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The BILAG multi-centre open randomized controlled trial comparing ciclosporin vs azathioprine in patients with severe SLE.

Griffiths, Bridget; Emery, Paul; Ryan, Vicky; Isenberg, David; Akil, Mohammed; Thompson, Robert; Maddison, Peter; Griffiths, Ian D; Lorenzi, Alice and Miles, Sarah, et al. (2010) In Rheumatology (Oxford, England) 49. p.723-732
Abstract
Objective. To determine whether low-dose ciclosporin was a more effective corticosteroid-sparing agent than AZA in patients with SLE. Methods. Patients with SLE requiring a change or initiation of a corticosteroid-sparing agent and who were taking >/=15 mg of prednisolone/day were randomized to receive either ciclosporin or AZA during this 12-month open-label multi-centre trial. There were strict guidelines for the reduction of prednisolone. The primary outcome was the absolute mean change in prednisolone. Results. Eighty-nine patients were randomized. Using an intention-to-treat analysis, the absolute mean change in prednisolone dose between baseline and 12 months, adjusted for baseline prednisolone dose, was 9.0 mg for ciclosporin... (More)
Objective. To determine whether low-dose ciclosporin was a more effective corticosteroid-sparing agent than AZA in patients with SLE. Methods. Patients with SLE requiring a change or initiation of a corticosteroid-sparing agent and who were taking >/=15 mg of prednisolone/day were randomized to receive either ciclosporin or AZA during this 12-month open-label multi-centre trial. There were strict guidelines for the reduction of prednisolone. The primary outcome was the absolute mean change in prednisolone. Results. Eighty-nine patients were randomized. Using an intention-to-treat analysis, the absolute mean change in prednisolone dose between baseline and 12 months, adjusted for baseline prednisolone dose, was 9.0 mg for ciclosporin (95% CI 7.2, 10.8) and 10.7 mg for AZA (95% CI 8.8, 12.7). The difference in the change between treatment groups was -1.7 mg (95% CI -4.4, 0.9; P = 0.2). No significant differences were detected for the secondary outcomes: change in disease activity [classic British Isles Lupus Assessment Group (BILAG) index], number of flares, development of new damage or change in quality of life. A similar number of patients in each arm stopped the study drugs due to adverse events and ineffectiveness. No patient developed severe hypertension or a persistent rise in creatinine. One patient in the ciclosporin arm developed a significant increase in proteinuria due to disease activity. Conclusions. Both drugs were effective corticosteroid-sparing agents. Ciclosporin was not a more effective corticosteroid-sparing agent. Ciclosporin may be considered in patients who are unable to tolerate AZA. Patients on ciclosporin require close monitoring of blood pressure and creatinine. Trial registration. Current Controlled Trials, http://www.controlled-trials.com/, ISRCTN35919612. (Less)
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Rheumatology (Oxford, England)
volume
49
pages
723 - 732
publisher
Oxford University Press
external identifiers
  • WOS:000275818700015
  • PMID:20081225
  • Scopus:77955730184
ISSN
1462-0332
DOI
10.1093/rheumatology/kep396
language
English
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8a890494-8a31-4096-be16-a22dd35fe79b (old id 1540977)
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http://www.ncbi.nlm.nih.gov/pubmed/20081225?dopt=Abstract
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2010-02-02 13:50:44
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@article{8a890494-8a31-4096-be16-a22dd35fe79b,
  abstract     = {Objective. To determine whether low-dose ciclosporin was a more effective corticosteroid-sparing agent than AZA in patients with SLE. Methods. Patients with SLE requiring a change or initiation of a corticosteroid-sparing agent and who were taking >/=15 mg of prednisolone/day were randomized to receive either ciclosporin or AZA during this 12-month open-label multi-centre trial. There were strict guidelines for the reduction of prednisolone. The primary outcome was the absolute mean change in prednisolone. Results. Eighty-nine patients were randomized. Using an intention-to-treat analysis, the absolute mean change in prednisolone dose between baseline and 12 months, adjusted for baseline prednisolone dose, was 9.0 mg for ciclosporin (95% CI 7.2, 10.8) and 10.7 mg for AZA (95% CI 8.8, 12.7). The difference in the change between treatment groups was -1.7 mg (95% CI -4.4, 0.9; P = 0.2). No significant differences were detected for the secondary outcomes: change in disease activity [classic British Isles Lupus Assessment Group (BILAG) index], number of flares, development of new damage or change in quality of life. A similar number of patients in each arm stopped the study drugs due to adverse events and ineffectiveness. No patient developed severe hypertension or a persistent rise in creatinine. One patient in the ciclosporin arm developed a significant increase in proteinuria due to disease activity. Conclusions. Both drugs were effective corticosteroid-sparing agents. Ciclosporin was not a more effective corticosteroid-sparing agent. Ciclosporin may be considered in patients who are unable to tolerate AZA. Patients on ciclosporin require close monitoring of blood pressure and creatinine. Trial registration. Current Controlled Trials, http://www.controlled-trials.com/, ISRCTN35919612.},
  author       = {Griffiths, Bridget and Emery, Paul and Ryan, Vicky and Isenberg, David and Akil, Mohammed and Thompson, Robert and Maddison, Peter and Griffiths, Ian D and Lorenzi, Alice and Miles, Sarah and Situnayake, Deva and Teh, Lee Suan and Plant, Mike and Ståhl Hallengren, Christina and Nived, Ola and Sturfelt, Gunnar and Chakravarty, Kuntal and Tait, Tim and Gordon, Caroline},
  issn         = {1462-0332},
  language     = {eng},
  pages        = {723--732},
  publisher    = {Oxford University Press},
  series       = {Rheumatology (Oxford, England)},
  title        = {The BILAG multi-centre open randomized controlled trial comparing ciclosporin vs azathioprine in patients with severe SLE.},
  url          = {http://dx.doi.org/10.1093/rheumatology/kep396},
  volume       = {49},
  year         = {2010},
}