Cyclosporine A found efficacious for refractory IC

Long-term cyclosporine A therapy may be an effective treatment option for refractory interstitial cystitis, say researchers from Brazil.

São Paulo, Brazil-Long-term cyclosporine A therapy may be an effective treatment option for refractory interstitial cystitis, say researchers from Brazil.

COMMENTARY - IC/BPS: Agent brings glimmer of hope

The authors report that cyclosporine A, 1.5 mg/kg twice per day given for 5 years, appears to produce clinically significant improvements in patient symptoms.

Researchers from the University of São Paulo Medical School, São Paulo, Brazil conducted a study with 45 IC patients (43 females and two males) who met the National Institute of Diabetes and Digestive and Kidney Diseases criteria for the diagnosis of IC. The primary purpose of the study was to analyze the impact of cyclosporine A on clinical and urodynamics outcomes at 5 years of follow-up.

All patients underwent cystoscopic examination, biopsy of the bladder, and urodynamic evaluation. The patients also kept a voiding diary. The authors measured symptoms before and after treatment using the O'Leary-Sant interstitial cystitis symptom index (ICSI) and interstitial cystitis problem index (ICPI). They assessed quality of life using the AUA QoL index, and all patients were evaluated before, during, and after treatment.

The authors found that the mean bladder capacity prior to treatment with cyclosporine A was 207 mL but increased to 318 mL after 5 years of follow-up. Additionally, the mean AUA QoL index went from 4.8 to 1.3 following 5 years of treatment.

READ: Companies acquire rights to low T, IC drugs

“We were very pleased and very impressed with our results. It was very interesting to see how patients didn’t want to stop the trial. All of these patients had suffered a lot before and had already had multiple treatments that had failed,” said co-author Daher Chade, MD, attending physician in the division of urology at the University of São Paulo Medical School and former fellow at Memorial Sloan Kettering Cancer Center in New York.

NEXT: Agent well tolerated

Agent well tolerated

Dr. ChadeDr. Chade, who presented the findings at the 2014 AUA annual meeting in Orlando, FL, said all the patients had been previously unsuccessfully treated with at least two other drugs. The study showed all 45 patients had an ICPI score above 8 before treatment, but only 22% of the patients remained in that group after treatment with cyclosporine A. The agent was found to be well tolerated, and no significant abnormalities were found for liver and renal function.

“The most common side effects were mild dyspepsia, diarrhea, and hair growth. The significant adverse events that led to dose reduction or interruption of treatment were hypertension and gingival hyperplasia (9/45 patients),” Dr. Chade said.

Study patients had a mean ICSI score of 36 at baseline, but it decreased to 21.6 at 6 months. At 5 years of treatment, that number dropped even further to 8.4. Dr. Chade said the study demonstrated that the mean initial filling sensation increased from 103 mL from baseline to 170 mL after 5 years of treatment.

“Although the etiology of interstitial cystitis is widely unknown, it seems that an autoimmune mechanism plays a significant role. Therefore, this and possibly several other immunemodulators may eventually become important alternatives for therapy in this challenging disease. I think it can be widely adopted. Some physicians are reluctant to prescribe it, but we had a good response. Our group is planning a multi-institutional trial with a larger cohort of patients with the aim of validating our findings,” Dr. Chade told Urology Times.