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Etanercept in Early Erosive Rheumatoid Arthritis (ERA Trial): Observations at 4 Years: Presented at ACR

By Bruce Sylvester

NEW ORLEANS, LA -- October 29, 2002 -- Researchers report that after four years, continuous monotherapy with etanercept (Enbrel) 25 mg twice weekly is safe and effective for the long-term treatment of early erosive rheumatoid arthritis (RA).

The finding was presented Monday at the meeting of the American College of Rheumatology.

In a previously published two-year, a double-blind, multicentre trial, subjects with early erosive RA who received treatment with etanercept 25 mg twice weekly achieved greater improvement in signs and symptoms of RA and inhibition of radiographic progression than treatment with methotrexate (Bathon, N Engl J Med 2000;343:1586-93; Genovese, Arthritis Rheum 2002;45[6]).

Subsequently, investigators reported data at three years on subjects who continued to receive etanercept 25 mg twice weekly in an open-label extension study (Genovese, Arthritis Rheum 2001;44:S78).

After one year in the randomised trial, subjects were allowed to taper treatment with etanercept or discontinue corticosteroids.

Out of 207 subjects randomised to 25 mg etanercept twice weekly in the two-year blinded trial, the investigators report that 161 continued in the open-label extension, and 136 subjects continue to use the regimen and participate in the on-going research.
The researchers evaluate for safety and efficacy every three months. They evaluate radiographic data annually.

At four years of etanercept therapy, 79 percent of the active subjects had achieved the American College of Rheumatology (ACR) 20, 58 percent had achieved the ACR 50, and 31 percent the ACR 70.

The investigators also noted that, after four years, 27 percent of subjects had no tender joints, 21 percent had no swollen joints, 23 percent had a zero Health Assessment Questionnaire score, and 73 percent had achieved a normal C-reactive protein level.

Radiographic progression continues to slow for subjects receiving 25 mg etanercept as it has throughout the study. Radiographic progression declined by 0.90 Sharp units per year in the first year, 0.57 Sharp units per year in the second year and 0.37 Sharp/units per year in the third year.

In the first year of the trial, 37 (50 percent) of 74 patients using corticosteroids were able to reduce their doses or discontinue their use. In ensuing years, 62 percent (year 2), 68 percent (year 3), and 73 percent (year 4) of patients reduced or ended their use of steroids.

The investigators report that etanercept therapy continues to be safe. Rates of infections requiring hospitalization or intravenous antibiotics, malignancies, and significant adverse events have not increased when compared to the original groups in the controlled trial.

"Etanercept 25 mg twice weekly as monotherapy has sustained safety and efficacy in the long-term treatment of early erosive rheumatoid arthritis," wrote lead author Mark Genovese, assistant professor of medicine at Stanford University Medical School in Stanford, CA.

The research was support by Immunex.

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