title: Long-term safety and efficacy of adalimumab in Japanese patients with moderate to severe Crohn's disease.
abstract: OBJECTIVE
  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.affiliation: Tokyo Medical and Dental University, Tokyo, Japan. Electronic address: mamoru.gast@tmd.ac.jp.
authors.forename: Mamoru
authors.initials: M
authors.lastname: Watanabe
authors.affiliation: Kitasato University, Kitasato Institute Hospital, Tokyo, Japan.
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
authors.affiliation: AbbVie Inc., North Chicago, IL, USA.
authors.forename: Nael M
authors.initials: NM
authors.lastname: Mostafa
authors.affiliation: AbbVie Inc., North Chicago, IL, USA.
authors.forename: Jingdong
authors.initials: J
authors.lastname: Chao
authors.affiliation: AbbVie Inc., North Chicago, IL, USA.
authors.forename: Vipin
authors.initials: V
authors.lastname: Arora
authors.affiliation: AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
authors.forename: Anne
authors.initials: A
authors.lastname: Camez
authors.affiliation: AbbVie Inc., Rungis, France.
authors.forename: Joel
authors.initials: J
authors.lastname: Petersson
authors.affiliation: AbbVie Inc., North Chicago, IL, USA.
authors.forename: Roopal
authors.initials: R
authors.lastname: Thakkar
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D001379:Azathioprine / Q000627:therapeutic use; D003424:Crohn Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007564:Japan; D060046:Maintenance Chemotherapy; D008297:Male; D015122:Mercaptopurine / Q000627:therapeutic use; D008875:Middle Aged; D011788:Quality of Life; D012074:Remission Induction; D012720:Severity of Illness Index; D013997:Time Factors; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D015122:Mercaptopurine; D000068879:Adalimumab; D001379:Azathioprine
keywords: Adalimumab; Crohn's disease; Japan; Long-term; Maintenance