Infliximab for the treatment of pyoderma gangrenosum: a randomised, double-blind placebo-controlled trial

Trevor N Brooklyn ¹, Giles S Dunnill ¹, Ajeya Shetty ², June J Bowden ³, Jason DL Williams ³, Christopher EM Griffiths ³, Alastair EM Forbes ², Rosemary Greenwood ¹ and Chris S Probert ^1*

¹ Bristol Royal Infirmary, United Kingdom
² St Mark's Hospital, United Kingdom
³ Hope Hospital, United Kingdom

^* To whom correspondence should be addressed. E-mail: c.s.j.probert{at}bristol.ac.uk.

Accepted 21 September 2005

Abstract

Background: Pyoderma gangrenosum (PG) is a chronic ulcerating skin condition that often occurs in association with inflammatory bowel disease (IBD). There have been a number of reports of PG responding to infliximab, a monoclonal antibody against tumour necrosis factor alpha (TNF).

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 5mg/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: 30 patients were entered into the study. After randomization, 13 patients received infliximab and 17 patients received placebo. At week 2, significantly more patients in the infliximab group had improved 46% (6/13) as 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. The 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 5mg/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.

Keywords: Infliximab, pyoderma gangrenosum

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