Rheumatoid arthritis treatment with weekly leflunomide: an open-label study

J Rheumatol. 2004 Feb;31(2):235-7.

Abstract

Objective: To assess the safety and effectiveness of leflunomide (LNF) using 100 mg/week in patients with rheumatoid arthritis (RA).

Methods: 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.

Results: 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 Five patients were withdrawn due to AE: 2 due to urticaria, 2 patients had elevated liver enzymes, and one had thrombocytopenia.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.

Conclusion: 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.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Arthritis, Rheumatoid / drug therapy*
  • Female
  • Humans
  • Isoxazoles / administration & dosage*
  • Isoxazoles / adverse effects
  • Leflunomide
  • Male
  • Middle Aged
  • Treatment Outcome

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Isoxazoles
  • Leflunomide