About three quarters (74.2 per cent) of rheumatoid arthritis (RA) patients treated with Enbrel (etanercept) plus methotrexate combination therapy experienced no progression of joint damage over a continuous two-year span, according to the new two-year results from the ongoing TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) study presented at the American College of Rheumatology's Annual Scientific Meeting in San Antonio, Texas.

At two years, 74.2 per cent of patients taking Enbrel and methotrexate combination therapy had no progression of joint damage as assessed by Total Sharp Scores (TSS). These validated scores are calculated by using x-ray measurements to assess joint damage. No progression is defined as a mean change from baseline in TSS less than or equal to 0. By comparison, 65.5 per cent and 59.2 per cent of Enbrel monotherapy and methotrexate monotherapy-treated patients, respectively, had no radiographic progression of joint damage at two years.

Further, data presented at ACR show that improvement in physical function scores were higher for the Enbrel combination group than those taking either therapy alone. Patients treated with Enbrel combination therapy experienced a 56 per cent mean improvement in Health Assessment Questionnaire (HAQ) scores from baseline, compared to 39 per cent mean improvement in patients treated with Enbrel alone and 36 per cent mean improvement in patients treated with methotrexate alone. HAQ scores measure a patient's ability to perform activities of daily living such as dressing, walking and grooming.

"It is remarkable to see that a large majority of patients experienced no progression of joint damage while on Enbrel and methotrexate combination therapy. Moreover, the patients taking the combination therapy had better mean x-ray scores as a group after two years compared to baseline," Desiree van der Heijde, professor of rheumatology, University of Maastricht in the Netherlands said adding, "These data confirm the one year results and underscore the importance of aggressive treatment to help prevent long-term disability."

The Enbrel TEMPO study randomized 686 patients with RA, of which 622 were included in the two-year radiographic analysis. Patients received either Enbrel (25 mg twice weekly), methotrexate (up to 20 mg once weekly), or Enbrel (25 mg twice weekly) plus methotrexate once weekly. Patients in the Enbrel TEMPO trial had active RA and an inadequate response to at least one disease-modifying antirheumatic drug (DMARD) other than methotrexate. The primary radiographic endpoint was the change from baseline in the van der Heijde-modified TSS at one year. Secondary radiographic endpoints included changes in total erosions, changes in total joint space narrowing, number of eroded joints and percent of patients with no radiographic progression. Treatment with Enbrel therapy was generally well-tolerated.

Enbrel is the only fully human TNF receptor approved to reduce signs and symptoms, induce major clinical response, improve physical function, and inhibit the progression of structural damage in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel is approved for first-line treatment of RA patients and can be used alone or in combination with methotrexate.

Amgen Inc and Wyeth Pharmaceuticals, a division of Wyeth, market Enbrel in North America. Wyeth markets Enbrel outside of North America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures Enbrel.