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.
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). Patients treated with ENBREL combination therapy experienced a 56 percent mean improvement in HAQ scores from baseline, compared to 39 percent mean improvement in patients treated with ENBREL alone and 36 percent mean improvement in patients treated with methotrexate alone.
Also presented at the meeting were data from the first year of the TEMPO study, showing that 80 percent of the combination-treated patients experienced no progression of joint damage on radiographs at one year as assessed by the van der Heijde-modified Total Sharp Score (TSS), compared with 68 percent of the patients treated with ENBREL monotherapy and 57 percent of patients treated with methotrexate monotherapy. The TSS is an X-ray measurement of changes in joint damage. “No progression” is defined as a unit change from baseline of
TSS < 0.5.
The ENBREL TEMPO study randomized 682 patients with RA to one of three treatment groups: ENBREL (25 mg twice weekly), methotrexate (up to 20 mg once weekly), or ENBREL (25 mg twice weekly) plus methotrexate. Patients in the ENBREL TEMPO trial had active RA and had failed at least one disease-modifying antirheumatic drug other than methotrexate.
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.