Rapid and Sustained Improvement with TNF Blockade in Early Rheumatoid Arthritis: Results from a Double Blind Placebo-controlled Study with MRI Outcomes

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Rapid and Sustained Improvement with TNF Blockade in Early Rheumatoid

Arthritis: Results from a Double Blind Placebo-controlled Study with MRI

Outcomes

Category:  17 RA‹treatment

Mark Quinn

University of Leeds, Leeds, United Kingdom

Presentation Number: 1388

Poster Board Number: 343

Keywords: Rheumatoid Arthritis, Infliximab, MRI

Table of Contents

Rheumatology and Rehabilitation Unit, University of Leeds, Leeds, United

Kingdom

Rheumatology and Rehabilitation Unit, University of Leeds, Leeds, United

Kingdom

Background: Infliximab has proven rapid, clinical efficacy in established

rheumatoid arthritis (RA). Magnetic resonance imaging (MRI) can

simultaneously quantify synovitis and bone damage. Synovitis has been shown

to precede bone oedema and subsequent erosions, suggesting its primacy in

RA. The aim of this study was to establish the use of infliximab in DMARD

naïve patients with early poor prognosis RA in a head to head comparison

with Methotrexate. For the first time, MRI synovial quantification was used

as the primary outcome measure.

Methods: All patients satisfied ACR RA classification criteria, had <12

months symptoms, were DMARD naïve and had MCP joint involvement. Baseline

assessment involved full clinical assessment with metrology, lab tests and

X-rays. MRI of the dominant hand MCP joints 2-5 was performed at 0, 4, 14

and 54 weeks and scored blindly for synovitis, bone oedema and erosions

using the scoring system proposed by OMERACT. Patients were randomised to

infliximab 3mg/kg or placebo in addition to MTX with standard dose

escalation. No corticosteroids were allowed in the first 14 weeks.

Results: 20 patients were recruited (10 each arm): mean age 52 years, 65%

RF+, mean symptom duration 6 months, mean CRP 42mg/l. There were no

significant differences in baseline characteristics between groups. At 4, 14

and 54 weeks there was significantly greater improvement in MRI scored

synovitis in the infliximab treated group than in the MTX treated group

(p<0.05).

  Synovitis Total Bone Oedema Score Total Bone Erosion Score

  Baseline Week 54 Baseline Week 54 Baseline Week 54

Infliximab 5.5 3.8 2.3 2.4 7.1 2.8

Methotrexate 6.8 6.6 2.8 4.5 7 5.8

At 14 weeks there were substantial differences in the percentages of

patients fulfilling ACR 50 response (55% of Infliximab group vs. 0% of MTX

group: p=0.006) and ACR 70 responses (55% vs. 0%: p=0.006). This difference

was also observed at 54 weeks in percentage of patients fulfilling ACR50

response (77% vs. 40%) and ACR 70 response (66% vs 30%).

Conclusions: Infliximab has demonstrated its ability as a superior

therapeutic agent in early RA compared to MTX. There is a more rapid

suppression of clinical and radiological disease, which is sustained over a

one year period.

We would like to acknowledge financial support from Centocor for the study.