El-Omar, Emad

Keenan, Ronald A

Ormerod, Anthony D

Rice, Shantini A

Woo, Pick N

BMC Research Notes

English

PubMed

Abstract. Background: Cutaneous Crohn's Disease is a notoriously difficult condition to treat and causes significant morbidity, impacting heavily on quality of life. This is the first study in adults examining the effect of topical tacrolimus on the different cutaneous manifestations of Crohn's Disease. Methods. This open label observational study of 20 patients with heterogeneous forms of cutaneous Crohn's disease used topical tacrolimus 0.1% ointment once daily to affected areas for 12 weeks with a maximal total dose of 90g. Therapy was stopped at 12 weeks to assess whether the condition relapsed. Thereafter relapsing patients optionally continued an open label extension of topical tacrolimus therapy and were observed for a total of 12 months. Results: Of seventeen patients completing the twelve-week study, fifteen improved using a specifically designed physicians' global severity scale. One patient cleared, four showed a pronounced improvement (51-75%) and ten demonstrated a mild (1-25%) or moderate improvement (25-50%) in twelve weeks. Over twelve months eleven patients remained in the study, nine of which improved, one cleared and one showed no change. Perineal disease responded better with two out of twelve clearing, four showing pronounced benefit and four mild to moderate improvement. Long-term application of 0.1% tacrolimus applied to broken skin and mucosa was safe and serum levels of tacrolimus were undetectable in all subjects throughout the study. Conclusion: 0.1% tacrolimus ointment was safe and effective in treating cutaneous manifestations of Crohn's disease, particularly perineal disease and pyoderma gangrenosum, yet it seldom cleared the condition. Clinical trial registration. ClinicalTrials.gov Protocol Registration System ID: 33000332. © 2013 Rice et al.; licensee BioMed Central Ltd

Rice, SA

Woo, PN

El-Omar, E 

Keenan, RA

Ormerod, AD

UNSWorks

Topical tacrolimus 0.1% ointment for treatment of cutaneous Crohn's Disease

Shantini A Rice

Pick N Woo

Emad El-Omar

Ronald A Keenan

Anthony D Ormerod

Springer - Publisher Connector

Topical tacrolimus 0.1% ointment for treatment of cutaneous Crohn’s Disease

Abstract
          
            Background
            Cutaneous Crohn’s Disease is a notoriously difficult condition to treat and causes significant morbidity, impacting heavily on quality of life. This is the first study in adults examining the effect of topical tacrolimus on the different cutaneous manifestations of Crohn’s Disease.
          
          
            Methods
            This open label observational study of 20 patients with heterogeneous forms of cutaneous Crohn’s disease used topical tacrolimus 0.1% ointment once daily to affected areas for 12 weeks with a maximal total dose of 90g. Therapy was stopped at 12 weeks to assess whether the condition relapsed. Thereafter relapsing patients optionally continued an open label extension of topical tacrolimus therapy and were observed for a total of 12 months.
          
          
            Results
            Of seventeen patients completing the twelve-week study, fifteen improved using a specifically designed physicians’ global severity scale. One patient cleared, four showed a pronounced improvement (51-75%) and ten demonstrated a mild (1-25%) or moderate improvement (25-50%) in twelve weeks. Over twelve months eleven patients remained in the study, nine of which improved, one cleared and one showed no change. Perineal disease responded better with two out of twelve clearing, four showing pronounced benefit and four mild to moderate improvement. Long-term application of 0.1% tacrolimus applied to broken skin and mucosa was safe and serum levels of tacrolimus were undetectable in all subjects throughout the study.
          
          
            Conclusion
            0.1% tacrolimus ointment was safe and effective in treating cutaneous manifestations of Crohn’s disease, particularly perineal disease and pyoderma gangrenosum, yet it seldom cleared the condition.
          
          
            Clinical trial registration
            ClinicalTrials.gov Protocol Registration System ID: 33000332
          </jats:sec

Crossref

The Open University

https://bmcresnotes.biomedcentral.com/track/pdf/10.1186/1756-0500-6-19?site=bmcresnotes.biomedcentral.com

Topical tacrolimus 0.1% ointment for treatment of cutaneous Crohn's Disease

Abstract

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UNSWorks

Springer - Publisher Connector

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The Open University