TY - JOUR
T1 - A treat-to-target strategy with methotrexate and intra-articular triamcinolone with or without adalimumab effectively reduces MRI synovitis, osteitis and tenosynovitis and halts structural damage progression in early rheumatoid arthritis
T2 - results from the OPERA randomised controlled trial
AU - Axelsen, Mette Bjørndal
AU - Eshed, Iris
AU - Hørslev-Petersen, Kim
AU - Stengaard-Pedersen, Kristian
AU - Hetland, Merete Lund
AU - Møller, Jakob
AU - Junker, Peter
AU - Pødenphanth, Jan
AU - Schlemmer, Annette
AU - Ellingsen, Torkell
AU - Ahlquist, Palle
AU - Lindegaard, Hanne
AU - Linauskas, Asta
AU - Dam, Mette Yde
AU - Hansen, Ib
AU - Horn, Hans Christian
AU - Ammitzbøll, Christian Gytz
AU - Jørgensen, Anette
AU - Krintel, Sophine B
AU - Raun, Johnny
AU - Krogh, Niels S
AU - Johansen, Julia Sidenius
AU - Østergaard, Mikkel
AU - OPERA study group
N1 - 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.
PY - 2015/5/1
Y1 - 2015/5/1
N2 - 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, intraarticular 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.
AB - 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, intraarticular 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.
KW - Adalimumab
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Anti-Inflammatory Agents
KW - Antibodies, Monoclonal, Humanized
KW - Antirheumatic Agents
KW - Arthritis, Rheumatoid
KW - Clinical Protocols
KW - Double-Blind Method
KW - Drug Therapy, Combination
KW - Female
KW - Humans
KW - Injections, Intra-Articular
KW - Magnetic Resonance Imaging
KW - Male
KW - Metacarpophalangeal Joint
KW - Methotrexate
KW - Middle Aged
KW - Osteitis
KW - Patient Care Planning
KW - Severity of Illness Index
KW - Synovitis
KW - Tenosynovitis
KW - Treatment Outcome
KW - Triamcinolone
KW - Wrist Joint
KW - Young Adult
U2 - 10.1136/annrheumdis-2013-204537
DO - 10.1136/annrheumdis-2013-204537
M3 - Journal article
C2 - 24412895
SN - 0003-4967
VL - 74
SP - 867
EP - 875
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
IS - 5
ER -