A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis

Background: Etanercept, which blocks the action of tumor necrosis factor, r educes disease activity in patients with long-standing rheumatoid arthritis . Its efficacy in reducing disease activity and preventing joint damage in patients with active early rheumatoid arthritis is unknown. Methods: We treated 632 patients with early rheumatoid arthritis with eithe r twice-weekly subcutaneous etanercept (10 or 25 mg) or weekly oral methotr exate (mean, 19 mg per week) for 12 months. Clinical response was defined a s the percent improvement in disease activity according to the criteria of the American College of Rheumatology. Bone erosion and joint-space narrowin g were measured radiographically and scored with use of the Sharp scale. On this scale, an increase of 1 point represents one new erosion or minimal n arrowing. Results: As compared with patients who received methotrexate, patients who received the 25-mg dose of etanercept had a more rapid rate of improvement, with significantly more patients having 20 percent, 50 percent, and 70 per cent improvement in disease activity during the first six months (P<0.05). The mean increase in the erosion score during the first 6 months was 0.30 i n the group assigned to receive 25 mg of etanercept and 0.68 in the methotr exate group (P=0.001), and the respective increases during the first 12 mon ths were 0.47 and 1.03 (P=0.002). Among patients who received the 25-mg dos e of etanercept, 72 percent had no increase in the erosion score, as compar ed with 60 percent of patients in the methotrexate group (P=0.007). This gr oup of patients also had fewer adverse events (P=0.02) and fewer infections (P=0.006) than the group that was treated with methotrexate. Conclusions: As compared with oral methotrexate, intravenous etanercept act ed more rapidly to decrease symptoms and slow joint damage in patients with early active rheumatoid arthritis. (N Engl J Med 2000;343:1586-93.) (C) 20 00, Massachusetts Medical Society.