Brooklyn TN, Dunnill MG, Shetty A, Bowden JJ, Williams JD, Griffiths CE, Forbes A, Greenwood R, Probert CS, et al.
Gut. Date of publication 2006 Apr 1;volume 55(4):505-9.
1. Gut. 2006 Apr;55(4):505-9. Epub 2005 Sep 27.
Infliximab for the treatment of pyoderma gangrenosum: a randomised, double blind,
placebo controlled trial.
Brooklyn TN(1), Dunnill MG, Shetty A, Bowden JJ, Williams JD, Griffiths CE,
Forbes A, Greenwood R, Probert CS.
Author information:
(1)Bristol Royal Infirmary, Bristol, UK.
BACKGROUND: Pyoderma gangrenosum (PG) is a chronic ulcerating skin condition that
often occurs in association with inflammatory bowel disease. There have been a
number of reports of PG responding to infliximab, a monoclonal antibody against
tumour necrosis factor alpha.
AIM: In the first randomised placebo controlled trial of any drug for the
treatment of PG, we have studied the role of infliximab in this disorder.
SUBJECTS: Patients 18 years of age or older with a clinical diagnosis of PG were
invited to take part.
METHODS: Patients were randomised to receive an infusion of infliximab at 5 mg/kg
or placebo at week 0. Patients were then assessed at week 2 and non-responders
were offered open labelled infliximab. The primary end point was clinical
improvement at week 2, with secondary end points being remission and improvement
at week 6.
RESULTS: Thirty patients were entered into the study. After randomisation, 13
patients received infliximab and 17 patients received placebo. At week 2,
significantly more patients in the infliximab group had improved (46% (6/13))
compared with the placebo group (6% (1/17); p = 0.025). Overall, 29 patients
received infliximab with 69% (20/29) demonstrating a beneficial clinical
response. Remission rate at week 6 was 21% (6/29). There was no response in 31%
(9/29) of patients.
CONCLUSIONS: This study has demonstrated that infliximab at a dose of 5 mg/kg is
superior to placebo in the treatment of PG. Open label treatment with infliximab
also produced promising results. Infliximab treatment should be considered in
patients with PG.
DOI: 10.1136/gut.2005.074815
PMCID: PMC1856164
PMID: 16188920 [Indexed for MEDLINE]
