Once-weekly administration of 50 mg of Enbrel in patients with active RA

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Arthritis Rheum. 2004 Feb;50(2):353-63.

Once-weekly administration of 50 mg etanercept in patients with active

rheumatoid arthritis: Results of a multicenter, randomized,

double-blind, placebo-controlled trial.

Keystone EC, Schiff MH, Kremer JM, Kafka S, Lovy M, DeVries T, Burge DJ.

Mt. Sinai Hospital, Toronto, Ontario, Canada.

OBJECTIVE: To evaluate the safety, efficacy, and pharmacokinetics of 50

mg etanercept administered subcutaneously once weekly in adult patients

with active rheumatoid arthritis (RA). METHODS: Four hundred twenty RA

patients were randomized to receive, in a blinded manner, the study drug

for up to 16 weeks: 214 patients 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. Efficacy

and safety were assessed at weeks 8 and 16. Pharmacokinetic analyses

were performed on serum samples from patients at selected study sites.

The primary efficacy end point was achievement of the American College

of Rheumatology (ACR) 20% improvement criteria (ACR20 response) at week

8. RESULTS: An ACR20 response was achieved at week 8 by 50% of the

patients receiving 50 mg etanercept once weekly, by 49% of the patients

receiving 25 mg etanercept twice weekly, and by 19% of the patients in

the placebo group (P </= 0.0001 for each etanercept group versus

placebo). Similarly, achievement of the ACR50 response was attained by

18% of patients in each of the 2 etanercept groups, compared with 6% of

patients in the placebo group (P < 0.03 for each comparison).

Pharmacokinetics of the 2 etanercept regimens were similar at steady

state. No clinically significant differences in efficacy or safety were

observed between the 2 etanercept groups.

CONCLUSION: Safety, efficacy, and pharmacokinetics were comparable

between the 2 etanercept dosing regimens. Thus, comparable clinical

outcomes are to be expected when patients are treated with etanercept

administered either as 50 mg once weekly or as 25 mg twice weekly.

PMID: 14872476

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