Comparison of the two most commonly used treatments for pyoderma gangrenosum: results of the STOP GAP randomised controlled trial

Anthony D. Ormerod, Kim S. Thomas*, Fiona E. Craig, Eleanor Mitchell, Nicola Greenlaw, John Norrie, James M. Mason, Shernaz Walton, Graham A. Johnston, Hywel C. Williams, Uk Dermatology Clinical Trials Net

*Corresponding author for this work

Research output: Contribution to journalArticle

75 Citations (Scopus)
3 Downloads (Pure)

Abstract

Objective: To determine whether ciclosporin is superior to prednisolone for the treatment of pyoderma gangrenosum, a painful, ulcerating skin disease with a poor evidence base for management.

Design: Multicentre, parallel group, observer blind, randomised controlled trial.

Setting: 39 UK hospitals, recruiting from June 2009 to November 2012.

Participants : 121 patients (73 women, mean age 54 years) with clinician diagnosed pyoderma gangrenosum. Clinical diagnosis was revised in nine participants after randomisation, leaving 112 participants in the analysis set (59 ciclosporin; 53 prednisolone).

Intervention: Oral prednisolone 0.75 mg/kg/day compared with ciclosporin 4 mg/kg/day, to a maximum dose of 75 and 400 mg/day, respectively.

Main outcome measures: The primary outcome was speed of healing over six weeks, captured using digital images and assessed by blinded investigators. Secondary outcomes were time to healing, global treatment response, resolution of inflammation, self reported pain, quality of life, number of treatment failures, adverse reactions, and time to recurrence. Outcomes were assessed at baseline and six weeks and when the ulcer had healed (to a maximum of six months).


Original languageEnglish
Article number2958
Number of pages8
JournalBMJ
Volume350
DOIs
Publication statusPublished - 12 Jun 2015

Keywords

  • inflammatory-bowel-disease
  • United-Kingdom
  • cyclosporine
  • therapy
  • multicenter
  • management
  • diagnosis
  • update
  • index

Cite this

Ormerod, A. D., Thomas, K. S., Craig, F. E., Mitchell, E., Greenlaw, N., Norrie, J., ... Uk Dermatology Clinical Trials Net (2015). Comparison of the two most commonly used treatments for pyoderma gangrenosum: results of the STOP GAP randomised controlled trial. BMJ, 350, [2958]. https://doi.org/10.1136/bmj.h2958

Comparison of the two most commonly used treatments for pyoderma gangrenosum : results of the STOP GAP randomised controlled trial. / Ormerod, Anthony D.; Thomas, Kim S.; Craig, Fiona E.; Mitchell, Eleanor; Greenlaw, Nicola; Norrie, John; Mason, James M.; Walton, Shernaz; Johnston, Graham A.; Williams, Hywel C.; Uk Dermatology Clinical Trials Net.

In: BMJ, Vol. 350, 2958, 12.06.2015.

Research output: Contribution to journalArticle

Ormerod, AD, Thomas, KS, Craig, FE, Mitchell, E, Greenlaw, N, Norrie, J, Mason, JM, Walton, S, Johnston, GA, Williams, HC & Uk Dermatology Clinical Trials Net 2015, 'Comparison of the two most commonly used treatments for pyoderma gangrenosum: results of the STOP GAP randomised controlled trial', BMJ, vol. 350, 2958. https://doi.org/10.1136/bmj.h2958
Ormerod, Anthony D. ; Thomas, Kim S. ; Craig, Fiona E. ; Mitchell, Eleanor ; Greenlaw, Nicola ; Norrie, John ; Mason, James M. ; Walton, Shernaz ; Johnston, Graham A. ; Williams, Hywel C. ; Uk Dermatology Clinical Trials Net. / Comparison of the two most commonly used treatments for pyoderma gangrenosum : results of the STOP GAP randomised controlled trial. In: BMJ. 2015 ; Vol. 350.
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title = "Comparison of the two most commonly used treatments for pyoderma gangrenosum: results of the STOP GAP randomised controlled trial",
abstract = "Objective: To determine whether ciclosporin is superior to prednisolone for the treatment of pyoderma gangrenosum, a painful, ulcerating skin disease with a poor evidence base for management.Design: Multicentre, parallel group, observer blind, randomised controlled trial.Setting: 39 UK hospitals, recruiting from June 2009 to November 2012.Participants : 121 patients (73 women, mean age 54 years) with clinician diagnosed pyoderma gangrenosum. Clinical diagnosis was revised in nine participants after randomisation, leaving 112 participants in the analysis set (59 ciclosporin; 53 prednisolone).Intervention: Oral prednisolone 0.75 mg/kg/day compared with ciclosporin 4 mg/kg/day, to a maximum dose of 75 and 400 mg/day, respectively.Main outcome measures: The primary outcome was speed of healing over six weeks, captured using digital images and assessed by blinded investigators. Secondary outcomes were time to healing, global treatment response, resolution of inflammation, self reported pain, quality of life, number of treatment failures, adverse reactions, and time to recurrence. Outcomes were assessed at baseline and six weeks and when the ulcer had healed (to a maximum of six months).",
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author = "Ormerod, {Anthony D.} and Thomas, {Kim S.} and Craig, {Fiona E.} and Eleanor Mitchell and Nicola Greenlaw and John Norrie and Mason, {James M.} and Shernaz Walton and Johnston, {Graham A.} and Williams, {Hywel C.} and {Uk Dermatology Clinical Trials Net}",
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AU - Ormerod, Anthony D.

AU - Thomas, Kim S.

AU - Craig, Fiona E.

AU - Mitchell, Eleanor

AU - Greenlaw, Nicola

AU - Norrie, John

AU - Mason, James M.

AU - Walton, Shernaz

AU - Johnston, Graham A.

AU - Williams, Hywel C.

AU - Uk Dermatology Clinical Trials Net

N1 - Funding: This publication presents independent research funded by the National Institute for Health Research (NIHR) under its programme grants for applied research (RP-PG-0407-10177).

PY - 2015/6/12

Y1 - 2015/6/12

N2 - Objective: To determine whether ciclosporin is superior to prednisolone for the treatment of pyoderma gangrenosum, a painful, ulcerating skin disease with a poor evidence base for management.Design: Multicentre, parallel group, observer blind, randomised controlled trial.Setting: 39 UK hospitals, recruiting from June 2009 to November 2012.Participants : 121 patients (73 women, mean age 54 years) with clinician diagnosed pyoderma gangrenosum. Clinical diagnosis was revised in nine participants after randomisation, leaving 112 participants in the analysis set (59 ciclosporin; 53 prednisolone).Intervention: Oral prednisolone 0.75 mg/kg/day compared with ciclosporin 4 mg/kg/day, to a maximum dose of 75 and 400 mg/day, respectively.Main outcome measures: The primary outcome was speed of healing over six weeks, captured using digital images and assessed by blinded investigators. Secondary outcomes were time to healing, global treatment response, resolution of inflammation, self reported pain, quality of life, number of treatment failures, adverse reactions, and time to recurrence. Outcomes were assessed at baseline and six weeks and when the ulcer had healed (to a maximum of six months).

AB - Objective: To determine whether ciclosporin is superior to prednisolone for the treatment of pyoderma gangrenosum, a painful, ulcerating skin disease with a poor evidence base for management.Design: Multicentre, parallel group, observer blind, randomised controlled trial.Setting: 39 UK hospitals, recruiting from June 2009 to November 2012.Participants : 121 patients (73 women, mean age 54 years) with clinician diagnosed pyoderma gangrenosum. Clinical diagnosis was revised in nine participants after randomisation, leaving 112 participants in the analysis set (59 ciclosporin; 53 prednisolone).Intervention: Oral prednisolone 0.75 mg/kg/day compared with ciclosporin 4 mg/kg/day, to a maximum dose of 75 and 400 mg/day, respectively.Main outcome measures: The primary outcome was speed of healing over six weeks, captured using digital images and assessed by blinded investigators. Secondary outcomes were time to healing, global treatment response, resolution of inflammation, self reported pain, quality of life, number of treatment failures, adverse reactions, and time to recurrence. Outcomes were assessed at baseline and six weeks and when the ulcer had healed (to a maximum of six months).

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KW - management

KW - diagnosis

KW - update

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