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首页> 外文期刊>Alimentary pharmacology & therapeutics. >The CHOICE trial: adalimumab demonstrates safety, fistula healing, improved quality of life and increased work productivity in patients with Crohn's disease who failed prior infliximab therapy.
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The CHOICE trial: adalimumab demonstrates safety, fistula healing, improved quality of life and increased work productivity in patients with Crohn's disease who failed prior infliximab therapy.

机译：CHOICE试验：阿达木单抗证明了英夫利昔单抗治疗失败的克罗恩病患者的安全性，瘘管愈合，生活质量改善和工作效率提高。

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BACKGROUND: Adalimumab induces and maintains remission in adults with Crohn's disease. AIM: To evaluate safety, fistula healing, quality of life and work productivity in adalimumab-treated patients who failed infliximab, including primary nonresponders. METHODS: After a >/=8-week infliximab washout, patients with moderate-to-severe Crohn's disease received open-label adalimumab as induction (160/80 mg at weeks 0/2) and maintenance (40 mg every other week) therapies. At/after 8 weeks, patients with flareonresponse could receive weekly therapy. Minimum study duration was 8 weeks, continuing until the commercial availability of adalimumab for Crohn's disease. RESULTS: Of 673 patients enrolled, 17% were infliximab primary nonresponders and 83% were initial responders. Three percent of patients had serious infections (mainly abscesses). Complete fistula healing was achieved by 34/88 (39%) patients with baseline fistulas. Improvements in quality of life and work productivity were sustained from week 4 to week 24 for all patients, as well as the subgroup of primary nonresponders. CONCLUSIONS: Blinded clinical trials have shown adalimumab to be both an effective first-line therapy for anti-TNF-naive patients and an important treatment option for infliximab-refractory or -intolerant patients. This trial presents open-label experience to support further the safety and effectiveness of adalimumab in patients who failed infliximab therapy, including primary nonresponders (NCT00338650).
机译：背景：阿达木单抗诱导并维持克罗恩氏病成人的缓解。目的：评估英夫利昔单抗治疗失败的患者（包括原发性无反应者）的安全性，瘘管愈合，生活质量和工作效率。方法：> / = 8周的英夫利昔单抗冲洗后，中度至重度克罗恩病患者接受开放标签阿达木单抗作为诱导治疗（0/2周为160/80 mg）和维持治疗（每隔一周40 mg） 。在8周/之后，耀斑/无反应的患者可以接受每周治疗。最小研究持续时间为8周，一直持续到阿达木单抗可用于克罗恩病的商业销售为止。结果：在673名患者中，英夫利昔单抗原发性无反应者占17％，初始有反应者占83％。 3％的患者患有严重感染（主要是脓肿）。 34/88（39％）基线瘘管患者实现了完全瘘管愈合。从第4周到第24周，所有患者以及原发性无反应者亚组的生活质量和工作效率均得到改善。结论：盲法临床试验表明，阿达木单抗既是抗TNF初治患者的有效一线治疗，又是对英夫利昔单抗难治或难治性患者的重要治疗选择。该试验提供了开放标签的经验，以进一步支持阿达木单抗在英夫利昔单抗治疗失败的患者（包括原发性无应答者）中的安全性和有效性（NCT00338650）。

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