New results from TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) demonstrated that Enbrel (etanercept) therapy allowed significantly more rheumatoid arthritis (RA) patients to achieve clinical remission at two years compared to patients treated with methotrexate alone.
Building on the one-year TEMPO results, this two-year data further supports the continued efficacy of Enbrel therapy over time.
More than 40 per cent of the 231 patients receiving combination therapy of Enbrel and methotrexate achieved clinical remission as assessed by the Disease Activity Score (DAS). Also, a significantly higher percentage of the 223 patients receiving Enbrel alone (23.3 per cent) achieved clinical remission, compared with the 228 patients receiving methotrexate alone (15.8 per cent). Clinical remission is defined as having a DAS of less than 1.6, which measures tender and swollen joints, erythrocyte sedimentation rate (ESR, an inflammatory marker) and overall general health.
Nearly half (48.5 per cent) of patients treated with the Enbrel combination therapy achieved an American College of Rheumatology (ACR) 70 score compared with 27.4 per cent of patients treated with Enbrel and 20.6 per cent of patients treated with methotrexate alone. The ACR response is defined by the level of improvement -20 per cent, 50 per cent, or 70 per cent -where 70 per cent describes an improvement that is greatest in degree and, therefore, most clinically meaningful.
Patients treated with Enbrel combination therapy also experienced significant improvement in functionality after two years. Improvement in functionality was significantly higher for the combination group as assessed by patients' responses to the Health Assessment Questionnaire (HAQ).
"The two-year data from the ongoing TEMPO trial show very good results for the combination of etanercept and methotrexate. We are particularly impressed by the high frequency of remission in patients who have had both a long previous history of RA and high disease activity at the start of the trial," said Lars Klareskog, principal investigator of the study from the rheumatology unit at the Karolinska Institute/Karolinska University Hospital in Stockholm, Sweden.
Treatment with ENBREL or combination therapy was generally well- tolerated. The safety profile was generally consistent with that previously observed, and the combination did not result in increased infections after two years of therapy.
Reports indicates that more than two million Americans suffer from RA, which causes 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.
According to company statements, Enbrel is the only fully human TNF receptor approved to reduce signs and symptoms, improve physical function, and inhibit the progression of structural damage in patients with moderately to severely active RA, and to reduce the signs and symptoms and inhibit the progression of structural damage of active arthritis in patients with psoriatic arthritis.
Amgen Inc and Wyeth Pharmaceuticals market Enbrel in North America. Immunex Corporation, a wholly- owned subsidiary of Amgen, manufactures ENBREL.
These results were presented during the EULAR (European League Against Rheumatism) Annual European Congress of Rheumatology in Berlin, Germany.