Efficacy and safety of the new DMARD leflunomide: comparison to placebo and sulfasalazine in active rheumatoid arthritis

Scand J Rheumatol Suppl. 1999:112:15-21. doi: 10.1080/030097499750042245-1.


The efficacy and safety of the novel DMARD leflunomide was compared to placebo and sulfasalazine in a randomized, double-blind study. At Week 24, leflunomide significantly reduced tender and swollen joint counts and physician and patient assessment scores compared to placebo (P < 0.001). Response rates with leflunomide were significantly greater than placebo: ACR 20% (55% vs 29%, P = 0.0001). Comparable response rates were observed with sulfasalazine (ACR 20%: 56%). Leflunomide significantly improved HAQ scores compared to placebo or sulfasalazine (P < 0.009). The onset of action with leflunomide was rapid and was seen as early as Week 2. Radiographic disease progression was significantly slower with leflunomide than placebo (P < 0.01). Leflunomide was well tolerated. No long-term safety issues were reported with leflunomide in patients who opted to continue treatment for up to 2 years. Efficacy of leflunomide in the treatment of RA was maintained at 2 years.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Antirheumatic Agents / therapeutic use*
  • Arthritis, Rheumatoid / diagnostic imaging
  • Arthritis, Rheumatoid / drug therapy*
  • Double-Blind Method
  • Female
  • Humans
  • Isoxazoles / therapeutic use*
  • Leflunomide
  • Male
  • Middle Aged
  • Radiography
  • Safety
  • Time Factors


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