Etanercept Can Be Safely Used for Up to Eight Years

May 15, 2008

Patients with juvenile rheumatoid arthritis can be safely and effectively treated with etanercept for up to eight years, according to the results of a study published in the May issue of Arthritis & Rheumatism.

THURSDAY, May 15 (HealthDay News) -- Patients with juvenile rheumatoid arthritis can be safely and effectively treated with etanercept for up to eight years, according to the results of a study published in the May issue of Arthritis & Rheumatism.

Daniel J. Lovell, M.D., of Children's Hospital Medical Center in Cincinnati, and colleagues enrolled 58 patients who participated in a long-term open-label extension trial of etanercept. The study comprised 318 patient-years of exposure to the drug. In all, 42 (72 percent) of the subjects took etanercept for at least three years and 26 patients (45 percent) entered the eighth year of treatment.

There were 39 serious adverse events reported by 16 patients, and there was no increase in the rate of incidents with an increased period of exposure to the drug, the researchers report. The medically important infection rate was low throughout the period of the study. Using American College of Rheumatology criteria, etanercept remained effective over the course of eight years.

"Efficacy data are reported at each time point only for the patients who chose to continue to receive etanercept treatment," the authors note. "A concern arises that the study population then becomes enriched with patients who are responders, since non-responders withdraw from the study and seek different treatment. However, over the course of this study, only seven patients (12 percent) withdrew because of a lack of efficacy," they write.

The study received support from Immunex Corporation. Several of the study authors report financial relationships with the pharmaceutical industry.

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