Ultrasonographic and radiographic results from a two‐year controlled trial of immediate or one‐year–delayed addition of infliximab to ongoing methotrexate therapy in patients with erosive early rheumatoid arthritis

Abstract

Objective To compare the impact of immediate and delayed introduction of anti–tumor necrosis factor therapy on inflammation and structural damage in methotrexate (MTX)–treated patients with early rheumatoid arthritis (RA). Methods Twenty‐four patients with erosive early RA (duration P = 0.005), as was the total color Doppler area (CDA; vascularity assessment) (median reduction 100% and 47.1%, respectively; P = 0.025). From week 0 to week 110, no significant between‐group difference was observed in the change from baseline for total synovial thickening or the total CDA. At week 54, greater progression in the Sharp/van der Heijde score was apparent in patients receiving placebo + MTX compared with those receiving infliximab + MTX. Although radiographic progression in the placebo + MTX group was greatly reduced in the second year (after initiation of infliximab therapy), marked differences were observed between the infliximab + MTX group (median change in the Sharp/van der Heijde score 4.0) and the placebo + MTX group (median change 14.5) from baseline to week 110 (P = 0.076). Conclusion The results indicate that the efficacy of 2 years of combination therapy with infliximab + MTX for inhibiting cumulative structural damage was superior to that of 1 year of treatment with MTX alone followed by the addition of infliximab.