Mette Bjørndal Axelsen1, Iris Eshed2, Kim Hørslev-Petersen3, Kristian Stengaard-Pedersen4, Merete Lund Hetland5, Jakob Møller6, Peter Junker7, Jan Pødenphant8, Annette Schlemmer9, Torkell Ellingsen10, Palle Ahlquist11, Hanne Lindegaard7, Asta Linauskas12, Mette Yde Dam10, Ib Hansen13, Hans Christian Horn11, Christian Gytz Ammitzbøll4, Anette Jørgensen4, Sophine B Krintel14, Johnny Raun3, Niels S Krogh15, Julia Sidenius Johansen16, Mikkel Østergaard5. 1. Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Glostrup, Denmark Faculty of Health and Medical Sciences, Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark. 2. Department of Radiology, Sheba Medical Center, Tel Aviv University, Tel Hashomer, Israel. 3. King Christian 10th Hospital for Rheumatic Diseases, Gråsten, Denmark South Jutland Hospital, Institute of Regional Health Services Research, University of Southern Denmark, Denmark. 4. Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark. 5. Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Glostrup, Denmark Faculty of Health and Medical Sciences, Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark The DANBIO Registry, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Glostrup, Denmark. 6. Department of Radiology, Copenhagen University Hospital at Herlev, Copenhagen, Denmark. 7. Department of Rheumatology C, Odense University Hospital, University of Southern Denmark, Odense, Denmark. 8. Department of Rheumatology, Copenhagen University Hospital at Gentofte, Gentofte, Denmark Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. 9. Department of Rheumatology, Aarhus University Hospital in Aalborg, Aalborg, Denmark. 10. Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark. 11. Department of Medicine, Vejle Regional Hospital, Vejle, Denmark. 12. Department of Rheumatology, Vendsyssel Hospital, Hjørring, Denmark. 13. Department of Rheumatology, Viborg Regional Hospital, Viborg, Denmark. 14. Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Glostrup, Denmark. 15. Zitelabs Aps, Copenhagen, Denmark. 16. Faculty of Health and Medical Sciences, Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark Department of Medicine and Oncology, Copenhagen University Hospital at Herlev, Herlev, Denmark.
Abstract
OBJECTIVES: To investigate whether a treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid injections suppresses MRI inflammation and halts structural damage progression in patients with early rheumatoid arthritis (ERA), and whether adalimumab provides an additional effect. METHODS: In a double-blind, placebo-controlled trial, 85 disease-modifying antirheumatic drug-naïve patients with ERA were randomised to receive methotrexate, intra-articular glucocorticosteroid injections and placebo/adalimumab (43/42). Contrast-enhanced MRI of the right hand was performed at months 0, 6 and 12. Synovitis, osteitis, tenosynovitis, MRI bone erosion and joint space narrowing (JSN) were scored with validated methods. Dynamic contrast-enhanced MRI (DCE-MRI) was carried out in 14 patients. RESULTS:Synovitis, osteitis and tenosynovitis scores decreased highly significantly (p<0.0001) during the 12-months' follow-up, with mean change scores of -3.7 (median -3.0), -2.2 (-1) and -5.3 (-4.0), respectively. No overall change in MRI bone erosion and JSN scores was seen, with change scores of 0.1 (0) and 0.2 (0). The tenosynovitis score at month 6 was significantly lower in the adalimumab group, 1.3 (0), than in the placebo group, 3.9 (2), Mann-Whitney: p<0.035. Furthermore, the osteitis score decreased significantly during the 12-months' follow-up in the adalimumab group, but not in the placebo group, Wilcoxon: p=0.001-0.002 and p=0.062-0.146. DCE-MRI parameters correlated closely with conventional MRI inflammatory parameters. Clinical measures decreased highly significantly during follow-up. CONCLUSIONS: A treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid in patients with ERA effectively decreased synovitis, osteitis and tenosynovitis and halted structural damage progression as judged by MRI. The findings suggest that addition of adalimumab is associated with further suppression of osteitis and tenosynovitis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
OBJECTIVES: To investigate whether a treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid injections suppresses MRI inflammation and halts structural damage progression in patients with early rheumatoid arthritis (ERA), and whether adalimumab provides an additional effect. METHODS: In a double-blind, placebo-controlled trial, 85 disease-modifying antirheumatic drug-naïve patients with ERA were randomised to receive methotrexate, intra-articular glucocorticosteroid injections and placebo/adalimumab (43/42). Contrast-enhanced MRI of the right hand was performed at months 0, 6 and 12. Synovitis, osteitis, tenosynovitis, MRI bone erosion and joint space narrowing (JSN) were scored with validated methods. Dynamic contrast-enhanced MRI (DCE-MRI) was carried out in 14 patients. RESULTS:Synovitis, osteitis and tenosynovitis scores decreased highly significantly (p<0.0001) during the 12-months' follow-up, with mean change scores of -3.7 (median -3.0), -2.2 (-1) and -5.3 (-4.0), respectively. No overall change in MRI bone erosion and JSN scores was seen, with change scores of 0.1 (0) and 0.2 (0). The tenosynovitis score at month 6 was significantly lower in the adalimumab group, 1.3 (0), than in the placebo group, 3.9 (2), Mann-Whitney: p<0.035. Furthermore, the osteitis score decreased significantly during the 12-months' follow-up in the adalimumab group, but not in the placebo group, Wilcoxon: p=0.001-0.002 and p=0.062-0.146. DCE-MRI parameters correlated closely with conventional MRI inflammatory parameters. Clinical measures decreased highly significantly during follow-up. CONCLUSIONS: A treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid in patients with ERA effectively decreased synovitis, osteitis and tenosynovitis and halted structural damage progression as judged by MRI. The findings suggest that addition of adalimumab is associated with further suppression of osteitis and tenosynovitis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Entities:
Keywords:
Magnetic Resonance Imaging; Rheumatoid Arthritis; Treatment
Authors: Jasvinder A Singh; Alomgir Hossain; Amy S Mudano; Elizabeth Tanjong Ghogomu; Maria E Suarez-Almazor; Rachelle Buchbinder; Lara J Maxwell; Peter Tugwell; George A Wells Journal: Cochrane Database Syst Rev Date: 2017-05-08
Authors: Jasvinder A Singh; Alomgir Hossain; Elizabeth Tanjong Ghogomu; Ahmed Kotb; Robin Christensen; Amy S Mudano; Lara J Maxwell; Nipam P Shah; Peter Tugwell; George A Wells Journal: Cochrane Database Syst Rev Date: 2016-05-13
Authors: Jasvinder A Singh; Alomgir Hossain; Elizabeth Tanjong Ghogomu; Amy S Mudano; Lara J Maxwell; Rachelle Buchbinder; Maria Angeles Lopez-Olivo; Maria E Suarez-Almazor; Peter Tugwell; George A Wells Journal: Cochrane Database Syst Rev Date: 2017-03-10