Rheumatology Advance Access published online on January 6, 2004
Rheumatology, doi:10.1093/rheumatology/keh009
Rheumatology © British Society for Rheumatology 2004; all rights reserved
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Original Papers
1 Department of Rheumatology, University of Schleswig-Holstein, Campus Luebeck, Rheumaklinik Bad Bramstedt GmbH, Bad Bramstedt, Germany
* Corresponding author. E-mail: RKeller{at}rheuma-zentrum.de.
Received 2 April 2003
; accepted 24 July 2003
Objective. To investigate the safety and efficacy of leflunomide plus low-dose prednisolone for the maintenance of remission in Wegener's granulomatosis (WG). Methods. This was a Phase II, single-centre, open-label clinical investigation of patients with generalized WG treated with leflunomide after the induction of complete (n = 4) or partial (n = 16) remission by cyclophosphamide/prednisolone combination therapy. Leflunomide treatment was initiated at 20 mg/day and increased to 30 mg/day after 12 weeks and, in patients with partial remission, to 40 mg/day after 24 weeks. Concomitant low-dose prednisolone ( Results. A total of 20 patients were enrolled in the trial. During a treatment period of up to 2.5 yr (median 1.75 yr, range 1-2.5 yr), one patient had a major relapse and required retreatment with cyclophosphamide/prednisolone. Eight patients had minor relapses that were successfully treated by dose increases to 40 mg/day leflunomide. Disease activity remained unchanged for the duration of the study. The most frequently reported adverse events were mild respiratory infection (40%), arthralgia (35%) and hypertension (35%); dry skin, nail disorder and diarrhoea were each reported by 30% of patients. Despite the aggressive pretreatment with cyclophosphamide, adverse events with leflunomide treatment at the higher dose (30-40 mg/day) were comparable with those seen with the standard dose (20 mg/day) for rheumatoid arthritis patients. Conclusion. Leflunomide appears to be safe and well tolerated for the maintenance of complete or partial remission of WG. The results of this pilot study encourage further controlled trials comparing leflunomide with alternative remission maintenance therapies.
Key words: Wegener's granulomatosis, Leflunomide, Prednisolone, Remission, Maintenance therapy.
Maintenance of remission with leflunomide in Wegener's granulomatosis
10 mg/day) was allowed during the study. In addition to the frequency of relapse, treatment efficacy was assessed by the standard measures of disease activity/extent.
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