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

Rheumatology (Oxford). 2010 Apr;49(4):723-32. doi: 10.1093/rheumatology/kep396. Epub 2010 Jan 16.


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 > or =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,, ISRCTN35919612.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenal Cortex Hormones / administration & dosage*
  • Adult
  • Azathioprine / administration & dosage
  • Azathioprine / therapeutic use*
  • Cyclosporine / administration & dosage
  • Cyclosporine / therapeutic use*
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Lupus Erythematosus, Systemic / drug therapy*
  • Male
  • Middle Aged
  • Prednisolone / administration & dosage*
  • Statistics as Topic
  • Sweden
  • Treatment Outcome
  • United Kingdom


  • Adrenal Cortex Hormones
  • Immunosuppressive Agents
  • Cyclosporine
  • Prednisolone
  • Azathioprine

Associated data

  • ISRCTN/ISRCTN35919612