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. Results were presented today during the EULAR (European League Against
Rheumatism) Annual European Congress of
Rheumatology in Berlin, Germany.
“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, M.D., Ph.D., principal investigator of the study from the rheumatology unit at the Karolinska Institute/Karolinska University Hospital in Stockholm, Sweden.
More than 40 percent 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 percent) achieved clinical remission, compared with the 228 patients receiving methotrexate alone (15.8 percent). Clinical remission is defined as having a DAS of <1.6, which measures tender and swollen joints, erythrocyte sedimentation rate (ESR, an inflammatory marker) and overall general health.
Nearly half (48.5 percent) of patients treated with the ENBREL combination therapy achieved an American College of Rheumatology (ACR) 70 score compared with 27.4 percent of patients treated with ENBREL and 20.6 percent of patients treated with methotrexate alone. ACR scores measure improvement in RA disease activity, including joint swelling and tenderness, pain, level of disability and overall patient- and physician assessment. The ACR response is defined by the level of improvement – 20 percent, 50 percent, or 70 percent – where 70 percent describes an improvement that is greatest in degree and, therefore, most clinically meaningful.