San Diego—Oral cyclosporine can offer a safe and effective treatment option for refractory interstitial (IC), even in patients who have been on chronic narcotic medications and particularly in those with Hunner’s lesions, according to the findings of a study presented by Cleveland Clinic urologists at the 2016 AUA annual meeting in San Diego.
“Cyclosporine has known efficacy for treating recalcitrant IC and is listed in the AUA guideline as a fifth tier therapy. Yet, urologists are often reluctant to prescribe cyclosporine because they are concerned about toxicity,” said first author Daniel Shoskes, MD, MSc, director of the Novick Center for Clinical and Translational Research, Glickman Urological and Kidney Institute, Cleveland Clinic, and professor of surgery at Cleveland Lerner College of Medicine, Case Western Reserve University, Cleveland.
“Our experience shows that cyclosporine can be used safely with proper monitoring and can provide dramatic responses for some ‘end-stage’ IC patients. Hopefully, dissemination of this information will increase urologists’ comfort with cyclosporine and its use,” Dr. Shoskes added.
Dr. Shoskes and colleagues evaluated the efficacy and safety of a 3-month course of cyclosporine for treatment of refractory IC in a study that enrolled 26 patients over a 2-year period. Patients were eligible for participation if they had an Interstitial Cystitis Symptom Index (ICSI) score >9 and had failed at least two prior classes of therapy. Median duration of symptoms for the enrolled cohort was 66 months, and nine (35%) patients were using narcotic medications for symptom relief.
Cyclosporine was initiated at 3 mg/kg in divided doses twice daily, and dose adjustments were made based on measurement of the serum cyclosporine level measured 2 hours after the morning dose (C2).
“Monitoring of the C2 level rather than the trough level is the gold standard in transplant medicine because it better reflects total exposure,” Dr. Shoskes explained.
Twenty-one patients completed 3 months of treatment and 17 patients were seen at a post-treatment visit 1 to 2 months later. Responses were assessed using both the 7-point global response assessment (GRA) and ICSI. Mean scores of both instruments were improved by the 1-month visit and the benefit was maintained at 3 months, but it did not persist after cyclosporine was discontinued.
At 3 months, 11 (52.4%) patients showed response by GRA and eight (38.1%) patients achieved >30% improvement in their ICSI score. The mean ICSI score was significantly reduced from 14.9 to 11.7.
“These response rates are somewhat modest, but then these were patients who had failed all other interventions,” Dr. Shoskes said.