The role of methotrexate as combination therapy with etanercept in rheumatoid arthritis: Retrospective analysis of a local registry.

OBJECTIVE: In a real-life setting, to analyse retrospectively the effects of different methotrexate regimens on etanercept efficacy during the first year of treatment for rheumatoid arthritis (RA).

METHODS: Demographic characteristics, clinical parameters and treatment data from patients with RA receiving the first-line biological disease-modifying antirheumatic drug, etanercept, as monotherapy or in combination with methotrexate were analysed at baseline and after 6 and 12 months. The study population was stratified into three groups according to the level of concomitant methotrexate therapy: no methotrexate, low-dose methotrexate (≤ 10 mg/week) or high-dose methotrexate (>10 mg/week).

RESULTS: Clinical response at 6 and 12 months and clinical outcome at 12 months were significantly better in patients concomitantly treated with high-dose methotrexate. Furthermore, this regimen was associated with the lowest discontinuation rate, suggesting a favourable safety profile.

CONCLUSION: These data confirm, in a real-life setting, the importance of methotrexate as a combination therapy with etanercept and suggest that the minimal effective dose of methotrexate is >10 mg/week.