Improved functional ability in patients with rheumatoid arthritis--longterm treatment with leflunomide versus sulfasalazine. European Leflunomide Study Group.

作者: JOACHIM R Kalden , DAVID L Scott , JOSEF S Smolen , MANFRED Schattenkirchner , BLAZ Rozman

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摘要: OBJECTIVE: We previously reported that the new disease modifying antirheumatic drug leflunomide resulted in significant improvement functional ability compared with placebo and sulfasalazine a 6 month double blind, randomized, Phase III trial rheumatoid arthritis (RA). The current study disability cohorts of patients RA from initial who volunteered to continue treatment or sulfasalazine. METHODS: Health Assessment Questionnaire (HAQ) was used assess completing months therapy chose blinded 12 24 extensions. Patients on active regimens continued taking 20 mg/day 2 g/day; those were switched at Month RESULTS: Leflunomide significantly improved patients' (p < = 0.0001) 0.01) months. These changes seen as early 1, improvements cohorts. Mean HAQ scores (-0.65 vs -0.36; p 0.0149); corresponding Disability Index (DI) -0.73 -0.56 not statistically different. is safe well tolerated no unexpected adverse events noted during year period; diarrhea, nausea, alopecia less frequent treatment. CONCLUSION: longterm data confirm improves shown by reductions scores. benefit reflected other efficacy criteria, such global assessments American College Rheumatology response rates, all which showed more than

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