Mycophenolate Mofetil Versus Cyclophosphamide for the Induction of Remission in Nonlife-Threatening Relapses of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: Randomized, Controlled Trial.

作者: Janneke Tuin , Patricia M. Stassen , Daria I. Bogdan , Jan Broekroelofs , Pieter van Paassen

DOI: 10.2215/CJN.11801018

关键词:

摘要: Background and objectives Cyclophosphamide has been the mainstay of treatment ANCA-associated vasculitis. However, cyclophosphamide unfavorable side effects alternatives are needed. Evidence suggests that mycophenolate mofetil can induce sustained remission in nonlife-threatening disease. The purpose this study was to compare efficacy safety versus for induction relapses proteinase 3-ANCA– myeloperoxidase-ANCA–associated Design, setting, participants, & measurements We conducted a multicenter randomized, controlled trial. Participants with first or second relapse vasculitis were randomized both combination glucocorticoids. Maintenance therapy consisted azathioprine arms. Primary outcome at 6 months, secondary outcomes included disease-free survival 2 4 years. Results Eighty-four participants enrolled, whom 41 received 43 cyclophosphamide. Eighty-nine percent 3-ANCA positive. At 27 (66%) mofetil–treated 35 (81%) cyclophosphamide-treated (P=0.11). Disease-free rates years 61% 39% cyclophosphamide, respectively, 43% 32% mofetil, respectively (at years, log rank test, P=0.17). Conclusions did not demonstrate be similarly effective as inducing relapsed might an alternative selected patients relapses.

参考文章(16)
Matthias Schaier, Christian Scholl, Dominik Scharpf, Wilhelm H. Schmitt, Vedat Schwenger, Martin Zeier, Claudia Sommerer, High interpatient variability in response to mycophenolic acid maintenance therapy in patients with ANCA-associated vasculitis Nephrology Dialysis Transplantation. ,vol. 30, ,(2015) , 10.1093/NDT/GFV065
Fei Han, Guangyi Liu, Xiaohui Zhang, Xiayu Li, Qiang He, Xuelin He, Qun Li, Suya Wang, Huiping Wang, Jianghua Chen, Effects of mycophenolate mofetil combined with corticosteroids for induction therapy of microscopic polyangiitis. American Journal of Nephrology. ,vol. 33, pp. 185- 192 ,(2011) , 10.1159/000324364
Melanie S. Joy, Susan L. Hogan, J. Charles Jennette, Ronald J. Falk, Patrick H. Nachman, A pilot study using mycophenolate mofetil in relapsing or resistant ANCA small vessel vasculitis Nephrology Dialysis Transplantation. ,vol. 20, pp. 2725- 2732 ,(2005) , 10.1093/NDT/GFI117
Gary S Hoffman, Gail S Kerr, Randi Y Leavitt, Claire W Hallahan, Robert S Lebovics, William D Travis, Menachem Rottem, Anthony S Fauci, Wegener Granulomatosis: An Analysis of 158 Patients Annals of Internal Medicine. ,vol. 116, pp. 488- 498 ,(1992) , 10.7326/0003-4819-116-6-488
J. C. Jennette, R. J. Falk, P. A. Bacon, N. Basu, M. C. Cid, F. Ferrario, L. F. Flores-Suarez, W. L. Gross, L. Guillevin, E. C. Hagen, G. S. Hoffman, D. R. Jayne, C. G. M. Kallenberg, P. Lamprecht, C. A. Langford, R. A. Luqmani, A. D. Mahr, E. L. Matteson, P. A. Merkel, S. Ozen, C. D. Pusey, N. Rasmussen, A. J. Rees, D. G. I. Scott, U. Specks, J. H. Stone, K. Takahashi, R. A. Watts, 2012 Revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides Arthritis & Rheumatism. ,vol. 65, pp. 1- 11 ,(2013) , 10.1002/ART.37715
W. Hu, C. Liu, H. Xie, H. Chen, Z. Liu, L. Li, Mycophenolate mofetil versus cyclophosphamide for inducing remission of ANCA vasculitis with moderate renal involvement Nephrology Dialysis Transplantation. ,vol. 23, pp. 1307- 1312 ,(2007) , 10.1093/NDT/GFM780
A. R. Exley, P. A. Bacon, R. A. Luqmani, G. D. Kitas, C. Gordon, C. O. S. Savage, D. Adu, Development and initial validation of the vasculitis damage index for the standardized clinical assessment of damage in the systemic vasculitides Arthritis & Rheumatism. ,vol. 40, pp. 371- 380 ,(1997) , 10.1002/ART.1780400222
Francisco Silva, Ulrich Specks, Sanjay Kalra, Marie C. Hogan, Nelson Leung, Sanjeev Sethi, Fernando C. Fervenza, Mycophenolate Mofetil for Induction and Maintenance of Remission in Microscopic Polyangiitis with Mild to Moderate Renal Involvement—A Prospective, Open-Label Pilot Trial Clinical Journal of The American Society of Nephrology. ,vol. 5, pp. 445- 453 ,(2010) , 10.2215/CJN.06010809
B. Chaigne, P. Gatault, F. Darrouzain, C. Barbet, D. Degenne, M. François, P. Szymanski, N. Rabot, G. Golea, E. Diot, F. Maillot, Y. Lebranchu, H. Nivet, G. Paintaud, J.-M. Halimi, L. Guillevin, M. Büchler, Mycophenolate mofetil in patients with anti‐neutrophil cytoplasmic antibody‐associated vasculitis: a prospective pharmacokinetics and clinical study Clinical and Experimental Immunology. ,vol. 176, pp. 172- 179 ,(2014) , 10.1111/CEI.12246