Therapeutic drug monitoring of cyclosporine microemulsion in patients with corticosteroid-resistant systemic lupus erythematosus

Mod Rheumatol. 2015 Sep;25(5):708-13. doi: 10.3109/14397595.2015.1034401. Epub 2015 Jul 24.

Abstract

Objectives: We retrospectively examined how the cyclosporine-A (CSA) microemulsion administration mode affected blood CSA levels, as well as how the dose and blood levels of CSA affected its therapeutic effect against systemic lupus erythematosus (SLE).

Methods: We calculated the area under the blood concentration time curve (AUC) of CSA in 16 patients with corticosteroid-resistant SLE, and analyzed its correlation with CSA levels at the blood sampling time points to investigate the optimum monitoring and dosing regimen.

Results: The blood CSA level peaked at 2 h after administration (C2) in all patients. AUC0-6, which most markedly reflects the immunosuppressive effect, significantly correlated with C2 (R2 = 0.905), but not with the trough (C0). In concentration/dose ratio (C/D) of CSA, C2/D level was significantly higher when administered once daily before breakfast than when administered in the divided dose after meals (R2 = 0.355, P = 0.015), but not C0/D. During the 6-month follow-up, the CSA C2 tended to correlate with improvement in SLE disease activity index 2000 (R2 = 0.633, P = 0.067).

Conclusions: The treatment with a single dose of CSA before breakfast, followed by monitoring of C2, may be useful for improving the therapeutic effect in patients with corticosteroid-resistant SLE.

Keywords: C2 monitoring; Cyclosporine; Systemic lupus erythematosus.

MeSH terms

  • Adolescent
  • Adrenal Cortex Hormones / therapeutic use*
  • Adult
  • Cyclosporine / administration & dosage
  • Cyclosporine / pharmacokinetics
  • Cyclosporine / therapeutic use*
  • Drug Monitoring
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / pharmacokinetics
  • Immunosuppressive Agents / therapeutic use*
  • Lupus Erythematosus, Systemic / drug therapy*
  • Male
  • Middle Aged
  • Retrospective Studies
  • Time Factors
  • Young Adult

Substances

  • Adrenal Cortex Hormones
  • Immunosuppressive Agents
  • Cyclosporine