Cyclosporine A for refractory interstitial cystitis/bladder pain syndrome: Experience of 3 tertiary centers
ABSTRACT Cyclosporine A is a fifth-tier treatment option in the American Urological Association guidelines for interstitial cystitis/bladder pain syndrome. It was more effective than pentosanpolysulfate in a Finnish trial, but experience elsewhere is limited. Some centers use cyclosporine A off label for carefully selected patients but the number of patients in each center is small. We performed a retrospective review combining data from 3 tertiary centers that focus on interstitial cystitis/bladder pain syndrome.
Charts were reviewed for patients with interstitial cystitis/bladder pain syndrome who received cyclosporine A. Response was defined as markedly improved on the 7-point global response assessment (2 centers) or as at least a 50% decrease in Interstitial Cystitis Symptom Index score (1 center).
The study included 14 men and 30 women. Mean patient age was 55.5 years (range 27 to 75) and mean followup was 20.8 months (range 3 to 81). A total of 34 patients had Hunner lesions. Of these patients 29 (85%) responded but 6 eventually stopped cyclosporine A for adverse events, resulting in a success rate of 68% (23 of 34) for patients with Hunner lesions. In contrast, only 3 of 10 patients without Hunner lesions responded (30%). For all responders, the response occurred within 4 months.
Cyclosporine A had a high success rate for patients with Hunner lesions in whom more conservative options, including endoscopic treatment, had failed. The success rate was low for patients without Hunner lesions. A 3 to 4-month trial is sufficient time to assess response. Adverse events were common and led to discontinuation of cyclosporine A for some patients. Close monitoring is needed, especially for blood pressure and renal function.
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ABSTRACT: The efficacy of adalimumab in the treatment of interstitial cystitis/bladder pain syndrome was investigated in a phase III, randomized, double blind, placebo controlled, proof of concept study. Interstitial cystitis/bladder pain syndrome patients were randomized to receive SQ adalimumab 80 mg loading dose followed by 40 mg every 2 weeks or SQ placebo for 12 weeks and outcome measures were assessed. Incidences of adverse events were assessed. Of the 43 patients, 21 received adalimumab and 22 received placebo. Of patients who received adalimumab, there was a statistically significant improvement demonstrated in the O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes (p = 0.0002), Interstitial Cystitis Symptom Index (p = 0.0011), Interstitial Cystitis Problem Index (p = 0.0002), and Pelvic Pain, Urgency, Frequency scale (p = 0.0017) at 12 weeks compared to baseline. At 12 weeks 11 of 21 (53%) of the adalimumab group had a ≥ 50% improvement in global response assessment (p = ≤0.0001). There was not a statistically significant improvement in any outcome measure in patients receiving adalimumab compared to placebo. There were no significant adverse events. Adalimumab treatment demonstrated a statistically significant improvement in outcome measures compared to baseline in patients with moderate to severe interstitial cystitis/bladder pain syndrome. Adalimumab failed to demonstrate positive proof of concept compared to placebo due to a significant placebo effect.The Journal of urology 06/2013; 191(1). DOI:10.1016/j.juro.2013.06.038 · 3.75 Impact Factor
Article: Urinary bladder drugs[Show abstract] [Hide abstract]
ABSTRACT: To describe drugs targeting urinary bladder to treat bladder dysfunctions such as OAB, NDO and bladder pain syndrome. Pubmed search for efficacy, mode of action and side effects for each molecule. Additional data were searched from the French regulatory agencies web sites (HAS and ANSM). Anticholinergics antimuscarinics remain the first-line treatment option for both OAB and NDO. Beta-3 adrenergics emerges as a new therapeutic class for OAB. Post approval safety as well as association with other micturition cycle's drugs need to be evaluated. Phosphodiesterase 5 inhibitors are effective to treat BPH-related LUTS including storage symptoms. Botulinum toxin type A injections within the detrusor are effective and approved to treat NDO in MS and spinal cord injured patients voiding with clean intermittent catheterization. Evaluation of such approach to treat OAB is ongoing. Drug therapy for bladder pain syndrome has limited efficacy including pentosan polyphosfate despite it has a temporary autorisation. There is no drug treatment to restore or improve bladder contraction. Armamenterium to treat bladder dysfunction has recently increased. Three new therapeutic classes emerged. Careful post approval evaluation is mandatory and study of these drugs' combination is expected. Results should drive changes in bladder dysfunction treatment algorithms.Progrès en Urologie 11/2013; 23(15):1271-86. DOI:10.1016/j.purol.2013.09.020 · 0.77 Impact Factor
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ABSTRACT: We report a case of interstitial cystitis (IC) associated with primary Sjögren's syndrome (SS) successfully controlled with combination therapy of tacrolimus and a corticosteroid. In 2011, a 69-year-old female, who had been diagnosed with primary SS 23 years ago, developed IC and was successfully treated with tacrolimus and prednisolone combination therapy. The mechanism of IC, including the involved autoimmunity, has not been elucidated. Clinical observation studies suggest a potential association between SS and IC. However, IC is currently thought to be underdiagnosed in patients with SS as well as in the general population. Based on our case and others reported previously, IC associated with SS responds well to immunosuppressive therapy. In particular, a combination of a calcineurin inhibitor (tacrolimus or cyclosporine) with a corticosteroid seems to be highly effective. The possibility of IC in patients with SS complaining of lower urinary tract symptoms without features of infection or other identifiable causes should be given attention.Modern Rheumatology 04/2014; DOI:10.3109/14397595.2014.895283 · 2.21 Impact Factor