Mycophenolate Mofetil Noninferior to Cyclophosphamide in ANCA-Associated Vasculitis

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Mycophenolate mofetil was noninferior to cyclophosphamide for remission induction, but resulted in higher rates of relapse.

For patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), mycophenolate mofetil (MMF) is noninferior to cyclophosphamide for remission induction but results in higher rates of relapse, according to results published in the Annals of the Rheumatic Diseases.

The study included participants who were newly diagnosed with AAV (n=140). They were randomly assigned to receive MMF or pulsed cyclophosphamide. All participants received the same glucocorticoid regimen and were switched to azathioprine after achieving remission. The study’s primary end point was remission by 6 months requiring compliance with the tapering glucocorticoid regimen.

In the MMF group, 67% (n=47) of participants achieved the primary remission end point compared with 61% (n=43) in the cyclophosphamide group, demonstrating noninferiority.

After achieving remission, 33% (n=23) of participants in the MMF group experienced relapse compared with 19% (n=13) in the cyclophosphamide group (incidence rate ratio, 1.97; 95% CI, 0.96-4.23; P =.049).

Among participants with myeloperoxidase ANCA, 12% of those in the cyclophosphamide group experienced relapse compared with 15% of the MMF group. Among participants with PR3-ANCA positivity, 24% of those in the cyclophosphamide group experienced relapse compared with 48% of the MMF group.

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The rate of serious infections was similar between the 2 groups, with infections occurring in 26% of participants in the MMF group compared with 17% of those in the cyclophosphamide group (odds ratio, 1.67; 95% CI, 0.68-4.19; P =.3).

“This study provides evidence that MMF is a potential alternative to [cyclophosphamide] for remission induction in non-life-threatening AAV, particularly in patients with low predicted relapse risk, such as the elderly who are [myeloperoxidase]-positive,” the researchers wrote.

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Reference

Jones RB, Hiemstra T, Ballarin J, et al. Mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA-associated vasculitis: a randomised, non-inferiority trial [published online January 5, 2019]. Ann Rheum Dis. doi:10.1136/annrheumdis-2018-214245