Efficacy and safety of the new DMARD leflunomide: comparison to placebo and sulfasalazine in active rheumatoid arthritis.
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.
Smolen
J S
JS
Division of Rheumatology, University of Vienna, Austria.
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000627:therapeutic use*; D000077339:Leflunomide; D008297:Male; D008875:Middle Aged; D011859:Radiography; D012449:Safety; D013997:Time Factors
D000894:Anti-Inflammatory Agents, Non-Steroidal; D018501:Antirheumatic Agents; D007555:Isoxazoles; D000077339:Leflunomide