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Antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis (AAV) is potentially associated with morbidity and mortality. Combined corticosteroid and cyclophosphamide treatment can induce remission, but chronic therapy with either agent can have numerous toxicities; cyclophosphamide is associated with possible infertility and birth defects. Previously, international groups cooperated to perform well-designed clinical trials of steroid-sparing and cyclophosphamide-sparing regimens for inducing and maintaining remission of AAV. They found that both methotrexate and rituximab remitted milder AAV as effectively as cyclophosphamide and that both azathioprine and methotrexate successfully maintained cyclophosphamide-induced remission of severe forms of new-onset AAV, including Wegener granulomatosis (WG) and microscopic polyarteritis (MPA). Investigators have now performed a multicenter, international clinical comparison of mycophenolate mofetil and azathioprine for maintaining remission of WG and MPA.
In this open-label randomized study, 156 patients with ANCA+ vasculitis who had a remission induced by prednisone and cyclophosphamide received either 2 mg/kg/day of azathioprine or 2 g/day of mycophenolate mofetil. In a follow-up period of just over 3 years, mycophenolate mofetil at this dose was inferior to azathioprine for maintaining remission in these patients. Relapses occurred in 42 of 76 mycophenolate mofetil recipients compared with 30 of 80 azathioprine recipients. Rates of adverse reactions were similar in the two treatment groups.
Hiemstra TF et al. Mycophenolate mofetil vs azathioprine for remission maintenance in antineutrophil cytoplasmic antibody–associated vasculitis: A randomized controlled trial. JAMA 2010 Dec 1; 304:2381.
Hoffman GS. Therapeutic interventions for systemic vasculitis. JAMA 2010 Dec 1; 304:2413.
Comment
This is a powerful data set. However, I wonder if the immunosuppressive doses were clinically equivalent and whether 3 g/day of mycophenolate would have produced efficacy similar to that of azathioprine. An editorialist points out that it took 7 years and the involvement of 42 medical centers in 11 European countries to identify the patients included in this study.
The completion of multiple well-designed studies of such a rare disease is a tribute to the ability of vasculitis experts (primarily rheumatologists and immunologists) to work together to answer important clinical questions. It is a model that perhaps we in dermatology should follow if we are serious about resolving clinical issues in relatively uncommon diseases.