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Etanercept/Methotrexate Combination Appears More Effective Rheumatoid Arthritis Treatment Than Either as Monotherapy: Presented at EULAR

By Paula Moyer

BERLIN, GERMANY -- June 15, 2004 -- Patients with rheumatoid arthritis fare better with a combination of etanercept (Enbrel) and methotrexate than with either drug as monotherapy, according to study findings.

In a presentation here June 10th at the European Congress of Rheumatology, principal investigator Lars Klareskog, MD, said,
"On the basis of our findings, there is no reason not to give a biologic therapy to a patient who is a candidate for it." He added, "Combined etanercept and methotrexate was more efficacious than either monotherapy for controlling disease activity." Dr. Klareskog is professor and chair of the rheumatology clinic and rheumatology research unit at the Karolinska Institute, in Stockholm, Sweden.

He and coinvestigators recruited 682 patients who had not responded to DMARDs to participate in a double-blind randomized study, the Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes (TEMPO). In this trial, 223 patients received 25 mg of etanercept twice weekly, 228 received up to 20 mg of methotrexate weekly, and 231 received a combination of etanercept with methotrexate. The investigators followed the patients for 2 years.

Outcomes measures included reductions of 20%, 50%, and 70% in the American College of Rheumatology criteria (ACR 20, 50, and 70), the disease activity score (DAS), rates of DAS remission, and mean percentage improvement in HAQ and C-reactive protein (CRP).

After 2 years, 40.7% of patients treated with the combination achieved remission, Dr. Klareskog said, noting that remission was documented in 15.8% of patients treated with methotrexate and 23.3% treated with etanercept monotherapies (P <.05). In the combination therapy arm, patients had a mean CRP improvement of 75.3%, compared to 54.2% in the etanercept monotherapy arm and 49.2% in the methotrexate monotherapy arm. The mean DAS scores were 2.2 in the combination therapy arm, 2.9 in the etanercept arm, and 3.0 in the methotrexate arm. In that order, the DAS remission rates were 55.8%, 38.8%, and 35.8%, respectively.

Among the patients overall, 71% of patients in the combination group remained in the study, compared with 52% in the methotrexate arm and 61% in the etanercept alone groups (P <.05). Fewer patients treated with combination therapy discontinued from the study because of lack of efficacy, 4%, compared with 14% of patients in the methotrexate arm and 13% of those in the etanercept arm (P <.05).

Dr. Klareskog reported that treatment with etanercept, either as monotherapy or in the combination, was well tolerated. No new safety findings were observed and the combination did not result in increased infections after 2 years of therapy, he concluded.


[Presentation title: Clinical Outcomes of a Double-Blind Study of Etanercept and Methotrexate, Alone and Combined, in Patients With Active Rheumatoid Arthritis (TEMPO Trial): Year 2 Results. Abstract OP003]

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