Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum

A prospective cohort study

Kim S Thomas, Anthony D. Ormerod, Fiona E Craig, Nicola Greenlaw, John Norrie, Eleanor Mitchell, James M Mason, Graham A Johnston, Shyamal Wahie, Hywel C Williams, UK Dermatology Clinical Trials Network's STOP GAP Team

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

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 retrospective 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.

Original languageEnglish
Pages (from-to)940-949
Number of pages10
JournalJournal of the American Academy of Dermatology
Volume75
Issue number5
Early online date5 Aug 2016
DOIs
Publication statusPublished - Nov 2016

Fingerprint

Pyoderma Gangrenosum
Cohort Studies
Prospective Studies
Therapeutics
Ulcer
Clobetasol
Confidence Intervals
Recurrence
Secondary Care
Tacrolimus
Treatment Failure
Skin Diseases
Adrenal Cortex Hormones
Retrospective Studies
Quality of Life
Inflammation

Keywords

  • cohort
  • corticosteroid
  • pyoderma gangrenosum
  • side effects
  • tacrolimus
  • topical therapy

Cite this

Thomas, K. S., Ormerod, A. D., Craig, F. E., Greenlaw, N., Norrie, J., Mitchell, E., ... UK Dermatology Clinical Trials Network's STOP GAP Team (2016). Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum: A prospective cohort study. Journal of the American Academy of Dermatology, 75(5), 940-949. https://doi.org/10.1016/j.jaad.2016.06.016

Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum : A prospective cohort study. / Thomas, Kim S; Ormerod, Anthony D.; Craig, Fiona E; Greenlaw, Nicola; Norrie, John; Mitchell, Eleanor; Mason, James M; Johnston, Graham A; Wahie, Shyamal; Williams, Hywel C; UK Dermatology Clinical Trials Network's STOP GAP Team.

In: Journal of the American Academy of Dermatology, Vol. 75, No. 5, 11.2016, p. 940-949.

Research output: Contribution to journalArticle

Thomas, KS, Ormerod, AD, Craig, FE, Greenlaw, N, Norrie, J, Mitchell, E, Mason, JM, Johnston, GA, Wahie, S, Williams, HC & UK Dermatology Clinical Trials Network's STOP GAP Team 2016, 'Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum: A prospective cohort study', Journal of the American Academy of Dermatology, vol. 75, no. 5, pp. 940-949. https://doi.org/10.1016/j.jaad.2016.06.016
Thomas, Kim S ; Ormerod, Anthony D. ; Craig, Fiona E ; Greenlaw, Nicola ; Norrie, John ; Mitchell, Eleanor ; Mason, James M ; Johnston, Graham A ; Wahie, Shyamal ; Williams, Hywel C ; UK Dermatology Clinical Trials Network's STOP GAP Team. / Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum : A prospective cohort study. In: Journal of the American Academy of Dermatology. 2016 ; Vol. 75, No. 5. pp. 940-949.
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abstract = "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 retrospective 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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author = "Thomas, {Kim S} and Ormerod, {Anthony D.} and Craig, {Fiona E} and Nicola Greenlaw and John Norrie and Eleanor Mitchell and Mason, {James M} and Johnston, {Graham A} and Shyamal Wahie and Williams, {Hywel C} and {UK Dermatology Clinical Trials Network's STOP GAP Team}",
note = "Acknowledgements We thank the patients who participated in the STOP GAP trial and the hospitals, doctors, and nurses who ensured that the study was a success (the full list of contributors appears below). We also thank our independent oversight committees, who guided this work with professionalism and care. The Trial Steering Committee includes John Ingram, Calum Lyon, Sarah Meredith, Paul Mussell, Frank Powell, and Daniel Wallach. The Data Monitoring Committee includes Angela Crook, Alison McDonald, and Julie Schofield. The trial was managed by the Nottingham Clinical Trials Unit, the UK Dermatology Clinical Trials Network, and the Robertson Centre for Biostatistics and the Centre for Healthcare Randomised Trials (CHaRT) in Aberdeen. Research nurses and administrators were provided through the National Institute for Health Research (NIHR) Clinical Research Networks in England, CRC Cymru Research Network in Wales, and NHS Research Scotland (NRS) for Scotland. Writing assistance was provided by Dr Natasha Rogers, and additional statistical support in preparation of this paper was provided by Dr Sally Wilkes.",
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T1 - Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum

T2 - A prospective cohort study

AU - Thomas, Kim S

AU - Ormerod, Anthony D.

AU - Craig, Fiona E

AU - Greenlaw, Nicola

AU - Norrie, John

AU - Mitchell, Eleanor

AU - Mason, James M

AU - Johnston, Graham A

AU - Wahie, Shyamal

AU - Williams, Hywel C

AU - UK Dermatology Clinical Trials Network's STOP GAP Team

N1 - Acknowledgements We thank the patients who participated in the STOP GAP trial and the hospitals, doctors, and nurses who ensured that the study was a success (the full list of contributors appears below). We also thank our independent oversight committees, who guided this work with professionalism and care. The Trial Steering Committee includes John Ingram, Calum Lyon, Sarah Meredith, Paul Mussell, Frank Powell, and Daniel Wallach. The Data Monitoring Committee includes Angela Crook, Alison McDonald, and Julie Schofield. The trial was managed by the Nottingham Clinical Trials Unit, the UK Dermatology Clinical Trials Network, and the Robertson Centre for Biostatistics and the Centre for Healthcare Randomised Trials (CHaRT) in Aberdeen. Research nurses and administrators were provided through the National Institute for Health Research (NIHR) Clinical Research Networks in England, CRC Cymru Research Network in Wales, and NHS Research Scotland (NRS) for Scotland. Writing assistance was provided by Dr Natasha Rogers, and additional statistical support in preparation of this paper was provided by Dr Sally Wilkes.

PY - 2016/11

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N2 - 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 retrospective 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.

AB - 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 retrospective 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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KW - corticosteroid

KW - pyoderma gangrenosum

KW - side effects

KW - tacrolimus

KW - topical therapy

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DO - 10.1016/j.jaad.2016.06.016

M3 - Article

VL - 75

SP - 940

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JO - Journal of the American Academy of Dermatology

JF - Journal of the American Academy of Dermatology

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