Author/Editor		Mladenović, Vlastimir; Domljan, Zlatko; Rozman, Blaž; Jajić, Ivo; Mihajlović, Dimitrije; Ðorđević, Jovan; Popović, Milan; Dimitrijević, Miroslava; Živković, Milutin; Campion, Giles
Title		Safety and effectiveness of leflunomide in the treatment of patients with active rheumatoid arthritis
Type		članek
Source		Arthritis Rheum
Vol. and No.		Letnik 38, št. 11
Publication year		1995
Volume		str. 1595-603
Language		eng
Abstract		Objective. To assess the safety and effectiveness of leflunomide versus placebo in patients with active rheumatoid arthritis (RA) treated for 6 months. Methods. Four hundred two patients were randomly assigned to receive placebo or leflunomide at 5 mg, 10 mg, or 25 mg daily. A washout period of 6-12 weeks from prior second-line therapy was required. Results. Statistically significant improvement in primary and seconodary outcome measures, as well as by responder analyses, occurred in the 10-mg and 25-mg dosage groups compared to placebo. Twenty-one patients (7.0%) in the active treatment groups withdrew due to adverse events (AEs). The incidence of AEs was higher with leflunomide than with placebo. Gastrointestinal symptoms, weight loss, allergic reactions, skin rash, and reversible alopecia were more common in the 10-mg and 25-mg dosage groups. The incidence of infections was similar between the treatment and placebo groups; no opportunistic infections were seen. Transient evevations in liver function studies were noted in a small number of patients. Conclusion. Leflunomide is effective in daily doses of 10 mg and 25 mg in patients with active RA. Improved efficacy at the 25-mg dose was associated with a higher incidence of AEs. Randomized, placebocontrolled trials using daily doses of 10 mg and 20 mg are under way in the US and Europe to confirm these positive results.
Descriptors		ARTHRITIS, RHEUMATOID ISOXAZOLES ADULT MIDDLE AGE AGED MULTICENTER STUDIES CLINICAL TRIALS, PHASE II