Watanabe Mamoru, Hibi Toshifumi, Mostafa Nael M, Chao Jingdong, Arora Vipin, Camez Anne, Petersson Joel, Thakkar Roopal
Tokyo Medical and Dental University, Tokyo, Japan.
Kitasato University, Kitasato Institute Hospital, Tokyo, Japan.
J Crohns Colitis. 2014 Nov;8(11):1407-16. doi: 10.1016/j.crohns.2014.04.012. Epub 2014 May 27.
Adalimumab has been shown to be effective and well tolerated in patients with Crohn's disease. This analysis reports the results of a cohort of Japanese patients with moderate to severe Crohn's disease who were evaluated for up to 3years to assess the long-term use of adalimumab.
The study consisted of a double-blind part and an open-label part. Patients were included either in the 52-week double-blind, placebo-controlled part of the study followed by a 96-week open-label extension or in the open-label part from the beginning or in the event of a flare. Patients were treated with adalimumab and evaluated for up to 148weeks as 3 data cohorts: the all-adalimumab cohort (patients receiving ≥1 injection of adalimumab), the 148-week follow-up subcohort (patients who completed 148weeks of follow-up after the first adalimumab dose), and the dose-escalation subcohort (patients receiving adalimumab doses that increased to 80mg every other week).
In the all-adalimumab cohort (n=79), clinical remission rates were approximately 30% after 36weeks of exposure to adalimumab and for the remainder of the study (35%, 33%, and 28% for weeks 48, 108, and 144, respectively). An improvement in quality of life was also maintained over the same period. In the dose-escalation subcohort (n=40), the clinical remission rate was 75% (6/8) 48weeks after dose escalation. Adalimumab was tolerated, and no deaths were reported.
Adalimumab is effective for maintaining long-term clinical remission in Japanese patients with moderate to severe Crohn's disease (NCT00445432).
已证明阿达木单抗对克罗恩病患者有效且耐受性良好。本分析报告了一组日本中重度克罗恩病患者的研究结果，这些患者接受了长达3年的评估，以评估阿达木单抗的长期使用情况。
该研究包括双盲部分和开放标签部分。患者要么纳入为期52周的双盲、安慰剂对照研究部分，随后进行96周的开放标签扩展，要么从一开始就纳入开放标签部分，或者在病情复发时纳入。患者接受阿达木单抗治疗，并作为3个数据队列进行长达148周的评估：全阿达木单抗队列（接受≥1次阿达木单抗注射的患者）、148周随访亚队列（在首次注射阿达木单抗后完成148周随访的患者）和剂量递增亚队列（接受每两周增加至80mg阿达木单抗剂量的患者）。
在全阿达木单抗队列（n = 79）中，在接触阿达木单抗36周后临床缓解率约为30%，在研究的其余时间（第48、108和144周分别为35%、33%和28%）。同期生活质量也得到了维持。在剂量递增亚队列（n = 40）中，剂量递增48周后的临床缓解率为75%（6/8）。阿达木单抗耐受性良好，未报告死亡病例。
阿达木单抗对维持日本中重度克罗恩病患者的长期临床缓解有效（NCT00445432）。
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