Source: Cancer  |  Posted 9 years ago

Addition of leflunomide to methotrexate provides statistically significant clinical benefit to patients with persistent rheumatoid arthritis who do not respond to methotrexate alone.

This combination is generally well tolerated, report specialists at 20 leading centres in the United States and Canada. The combination can be used safely with appropriate liver enzyme and haematological monitoring, they say.

Their study assessed the efficacy and safety of leflunomide, a disease-modifying anti-rheumatic drug, versus placebo when added to ongoing, stable-dose methotrexate, an antimetabolite agent, in a 24-week, randomised, double-blind trial.

Patients had had persistently active rheumatoid arthritis as defined by standard American College of Rheumatology criteria that did not respond to at least six months of methotrexate treatment.

The primary efficacy variable was the rate of achievement of a 20 percent improvement in American College of Rheumatology criteria (ACR20) at the end of the study. The Health Assessment Questionnaire Disability Index was determined at each visit and the Medical Outcomes Study 36-Item Short Form was completed as an end point analysis.

At 24 weeks, 46.2 percent of patients given leflunomide met ACR20 criteria compared with 19.5 percent of those given placebo (p<0.001). Clinical improvement was shown by statistically significant mean changes in individual components of the ACR20 response criteria.

The two groups had similar discontinuation rates (23.1 versus 24.8 percent.) and incidences of adverse events (89.2 versus 89.5 percent), which were chiefly mild or moderate.