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Rituximab versus Cyclophosphamide in ANCA-Associated Renal Vasculitis.

Jones, Rachel B. (författare)
Vasculitis and Lupus Clinic, Renal Unit, Addenbrooke’s Hospital, Cambridge, UK
Tervaert, Jan Willem Cohen (författare)
Division of Clinical and Experimental Immunology, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, the Netherlands
Hauser, Thomas (författare)
ImmunologieZentrum Zürich and University Hospital, Zurich, Switzerland
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Luqmani, Raashid (författare)
Department of Rheumatology, Nuffield Orthopaedic Centre, Oxford , UK
Morgan, Matthew D. (författare)
Department of Renal Immunobiolo - gy, School of Immunity and Infection, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
Peh, Chen Au (författare)
Renal Unit, Royal Adelaide Hospital, Adelaide, Australia
Savage, Caroline O. (författare)
Department of Renal Immunobiolo - gy, School of Immunity and Infection, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
Segelmark, Mårten (författare)
Östergötlands Läns Landsting,Linköpings universitet,Lund University,Lunds universitet,Njurmedicin,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Nephrology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Avdelningen för läkemedelsforskning,Hälsouniversitetet,Njurmedicinska kliniken US,Department of Nephrology in Lund, University Hospital of Skane and Lund University, Lund, Sweden
Tesar, Vladimir (författare)
First Faculty of Medicine, Charles University, Prague, Czech Republic
van Paassen, Pieter (författare)
Division of Clinical and Experimental Immunology, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, the Netherlands
Walsh, Dorothy (författare)
Vasculitis and Lupus Clinic, Renal Unit, Addenbrooke’s Hospital, Cambridge, UK
Walsh, Michael (författare)
Vasculitis and Lupus Clinic, Renal Unit, Addenbrooke’s Hospital, Cambridge, UK
Westman, Kerstin (författare)
Lund University,Lunds universitet,Njurmedicin,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Nephrology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Department of Nephrology and Transplantation in Malmö, University Hospital of Skane and Lund University, Malmö, Sweden
Jayne, David R. W. (författare)
Vasculitis and Lupus Clinic, Renal Unit, Addenbrooke’s Hospital, Cambridge, UK
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 (creator_code:org_t)
Boston, MA, USA : Massachusetts Medical Society, 2010
2010
Engelska.
Ingår i: New England Journal of Medicine. - Boston, MA, USA : Massachusetts Medical Society. - 0028-4793 .- 1533-4406. ; 363:3, s. 211-220
Relaterad länk:
http://www.nejm.org/... (free)
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http://dx.doi.org/10...
https://lup.lub.lu.s...
https://doi.org/10.1...
https://urn.kb.se/re...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • Background: Cyclophosphamide induction regimens for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis are effective in 70 to 90% of patients, but they are associated with high rates of death and adverse events. Treatment with rituximab has led to remission rates of 80 to 90% among patients with refractory ANCA-associated vasculitis and may be safer than cyclophosphamide regimens. Methods: We compared rituximab with cyclophosphamide as induction therapy in ANCA-associated vasculitis. We randomly assigned, in a 3:1 ratio, 44 patients with newly diagnosed ANCA-associated vasculitis and renal involvement to a standard glucocorticoid regimen plus either rituximab at a dose of 375 mg per square meter of body-surface area per week for 4 weeks, with two intravenous cyclophosphamide pulses (33 patients, the rituximab group), or intravenous cyclophosphamide for 3 to 6 months followed by azathioprine (11 patients, the control group). Primary end points were sustained remission rates at 12 months and severe adverse events. Results: The median age was 68 years, and the glomerular filtration rate (GFR) was 18 ml per minute per 1.73 m(sup 2) of body-surface area. A total of 25 patients in the rituximab group (76%) and 9 patients in the control group (82%) had a sustained remission (P=0.68). Severe adverse events occurred in 14 patients in the rituximab group (42%) and 4 patients in the control group (36%) (P=0.77). Six of the 33 patients in the rituximab group (18%) and 2 of the 11 patients in the control group (18%) died (P=1.00). The median increase in the GFR between 0 and 12 months was 19 ml per minute in the rituximab group and 15 ml per minute in the control group (P=0.14). Conclusions: A rituximab-based regimen was not superior to standard intravenous cyclophosphamide for severe ANCA-associated vasculitis. Sustained-remission rates were high in both groups, and the rituximab-based regimen was not associated with reductions in early severe adverse events. (Funded by Cambridge University Hospitals National Health Service Foundation Trust and F. Hoffmann-La Roche; Current Controlled Trials number, ISRCTN28528813.) N Engl J Med 2010;363:211-20.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Urology and Nephrology (hsv//eng)

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