Improved functional ability in patients with rheumatoid arthritis - Longterm treatment with leflunomide versus sulfasalazine

Objective. We previously reported that the new disease modifying antirheuma tic drug leflunomide resulted in significant improvement in functional abil ity compared with placebo and sulfasalazine in a 6 month double blind, rand omized, Phase III trial in rheumatoid arthritis (RA). The current study com pared functional disability in cohorts of patients with RA from the initial study who volunteered to continue treatment with leflunomide or sulfasalaz ine. Methods. The Health Assessment Questionnaire (HAQ) was used to assess funct ional ability in patients completing 6 months of therapy who chose to conti nue in double blinded 12 and 24 month extensions. Patients on active regime ns continued taking leflunomide 20 mg/day or sulfasalazine 2 g/day; those t aking placebo were switched at Month 6 to sulfasalazine. Results. Leflunomide significantly improved patients' functional ability co mpared to placebo (p less than or equal to0.0001) and sulfasalazine (p less than or equal to0.01) at 6 months. These changes were seen as early as Mon th 1, and continued improvements were seen in 12 and 24 month cohorts. Mean HAQ scores were significantly improved with leflunomide compared with sulf asalazine at 24 months (-0.65 vs -0.36; p = 0.0149); corresponding changes in HAQ Disability Index (DI) were -0.73 vs -0.56 and were not statistically different. Leflunomide is safe and well tolerated and no unexpected advers e events were noted during the 2 year period: diarrhea, nausea, and alopeci a were less frequent with continued treatment. Conclusion. These longterm data confirm leflunomide improves functional abi lity as shown by reductions in HAQ scores. The benefit of leflunomide is re flected in other efficacy criteria, such as global assessments and the Amer ican College of Rheumatology response rates, all of which showed significan tly more improvement with leflunomide than sulfasalazine at 24 months.