Etanercept Better Than Methotrexate in Rheumatoid Arthritis

Laurie Barclay, MD

June 28, 2002

July 1, 2002 -- Etanercept was significantly better than methotrexate in patients with early but aggressive rheumatoid arthritis (RA), according to results of a double-blind, randomized trial reported in the June issue of Arthritis & Rheumatism. This study is the largest and longest trial to date comparing two continuous monotherapies in patients with early RA.

"Etanercept is a fully human fusion protein that inhibits tumor necrosis factor and the subsequent inflammatory cytokine cascade," write Mark C. Genovese, from Stanford University in California, and colleagues. "Etanercept as monotherapy was safe and was superior to methotrexate in reducing disease activity, arresting structural damage and decreasing disability over two years in patients with early, aggressive RA."

In the Enbrel ERA (early RA) trial, 632 patients with early, active RA were randomized to treatment with twice weekly subcutaneous etanercept, 10 mg or 25 mg, or weekly oral methotrexate (mean dosage, 19 mg/week) for at least one year, followed by an additional year of open-label treatment with the same agent.

At 24 months, 72% of patients receiving 25 mg etanercept and 59% of patients receiving methotrexate met American College of Rheumatology criteria for 20% improvement ( P=.005). Radiologists blinded to treatment group assignment and to chronologic order of X-rays determined that joint erosion was significantly less in the etanercept group ( P=.01).

Improvement of at least 0.5 units on the Health Assessment Questionnaire disability index occurred in 55% of patients receiving 25 mg etanercept but in only 37% of patients receiving methotrexate ( P<.001). Fewer patients receiving etanercept than those receiving methotrexate had adverse events or discontinued treatment because of adverse events.

Study limitations include lower sensitivity of the radiographs and of the scoring system, and the open-label design of the second year of the study.

"Results of the current trial support the utility of early aggressive therapy, because the significant impact on disease progression may reduce the functional decline that occurs over many years," the authors write.

Immunex provided financial support to some of this study's authors. Arthritis Rheum. 2002;46(6):1443-1450

Reviewed by Gary D. Vogin, MD

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