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Two Etanercept Dosing Regimens Produce Comparable Outcomes in Patients With Rheumatoid Arthritis

Safety, efficacy, and pharmacokinetics appear comparable in patients with rheumatoid arthritis (RA) who are treated with either etanercept 50 mg once weekly or 25 mg twice weekly, according to the findings of a randomised trial.

Previous research has found that predicted serum levels of etanercept at 50 mg once weekly would be similar to those observed in patients treated with etanercept at 25 mg twice weekly.

Edward C. Keystone, MD, with the Mt. Sinai Hospital, in Toronto, Ontario, Canada, and colleagues anticipated that both efficacy and safety would also be comparable. In addition, once-weekly dosing would be more convenient for patients with inflammatory arthritis who self-administer etanercept subcutaneously.

The researchers randomised 420 patients with RA to receive the study drug for up to 16 weeks: 214 received 50 mg etanercept once weekly, 153 received 25 mg etanercept twice weekly, and 53 received placebo for 8 weeks followed by 25 mg etanercept twice weekly for 8 weeks.

The researchers assessed efficacy and safety at weeks 8 and 16, and performed pharmacokinetic analyses on serum samples from patients at selected study sites. The primary efficacy end point determined by whether or not patients met the American College of Rheumatology (ACR) 20% improvement criteria (ACR20 response) at week 8.

At week 8, 50% of the patients receiving 50 mg etanercept once weekly achieved an ACR20 response compared to 49% of the patients receiving 25 mg etanercept twice weekly, and 19% of the patients in the placebo group (P < .0001 for each etanercept group versus placebo). Likewise, 18% of patients in each of the 2 etanercept groups achieved an ACR50 compared with 6% of patients in the placebo group (P < .03 for each comparison).

At steady state, pharmacokinetics of the 2 etanercept regimens were similar. No clinically significant differences in efficacy or safety were observed between the 2 etanercept groups

According to the researchers, the proportions of patients who experienced serious adverse events were similar in the 2 etanercept treatment groups.

"The results of this 16-week study confirm the predictions of the pharmacokinetic modeling," Dr. Keystone and colleagues conclude.

Arthritis Rheum 2004;50:353-363. "Once-weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis: Results of a multicenter, randomized, double-blind, placebo-controlled trial"

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