This article is more than 5 years old. Information may no longer be current.
Etanercept efficacy may not be dependent on methotrexate background therapy
Click Here to Manage Email Alerts
Improvements in disease activity in patients with rheumatoid arthritis who were treated with etanercept were not related to the dosage of background therapy with methotrexate, according to an analysis of results of two clinical trials.
Researchers analyzed the data from the Combination of Methotrexate and Etanercept in Active Early Rheumatoid Arthritis results (COMET) and Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes (TEMPO) studies. In each trial, patients received 7.5 mg per week of methotrexate, which was increased to 15-mg methotrexate in the presence of inadequate response, or 20-mg methotrexate at 8 weeks in the presence of an inadequate response.
At 24 months, 276 patients with rheumatoid arthritis (RA) received both methotrexate and etanercept (Enbrel, Amgen) and 218 patients received methotrexate monotherapy. The mean dose of methotrexate at 24 months was 11 mg. The median dose was 10 mg and remained stable throughout the study.
Numerically similar rates of remission based on DAS28 criteria were observed at 6 months, 12 months and 24 months. At 24 months, greater than 60% of patients who received both etanercept and methotrexate met DAS28 remission or low disease activity criteria, while patients who received methotrexate monotherapy were less likely to achieve remission or low disease activity.
Improvements in baseline DAS28, Health Assessment Questionnaire-Disability Index and EuroQol 5-Dimensions were unrelated to methotrexate dosage.
“In this subanalysis of two large randomized [etanercept] ETN studies, achievement of core clinical outcomes was independent of the dose of [methotrexate] MTX used,” the researchers wrote. “This suggests that low doses of MTX can be considered in cases of MTX intolerance or
for patients in remission who no longer wish to take high-dose MTX due to its adverse event profile.” – by Shirley Pulawski
Disclosure s : Gallo reports being a full-time employee at Pfizer. Please see the entire study for all authors’ full disclosure information.
Click Here to Manage Email Alerts