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: results from the OPERA randomised controlled trial.

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.

• Authors: Mette Bjørndal Axelsen, Iris Eshed, Kim Hørslev-Petersen, Kristian Stengaard-Pedersen, Merete Lund Hetland, Jakob Møller, Peter Junker, Jan Pødenphant, Annette Schlemmer, Torkell Ellingsen, Palle Ahlquist, Hanne Lindegaard, Asta Linauskas, Mette Yde Dam, Ib Hansen, Hans Christian Horn, Christian Gytz Ammitzbøll, Anette Jørgensen, Sophine B Krintel, Johnny Raun, Niels S Krogh, Julia Sidenius Johansen, Mikkel Østergaard, OPERA study group
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 74 Issue 5 Pg. 867-75 (May 2015) ISSN: 1468-2060 [Electronic] England
• PMID: 24412895 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: 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.

Chemical References

• Anti-Inflammatory Agents
• Antibodies, Monoclonal, Humanized
• Antirheumatic Agents
• Triamcinolone
• Adalimumab
• Methotrexate

Topics

• Adalimumab
• Adult
• Aged
• Aged, 80 and over
• Anti-Inflammatory Agents (therapeutic use)
• Antibodies, Monoclonal, Humanized (therapeutic use)
• Antirheumatic Agents (therapeutic use)
• Arthritis, Rheumatoid (complications, drug therapy, pathology)
• Clinical Protocols
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Humans
• Injections, Intra-Articular
• Magnetic Resonance Imaging
• Male
• Metacarpophalangeal Joint (pathology)
• Methotrexate (therapeutic use)
• Middle Aged
• Osteitis (drug therapy, etiology, pathology)
• Patient Care Planning
• Severity of Illness Index
• Synovitis (drug therapy, etiology, pathology)
• Tenosynovitis (drug therapy, etiology, pathology)
• Treatment Outcome
• Triamcinolone (therapeutic use)
• Wrist Joint (pathology)
• Young Adult