Efficacy and safety of leflunomide and predisposing factors for treatment response in patients with active rheumatoid arthritis: RELIEF 6-month data.
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.


CONCLUSIONS
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.
Dougados
Maxime
M
René Descartes University, Hôpital Cochin, 27 rue du Faubourg Saint-Jacques, 75679 Paris Cedex 14, France.
Emery
Paul
P
Lemmel
Ernst-Martin
EM
de la Serna
Rodriguez
R
Zerbini
Cristiano A
CA
Brin
Sylvie
S
van Riel
Piet
P
D000328:Adult; D000368:Aged; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000503:physiopathology; D015331:Cohort Studies; D004185:Disability Evaluation; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D006304:Health Status; D006801:Humans; D007391:International Cooperation; D007555:Isoxazoles / Q000627:therapeutic use*; D007596:Joints / Q000187:drug effects / Q000503:physiopathology; D000077339:Leflunomide; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome
D004791:Enzyme Inhibitors; D007555:Isoxazoles; D000077339:Leflunomide