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Community-Based Evaluation of Etanercept in Patients with Rheumatoid Arthritis

PENDAR FARAHANI, MITCHELL LEVINE, KATHRYN GAEBEL, EDWARD C.Y. WANG, and NADER KHALIDI

ABSTRACT.

Objective. Etanercept is one of a new subgroup of biological disease modifying antirheumatic drugs (DMARD) to treat patients with rheumatoid arthritis (RA) who are non-responsive or intolerant to conventional DMARD. We evaluated the effects of etanercept (Enbrel®) therapy in patients with RA in community-based clinical practice in Canada.

Methods. Using a cohort design, patients requesting etanercept therapy were stratified into treatment and control arms based upon their individual accessibility to obtain the drug. Patients were interviewed serially during a 12-month period of monitoring. The study measured painful or tender joint count, morning stiffness, pain severity, quality of life measures, medication utilization, health services utilization, and presence of adverse events.

Results. The baseline demographic and clinical variables for the treatment group (n = 223) and the control group (n = 208) were similar, except for education, income, and drug plan coverage. In followup, there was greater improvement in most clinical variables in the treatment arm compared to the control arm during the first 6 months, but the magnitude of difference between the 2 groups for some clinical variables decreased or became non-significant during the second 6 months. During the 12 month followup period there were 40 (18%) patient dropouts in the treatment group

Conclusion. In a community based setting for the treatment of RA, etanercept can effectively improve the disease state, functional class, work disability, and quality of life during the first 6 months of use. To determine the longterm sustainability of these effects studies with more than 12 months' duration will be required. (First Release Mar 1, 2006; J Rheumatol 2006;33:665–70)

 

Key Indexing Terms:

ETANERCEPT
RHEUMATOID ARTHRITIS
COHORT STUDY


From the Centre for Evaluation of Medicines, St. Joseph's Healthcare, Hamilton, Ontario, Canada.

Supported by a grant from Wyeth Pharma, Markham, Ontario

P. Farahani, MD, Centre for Evaluation of Medicines, St. Joseph's Healthcare; M. Levine, MD, MSc, FRCPC, FISPE, Centre for Evaluation of Medicines, St. Joseph's Healthcare; and Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton; K. Gaebel, MSc, Centre for Evaluation of Medicines; E.C.Y. Wang, PharmD, MBA, Cephalon, Inc. Frazer, Pennsylvania, USA; N. Khalidi, MD, FRCPC, Division of Rheumatology, Department of Medicine, Faculty of Health Sciences, McMaster University.

Address reprint requests to Dr. M. Levine, Centre for Evaluation of Medicines, 105 Main Street East, Level 1, Hamilton, ON L8N 1G6 Canada. E-mail: LEVINEM@mcmaster.ca

Accepted for publication November 25, 2005.


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