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Switching From Methotrexate to Etanercept (Enbrel) Appears Efficacious and Safe for Rheumatoid Arthritis Patients: Presented at ACR

By Bruce Sylvester

SAN DIEGO, CA -- November 22, 2005 -- Rheumatoid arthritis patients who respond inadequately to methotrexate monotherapy achieved significant improvements in physical function and quality of life when switched to combination etanercept (Enbrel) plus methotrexate therapy or to etanercept monotherapy, researchers reported here.

The research, conducted in Ireland, The Netherlands, Germany, Denmark, and the United States, was presented on November 16^th at the American College of Rheumatology Annual Scientific Meeting (ACR).

"This was a practical study designed to examine the efficacy of combination therapy, and also to test whether it's okay for patients having problems with methotrexate to stop taking it and to continue on with etanercept," said investigator and presenter David MacPeek, MD, clinical investigator, Wyeth Pharmaceuticals, Collegeville, Pennsylvania.

"After 16 weeks we found that patients fared just as well with monotherapy on etanercept," Dr. MacPeek said, "So clinicians may have a bit more confidence in stopping -- if necessary -- methotrexate treatment or methotrexate treatment in combination with etanercept."

The investigators randomized 160 patients to etanercept and 155 to etanercept plus methotrexate. Baseline demographics and disease characteristics for both cohorts were similar.

A Health Assessment Questionnaire (HAQ) was administered at baseline and at week 16. The EuroQol/Quality-of-Life instrument (EQ-5D) and EQ-5D general health visual analog scale (EQ-5D GH VAS) were administered at baseline and at weeks 4, 8, 12, and 16.

At week 16, both treatment groups showed significant improvements in all 3 quality-of-life assessments, with no significant differences appearing between the 2 groups.

"Our study lacks the x-ray data to back it up," Dr. MacPeek noted. "Still, we can say that usually x-ray results follow the general improvements in patient health and the decline in disease activity."

The study's first author is Allister J. Taggart, MD, clinical director of rheumatology, Musgrave Park Hospital, and consultant rheumatologist, Musgrave Park and Belfast City Hospitals, Belfast, Ireland, United Kingdom.

The study was supported by Wyeth Pharmaceuticals.


[Presentation title: Assessment of Functional Status and Quality of Life in a Randomized Study Comparing Etanercept (ENBREL(R)) and Methotrexate With Etanercept Alone in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy: The ADORE Study. Abstract 550]

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