Rituximab for treatment of severe renal disease in ANCA associated vasculitis.

Abstract

BACKGROUND:

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.

METHODS:

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 m(2). 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.

RESULTS:

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 m(2) (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/m(2). 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.

CONCLUSIONS:

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.

• Authors: Duvuru Geetha, Zdenka Hruskova, Marten Segelmark, Jonathan Hogan, Matthew D Morgan, Teresa Cavero, Per Eriksson, Philip Seo, Rebecca L Manno, Jessica Dale, Lorraine Harper, Vladimir Tesar, David Rw Jayne
• Journal: Journal of nephrology (J Nephrol) Vol. 29 Issue 2 Pg. 195-201 (Apr 2016) ISSN: 1724-6059 [Electronic] Italy
• PMID: 25986390 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Glucocorticoids
• Immunosuppressive Agents
• Rituximab
• Cyclophosphamide

Topics

• Aged
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (diagnosis, drug therapy, immunology, mortality)
• Combined Modality Therapy
• Cyclophosphamide (therapeutic use)
• Disease Progression
• Drug Therapy, Combination
• Europe
• Female
• Glomerular Filtration Rate (drug effects)
• Glomerulonephritis (diagnosis, drug therapy, immunology, mortality)
• Glucocorticoids (therapeutic use)
• Humans
• Immunosuppressive Agents (adverse effects, therapeutic use)
• Kidney (drug effects, physiopathology)
• Kidney Failure, Chronic (immunology, prevention & control)
• Male
• Middle Aged
• Plasma Exchange
• Recovery of Function
• Remission Induction
• Renal Dialysis
• Retrospective Studies
• Rituximab (adverse effects, therapeutic use)
• Severity of Illness Index
• Time Factors
• Treatment Outcome
• United States