Mamoru Watanabe1, Toshifumi Hibi2, Nael M Mostafa3, Jingdong Chao3, Vipin Arora3, Anne Camez4, Joel Petersson5, Roopal Thakkar3. 1. Tokyo Medical and Dental University, Tokyo, Japan. Electronic address: mamoru.gast@tmd.ac.jp. 2. Kitasato University, Kitasato Institute Hospital, Tokyo, Japan. 3. AbbVie Inc., North Chicago, IL, USA. 4. AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany. 5. AbbVie Inc., Rungis, France.
Abstract
BACKGROUND AND AIMS: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS:Adalimumab is effective for maintaining long-term clinical remission in Japanese patients with moderate to severe Crohn's disease (NCT00445432).
RCT Entities:
BACKGROUND AND AIMS: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS:Adalimumab is effective for maintaining long-term clinical remission in Japanese patients with moderate to severe Crohn's disease (NCT00445432).
Authors: Mark T Osterman; William J Sandborn; Jean-Frederic Colombel; Laurent Peyrin-Biroulet; Anne M Robinson; Qian Zhou; James D Lewis Journal: Am J Gastroenterol Date: 2016-09-27 Impact factor: 10.864
Authors: Kai-Chun Wu; Zhi Hua Ran; Xiang Gao; Minhu Chen; Jie Zhong; Jian-Qiu Sheng; Michael A Kamm; Simon Travis; Kori Wallace; Nael M Mostafa; Marisa Shapiro; Yao Li; Roopal B Thakkar; Anne M Robinson Journal: Intest Res Date: 2016-04-27