Leflunomide Effective at Preventing Wegener's Relapse

Methotrexate, however, leads to significant number of major relapses

WEDNESDAY, July 18 (HealthDay News) -- Leflunomide can prevent relapse of Wegener's granulomatosis, but with a high incidence of adverse events compared to methotrexate, according to the results of a randomized trial published in the July issue of Rheumatology. However, the high relapse rate associated with methotrexate caused that arm of the study to be halted early.

Claudia Metzler, M.D., of the University Hospital of Schleswig-Holstein in Luebeck, Germany, and colleagues studied 54 patients in a two-year, prospective, randomized trial of leflunomide and methotrexate for maintenance of remission from Wegener's granulomatosis.

The study was halted due to the high number of major relapses in the methotrexate arm (four renal, two pulmonary hemorrhage, and one central nervous system granuloma).

Six of 26 patients in the leflunomide group suffered relapses, one of which was major (a pulmonary granuloma with infiltrations at 20 months). Fifty-one total adverse events were recorded, 34 in the leflunomide group, 17 in the methotrexate group. No patients were withdrawn from the methotrexate arm due to side effects, but six were withdrawn from the leflunomide group.

"Overall, results from the present study confirm data from an earlier open-label pilot trial and provide further evidence that leflunomide has the potential to maintain remission in Wegener's granulomatosis," the authors conclude.

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