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Etanercept Effective In Long-Term Therapy For Rheumatoid Arthritis: Presented at EULAR

By Adrian Burton

LISBON, PORTUGAL -- June 20, 2003 -- Rheumatoid arthritis (RA) can be effectively and safely treated with etanercept for at least 4 years, according to study findings.

The use of the same drug over long periods of time may see changes in its efficacy and safety profiles, and physicians need to be constantly aware of alterations in the risk/benefit ratio. Etanercept has been shown both safe and effective in the treatment of RA, but until now it was not known if it would remain so over the longer term.

To test this, a double-blind, placebo-controlled, multi-centre, open-label trial extension study involving 612 initial patients was undertaken, explained Dr. Joe Wajdula, Clinical Research Director, Wyeth Research, Collegeville Pennsylvania, United States. The findings were presented at the Annual European Congress of Rheumatology yesterday.

Prior to treatment, all patients had inadequate disease modified anti-rheumatic drug (DMARD) scores. All received 25 mg etanercept twice weekly. Seventy eight percent of patients completed 1 year of treatment, 70% completed 2 years, 62% completed 3 years, and 54% completed 4 years. Seventeen percent discontinued treatment because of adverse effects, 14% because of unsatisfactory response.

At baseline, the mean number of painful joints experienced by patients was 31, falling within months to 11. This figure was maintained across the four years for which results are available. Similarly, the mean number of swollen joints fell from a baseline figure of 23 to 7 within months, and once again this improvement was maintained.

The number of patients achieving an American College of Rheumatology (ACR) score of 20 after initiating etanercept treatment was approximately 80%, while 50% achieved an ACR of 50, and 20% achieved an ACR of 70. At the end of the four year follow-up, these figures were also maintained.

Two areas of concern regarding long-term treatment were possible increases in serious infections and malignancies. However, the number of infections per patient year fell slightly from 0.065 in the first year of treatment to 0.043 at 4 years. Malignancies were 0.011 per patient year for the first year of treatment and, 0.014 in years 3-4.

Dr. Wajdula concluded that once response was achieved it was maintained and consistent, and that etanercept could provide continued clinical benefit to RA patients for at least the number of years covered so far by the study.

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