RESEARCH - Radiographic changes in RA patients attaining different disease activity states with MTX monotherapy and Remicade plus MTX

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Ann Rheum Dis. Published Online First: 1 July 2008. doi:10.1136/ard.2008.090019

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Extended Report

Radiographic changes in rheumatoid arthritis patients attaining

different disease activity states with methotrexate monotherapy and

infliximab plus methotrexate: the impacts of remission and

TNF-blockade

f S Smolen 1*, Chenglong Han 2, Désirée MFM van der Heijde 3,

Emery 4, Joan M Bathon 5, Keystone 6, Ravinder N Maini 7,

Joachim R Kalden 8, Aletaha 1, Baker 9, Han 9,

Mohan Bala 2 and E St.Clair 10

1 Medical University of Vienna, Austria

2 & Pharmaceutical Services, United States

3 Leiden University Medical Center, Netherlands

4 Dept of Rheumatology, United Kingdom

5 s Hopkins, United States

6 Mt Sinai, Canada

7 Imperial College, United Kingdom

8 Institute for Clinical Immun. & Rheum., Germany

9 Centocor, United States

10 Duke Medical School, United States

Abstract

Objective: To examine the association of radiographic progression and

disease activity states in patients with rheumatoid arthritis (RA)

treated with methotrexate with or without infliximab.

Methods: Patients (n=1049) with active RA for T3 years and no prior

methotrexate treatment were randomly assigned (4:5:5) to receive

methotrexate plus placebo or methotrexate plus infliximab 3 or 6 mg/kg

at weeks 0, 2, and 6, and every 8 weeks thereafter through week 46.

Disease activity was classified by the simplified disease activity

index (SDAI) score as remission (3.3), low (>3.3 to T11), moderate

(>11 to " T26), high (>26). Radiographic progression was measured as

change from baseline to week 54 in total Sharp score (TSS).

Results: At weeks 14 and 54, more patients receiving methotrexate plus

infliximab than methotrexate plus placebo were in remission (10.7% vs.

2.8% week 14; 21.3% vs. 12.3% week 54; p<0.001 for both). Methotrexate

plus placebo halted radiographic progression only if patients achieved

remission within 3 months, while methotrexate plus infliximab also

halted or minimised progression in patients with low or moderate

activity, respectively. Patients with persistently high disease

activity levels had much less progression of joint damage if treated

with methotrexate plus infliximab versus methotrexate monotherapy.

However, even with infliximab plus methotrexate there was a direct

relationship between disease activity and radiographic changes,

although the slope was deflected when compared to methotrexate

monotherapy.

Conclusion: With methotrexate, joint damage progresses even at low and

moderate disease activity levels, while methotrexate plus infliximab

inhibits radiographic progression across all disease activity states.

http://ard.bmj.com/cgi/content/abstract/ard.2008.090019v2

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