Enbrel plus Methotrexate: First treatment to demonstrate ability to inhibit radiographic progression of joint damage for three consecutive years
THOUSAND OAKS, Calif. and COLLEGEVILLE, Pa., November 13, 2005 – Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced data from a long-term blinded study of anti-TNF agent in patients with rheumatoid arthritis (RA) demonstrated that more than three quarters of patients treated with Enbrel® (etanercept) plus methotrexate combination therapy experienced no progression of joint damage at three years. These new results from the TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) study will be presented at the American College of Rheumatology's (ACR) Annual Scientific Meeting in San Diego, California.
"Rheumatoid arthritis is a chronic condition requiring long-term treatment. It is critical to provide patients with treatment options that not only reduce the signs and symptoms of the disease, but also inhibit the progression of joint damage," said Désirée van der Heijde, M.D., professor of rheumatology, University of Maastricht in the Netherlands. "The TEMPO results reinforce the benefits of ENBREL and methotrexate combination therapy and underscore the importance of effective treatment."
At three years, the majority of patients taking ENBREL and methotrexate combination therapy had no progression of joint damage. These results were significantly better than those achieved in ENBREL monotherapy and methotrexate monotherapy-treated patients. Patients receiving ENBREL monotherapy also had significantly better results than patients receiving methotrexate monotherapy. Total Sharp Score was calculated by assessing changes in joint space narrowing and bone erosion as captured by radiographic imaging.
Further, additional data presented at ACR showed that improvement in physical function was higher for the ENBREL combination group than for either therapy alone. Patients treated with ENBREL combination therapy experienced a 56 percent mean improvement in Health Assessment Questionnaire (HAQ) scores from baseline, compared to 37 percent mean improvement in patients treated with ENBREL alone and 33 percent 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.
The ENBREL TEMPO study randomized 686 patients with RA, of which 638 were included in the three-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.
ENBREL was generally well tolerated.
More than two million Americans suffer from RA, which can cause stiffness, swelling, and limitation in the motion and function of multiple joints. If RA is left untreated, patients can become disabled from joint damage caused by the disease, limiting their ability to function.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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