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 Network's STOP GAP Team

doi:10.1136/bmj.h2958

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 Network's STOP GAP Team

^*Corresponding author for this work

Health Services Research Unit (HSRU)

Research output: Contribution to journal › Article › peer-review

178 Citations (Scopus)

6 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 language	English
Article number	2958
Number of pages	8
Journal	BMJ
Volume	350
DOIs	https://doi.org/10.1136/bmj.h2958
Publication status	Published - 12 Jun 2015

Bibliographical note

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).

Keywords

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

Access to Document

10.1136/bmj.h2958Licence: CC BY

Comparison of the two most commonly used treatments for pyoderma gangrenosum
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by.
Final published version, 509 KBLicence: CC BY

Cite this

Ormerod, A. D., Thomas, K. S., Craig, F. E., Mitchell, E., Greenlaw, N., Norrie, J., Mason, J. M., Walton, S., Johnston, G. A., Williams, H. C., & UK Dermatology Clinical Trials Network's STOP GAP Team (2015). Comparison of the two most commonly used treatments for pyoderma gangrenosum: results of the STOP GAP randomised controlled trial. BMJ, 350, Article 2958. https://doi.org/10.1136/bmj.h2958

Ormerod, AD, Thomas, KS, Craig, FE, Mitchell, E, Greenlaw, N, Norrie, J, Mason, JM, Walton, S, Johnston, GA, Williams, HC & UK Dermatology Clinical Trials Network's STOP GAP Team 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

@article{e44be70fff7545738828cb4dd32e7a4e,

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).",

keywords = "inflammatory-bowel-disease, United-Kingdom, cyclosporine, therapy, multicenter, management, diagnosis, update, index",

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 Network's STOP GAP Team}",

note = "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). ",

year = "2015",

month = jun,

day = "12",

doi = "10.1136/bmj.h2958",

language = "English",

volume = "350",

journal = "BMJ",

issn = "1756-1833",

publisher = "BMJ Publishing Group",

}

TY - JOUR

T1 - Comparison of the two most commonly used treatments for pyoderma gangrenosum

T2 - results of the STOP GAP randomised controlled trial

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 Network's STOP GAP Team

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).

KW - inflammatory-bowel-disease

KW - United-Kingdom

KW - cyclosporine

KW - therapy

KW - multicenter

KW - management

KW - diagnosis

KW - update

KW - index

U2 - 10.1136/bmj.h2958

DO - 10.1136/bmj.h2958

M3 - Article

SN - 1756-1833

VL - 350

JO - BMJ

JF - BMJ

M1 - 2958

ER -

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

Abstract

Bibliographical note

Keywords

Access to Document

Fingerprint

Cite this