阿达木单抗在加拿大中重度克罗恩病患者中的疗效与安全性：加拿大中重度克罗恩病患者使用阿达木单抗（ACCESS）试验结果
Efficacy and safety of adalimumab in Canadian patients with moderate to severe Crohn's disease: results of the Adalimumab in Canadian SubjeCts with ModErate to Severe Crohn's DiseaSe (ACCESS) trial.
作者信息
Panaccione Remo, Loftus Edward V, Binion David, McHugh Kevin, Alam Shamsul, Chen Naijun, Guerette Benoît, Mulani Parvez, Chao Jingdong
机构信息
University of Calgary, Calgary, Alberta, USA.
出版信息
Can J Gastroenterol. 2011 Aug;25(8):419-25. doi: 10.1155/2011/724813.
OBJECTIVE
To evaluate open-label adalimumab therapy for clinical effectiveness, fistula healing, patient-reported outcomes and safety in Canadian patients with moderate to severe Crohn's disease (CD) who were either naive to or previously exposed to antitumour necrosis factor (anti-TNF) therapy.
METHODS
Patients with moderate to severe CD (CD activity index [CDAI] score of greater than 220, or Harvey-Bradshaw index [HBI] of 7 or greater) were eligible. Patients received open-label adalimumab as induction (160 mg and 80 mg subcutaneously [sc]) at weeks 0 and 2, respectively and maintenance (40 mg sc every other week) therapy. At or after eight weeks, patients with flare or nonresponse could have their dosage increased to 40 mg sc weekly. Patients were followed for a minimum of six months or until adalimumab was commercially available in Canada.
RESULTS
Of the 304 patients enrolled, 160 were infliximab experienced, while 144 were anti-TNF naive. HBI remission (HBI score of 4 or lower) at week 24 was achieved by 53% of anti-TNF-naive and 36% of infliximab-experienced patients (P<0.01; P<0.001 for both groups for all visits versus baseline). Fistula healing rates at week 12 were 48% for anti-TNF-naive patients, and 26% for infliximab-experienced patients. At week 24, fistula healing rates were significantly greater for the anti-TNF-naive group (60% versus 28%; P<0.01). Improvements in quality of life and work productivity were sustained from week 4 to week 24 for all patients. Serious infections occurred in 2% of patients.
CONCLUSIONS
Adalimumab therapy induced and sustained steroidfree remission in both infliximab-experienced and anti-TNF-naive patients with moderate to severe CD. Clinically meaningful rates of fistula healing were also observed. Improvements in patient-reported outcomes were sustained throughout the 24-week study period.
目的
评估开放标签的阿达木单抗治疗对加拿大中重度克罗恩病（CD）患者的临床疗效、瘘管愈合情况、患者报告的结局及安全性，这些患者既往未接受过抗肿瘤坏死因子（抗TNF）治疗或曾接受过抗TNF治疗。
方法
符合条件的患者为中重度CD患者（克罗恩病活动指数[CDAI]评分大于220，或哈维-布拉德肖指数[HBI]为7或更高）。患者接受开放标签的阿达木单抗诱导治疗（分别在第0周和第2周皮下注射160mg和80mg）及维持治疗（每隔一周皮下注射40mg）。在第8周及以后，病情复发或无反应的患者可将剂量增加至每周皮下注射40mg。对患者进行至少6个月的随访，或直至阿达木单抗在加拿大上市。
结果
在纳入的304例患者中，160例曾使用过英夫利昔单抗，144例既往未接受过抗TNF治疗。在第24周时，53%既往未接受过抗TNF治疗的患者和36%曾使用过英夫利昔单抗的患者实现了HBI缓解（HBI评分为4或更低）（P<0.01；两组在所有访视时与基线相比P均<0.001）。在第12周时，既往未接受过抗TNF治疗的患者瘘管愈合率为48%，曾使用过英夫利昔单抗的患者为26%。在第24周时，既往未接受过抗TNF治疗组的瘘管愈合率显著更高（60%对28%；P<0.01）。所有患者从第4周到第24周生活质量和工作生产力均持续改善。2%的患者发生了严重感染。
结论
阿达木单抗治疗在曾使用过英夫利昔单抗和既往未接受过抗TNF治疗的中重度CD患者中均诱导并维持了无类固醇缓解。还观察到具有临床意义的瘘管愈合率。在整个24周的研究期间，患者报告的结局持续改善。
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