RESEARCH - MTX + Remicade versus MTX + 1-year-delayed Remicade

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Arthritis Rheum. 2006 Jan;54(1):47-53.

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.

PC, Steuer A, Gruber J, McClinton C, Cosgrove DO, Blomley MJ,

Marsters PA, Wagner CL, Maini RN.

Kennedy Institute of Rheumatology Division, Imperial College School of

Medicine, London, UK.

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 <3 years) who

were receiving MTX were randomized to receive infliximab 5 mg/kg or placebo

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

Beginning at week 54 and thereafter, all patients received infliximab 5

mg/kg. Metacarpophalangeal joints were scanned using high-frequency

ultrasonography and power Doppler imaging. Radiographs were evaluated using

the modified Sharp/van der Heijde scoring system. RESULTS: From baseline to

week 54, total synovial thickness was significantly improved in the

infliximab + MTX group compared with the placebo + MTX group (median

reduction 95.8% versus 37.5%; 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.

PMID: 16385521

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

6385521 & dopt=Abstract

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