Efficacy and safety of Arava and predisposing factors for treatment response in patients with active RA: RELIEF 6-month data

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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.

Dougados M, Emery P, Lemmel EM, de la Serna R, Zerbini CA, Brin S, van

Riel P.

Rene Descartes University, Hopital Cochin, 27 rue du Faubourg

Saint-Jacques, 75679 Paris Cedex 14, France.

OBJECTIVE: The RELIEF investigation was a 48-week, multicenter,

international study comprising 2 phases. Results from the first phase, a

24-week open-label cohort study that evaluated the safety and efficacy

of leflunomide, as well as predisposing factors to treatment response,

are reported here. METHODS: Patients received leflunomide 100 mg once

daily for 3 days, followed by 20 mg once daily thereafter. All adverse

events were documented. Efficacy variables were 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. At Week 24, baseline

data were analyzed to determine predictive factors for treatment

response. RESULTS: A total of 969 patients were entered in the trial. No

adverse events that have not previously been seen with leflunomide were

reported. Among 968 evaluable patients, 673 (69.6%) completed 24 weeks

of treatment and were responders according to DAS 28 response rate, and

587 (60.6%) completed 24 weeks of treatment and were responders

according to ACR 20%. Thus, there was a high correlation between the

EULAR and ACR criteria in determining treatment response. In addition,

240 (24.8%) patients had a low DAS 28 (< or = 3.2) and 123 (12.7%)

patients fulfilled the disease remission criteria (DAS 28 < 2.6) at the

end of the study.

CONCLUSION: This study demonstrates that leflunomide is well tolerated,

with a safety profile similar to that seen previously in Phase III

studies, and confirms the efficacy of leflunomide across a range of

patient categories.

PMID: 14719196

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