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NDT Advance Access originally published online on September 27, 2005
Nephrology Dialysis Transplantation 2005 20(12):2725-2732; doi:10.1093/ndt/gfi117
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© The Author [2005]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Original Article

A pilot study using mycophenolate mofetil in relapsing or resistant ANCA small vessel vasculitis

Melanie S. Joy, Susan L. Hogan, J. Charles Jennette1, Ronald J. Falk and Patrick H. Nachman

Department of Medicine and 1 Department of Pathology, University of North Carolina, Chapel Hill, NC, USA

Correspondence and offprint requests to: Patrick H. Nachman, MD, Division of Nephrology and Hypertension, CB#7155, 307 MacNider Building, University of North Carolina, Chapel Hill, NC, USA. Email: Patrick_Nachman{at}med.unc.edu

Background. The treatment approaches to antineutrophil cytoplasmic autoantibody (ANCA) small vessel vasculitis expose patients to the risks associated with long-term use of corticosteroids and cytotoxic agents. In an effort to explore approaches to minimize risks, we conducted a pilot efficacy and safety study of mycophenolate mofetil (MMF) in the treatment of subjects with nonlife-threatening recurrent or cyclophosphamide-resistant ANCA-vasculitis.

Methods. MMF was initiated at 500 mg orally twice daily and gradually increased to a target dose of 1000 mg twice daily for a duration of 24 weeks. Concomitant therapy with corticosteroids was allowed. The Birmingham Vasculitis Activity Score (BVAS) was used to assess disease activity and treatment efficacy. ANCA titres, serum creatinine and adverse events were secondary measures of efficacy and/or toxicity.

Results. Twelve subjects were enrolled in the study. Treatment with MMF led to an improvement in disease activity as measured by the BVAS at 24 weeks (P = 0.0013) and 52 weeks (P = 0.0044) as compared to baseline. The BVAS decreased from an average of 9.1±3.5 at baseline (range, 3–17) to an average of 2.8±1.9 (range, 1–6) at 24 weeks and to 2.8±4.3 (range, 0–13) at 52 weeks. Early and sustained reductions in BVAS occurred in subjects initially classified as disease relapses vs those with treatment resistance. Side effect profile was consistent with the mechanism of action and pharmacokinetic disposition of MMF.

Conclusions. MMF is a reasonable option in the treatment of non-life-threatening recurrent or resistant vasculitis and may obviate the immediate need for recurrent use of cytotoxic agents.

Keywords: ANCA; antineutrophil cytoplasmic autoantibodies; microscopic polyangiitis; mycophenolate mofetil; Wegener's granulomatosis; vasculitis


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