Anthony D. Ormerod
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 Network’s STOP GAP team
Professor KIM THOMAS KIM.THOMAS@NOTTINGHAM.AC.UK
Professor of Applied Dermatology Research
Fiona E. Craig
ELEANOR MITCHELL firstname.lastname@example.org
Assistant Professor of Clinical Trials
James M. Mason
Graham A. Johnston
HYWEL WILLIAMS email@example.com
Professor of Dermato-Epidemiology
UK Dermatology Clinical Trials Network’s STOP GAP team
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 rednisolone).
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).
Of the 112 participants, 108 had complete primary outcome data at baseline and six weeks (57 ciclosporin; 51 rednisolone). Groups were balanced at baseline. The mean (SD) speed of healing at six weeks was −0.21 (1.00) cm2/day in the ciclosporin group compared with −0.14 (0.42) cm2/day in the prednisolone group. The adjusted mean difference showed no between group difference (0.003 cm2/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.
Ormerod, A. D., Thomas, K. S., Craig, F. E., Mitchell, E., Greenlaw, N., Norrie, J., …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, https://doi.org/10.1136/bmj.h2958
|Journal Article Type||Article|
|Acceptance Date||Apr 27, 2015|
|Publication Date||Jun 12, 2015|
|Deposit Date||Apr 1, 2016|
|Publicly Available Date||Apr 1, 2016|
|Publisher||BMJ Publishing Group|
|Peer Reviewed||Peer Reviewed|
|Copyright Statement||Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0|
Publisher Licence URL
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0