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Scand J Rheumatol. 2017 Sep;46(5):335-345. doi: 10.1080/03009742.2016.1209550. Epub 2016 Oct 24.

Effect of a treat-to-target strategy based on methotrexate and intra-articular betamethasone with or without additional cyclosporin on MRI-assessed synovitis, osteitis, tenosynovitis, bone erosion, and joint space narrowing in early rheumatoid arthritis: results from a 2-year randomized double-blind placebo-controlled trial (CIMESTRA).

Author information

1
a Copenhagen Centre for Arthritis Research, Centre for Rheumatology and Spine Diseases , Rigshospitalet , Glostrup , Denmark.
2
b Department of Rheumatology , Slagelse Hospital , Slagelse , Denmark.
3
c Department of Radiology , Sheba Medical Centre , Tel Hashomer , Israel.
4
d King Christian X's Hospital for Rheumatic Diseases , Graasten , Denmark.
5
e The DANBIO Registry, Centre for Rheumatology and Spine Diseases , Rigshospitalet , Glostrup , Denmark.
6
f Department of Radiology , Aarhus University Hospital , Aarhus , Denmark.
7
g Department of Radiology , Herlev-Gentofte University Hospital , Herlev , Denmark.
8
h Department of Radiology , Odense University Hospital , Odense , Denmark.
9
i Department of Rheumatology , Aarhus University Hospital , Aarhus , Denmark.
10
j Department of Rheumatology , Odense University Hospital , Odense , Denmark.
11
k Zitelab ApS , Copenhagen , Denmark.
12
l Department of Rheumatology , Vejle Hospital , Vejle , Denmark.
13
m Department of Rheumatology , Herlev-Gentofte University Hospital , Gentofte , Denmark.
14
n Department of Epidemiology , Institute of Public Health, University of Southern Denmark , Odense , Denmark.
15
o Centre for Functional and Diagnostic Imaging and Research , Danish Research Centre for Magnetic Resonance (DRCMR), Copenhagen University Hospital Hvidovre , Hvidovre , Denmark.
16
p Biomedical Engineering, Elektro , Technical University of Denmark (DTU) , Lyngby , Denmark.
17
q Department of Radiology , Copenhagen University Hospita Hvidovrel , Hvidovre , Denmark.

Abstract

OBJECTIVES:

To investigate whether a treat-to-target strategy based on methotrexate (MTX) and intra-articular (IA) betamethasone suppresses magnetic resonance imaging (MRI)-determined measures of disease activity and reduces joint destruction in early rheumatoid arthritis (eRA) patients, and to investigate whether concomitant cyclosporin A (CyA) provides an additional effect.

METHOD:

In the 2-year randomized, double-blind, treat-to-target trial CIMESTRA, 160 patients with eRA (< 6 months) were randomized to MTX, intra-articular betamethasone and CyA, or placebo CyA. A total of 129 patients participated in the MRI substudy, and had contrast-enhanced MR images of the non-dominant hand at months 0, 6, 12, and 24. MR images were evaluated for osteitis, synovitis, tenosynovitis, bone erosion, and joint space narrowing (JSN), using validated scoring methods.

RESULTS:

Significant reductions were seen at 6 months in all inflammatory parameters [synovitis, mean change -1.6 (p < 0.001, Wilcoxon), tenosynovitis, -3.5 (p < 0.001), and osteitis, -1.3 (p < 0.05)] and at 12/24 months in synovitis and tenosynovitis [-1.6/-2.2 and -3.6/-3.8, respectively; all p < 0.001]. MRI signs of inflammation were not fully eliminated, and increases in erosion and JSN scores were observed at 6 months [0.4 (p < 0.01)/0.1 (p < 0.05)], 12 months [0.8 (p < 0.001)/0.3 (p < 0.01)], and 24 months [1.0 (p < 0.001)/0.4 (p < 0.001)]. Clinical measures decreased significantly (p < 0.001) at all time points. There were no consistent statistically significant differences between treatment groups.

CONCLUSIONS:

In this eRA treat-to-target trial, MTX and intra-articular glucocorticoids markedly reduced, but did not eliminate, MRI osteitis, synovitis, and tenosynovitis. Accordingly, minimal but statistically significant increases in bone erosion and JSN were observed. No additional effect of CyA was demonstrated.

PMID:
27775461
DOI:
10.1080/03009742.2016.1209550
[Indexed for MEDLINE]

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