RESEARCH - Longterm safety, efficacy, and radiographic outcome with Enbrel in patients with early RA

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J Rheumatol. 2005 Jul;32(7):1232-42.

Longterm safety, efficacy, and radiographic outcome with etanercept

treatment in patients with early rheumatoid arthritis.

Genovese MC, Bathon JM, Fleischmann RM, Moreland LW, RW, Whitmore JB,

Tsuji WH, Leff JA.

OBJECTIVE: To evaluate safety, efficacy, and radiographic progression in

patients with early rheumatoid arthritis (RA) undergoing longterm treatment

with etanercept. METHODS: Patients with early RA (disease duration of 3

years or less) who had completed a 2-year efficacy study comparing

etanercept and methotrexate (MTX) were followed in an extension where they

received 25 mg etanercept twice weekly. Safety was summarized descriptively

and compared with data from the efficacy study. Efficacy and radiographic

progression were assessed using American College of Rheumatology response

criteria, disease activity scores, and Total Sharp Score (TSS). RESULTS:

Rates of serious adverse events and serious infections did not increase with

longterm exposure to etanercept, and were similar to rates reported for the

blinded portion of the efficacy study. Efficacy was sustained in patients

who completed 5 years of etanercept treatment at the time of this report (N

= 201), even in those who decreased or discontinued use of MTX or

corticosteroids. No radiographic progression (change in TSS </= 0) was seen

in 55% of patients with 5-year radiographs; negative change (TSS < 0) was

seen in 11%. CONCLUSION: Etanercept treatment in patients with early RA was

generally well tolerated for up to 5 years. The results indicate sustained

efficacy and decreased rate of radiographic progression. The rate of

radiographic progression was low compared with other studies, emphasizing

the benefit gained in patients with early aggressive RA who undergo longterm

treatment with etanercept.

PMID: 15996057

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

5996057 & dopt=Abstract

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