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Clinical Trial
. 2004 Feb;63(2):149-55.
doi: 10.1136/ard.2003.013961.

Infliximab in active early rheumatoid arthritis

Affiliations
Clinical Trial

Infliximab in active early rheumatoid arthritis

F C Breedveld et al. Ann Rheum Dis. 2004 Feb.

Abstract

Objective: To examine the impact of the combination of infliximab plus methotrexate (MTX) on the progression of structural damage in patients with early rheumatoid arthritis (RA).

Methods: Subanalyses were carried out on data for patients with early RA in the Anti-TNF Therapy in RA with Concomitant Therapy (ATTRACT) study, in which 428 patients with active RA despite MTX therapy received placebo with MTX (MTX-only) or infliximab 3 mg/kg or 10 mg/kg every (q) 4 or 8 weeks with MTX (infliximab plus MTX) for 102 weeks. Early RA was defined as disease duration of 3 years or less; 82 of the 428 patients (19%) met this definition. Structural damage was assessed with the modified van der Heijde-Sharp score. The changes from baseline to week 102 in total modified van der Heijde-Sharp score were compared between the infliximab plus MTX groups and the MTX-only group.

Results: The erosion and joint space narrowing scores from baseline to week 102 in the cohort of patients with early RA decreased significantly in each infliximab dose regimen compared with the MTX-only regimen. Consistent benefit was seen in the joints of both hands and feet.

Conclusions: Infliximab combined with MTX inhibited the progression of structural damage in patients with early RA during the 2 year period of treatment. Early intervention with infliximab in patients with active RA despite MTX therapy may provide long term benefits by preventing radiographic progression and preserving joint integrity.

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Figures

Figure 1
Figure 1
Median change in total radiographic score from baseline to week 102 for all patients with RA (All) v patients with early RA (ERA) who were randomised to MTX only (MTX) or infliximab plus MTX (Infliximab+MTX) in ATTRACT (disease duration ⩽3 years).
Figure 2
Figure 2
Median change in erosion scores from baseline to week 102 for patients with early RA in ATTRACT (disease duration ⩽3 years).
Figure 3
Figure 3
Median change in joint space narrowing scores from baseline to week 102 for patients with early RA in ATTRACT (disease duration ⩽3 years).
Figure 4
Figure 4
Proportions of patients with change >SDD and change >0.5 from baseline in modified van der Heijde-Sharp score at week 102. p = 0.069 for 3 mg/kg every 4 weeks v placebo, >0.5 cut off criteria. p<0.05 infliximab v placebo for all other comparisons.

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