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EULAR randomised controlled trial of pulse cyclophosphamide and methylprednisolone versus continuous cyclophosphamide and prednisolone followed by azathioprine and prednisolone in lupus nephritis

Yee, CS; Gordon, C; Dostal, C; Petera, P; Dadoniene, J; Griffiths, B; Rozman, B; Isenberg, DA; Sturfelt, Gunnar LU and Nived, Ola LU , et al. (2004) In Annals of the Rheumatic Diseases 63(5). p.525-529
Abstract
Objective: To compare the efficacy and side effects of intermittent pulse cyclophosphamide plus methylprednisolone with continuous oral cyclophosphamide plus prednisolone, followed by azathioprine, in patients with proliferative glomerulonephritis caused by systemic lupus erythematosus (SLE). Methods: A multicentre randomised controlled trial was conducted between June 1992 and May 1996 involving eight European centres. All patients satisfied the American College of Rheumatology criteria for SLE and had biopsy proven proliferative lupus nephritis. All received corticosteroids in addition to cytotoxic drugs, as defined in the protocol, for two years. The trial was terminated after four years as recruitment was disappointing. Results: 32 SLE... (More)
Objective: To compare the efficacy and side effects of intermittent pulse cyclophosphamide plus methylprednisolone with continuous oral cyclophosphamide plus prednisolone, followed by azathioprine, in patients with proliferative glomerulonephritis caused by systemic lupus erythematosus (SLE). Methods: A multicentre randomised controlled trial was conducted between June 1992 and May 1996 involving eight European centres. All patients satisfied the American College of Rheumatology criteria for SLE and had biopsy proven proliferative lupus nephritis. All received corticosteroids in addition to cytotoxic drugs, as defined in the protocol, for two years. The trial was terminated after four years as recruitment was disappointing. Results: 32 SLE patients with lupus nephritis were recruited: 16 were randomised to intermittent pulse cyclophosphamide and 16 to continuous cyclophosphamide plus azathioprine. Mean duration of follow up was 3.7 years in the continuous group (range 0 to 5.6) and 3.3 years in the pulse group ( range 0.25 to 6). Three patients were excluded from the pulse therapy group as they were later found to have pure mesangial glomerulonephritis. Two patients in the continuous therapy group developed end stage renal failure requiring dialysis, but none in the intermittent pulse therapy (p = 0.488; NS). There were similar numbers of side effects and withdrawals from treatment in both groups. There were three deaths: two in the intermittent pulse therapy group and one in the continuous therapy group. Conclusions: There was no statistically significant difference in efficacy and side effects between the two regimens. Infectious complications occurred commonly, so careful monitoring is required during treatment. (Less)
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Contribution to journal
publication status
published
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in
Annals of the Rheumatic Diseases
volume
63
issue
5
pages
525 - 529
publisher
British Medical Association
external identifiers
  • wos:000220813600010
  • pmid:15082482
  • scopus:11144356023
ISSN
1468-2060
DOI
10.1136/ard.2002.003574
language
English
LU publication?
yes
id
526740e8-123f-441b-ac14-60a4cf41ac5d (old id 281937)
date added to LUP
2007-11-07 08:21:04
date last changed
2017-10-22 04:30:06
@article{526740e8-123f-441b-ac14-60a4cf41ac5d,
  abstract     = {Objective: To compare the efficacy and side effects of intermittent pulse cyclophosphamide plus methylprednisolone with continuous oral cyclophosphamide plus prednisolone, followed by azathioprine, in patients with proliferative glomerulonephritis caused by systemic lupus erythematosus (SLE). Methods: A multicentre randomised controlled trial was conducted between June 1992 and May 1996 involving eight European centres. All patients satisfied the American College of Rheumatology criteria for SLE and had biopsy proven proliferative lupus nephritis. All received corticosteroids in addition to cytotoxic drugs, as defined in the protocol, for two years. The trial was terminated after four years as recruitment was disappointing. Results: 32 SLE patients with lupus nephritis were recruited: 16 were randomised to intermittent pulse cyclophosphamide and 16 to continuous cyclophosphamide plus azathioprine. Mean duration of follow up was 3.7 years in the continuous group (range 0 to 5.6) and 3.3 years in the pulse group ( range 0.25 to 6). Three patients were excluded from the pulse therapy group as they were later found to have pure mesangial glomerulonephritis. Two patients in the continuous therapy group developed end stage renal failure requiring dialysis, but none in the intermittent pulse therapy (p = 0.488; NS). There were similar numbers of side effects and withdrawals from treatment in both groups. There were three deaths: two in the intermittent pulse therapy group and one in the continuous therapy group. Conclusions: There was no statistically significant difference in efficacy and side effects between the two regimens. Infectious complications occurred commonly, so careful monitoring is required during treatment.},
  author       = {Yee, CS and Gordon, C and Dostal, C and Petera, P and Dadoniene, J and Griffiths, B and Rozman, B and Isenberg, DA and Sturfelt, Gunnar and Nived, Ola and Turney, JH and Venalis, A and Adu, D and Smolen, JS and Emery, P},
  issn         = {1468-2060},
  language     = {eng},
  number       = {5},
  pages        = {525--529},
  publisher    = {British Medical Association},
  series       = {Annals of the Rheumatic Diseases},
  title        = {EULAR randomised controlled trial of pulse cyclophosphamide and methylprednisolone versus continuous cyclophosphamide and prednisolone followed by azathioprine and prednisolone in lupus nephritis},
  url          = {http://dx.doi.org/10.1136/ard.2002.003574},
  volume       = {63},
  year         = {2004},
}