Eng G, Jørgensen NR, and Pedersen SJ
- Subjects
- Adalimumab administration & dosage, Adalimumab pharmacology, Adult, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Antirheumatic Agents administration & dosage, Antirheumatic Agents pharmacology, Denmark, Double-Blind Method, Female, Follow-Up Studies, Humans, Logistic Models, Magnetic Resonance Imaging methods, Male, Middle Aged, Severity of Illness Index, Statistics, Nonparametric, Treatment Outcome, Tumor Necrosis Factor-alpha antagonists & inhibitors, Adalimumab therapeutic use, Antirheumatic Agents therapeutic use, Sacroiliitis drug therapy, Spondylitis drug therapy, Spondylitis, Ankylosing diagnostic imaging, Spondylitis, Ankylosing drug therapy, Whole Body Imaging methods
- 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.
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- 2018
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44. Inflammatory and structural changes in vertebral bodies and posterior elements of the spine in axial spondyloarthritis: construct validity, responsiveness and discriminatory ability of the anatomy-based CANDEN scoring system in a randomised placebo-controlled trial.
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Krabbe S, Sørensen IJ, Jensen B, Møller JM, Balding L, Madsen OR, Lambert RGW, Maksymowych WP, Pedersen SJ, and Østergaard M
- Abstract
Background: The Canada-Denmark (CANDEN) definitions of spinal MRI lesions allow a detailed anatomy-based evaluation of inflammatory and structural lesions in vertebral bodies and posterior elements of the spine in patients with axial spondyloarthritis (axSpA). The objective was to examine the reliability, responsiveness and discrimination of scores for spinal inflammation, fat, bone erosion and new bone formation based on the CANDEN system and to describe patterns of inflammatory and structural lesions and their temporal development., Methods: 49 patients with axSpA from an investigator-initiated, randomised, placebo-controlled trial of adalimumab underwent spinal MRI at weeks 0/6/24/48. MR images were scored according to the CANDEN system and the Spondyloarthritis Research Consortium of Canada (SPARCC) method. Total scores, and various subscores, were created by summing individual lesion scores., Results: The CANDEN spine inflammation score had high responsiveness, similar to the SPARCC MRI spine index (Guyatt's responsiveness index 1.88 and 1.67, respectively), and discriminated between adalimumab and placebo treatment already at 6 weeks' follow-up (P=0.03). Anterior/posterior corner inflammation subscores showed similar responsiveness. Inter-reader reliability for the CANDEN spine inflammation and fat scores was good to very good for status and change scores (intraclass correlation coefficient (ICC)=0.71-0.92). Reliability for CANDEN new bone formation and erosion scores was good to very good for status scores (ICC=0.61-0.75) but, due to minimal progression, poor for change scores (ICC≤0.40)., Conclusions: The CANDEN spine inflammation score showed good responsiveness, discrimination between active treatment and placebo and reliability. The CANDEN spine structural scores had good cross-sectional reliability, but longer studies are needed to investigate their sensitivity to change., Trial Registration Number: NCT01029847; Results., Competing Interests: Competing interests: None declared.
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- 2018
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45. Development and Validation of MRI Sacroiliac Joint Scoring Methods for the Semiaxial Scan Plane Corresponding to the Berlin and SPARCC MRI Scoring Methods, and of a New Global MRI Sacroiliac Joint Method.
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Hededal P, Østergaard M, Sørensen IJ, Loft AG, Hindrup JS, Thamsborg G, Asmussen K, Hendricks O, Nørregaard J, Møller JM, Jurik AG, Morsel L, Balding L, and Pedersen SJ
- Subjects
- Adalimumab administration & dosage, Adalimumab therapeutic use, Adult, Antirheumatic Agents administration & dosage, Antirheumatic Agents therapeutic use, Double-Blind Method, Feasibility Studies, Female, Follow-Up Studies, Humans, Linear Models, Male, Middle Aged, Reproducibility of Results, Sensitivity and Specificity, Spondylitis, Ankylosing drug therapy, Bone Marrow Diseases diagnostic imaging, Edema diagnostic imaging, Magnetic Resonance Imaging methods, Research Design, Sacroiliac Joint pathology, Spondylitis, Ankylosing diagnostic imaging
- Abstract
Objective: To develop semiaxial magnetic resonance imaging (MRI) scoring methods for assessment of sacroiliac joint (SIJ) bone marrow edema (BME) in patients with axial spondyloarthritis, and to compare the reliability with equivalent semicoronal scoring methods., Methods: Two semiaxial SIJ MRI scoring methods were developed based on the principles of the semicoronal Berlin and Spondyloarthritis Research Consortium of Canada (SPARCC) methods. A global quadrant-based method was also developed. Baseline and 12-week MRI of the SIJ from 51 patients participating in a randomized double-blind placebo-controlled trial of adalimumab 40 mg every other week versus placebo were scored by the semiaxial and the corresponding semicoronal methods. Results were compared by linear regression analysis. The reproducibility and sensitivity were evaluated by intraclass correlation coefficients (ICC) and smallest detectable change [SDC, absolute values and percentage of the highest observed score (SDC-HOS)]., Results: Interreader and intrareader ICC were moderate to very high for semiaxial scoring methods (baseline 0.83-0.88 and 0.85-0.97; change 0.33-0.78), while high to very high for semicoronal scoring methods (baseline 0.90-0.92 and 0.93-0.97; change 0.77-0.89). Association between semiaxial and semicoronal scores were high for both the Berlin and SPARCC method (baseline: R
2 = 0.93 and 0.88; change: R2 = 0.82 and 0.87, respectively), while lower for the global method (baseline: R2 = 0.79; change: R2 = 0.54). The SDC-HOS were 9.8-18.6% and 5.9-10.7% for the semiaxial and semicoronal methods, respectively., Conclusion: Detection of SIJ BME in the semiaxial scan plane is feasible and reproducible. However, a slightly lower reliability of all 3 semiaxial methods supports the general practice of using the coronal scan-plane in therapeutic studies.- Published
- 2018
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46. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry.
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Glintborg B, Sørensen IJ, Loft AG, Lindegaard H, Linauskas A, Hendricks O, Hansen IMJ, Jensen DV, Manilo N, Espesen J, Klarlund M, Grydehøj J, Dieperink SS, Kristensen S, Olsen JS, Nordin H, Chrysidis S, Dalsgaard Pedersen D, Sørensen MV, Andersen LS, Grøn KL, Krogh NS, Pedersen L, and Hetland ML
- Subjects
- Adult, Aged, Biosimilar Pharmaceuticals, Denmark, Female, Humans, Male, Middle Aged, Treatment Outcome, Antibodies, Monoclonal therapeutic use, Antirheumatic Agents therapeutic use, Arthritis, Psoriatic drug therapy, Arthritis, Rheumatoid drug therapy, Drug Substitution, Infliximab, Registries, Spondylarthropathies drug therapy
- Abstract
Objectives: According to guidelines, a nationwide non-medical switch from originator (INX, Remicade) to biosimilar infliximab (Remsima, CT-P13) was conducted in Danish patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA). We investigated disease activity before/after switching and retention rates in the DANBIO registry., Methods: Disease activities 3 months before and after switch and changes over time were calculated. Flare was defined as change in 28 Joint Disease Activity Score (∆DAS28) ≥1.2 (RA/PsA) or Ankylosing Spondylitis Disease Activity Score (∆ASDAS) ≥1.3 (AxSpA). Crude and adjusted retention rates were compared with a historic cohort of INX-treated patients., Results: Eight hundred and two patients switched (403 RA/120 PsA/279 AxSpA; 51% women, age (median (IQR): 55 (44-66)) years). Follow-up was 413 (339-442) days. Prior INX treatment duration was 6.8 (4.3-9.5) years. Disease activities were similar 3 months before/after switch. Crude 1-year CT-P13 retention rate (84.1 (95% CI 81.3 to 86.5)) was similar to the historic IFX cohort (86.2 (95% CI 84.0 to 88.0), p=0.22). The adjusted absolute retention rates were 83.4 (95% CI 80.8 to 86.2) and 86.8% (95% CI 84.8 to 88.8), respectively (p=0.03). In total 132 patients withdrew (lack of effect: 71/132=54%, adverse events: 37/132=28%). Patients with previous INX treatment duration >5 years had longer CT-P13 retention., Conclusion: In 802 arthritis patients treated with INX for median >6 years, a nationwide non-medical switch to CT-P13 had no negative impact on disease activity. Adjusted 1-year CT-P13 retention rate was slightly lower than for INX in a historic cohort., Competing Interests: Competing interests: BG: AbbVie; IMJH: Roche; AGL, MLH: AbbVie, BMS, MSD, Pfizer, Roche and UCB; the remaining authors: none declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)
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- 2017
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47. Ankylosing Spondylitis versus Nonradiographic Axial Spondyloarthritis: Comparison of Tumor Necrosis Factor Inhibitor Effectiveness and Effect of HLA-B27 Status. An Observational Cohort Study from the Nationwide DANBIO Registry.
- Author
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Glintborg B, Sørensen IJ, Østergaard M, Dreyer L, Mohamoud AA, Krogh NS, Hendricks O, Andersen LS, Raun JL, Kowalski MR, Danielsen L, Pelck R, Nordin H, Pedersen JK, Kraus DG, Christensen SR, Hansen IM, Esbesen J, Schlemmer A, Loft AG, Al Chaer N, Salomonsen L, and Hetland ML
- Subjects
- Adult, Cohort Studies, Female, Humans, Male, Medication Adherence, Middle Aged, Registries, Sacroiliac Joint diagnostic imaging, Severity of Illness Index, Spondylarthritis diagnostic imaging, Spondylarthritis genetics, Spondylitis, Ankylosing blood, Spondylitis, Ankylosing diagnostic imaging, Treatment Outcome, Tumor Necrosis Factor-alpha antagonists & inhibitors, Antirheumatic Agents therapeutic use, Biological Products therapeutic use, HLA-B27 Antigen blood, Spondylarthritis drug therapy, Spondylitis, Ankylosing drug therapy
- Abstract
Objective: To compare baseline disease activity and treatment effectiveness in biologic-naive patients with nonradiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) who initiate tumor necrosis factor inhibitor (TNFi) treatment and to study the role of potential confounders (e.g., HLA-B27 status)., Methods: Observational cohort study based on prospectively registered data in the nationwide DANBIO registry. We used Kaplan-Meier plots, Cox, and logistic regression analyses to study the effect of diagnosis (nr-axSpA vs AS) and potential confounders (sex/age/start yr/HLA-B27/disease duration/TNFi-type/smoking/baseline disease activity) on TNFi adherence and response [e.g., Bath Ankylosing Spondylitis Activity Index (BASDAI) 50%/20 mm]., Results: The study included 1250 TNFi-naive patients with axSpA (29% nr-axSpA, 50% AS, 21% lacked radiographs of sacroiliac joints). Patients with nr-axSpA were more frequently women (50%/27%) and HLA-B27-negative (85/338 = 25%), compared to AS (81/476 = 17%; p < 0.01). At TNFi start patients with nr-axSpA had higher visual analog scale scores [median (quartiles)] for pain: 72 mm (55-84)/65 mm (48-77); global: 76 mm (62-88)/68 mm (50-80); fatigue: 74 mm (55-85)/67 mm (50-80); and BASDAI: 64 (54-77)/59 (46-71); all p < 0.01. However, patients with nr-axSpA had lower C-reactive protein: 7 mg/l (3-17)/11 mg/l (5-22); and BAS Metrology Index: 20 (10-40)/40 (20-50); all p < 0.01. Median (95% CI) treatment adherence was poorer in nr-axSpA than in AS: 1.59 years (1.15-2.02) versus 3.67 years (2.86-4.49), p < 0.0001; but only in univariate and not confounder-adjusted analyses (p > 0.05). Response rates were similar in AS and nr-axSpA (p > 0.05). HLA-B27 negativity was associated with poorer treatment adherence [HLA-B27 negative/positive, nr-axSpA: HR 1.74 (1.29-2.36), AS: HR 2.04 (1.53-2.71), both p < 0.0001]; and lower response rates (nr-axSpA: 18/61 = 30% vs 93/168 = 55%; AS: 17/59 = 29% vs 157/291 = 54%, both p < 0.05)., Conclusion: In this nationwide cohort, patients with nr-axSpA had higher subjective disease activity at start of first TNFi treatment, but similar outcomes to patients with AS after confounder adjustment. HLA-B27 positivity was associated with better outcomes irrespective of axSpA subdiagnosis.
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- 2017
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48. Using an electronic platform interactively to improve treatment outcome in patients with rheumatoid arthritis: new developments from the DANBIO registry.
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Hetland ML, Krogh NS, Hørslev-Petersen K, Schiøttz-Christensen B, Sørensen IJ, and Dorte Vendelbo J
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- Aged, Antirheumatic Agents adverse effects, Arthritis, Rheumatoid diagnosis, Arthritis, Rheumatoid physiopathology, Denmark, Female, Humans, Male, Middle Aged, Patient Selection, Predictive Value of Tests, Registries, Reminder Systems, Risk Factors, Severity of Illness Index, Surveys and Questionnaires, Treatment Outcome, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid drug therapy, Decision Support Systems, Clinical, Decision Support Techniques, Drug Therapy, Computer-Assisted, Medical Informatics, Rheumatology methods
- Abstract
Objectives: Electronic platforms have been developed to help the clinician monitor disease activity in rheumatoid arthritis (RA) to support at treat-to-target strategy. We present an initiative to interactively improve disease control in patients with rheumatoid arthritis., Methods: In patients who presented with one or more swollen joints AND moderate/high disease activity (i.e. either CDAI≥10.1 and/or DAS-28CRP>3.2, which is automatically calculated in the DANBIO registry), a red alert was shown, which activated a pop-up: "This patient has at least one swollen joint AND either CDAI≥ 10.1 or DAS28CRP>3.2. Which action do you as a physician take today: □ Intensify treatment, □ Treatment intensification is not possible currently/awaiting results of additional investigations, □ No further treatment intensification is possible, □ The patient does not want to intensify treatment, □ Other decisions taken" RESULTS: Of 21,056 patients with RA, 40% fulfilled the criteria for getting the alert message. The pop-up was activated and completed by the physician in 65% of those (5,428 patients). Treatment was intensified in 67%. In 2% of patients, no additional treatment intensification was possible, and 8% of the patients objected to intensification., Conclusions: In >8,000 RA patients who presented with objective signs of active disease in routine care, an interactive feature of the DANBIO registry was introduced, which prompted the physician to take action and consider treatment intensification. In two-thirds of the cases, the treating physician reported that treatment was intensified.
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- 2016
49. Predictive validity of the ASAS classification criteria for axial and peripheral spondyloarthritis after follow-up in the ASAS cohort: a final analysis.
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Sepriano A, Landewé R, van der Heijde D, Sieper J, Akkoc N, Brandt J, Braun J, Collantes-Estevez E, Dougados M, Fitzgerald O, Huang F, Gu J, Kirazli Y, Maksymowych WP, Marzo-Ortega H, Olivieri I, Ozgocmen S, Roussou E, Scarpato S, Sørensen IJ, Valle-Oñate R, Van den Bosch F, van der Horst-Bruinsma I, Weber U, Wei J, and Rudwaleit M
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- Adult, Age of Onset, Axis, Cervical Vertebra, Back Pain etiology, Female, Follow-Up Studies, Humans, Male, Middle Aged, Predictive Value of Tests, Prospective Studies, Reproducibility of Results, Spondylarthritis complications, Back Pain diagnosis, Spondylarthritis diagnosis
- Abstract
Objective: To establish the predictive validity of the Assessment of SpondyloArthritis international Society (ASAS) spondyloarthritis (SpA) classification criteria., Methods: 22 centres (N=909 patients) from the initial 29 ASAS centres (N=975) participated in the ASAS-cohort follow-up study. Patients had either chronic (>3 months) back pain of unknown origin and age of onset below 45 years (N=658) or peripheral arthritis and/or enthesitis and/or dactylitis (N=251). At follow-up, information was obtained at a clinic visit or by telephone. The positive predictive value (PPV) of the baseline classification by the ASAS criteria was calculated using rheumatologist's diagnosis at follow-up as external standard., Results: In total, 564 patients were assessed at follow-up (345 visits; 219 telephone) with a mean follow-up of 4.4 years (range: 1.9; 6.8) and 70.2% received a SpA diagnosis by the rheumatologist. 335 patients fulfilled the axial SpA (axSpA) or peripheral SpA (pSpA) criteria at baseline and of these, 309 were diagnosed SpA after follow-up (PPV SpA criteria: 92.2%). The PPV of the axSpA and pSpA criteria was 93.3% and 89.5%, respectively. The PPV for the 'clinical arm only' was 88.0% and for the 'clinical arm'±'imaging arm' 96.0%, for the 'imaging arm only' 86.2% and for the 'imaging arm'+/-'clinical arm' 94.7%. A series of sensitivity analyses yielded similar results (range: 85.1-98.2%)., Conclusions: The PPV of the axSpA and pSpA criteria to forecast an expert's diagnosis of 'SpA' after more than 4 years is excellent. The 'imaging arm' and 'clinical arm' of the axSpA criteria have similar predictive validity and are truly complementary., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)
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- 2016
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50. 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.
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Pedersen SJ, Poddubnyy D, Sørensen IJ, Loft AG, Hindrup JS, Thamsborg G, Asmussen K, Hendricks O, Nørregaard J, Piil AD, Møller JM, Jurik AG, Balding L, Lambert RG, Sieper J, and Østergaard M
- Subjects
- Adult, Denmark, Double-Blind Method, Female, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Spondylarthropathies drug therapy, Spondylarthropathies pathology, Spondylitis, Ankylosing pathology, Treatment Outcome, Adalimumab therapeutic use, Antirheumatic Agents therapeutic use, Inflammation pathology, Sacroiliac Joint pathology, Spondylitis, Ankylosing drug therapy
- Abstract
Objective: To investigate changes in magnetic resonance imaging (MRI)-assessed inflammation and structural lesions in the sacroiliac (SI) joints during treatment with adalimumab versus placebo., Methods: In a 48-week double-blind, placebo-controlled trial, 52 patients with spondyloarthritis were randomized to receive subcutaneous injections of either adalimumab 40 mg (n = 25) or placebo (n = 27) every other week for 12 weeks. Patients in the adalimumab group continued to receive and patients in the placebo group were switched to adalimumab 40 mg every other week for an additional 12 weeks. MRI of the SI joints was performed at weeks 0, 12, 24, and 48, and the images were assessed independently in a blinded manner using the modified Berlin and the Spondyloarthritis Research Consortium of Canada (SPARCC) MRI scores for inflammation and structural lesions of the SI joints., Results: At baseline, 56% of the adalimumab group and ∼72% of the placebo group had an MRI-assessed inflammation score of ≥1. Among the patients with inflammation at baseline, the mean percent reductions in MRI scores for inflammation from week 0 to 12 were greater in the adalimumab group compared with the placebo group (Berlin method, -62% versus -5%; SPARCC method, -58% versus -12% [both P < 0.04]). Furthermore, the mean SPARCC erosion score decreased (-0.6) and the SPARCC backfill score increased (+0.8) in the adalimumab group from week 0 to week 12. From week 12 to week 24, larger absolute reductions in the Berlin/SPARCC inflammation scores and the SPARCC erosion score and larger increases in the Berlin/SPARCC fatty lesion scores were seen in the placebo group compared with the adalimumab group. In univariate regression analyses (analysis of covariance) and multivariate stepwise regression analyses, treatment with adalimumab was independently associated with regression of the SPARCC erosion score from week 0 to 12 but not with changes in the other types of MRI lesions., Conclusion: Significant changes in the Berlin and SPARCC MRI-assessed inflammation scores and in the SPARCC MRI-assessed erosion scores occurred within 12 weeks after initiation of adalimumab. Tumor necrosis factor inhibitor treatment was associated with resolution of erosions and the development of backfill., (© 2016, American College of Rheumatology.)
- Published
- 2016
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