To evaluate the efficacy of oral Cyclosporine A (CyA) in treatment of refractory interstitial cystitis/bladder pain syndrome (IC/BPS) and assess safety using drug level and renal function monitoring.
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 drug level measured 2 hours after the morning dose (C2). Primary end point was marked or moderate improvement of global response assessment (GRA) or >50% improvement on the Interstitial Cystitis Symptom Index (ICSI) or Interstitial Cystitis Problem Index (ICPI) at 3 months.
Twenty-two of 26 patients completed 3-month follow-up; 18 completed the post-study evaluation. Median symptom duration was 66 months (12-336). At 3 months 31%(8/26) improved by GRA, 15%(4/26) had >50% improvement in ICSI, 19% (5/26) in ICPI. Hunner's lesions (HL) predicted improvement in ICSI (OR=15.4; 95%CI:1.7-224.6, p=0.01) with 75%(3/4) of responders having HL. Two patients withdrew due to hypertension or elevated serum glucose. Mean nuclear glomerular filtration rate declined at 3 months (98.9±31.6 vs. 84.2±25.5 ml/min/1.73m2, p=0.01) and reversed to baseline after treatment discontinuation. C2 levels did not correlate with symptoms but allowed dose reduction in 11 patients.
Per AUA guidelines Cyclosporine A 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.
Urology. 2017 May 18 [Epub ahead of print]
Iryna M Crescenze, Barbara Tucky, Jianbo Li, Courtenay Moore, Daniel Shoskes
Glickman Urologic and Kidney Institute, Cleveland Clinic, 9500 Euclid Ave, Q10-1, Cleveland, OH 44195.. Electronic address: ., Glickman Urologic and Kidney Institute, Cleveland Clinic, 9500 Euclid Ave, Q9-1, Cleveland, OH 44195.. Electronic address: ., Glickman Urologic and Kidney Institute, Cleveland Clinic, 9500 Euclid Ave, JJN3, Cleveland, OH 44195.. Electronic address: ., Glickman Urologic and Kidney Institute, Cleveland Clinic, 9500 Euclid Ave, Q10-1, Cleveland, OH 44195.. Electronic address: ., Glickman Urologic and Kidney Institute, Cleveland Clinic, 9500 Euclid Ave, Q10-1, Cleveland, OH 44195.. Electronic address: .