Lémann Marc, Mary Jean-Yves, Duclos Bernard, Veyrac Michel, Dupas Jean-Louis, Delchier Jean Charles, Laharie David, Moreau Jacques, Cadiot Guillaume, Picon Laurence, Bourreille Arnaud, Sobahni Iradj, Colombel Jean-Frederic
Department of Gastroenterology, Hôpital Saint-Louis, Paris, France.
Gastroenterology. 2006 Apr;130(4):1054-61. doi: 10.1053/j.gastro.2006.02.014.
BACKGROUND & AIMS: The aim of this study was to evaluate the usefulness of short-term infliximab combined with azathioprine (AZA) or 6-mercaptopurine (6-MP) in steroid-dependent Crohn's disease patients.
Patients with active disease despite prednisone given for more than 6 months were eligible and were stratified as follows: the failure stratum consisted of patients receiving AZA/6-MP at a stable dose for more than 6 months, and the naive stratum consisted of patients not treated previously with AZA/6-MP. Patients were randomized to infliximab 5 mg/kg or placebo at weeks 0, 2, and 6. All patients were treated with AZA/6-MP maintained at a stable dose throughout the 52 weeks of the study. The primary end point was remission off steroids at week 24.
Among the 113 enrolled patients (55 in the failure stratum), 57 were assigned to infliximab. At week 24, the success rate (intent-to-treat analysis) was higher in the infliximab group than in the placebo group (57% vs 29%; P = .003); at weeks 12 and 52, the corresponding rates were 75% vs 38% (P < .001) and 40% vs 22% (P = .04), respectively. In each stratum, the success rate was significantly higher in the infliximab group at weeks 12 and 24, and a trend was found at week 52. In the failure stratum, only 27% of the patients in the infliximab group were still in remission off steroids, compared with 52% in the naive stratum. Steroid resistance was less common and the cumulative dose of prednisone was lower in the infliximab group.
Infliximab plus AZA/6-MP is more effective than AZA/6-MP alone in steroid-dependent Crohn's disease patients.
本研究旨在评估短期英夫利昔单抗联合硫唑嘌呤（AZA）或6-巯基嘌呤（6-MP）用于激素依赖型克罗恩病患者的有效性。
尽管接受泼尼松治疗超过6个月但仍患有活动性疾病的患者符合条件，并进行如下分层：失败组由接受稳定剂量AZA/6-MP治疗超过6个月的患者组成，初治组由先前未接受过AZA/6-MP治疗的患者组成。患者在第0、2和6周随机接受5 mg/kg英夫利昔单抗或安慰剂治疗。在整个52周的研究中，所有患者均接受稳定剂量的AZA/6-MP治疗。主要终点是第24周时停用激素后的缓解情况。
在113例入组患者中（失败组55例），57例被分配接受英夫利昔单抗治疗。在第24周时，英夫利昔单抗组的成功率（意向性分析）高于安慰剂组（57%对29%；P = 0.003）；在第12周和第52周时，相应的比率分别为75%对38%（P < 0.001）和40%对22%（P = 0.04）。在各层中，英夫利昔单抗组在第12周和第24周时的成功率显著更高，在第52周时发现有此趋势。在失败组中，英夫利昔单抗组只有27%的患者停用激素后仍处于缓解状态，而初治组为52%。英夫利昔单抗组激素抵抗较少见，泼尼松累积剂量较低。
在激素依赖型克罗恩病患者中，英夫利昔单抗加AZA/6-MP比单独使用AZA/6-MP更有效。
