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

Research output: Contribution to journalArticle

15 Citations (Scopus)
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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.

Original languageEnglish
Article number19
JournalBMC Research Notes
Volume6
DOIs
Publication statusPublished - 18 Jan 2013

Fingerprint

Tacrolimus
Ointments
Skin Diseases
Crohn Disease
Skin Manifestations
Labels
Therapeutics
Pyoderma Gangrenosum
Observational Studies
Skin
Mucous Membrane
Quality of Life
Morbidity
Physicians
Serum

Keywords

  • Administration, Topical
  • Adolescent
  • Adult
  • Aged
  • Child
  • Crohn Disease
  • Female
  • Humans
  • Immunosuppressive Agents
  • Male
  • Middle Aged
  • Ointments
  • Skin Diseases
  • Tacrolimus
  • Young Adult

Cite this

Rice, S. A., Woo, P. N., El-Omar, E., Keenan, R. A., & Ormerod, A. D. (2013). Topical tacrolimus 0.1% ointment for treatment of cutaneous Crohn's Disease. BMC Research Notes, 6, [19]. https://doi.org/10.1186/1756-0500-6-19

Topical tacrolimus 0.1% ointment for treatment of cutaneous Crohn's Disease. / Rice, Shantini A; Woo, Pick N; El-Omar, Emad; Keenan, Ronald A; Ormerod, Anthony D.

In: BMC Research Notes, Vol. 6, 19, 18.01.2013.

Research output: Contribution to journalArticle

Rice, Shantini A ; Woo, Pick N ; El-Omar, Emad ; Keenan, Ronald A ; Ormerod, Anthony D. / Topical tacrolimus 0.1% ointment for treatment of cutaneous Crohn's Disease. In: BMC Research Notes. 2013 ; Vol. 6.
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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.",
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T1 - Topical tacrolimus 0.1% ointment for treatment of cutaneous Crohn's Disease

AU - Rice, Shantini A

AU - Woo, Pick N

AU - El-Omar, Emad

AU - Keenan, Ronald A

AU - Ormerod, Anthony D

PY - 2013/1/18

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N2 - 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.

AB - 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.

KW - Administration, Topical

KW - Adolescent

KW - Adult

KW - Aged

KW - Child

KW - Crohn Disease

KW - Female

KW - Humans

KW - Immunosuppressive Agents

KW - Male

KW - Middle Aged

KW - Ointments

KW - Skin Diseases

KW - Tacrolimus

KW - Young Adult

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DO - 10.1186/1756-0500-6-19

M3 - Article

C2 - 23331739

VL - 6

JO - BMC Research Notes

JF - BMC Research Notes

SN - 1756-0500

M1 - 19

ER -