Author/Editor		Rozman, Blaž
Title		Clinical experience with leflunomide in rheumatoid arthritis
Type		članek
Source		J Rheumatol Suppl
Vol. and No.		Letnik 25, št. Suppl 53
Publication year		1998
Volume		str. 27-32
Language		eng
Abstract		Leflunomide is a novel isoxazol drug with disease modifying properties for the treatment of rheumatoid arthritis (RA). Several Phase II trials have been completed and 3 large Phase III trials are nearing completion. A multicenter Phase II randomized, double blind, placebo controlled, 24 week study of 402 patients with active RA revealed that leflunomide 25 mg once daily was significantly (p<0.05) superior to placebo in all primary and secondary outcome measures; leflunomide 10 mg daily was also statistically superior to placebo for all outcome measure except tender joint count and score. Significantly (p<0.05) more patients responded to leflunomide 10 and 25 mg than to placebo. Leflunomide appearts to be well tolerated in patients treated for up to 18 monts. Gastrointestinal events, weight loss, rash/allergic reactions, and reversible alopecia were the most frequently report drug related adverse events. Patients treated with leflunomide were not more susceptible to infections than those given placebo. Based upon the results of a population based pharmacokinetic/pharmacodynamic model, leflunomide 20 mg was selected as optiml dose for the Phase III studies; these are 6 to 12 month multicenter, randomized, double blind, controlled triasl that include as active comparators methotrexate and sulfaslazine. Once-daily administration of leflunomide is effective in patients with active RA.
Descriptors		ARTHRITIS, RHEUMATOID ANTIRHEUMATIC AGENTS ISOXAZOLES IMMUNOSUPPRESSIVE AGENTS