title: Clinical efficacy of adalimumab in Crohn's disease: a real practice observational study in Japan.
abstract: BACKGROUND
  There are few reports of the efficacy of adalimumab (ADA) for clinical remission and preventing postoperative recurrence in Crohn's disease (CD) in Asian real practice settings. We conducted a Japanese multicenter retrospective observational study.
  
  
  METHODS
  We evaluated patients with CD who were treated with ADA at 11 medical institutions in Japan to investigate the clinical efficacy of remission up to 52 weeks and the associated factors to achieve remission with a CD Activity Index (CDAI) < 150. The effects of preventing postoperative recurrence were also evaluated.
  
  
  RESULTS
  In 62 patients, the remission rates were 33.9, 74.2, 75.8, 77.4, and 66.1 % at 0, 4, 12, 26, and 52 weeks, respectively. Although 10 patients discontinued treatment due to primary nonresponse, secondary nonresponse, or adverse events, the ongoing treatment rate at 52 weeks was 83.9 %. Comparison of remission and non-remission on univariate analysis identified colonic type and baseline CDAI value as significant associated factors (P < 0.05). In 16 patients who received ADA to prevent postoperative recurrence, the clinical remission maintenance rate was 93.8 % and the mucosal healing rate was 64.3 % during a mean postoperative follow-up period of 32.3 months.
  
  
  CONCLUSIONS
  ADA effectively induced remission and prevented postoperative recurrence in patients with CD in a real practice setting.
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan. ftake@nagasaki-u.ac.jp.
authors.forename: Fuminao
authors.initials: F
authors.lastname: Takeshima
authors.affiliation: Department of Gastroenterology and Hepatology, Sasebo City General Hospital, 9-3 Hirase-cho, Sasebo City, Nagasaki, 857-8511, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Yoshikawa
authors.affiliation: Department of Gastroenterology, National Hospital Organization Nagasaki Medical Center, 2-1001-1 Kubara, Ohmura City, Nagasaki, 856-8562, Japan.
authors.forename: Syuntaro
authors.initials: S
authors.lastname: Higashi
authors.affiliation: Department of Gastroenterology and Hepatology, National Hospital Organization Ureshino Medical Center, 2436 Ureshino-cho, Ureshino City, Saga, 843-0393, Japan.
authors.forename: Tomohito
authors.initials: T
authors.lastname: Morisaki
authors.affiliation: Department of Gastroenterology and Hepatology, Sasebo Chuo Hospital, 15 Yamato-cho, Sasebo City, Nagasaki, 857-1195, Japan.
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Oda
authors.affiliation: Department of Internal Medicine, Kouseikai Hospital, 1-3-12 Hayama, Nagasaki City, Nagasaki, 852-8053, Japan.
authors.forename: Maho
authors.initials: M
authors.lastname: Ikeda
authors.affiliation: Department of Internal Medicine, Shunkaikai Inoue Hospital, 6-12 Takara-machi, Nagasaki City, Nagasaki, 850-0045, Japan.
authors.forename: Haruhisa
authors.initials: H
authors.lastname: Machida
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
authors.forename: Kayoko
authors.initials: K
authors.lastname: Matsushima
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
authors.forename: Hitomi
authors.initials: H
authors.lastname: Minami
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Akazawa
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Yamaguchi
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Ohnita
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
authors.forename: Hajime
authors.initials: H
authors.lastname: Isomoto
authors.affiliation: Integrated Marketing Department, Eisai Co., Ltd., 13-1 Nishigoken-cho, Shinjuku-ku, Tokyo, 162-0812, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Ueno
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakao
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use*; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy* / Q000601:surgery; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D012189:Retrospective Studies; D055502:Secondary Prevention
chemical_list: D000893:Anti-Inflammatory Agents; D000068879:Adalimumab
keywords: Adalimumab; Crohn’s disease; Japanese patients; Preventing postoperative recurrence; Real practice