Oussalah A, Babouri A, Chevaux J-B, Stancu L, Trouilloud I, Bensenane M, Boucekkine T, Bigard M-A, Peyrin-Biroulet L
Inserm, U724, and Department of Hepato-Gastroenterology, University Hospital of Nancy, Vandoeuvre-les-Nancy, France.
Aliment Pharmacol Ther. 2009 Feb 15;29(4):416-23. doi: 10.1111/j.1365-2036.2008.03902.x. Epub 2008 Nov 25.
Adalimumab is effective in inducing clinical remission in patients with Crohn's disease who lost response or became intolerant to infliximab.
To evaluate long-term efficacy and safety of adalimumab as a second line therapy in luminal and fistulizing Crohn's disease.
We report our single-centre experience in 53 patients. We evaluated maintenance of clinical response defined as the absence of adverse events leading to drug withdrawal, no major abdominal surgery and no loss of clinical response in initial responders. Major abdominal surgery, steroid sparing, complete fistula closure and safety were also assessed.
The probability of maintaining clinical response was 77.2%, 67.8% and 50.8% at 26, 52 and 130 weeks respectively. The probability of remaining major abdominal surgery-free was 82.3% at 26, 52 and 130 weeks. Complete fistula closure occurred in six of 10 patients, and eight of 10 patients were able to taper steroid therapy. Adverse events occurred in 31 patients (58.5%) leading to adalimumab withdrawal in nine patients (17%).
Adalimumab therapy may be effective in the long term in both luminal and fistulizing Crohn's disease in infliximab-failure patients, half of patients maintaining clinical response and potentially avoiding major abdominal surgery in 80% of cases.
对于对英夫利昔单抗失去反应或不耐受的克罗恩病患者,阿达木单抗在诱导临床缓解方面有效。
评估阿达木单抗作为腔外型和瘘管型克罗恩病二线治疗的长期疗效和安全性。
我们报告了在53例患者中的单中心经验。我们评估了临床反应的维持情况,定义为无导致停药的不良事件、无重大腹部手术且初始有反应者无临床反应丧失。还评估了重大腹部手术、类固醇减量、瘘管完全闭合及安全性。
在26周、52周和130周时维持临床反应的概率分别为77.2%、67.8%和50.8%。在26周、52周和130周时无重大腹部手术的概率为82.3%。10例患者中有6例瘘管完全闭合,10例患者中有8例能够逐渐减少类固醇治疗。31例患者(58.5%)发生不良事件,其中9例患者(17%)因不良事件停用阿达木单抗。
对于英夫利昔单抗治疗失败的患者,阿达木单抗治疗在腔外型和瘘管型克罗恩病中可能长期有效,半数患者维持临床反应,80%的患者可能避免重大腹部手术。