Rituximab for treatment of severe renal disease in ANCA associated vasculitis
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Rituximab (RTX) is approved for remission induction in ANCA associated vasculitis (AAV). However, data on use of RTX in patients with severe renal disease is lacking.
We conducted a retrospective multi-center study to evaluate the efficacy and safety of RTX with glucocorticoids (GC) with and without use of concomitant cyclophosphamide (CYC) for remission induction in patients presenting with e GFR less than 20 ml/min/1.73 m2. We evaluated outcomes of remission at 6 months (6 M), renal recovery after acute dialysis at diagnosis, e-GFR rise at 6 M, patient and renal survival and adverse events.
A total 37 patients met the inclusion criteria. The median age was 61 years. (55–73), 62 % were males, 78 % had new diagnosis and 59 % were MPO ANCA positive. The median (IQR) e-GFR at diagnosis was 13 ml/min/1.73 m2 (7–16) and 15 required acute dialysis. Eleven (30 %) had alveolar hemorrhage. Twelve (32 %) received RTX with GC, 25 (68 %) received RTX with GC and CYC and seventeen (46 %) received plasma exchange. The median (IQR) follow up was 973 (200–1656) days. Thirty two of 33 patients (97 %) achieved remission at 6 M and 10 of 15 patients (67 %) requiring dialysis recovered renal function. The median prednisone dose at 6 M was 6 mg/day. The mean (SD) increase in e-GFR at 6 months was 14.5 (22) ml/min/m2. Twelve patients developed ESRD during follow up. There were 3 deaths in the first 6 months. When stratified by use of concomitant CYC, there were no differences in baseline e GFR, use of plasmapheresis, RTX dosing regimen or median follow up days between the groups. No differences in remission, renal recovery ESRD or death were observed.
This study of AAV patients with severe renal disease demonstrates that the outcomes appear equivalent when treated with RTX and GC with or without concomitant CYC.
KeywordsRituximab Renal disease ANCA vasculitis
Parts of this work were presented at the American Society of Nephrology meeting in Philadelphia, Pennsylvania in November 2014. “This publication was made possible by the Johns Hopkins Institute for Clinical and Translational Research (ICTR) which is funded in part by Grant Number UL1 TR 001079 from the National Center for Advancing Translational Sciences (NCATS) a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of the Johns Hopkins ICTR, NCATS or NIH.”
Conflict of interest
Duvuru Geetha, M.D., MR.C.P. (U.K.), Consultant for Genentech, Zdenka Hruskova, M.D., PhD: lecture fees/honoraria from GSK and Biogen Idec, Marten Segelmark, M.D.: lecture fees from Roche, Matthew, D. Morgan, MB ChB, MRCP, PhD: none, Jonathan Hogan, M.D.: none, Per Erikson: none, Philip Seo: none, Rebecca Manno: none, Teresa Cavero: none, Jessica Dale: none, Lorraine, Harper, PhD, MRCP: none, Vladimir Tesar, MD, PhD, MBA: fees for lecture and advisory board: Amgen, Abbvie, Baxter, Chemocentryx, Fresenius, GSK. David RW Jayne, M.D., FRCP: Research grant and consulting and lecture fees from Roche/Genentech.
All procedures performed in studies involving human participants were done in accordance with ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
The study was approved as an exempt research study by the institutional review board due to the retrospective nature of the study.
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