RESEARCH - A long-term, open-label trial of the safety and efficacy of Enbrel in patients with RA not treated with other DMARDs

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Published Online First: 15 March 2006. doi:10.1136/ard.2005.038349

ls of the Rheumatic Diseases 2006;65:1578-1584

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EXTENDED REPORT

A long-term, open-label trial of the safety and efficacy of etanercept

(Enbrel) in patients with rheumatoid arthritis not treated with other

disease-modifying antirheumatic drugs

L Klareskog 1, M Gaubitz 2, V -Valverde 3, M Malaise 4, M

Dougados 5, J Wajdula 6 for The Etanercept Study 301 Investigators

1 Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden

2 Kooperatives Rheumazentrum Munster, Munster, Germany

3 Hospital Universitario Marqués de Valdecilla, Santander, Spain

4 CHU Sart Tilman, Liege, Belgium

5 Hospital Cochin, Paris, France

6 Wyeth Research, Collegeville, Pennsylvania, USA

Objective: To evaluate the long-term safety and efficacy of etanercept

in patients with rheumatoid arthritis.

Methods: 549 patients entered this 5-year, open-label extension study

and received etanercept 25 mg twice weekly. All patients showed

inadequate responses to disease-modifying antirheumatic drugs before

entry into the double-blind studies. Safety assessments were carried

out at regular intervals. Primary efficacy end points were the numbers

of painful and swollen joints; secondary variables included American

College of Rheumatology (ACR) response rate, Disease Activity Score

and acute-phase reactants. Efficacy was analysed using the

last-observation-carried-forward approach.

Results: Of the 549 patients enrolled in the open-label trial, 467

(85%), 414 (75%) and 371 (68%) completed 1, 2 and 3 years,

respectively; 363 (66%) remained in the study at the time of this

analysis. A total exposure of 1498 patient-years, including the

double-blind study, was accrued. In the open-label trial, withdrawals

for efficacy-related and safety-related reasons were 11% and 13%,

respectively. Frequent adverse events included upper respiratory

infections, flu syndrome, rash and injection-site reactions. Rates of

serious infections and malignancies remained unchanged over the course

of the study; there were no reports of patients with central

demyelinating disease or serious blood dyscrasias. After 3 years,

ACR20, ACR50 and ACR70 response rates were 78%, 51% and 27%,

respectively. The Disease Activity Score score was reduced to 3.0 at 3

months and 2.6 at 3 years from 5.1. A sustained improvement was found

in Health Assessment Questionnaire scores throughout the 3-year time

period.

Conclusion: After 3 years of treatment, etanercept showed sustained

efficacy and a favourable safety profile.

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Reead the entire article here:

http://ard.bmj.com/cgi/content/full/65/12/1578

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