Addition of infliximab to ongoing MTX therapy in patients w/erosive early arthritis

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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.

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

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 [PubMed - in process]