To assess the safety and effectiveness of leflunomide (LNF) using 100 mg/week in patients with rheumatoid arthritis (RA).
Patients who were clinically active using the American College of Rheumatology criteria for RA were enrolled. They received a loading dose of 100 mg of LFN for 3 days, followed by 100 mg of LFN weekly. Efficacy and adverse events (AE) were recorded.
Fifty patients were enrolled; 46 (93.6%) were women with a mean age of 45.6 years (range: 24 to 83). Disease duration was 3.7 years (range: 0.5 to 12). Twenty patients (40.8%) had previously taken disease modifying antirheumatic drugs. Outcomes achieved after 24 weeks of treatment were as follows: ACR20 (74%), ACR50 (64%), and ACR70 (28%). Five patients were withdrawn due to AE: 2 due to urticaria, 2 patients had elevated liver enzymes, and one had thrombocytopenia. Six patients (12%) were lost to followup. No severe AE were seen.
The results in our preliminary report indicate that using a 100 mg/week dose achieves a similar benefit to the LFN 20 mg/day treatment, and there were no severe AE. In addition, a single LFN weekly dose has better treatment compliance. A secondary important benefit is the reduction of the monthly cost of medication. Comparative and blind trials are necessary in order to confirm longterm improvement and benefits on this regimen.