Etanercept and Methotrexate combination has demonstrated improvement in physical function and kept joint damage from progressing

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Rheumatoid arthritis: Etanercept and Methotrexate combination has

demonstrated improvement in physical function and kept joint damage

from progressing

Data from a long-term blinded study of anti-TNF agent in patients

with rheumatoid arthritis 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 were

presented at the American College of Rheumatology's ( ACR ) Annual

Scientific Meeting.

" 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, at the University of Maastricht in the Netherlands. " The

TEMPO results reinforce the benefits of Etanercept and Methotrexate

combination therapy and underscore the importance of effective

treatment. "

At three years, the majority of patients taking Etanercept and

Methotrexate combination therapy had no progression of joint damage.

These results were significantly better than those achieved in

Etanercept monotherapy and Methotrexate monotherapy-treated patients.

Patients receiving Etanercept monotherapy also had significantly

better results than patients receiving Methotrexate monotherapy.

Further, additional data showed that improvement in physical function

was higher for the Etanercept combination group than for either

therapy alone.

Patients treated with 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 Etanercept 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 TEMPO study randomized 686 patients with rheumatoid arthritis ,

of which 638 were included in the three-year radiographic analysis.

Patients received either Etanercept ( 25 mg twice weekly ),

Methotrexate ( up to 20 mg once weekly ), or Etanercept ( 25 mg twice

weekly ) plus Methotrexate once weekly.

Patients in the TEMPO trial had active rheumatoid arthritis 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.

Source: Amgen, 2005