Topical tacrolimus in the management of peristomal pyoderma gangrenosum

Lyon, C. C.; Stapleton, Mark; Smith, Amanda; Mendelsohn, S.S.; Beck, M. H.; Griffiths, C.E.M.

doi:10.1080/095466301750163518

Cited by 97 publications

(68 citation statements)

References 15 publications

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“…However, the chronic nature of the autoimmune mucocutaneous diseases that are often associated with DG might require long-term (6-12 weeks) use of topical tacrolimus, which could be associated with immunosuppressant toxicity, including malignancy. 7,8,[12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28]35,36 The specific cause (ie, oral lichen planus, pemphigoid) of DG was not determined in the 24 patients in this study.…”

Section: Discussionmentioning

confidence: 99%

Comparison of topical tacrolimus 0.1 % in pectin ointment with clobetasol 0.5% ointment in adults with moderate to severe desquamative gingivitis: A 4-week, randomized, double-blind clinical trial

Corrocher

Lorenzo

Mansueto

et al. 2006

Clinical Therapeutics

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Background: Desquamative gingivitis (DG) is a clinical condition characterized by red, painful, glazed, and friable gingiva, which might be a manifestation of some autoimmune mucocutaneous diseases. The time from the development of initial signs of DG to diagnosis can vary from months to years. Based on a literature search, no data concerning patients with DG without signs of autoimmune disease were available.Objective: The aim of this trial was to compare the efficacy and tolerability of monotherapy with topical tacrolimus 0.1% in pectin ointment versus clobetasol propionate 0.5% ointment in adults affected by DG.Methods: This randomized, double-blind clinical trial was conducted at the Dipartimento di Medicina Clinica e Sperimentale, Universitfi di Verona, Verona, Italy. Patients aged >18 years were selected using the department's electronic medical records based on a clinical diagnosis of moderate to severe DG. After a 2-week washout period, patients were randomly assigned to receive 2 mL of tacrolimus 0.1% in pectin (equivalent to 0.2 mg of tacrolimus) or 2 mL of clobetasol propionate 0.5% ointment (equivalent to 1 mg of clobetasol) QD for 4 weeks. Evaluations were performed before treatment (baseline), after the treatment period (week 4), and at 2 follow-up visits at weeks 6 and 8. The signs of DG (ie, erythema [atrophy] and desquamation [erosions/ulceration]) were quantified by a blinded investigator using a calculated score based on their surface extension, using a drawing in which the areas of various zones of the mouth were indicated as a percentage of the whole oral mucosa. Severity of erythema and desquamation was rated on a 4-point scale (0 = absent; 1 = involvement of <5% of surface [mild]; 2 = 5%-15% [moderate]; and 3 = >15% [severe]). The primary end point was the number of patients who achieved remission (severity score of 0) in either sign; the secondary end point was the proportions of patients achieving improvement (severity score of 0 or 1) in either sign. Before and after treatment, we measured the serum concentrations of tacrolimus and its metabolites with an immunoenzymatic assay kit. Tolerability was assessed using hematology, biochemistry, urinalysis, measurements of systolic/ diastolic blood pressure and heart rate, patient interview, and spontaneous reporting.Results: A total of 24 patients (18 women, 6 men; all white of Italian origin; age range, 21-65 years; 12 patients per treatment group) were enrolled in the study. In the tacrolimus group, 11 (91.7%) patients achieved remission of erythema and/or desquamation at weeks 4 and 6; at week 8, these rates were 9 (75.0%) and 8 (66.7%), respectively; none of the patients in the clobetasol group achieved remission of either sign at any time point (all, P < 0.001). At weeks 4, 6, and 8, significantly greater proportions of patients treated Accepted for publication September 13, 2006. 1296Volume 28 Number 9 G. Corrocher et al.with tacrolimus had improved erythema and desquamation compared with those treated with clobetasol (all...

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Section: Discussionmentioning

confidence: 99%

Comparison of topical tacrolimus 0.1 % in pectin ointment with clobetasol 0.5% ointment in adults with moderate to severe desquamative gingivitis: A 4-week, randomized, double-blind clinical trial

Corrocher

Lorenzo

Mansueto

et al. 2006

Clinical Therapeutics

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“…4,5,14 Clinicians prescribed topical medication in line with local practice, but treatment allocations were not randomised. As a result, it is not possible to make formal comparison of different topical treatments such as corticosteroids versus tacrolimus.…”

Section: Strengths and Limitationsmentioning

confidence: 99%

“…Nevertheless, topical treatments (e.g. corticosteroids and calcineurin inhibitors) have also been recommended for localised disease 4,5 and may be a useful first-line therapy for some patients.…”

Section: Introductionmentioning

confidence: 99%

Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum: A prospective cohort study

Kim

Ormerod

Craig

et al. 2016

Journal of the American Academy of Dermatology

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BACKGROUND: Pyoderma gangrenosum (PG) is an uncommon dermatosis with a limited evidence base for treatment. OBJECTIVE: We sought to estimate the effectiveness of topical therapies in the treatment of patients with PG. METHODS: This was a prospective cohort study of UK secondary care patients with a clinical diagnosis of PG that was suitable for topical treatment (recruited between July 2009 and June 2012). Participants received topical therapy after normal clinical practice (primarily topical corticosteroids [classes I-III] and tacrolimus 0.03% or 0.1%). The primary outcome was speed of healing at 6 weeks. Secondary outcomes included the following: proportion healed by 6 months; time to healing; global assessment; inflammation; pain; quality of life; treatment failure; and recurrence. RESULTS: Sixty-six patients (22-85 years of age) were enrolled. Clobetasol propionate 0.05% was the most commonly prescribed therapy. Overall, 28 of 66 (43.8%) ulcers healed by 6 months. The median time to healing was 145 days (95% confidence interval, 96 days to ∞). Initial ulcer size was a significant predictor of time to healing (hazard ratio, 0.94 [95% confidence interval, 0.88-1.00); P = .043). Four patients (15%) had a recurrence. LIMITATIONS: Our study did not include a randomized comparator. CONCLUSION: Topical therapy is potentially an effective first-line treatment for PG that avoids the possible side effects associated with systemic therapy. It remains unclear whether more severe disease will respond adequately to topical therapy alone

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“…For example, in a study of 23 patients with peristomal PG, lesions were completely healed in 7 out of 11 patients treated with topical tacrolimus 0.3% [in a carmellose sodium paste (Orabase™; Convatec Ltd, Uxbridge, UK)] compared with 5 out of 13 treated with clobetasol propionate 0.05%. 751 In five patients who had failed to respond adequately to multiple systemic and topical treatments for peristomal PG, the addition of topical tacrolimus was associated with healing within 6 weeks. 751 Given the risks associated with systemic therapy and the evidence of increased mortality among patients with PG, we included a parallel observational cohort study alongside the STOP GAP RCT (see A randomised controlled trial of prednisolone versus ciclosporin in the treatment of pyoderma gangrenosum: STOP GAP trial), 740 to investigate the efficacy of topical therapy as a first-line treatment approach.…”

Section: Clinical Conclusionmentioning

confidence: 99%

A programme of research to set priorities and reduce uncertainties for the prevention and treatment of skin disease

Kim

Batchelor

Bath‐Hextall

et al. 2016

Programme Grants Appl Res

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Programme Grants for Applied ResearchISSN 2050-4322 (Print) ISSN 2050-4330 (Online) This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (www.publicationethics.org/).Editorial contact: nihredit@southampton.ac.ukThe full PGfAR archive is freely available to view online at www.journalslibrary.nihr.ac.uk/pgfar. Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: www.journalslibrary.nihr.ac.uk Criteria for inclusion in the Programme Grants for Applied Research journalReports are published in Programme Grants for Applied Research (PGfAR) if (1) they have resulted from work for the PGfAR programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors. Programme Grants for Applied Research programmeThe Programme Grants for Applied Research (PGfAR) programme, part of the National Institute for Health Research (NIHR), was set up in 2006 to produce independent research findings that will have practical application for the benefit of patients and the NHS in the relatively near future. The Programme is managed by the NIHR Central Commissioning Facility (CCF) with strategic input from the Programme Director.The programme is a national response mode funding scheme that aims to provide evidence to improve health outcomes in England through promotion of health, prevention of ill health, and optimal disease management (including safety and quality), with particular emphasis on conditions causing significant disease burden.For more information about the PGfAR programme please visit the website: http://www.nihr.ac.uk/funding/programme-grants-forapplied-research.htm This reportThe research reported in this issue of the journal was funded by PGfAR as project number RP-PG-0407-10177. The contractual start date was in September 2008. The final report began editorial review in April 2014 and was accepted for publication in April 2016. As the funder, the PGfAR programme agreed the research questions and study designs in advance with the investigators. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PGfAR editors and production house have tried to ensure the accuracy of the authors' report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, CCF, NETSCC, PGfAR or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, ...

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Topical tacrolimus in the management of peristomal pyoderma gangrenosum

Cited by 97 publications

References 15 publications

Comparison of topical tacrolimus 0.1 % in pectin ointment with clobetasol 0.5% ointment in adults with moderate to severe desquamative gingivitis: A 4-week, randomized, double-blind clinical trial

Comparison of topical tacrolimus 0.1 % in pectin ointment with clobetasol 0.5% ointment in adults with moderate to severe desquamative gingivitis: A 4-week, randomized, double-blind clinical trial

Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum: A prospective cohort study

A programme of research to set priorities and reduce uncertainties for the prevention and treatment of skin disease

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