Amsterdam Rheumatoid arthritis patients who are on standard methotrexate therapy may benefit from the addition of the biologic treatment, ENBREL* (etanercept), according to new data from a one-year, open-label extension of the international TEMPO trial. The study results, presented today at the Annual European Congress of Rheumatology, also known as the European League Against Rheumatism (EULAR), 2006, also showed that the safety profile and clinical efficacy of combination therapy of ENBREL and methotrexate were sustained at four years of treatment.1

The TEMPO extension trial was an open-label 52 week study involving subjects who had completed the 3-year double-blind TEMPO trial. At the end of the 3-year TEMPO trial, 227 subjects who met the specific predefined criteria continued into the 1-year, open-label extension. All subjects received treatment with the combination of ENBREL and methotrexate. Subjects receiving methotrexate monotherapy during the 3-year double-blind TEMPO trial were switched to the combination of ENBREL and methotrexate (n = 55). Subjects receiving ENBREL monotherapy during the 3-year double-blind TEMPO trial were switched to the combination of ENBREL and methotrexate (n = 76). Subjects receiving combination therapy during the 3-year double-blind TEMPO trial were continued on the same regimen (n = 96).

Commenting on the implications of the results, study investigator Dr Emilio Martn Mola, chief of the rheumatology department, Hospital Universitario de La Paz in Madrid and professor, Universidad Autnoma de Madrid, Spain said: "Patients with rheumatoid arthritis, who have active disease after an adequate regimen of methotrexate, can improve significantly when etanercept is added. Whether newly diagnosed patients with active rheumatoid arthritis should be put on this combination regimen is a matter for discussion, but it is a good therapeutic strategy for those patients with aggressive, rheumatoid arthritis."

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Contact: Jes Lauritzen
jes.lauritzen@ketchum.com
44-781-437-7386
Ketchum
22-Jun-2006

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