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., et al.
BMJ (Clinical research ed.). Date of publication 2015 Jun 12;volume 350():h2958.
1. BMJ. 2015 Jun 12;350:h2958. doi: 10.1136/bmj.h2958.
Comparison of the two most commonly used treatments for pyoderma gangrenosum:
results of the STOP GAP randomised controlled trial.
Ormerod AD(1), Thomas KS(2), Craig FE(3), Mitchell E(4), Greenlaw N(5), Norrie
J(6), Mason JM(7), Walton S(8), Johnston GA(9), Williams HC(10); UK Dermatology
Clinical Trials Network’s STOP GAP Team.
Collaborators: Ingram J, Lyon C, Meredith S, Mussell P, Powell F, Wallach D,
Barnes J, Craig F, Foster K, Greenlaw N, Harrison E, Maplethorpe A, Mason J,
Mitchell E, Norrie J, Ormerod T, Shafayat A, Simpkins D, Thomas K, Whitham D,
Williams H, Crook A, McDonald A, Schofield J, Ormerod A, Craig F, Lawson L,
Anstey A, Watkins C, Mitchell S, Goodwin R, Benge C, Lawlor F, Skibinska G,
Ariffin N, Armitt J, Mguni N, Masuku M, Goodsell K, Johnson L, Williamson D,
Williams R, Turczanska E, Devine A, Steen A, Loftus V, Marsden C, Farrant P,
Flowerdew M, Harman W, Atkinson L, Felton J, deGiovanni C, Ingram J, Patel G,
Chowdhury M, Motley R, Thomas A, Long C, Morris A, Piguet V, Kalavala M,
Katugampla R, Ezughah F, Colver G, Whileman A, Gascoigne A, Blasdale C, Lateo S,
Rajan N, Thomson A, Natarajan S, Wahie S, Sripathy T, Vatve M, Bajaj V, Thomson
A, Freeman K, Carr M, Ferguson A, Riches K, Baron S, Fuller C, Potter A, Brockway
L, Cooper A, Thompson S, Duarte-Williamson E, Smith C, Minifie G, Hare N,
Thornberry K, Gupta S, Langan S, Layton A, Wray A, Walker B, Law G, Marshall E,
Walton S, Ashton K, Oswald A, Graham D, Jones P, Smith V, Shipley D, Duggan C,
Jones S, Thomas C, Rolls SA, Veysey E, Meggitt S, Evans C, Clements S, Moreland
G, Nisbet M, Levell N, Lee K, Rakvit P, Millington G, Banks-Dunnell K, Chetty N,
Grattan C, Shah S, Butcher D, Gilbanks K, Cox N, Davies K, Lawton N, English J,
Murphy R, Perkins W, Williams H, Littlewood S, Bong J, Malik M, Batchelor J,
Wootton C, Davies-Jones S, Llewellyn J, Cheng S, Sharma M, Angus J, Varma S,
Cohen S, English J, Murphy R, Perkins W, Williams H, Littlewood S, Bong J, Malik
M, Batchelor J, Wootton C, Davies-Jones S, Llewellyn J, Cheng S, Sharma M, Angus
J, Varma S, Cohen S, Ogg G, Burge S, Venning V, Cooper S, McPherson T, Matter L,
Vestey J, Martin P, Ross S, Barr C, Seukeran D, Malhomme H, King J, Dua J,
Wilmott K, Bower C, James R, Velangi S, Szczecinska W, Shumba T, Ravenscroft J,
English J, Bong J, Yaakub A, Clegg A, Adams J, Burns S, Frost T, Chapman A,
Miller N, Estfan Y, Reeves G, Wachsmuth R, Lewis V, Bell H, Azurdia R, Walsh M,
Angit C, Ngan K, Young A, Murgaza J, Taylor P, Hunter H, Martin-Clavijo A,
Raghavenan R, Evriviades L, Lewis H, Dunnill G, Bray A, De Berker D, Johnston G,
McKenna J, Shelley C, Ghazavi M, Hill A, Kirkup M, Saunders G, Lloyd-Jones H,
Simmons D, Cotterill D, Bewley A, Galivo M, Watts J, Gibbon K, Sahota A, Lyon C,
Green J, Stainforth J.
Author information:
(1)Division of Applied Medicine, Aberdeen University, Aberdeen, UK.
(2)Centre of Evidence Based Dermatology, University of Nottingham, NG7 2NR, UK
kim.thomas@nottingham.ac.uk.
(3)Department of Dermatology, Aberdeen Royal Infirmary, Aberdeen, UK.
(4)Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
(5)Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
(6)Centre for Healthcare Randomised Trials, Aberdeen University, Aberdeen, UK.
(7)School of Medicine, Pharmacy and Health, Durham University, Durham, UK.
(8)Department of Dermatology, Hull Royal Infirmary, Hull, UK.
(9)Department of Dermatology, Leicester Royal Infirmary, Leicester, UK.
(10)Centre of Evidence Based Dermatology, University of Nottingham, NG7 2NR, UK.
Erratum in
BMJ. 2017 Mar 21;356:j1462.
Comment in
BMJ. 2015;350:h3175.
BMJ. 2015;351:h5113.
BMJ. 2015;351:h5115.
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).
RESULTS: Of the 112 participants, 108 had complete primary outcome data at
baseline and six weeks (57 ciclosporin; 51 prednisolone). Groups were balanced at
baseline. The mean (SD) speed of healing at six weeks was -0.21 (1.00) cm(2)/day
in the ciclosporin group compared with -0.14 (0.42) cm(2)/day in the prednisolone
group. The adjusted mean difference showed no between group difference (0.003
cm(2)/day, 95% confidence interval -0.20 to 0.21; P=0.97). By six months, ulcers
had healed in 28/59 (47%) participants in the ciclosporin group compared with
25/53 (47%) in the prednisolone group. In those with healed ulcers, eight (30%)
receiving ciclosporin and seven (28%) receiving prednisolone had a recurrence.
Adverse reactions were similar for the two groups (68% ciclosporin and 66%
prednisolone), but serious adverse reactions, especially infections, were more
common in the prednisolone group.
CONCLUSION: Prednisolone and ciclosporin did not differ across a range of
objective and patient reported outcomes. Treatment decisions for individual
patients may be guided by the different side effect profiles of the two drugs and
patient preference. Trial registration Current Controlled Trials ISRCTN35898459.
© Ormerod et al 2015.
DOI: 10.1136/bmj.h2958
PMCID: PMC4469977
PMID: 26071094 [Indexed for MEDLINE]
