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Leflunomide is a safe and effective treatment in patients with active rheumatoid arthritis, according to a European team of researchers. Dr. Maxime Dougados, from Hopital Cochin, Paris, and colleagues examined the safety and efficacy of leflunomide, one of a novel class of disease modifying antirheumatic drugs (DMARD), that may be achieved in clinical practice. They report the results of the first phase of the RELIEF study, which involved a 24-week, open-label cohort, in the December issue of the Journal of Rheumatology. The 969 participants received 100 mg leflunomide once daily for 3 days, followed by 20 mg once daily thereafter. The team recorded all adverse events. Efficacy variables included the European League Against Rheumatism (EULAR) response criteria using the Disease Activity Score (DAS 28) responder rate and the response rate according to American College of Rheumatology (ACR) criteria.
The team observed no adverse events that had not previously been reported with leflunomide. Of the 968 evaluable patients, 69.6% were responders according to DAS 28 and 60.6% were responders according to ACR criteria. "There was a high correlation between the EULAR and ACR criteria in determining treatment response," Dr. Dougados and colleagues report. They found that at study endpoint, 24.8% had low disease activity and 12.7% met the criteria for disease remission. Overall, the findings "confirm the acceptable safety profile and clinical efficacy of leflunomide in patients with active RA," they write. The data also suggest that this drug is effective "across a broad range of patient characteristics as there were no clinically significant differences in predisposing factors to treatment response." J Rheumatol 2003;30:2572-2579. Source: Medscape