Infliximab for the treatment of pyoderma gangrenosum: a randomised, double blind, placebo controlled trial
Infliximab for the treatment of pyoderma gangrenosum: a randomised, double blind, placebo controlled trial
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DOI：
10.1136/gut.2005.074815
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发表时间：
2006-04-01
期刊：
影响因子：
24.5
通讯作者：
Probert, CS
中科院分区：
文献类型：
--
作者：
Brooklyn, TN;Dunnill, MGS;Probert, CS
背景：坏疽性脓皮病（PG）是一种慢性溃疡性皮肤病，通常与炎症性肠病相关。已有许多关于 PG 对英夫利昔单抗（一种针对肿瘤坏死因子 a 的单克隆抗体）有反应的报道。目的：在第一个治疗 PG 药物的随机安慰剂对照试验中，我们研究了英夫利昔单抗在这种疾病中的作用。受试者：邀请临床诊断为 PG 的 18 岁或以上患者参加。方法：患者被随机分配接受 5 mg/kg 或 5 mg/kg 剂量的英夫利昔单抗输注。第 0 周给予安慰剂。然后在第 2 周对患者进行评估，无反应者接受开放标记的英夫利昔单抗治疗。主要终点是第 2 周时的临床改善，次要终点是第 6 周时的缓解和改善。 结果：30 名患者参与了该研究。随机分组后，13 名患者接受英夫利昔单抗治疗，17 名患者接受安慰剂治疗。第 2 周时，与安慰剂组 (6% (1/17)；p = 0.025) 相比，英夫利昔单抗组中有更多患者出现改善 (46% (6/13))。总体而言，29 名患者接受了英夫利昔单抗治疗，其中 69% (20/29) 表现出有益的临床反应。第 6 周缓解率为 21% (6/29)。 31% (9/29) 的患者没有缓解。 结论：本研究证明，5 mg/kg 剂量的英夫利昔单抗在治疗 PG 方面优于安慰剂。英夫利昔单抗的开放标签治疗也产生了有希望的结果。 PG 患者应考虑英夫利昔单抗治疗。
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 a.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.