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Leflunomide Appears Safe, Effective In Treatment Of Active Rheumatoid Arthritis

Leflunomide is safe, well tolerated, and effective across a range of patient types for rheumatoid arthritis (RA), according to results obtained in the first phase of the Rheumatoid arthritis Evaluation of Leflunomide further Insights into its EFficacy (RELIEF) study.

"This is the first study of primary therapy with leflunomide and it illustrates the safety and efficacy that may be achieved in daily clinical practice," noted lead researcher Maxime Dougados, MD, of Rene Descartes University, Hopital Cochin, Paris, France, and colleagues.

The RELIEF investigation was a 48-week, multicentre, international study that consisted of 2 phases, the first of which was a 24-week open-label cohort study to evaluate the safety and efficacy of leflunomide, and predisposing factors to treatment response.

The study included 969 patients with active RA, of whom 806 received leflunomide 100 mg once daily for 3 days, followed by 20 mg once daily thereafter for the remainder of the study. Nonsteriodal anti-inflammatory drugs or oral corticosteroids were permitted as concomitant medications.

Efficacy variables, change in disease activity as measured by the European League Against Rheumatism (EULAR) response criteria using the Disease Activity Score (DAS 28) responder rate and response rate according to American College of Rheumatology (ACR) criteria, were evaluated at 4-week intervals and at endpoint.

Of participating patients, 69.6% completed the 24 weeks of treatment and were responders according to DAS 28 response rate, and 60.6% completed 24 weeks of treatment and were responders according to ACR 20%.

Both DAS 28 and ACR 20% response rates revealed treatment responses occurring as early as 4 weeks. In addition, these efficacy variables reached a plateau at 20-24 weeks, suggesting an optimum time for treatment response.

At study end, 24.8% of patients had a low disease activity (DAS 28 less than or equal to 3.2) and 12.7% of patients were in remission (DAS 28 < 2.6). Erythrocyte sedimentation rate and C-reactive protein levels were not observed to influence response to leflunomide.

Adverse events possibly related to treatment occurred in 56.1% of patients, and included diarrhoea (14.6%), hair loss (13.8%), headache (6.1%), nausea (5.8%), hypertension (5.4%), and rash (4.5%).

The study was supported by Aventis Pharma.

J Rheumatol 2003 Dec;30:12:2572-9. "Efficacy and Safety of Leflunomide and Predisposing Factors for Treatment Response in Patients with Active Rheumatoid Arthritis: RELIEF 6-Month Data"

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