RESEARCH - Once-weekly administration of 50 mg 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. edkeystone@...

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

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Retrieve & dopt=Abstra\

ct & list_uids=14872476

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