Efficacy, Side Effects, and Monitoring of Oral Cyclosporine in Interstitial Cystitis-Bladder Pain Syndrome

Urology. 2017 Sep;107:49-54. doi: 10.1016/j.urology.2017.05.016. Epub 2017 May 18.

Abstract

Objective: To evaluate the efficacy of oral cyclosporine A (CyA) in the treatment of refractory interstitial cystitis-bladder pain syndrome (IC-BPS) and to assess safety using drug level and renal function monitoring.

Materials and methods: Patients with IC-BPS who failed at least 2 prior treatments were enrolled in an open-label study of oral CyA. Medication was started at 3 mg/kg divided twice daily for 3 months. Dose was adjusted based on side effects and the drug level was measured 2 hours after the morning dose (C2). The primary end point was moderate or marked improvement of global response assessment or >50% improvement on the Interstitial Cystitis Symptom Index (ICSI) or Interstitial Cystitis Problem Index at 3 months.

Results: Twenty-two of 26 patients completed the 3-month follow-up; 18 completed the poststudy evaluation. The median symptom duration was 66 months (12-336). At 3 months, 31% (8/26) improved by global response assessment, 15% (4/26) had >50% improvement in the ICSI score, and 19% (5/26) had an improvement in the Interstitial Cystitis Problem Index score. Hunner lesions (HLs) predicted an improvement in the ICSI score (odds ratio = 15.4, 95% confidence interval: 1.7-224.6, P = .01), with 75% (3/4) of the responders having HL. Two patients withdrew because of hypertension or elevated serum glucose. The mean nuclear glomerular filtration rate declined at 3 months (98.9 ± 31.6 vs 84.2 ± 25.5 mL/min/1.73 m2, P = .01) and reversed to baseline after discontinuation of treatment. C2 levels did not correlate with symptoms but allowed dose reduction in 11 patients.

Conclusion: Per American Urological Association guidelines, CyA can be effective in a proportion of patients with refractory IC-BPS. Patients with HL are more likely to benefit. Monitoring of C2 rather than trough levels can lead to dose reduction, thereby minimizing toxicity.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Cyclosporine / administration & dosage*
  • Cyclosporine / pharmacokinetics
  • Cystitis, Interstitial / complications
  • Cystitis, Interstitial / drug therapy*
  • Cystitis, Interstitial / metabolism
  • Dose-Response Relationship, Drug
  • Drug Monitoring / methods*
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / pharmacokinetics
  • Male
  • Middle Aged
  • Pain / drug therapy
  • Pain / etiology*
  • Prospective Studies
  • Time Factors
  • Treatment Outcome
  • Young Adult

Substances

  • Immunosuppressive Agents
  • Cyclosporine