RA Treatments - TNF Inhibitors
Alan
Matsumoto, M.D.
Joan Bathon,
M.D.
The new data presented at the ACR meetings for the TNF inhibitors was very exciting. In general, three different agents that inhibit TNF were shown to be disease modifying that is, in addition to reducing the signs and symptoms of the disease, they have now been clearly shown to slow, or even stop, damage to the joints. In these studies, the ability of an agent to slow disease progression was assessed radiographically by suppression of the development of new bone erosions and/or by the suppression of destruction of cartilage (measured by joint space narrowing).
Abstract 280 A Phase III Trial of Etanercept (Enbrel) vs Methotrexate (MTX) in Early Rheumatoid Arthritis (Enbrel ERA Trial)
B Finck, R Martin, R Fleischmann, L Moreland, M Schiff, J Bathon Seattle, Grand Rapids, Dallas, Birmingham, Denver, Baltimore
The purpose of this study was to evaluate the efficacy of etanercept in early disease, to investigate its disease modifying potential, and to compare these results head-to-head with methotrexate. 632 patients had disease of 3 years duration or less, and were randomized to treatment with either etanercept 25 mg, etanercept 10 mg, or methotrexate (MTX) for one year. MTX was rapidly dose escalated to a maximum of 20 mg qwk by the 8th week of study treatment. Patient demographics were similar among the 3 treatment groups, as were the parameters of arthritis activity, at baseline.
Approximately 80% of patients completed 12 months of study drug treatment. A mean dose of 18.3 mg of MTX was achieved. More patients in the MTX group (21%), than 25 mg etanercept group (15%), withdrew for adverse events including persistent elevation of LFTs. MTX and both doses of etanercept were highly effective in reducing the signs and symptoms of RA in these patients. Area Under the Curve (AUC), calculated with numeric-ACR scores, was significantly higher in the etanercept 25 mg group, than in the other 2 groups, at both 6 months (15.3 vs 11.5, respectively, p .002) and 12 months (34.9 vs 28.7, respectively, p .009). Both doses of etanercept and MTX dramatically reduced the rate of radiographic progression, and etanercept 25 mg group was significantly better at reducing the rate of erosions than MTX.