title: Real life results in using 5-ASA for maintaining mild to moderate UC patients in Japan, a multi-center study, OPTIMUM Study.
abstract: BACKGROUND
  Efficacy of maintenance therapy in ulcerative colitis (UC) in the remission stage has been reported to depend on release profile or dosing regimen of oral 5-aminosalicylic acid (5-ASA) products used. Aim of this study is to investigate real life results in using oral 5-ASA products for maintaining mild to moderate UC patients in Japan.
  
  
  METHODS
  Adult UC outpatients treated with oral 5-ASA products were enrolled from 379 sites in Japan between July 2012 and July 2013, and followed for 52 weeks. Remission maintenance rate was evaluated by products and dosages. Factors affecting recurrence were also examined.
  
  
  RESULTS
  A total of 5695 UC patients were registered. Among the 4677 patients in whom remission maintenance was observed, remission maintenance rate at week 52 was 80.2%. As for disease duration and dosage, Pentasa® 4000 mg/day in 2 divided doses was administered to 480 (21.0%) patients in remission and 341 (46.6%) patients in active stage, and Asacol® 3600 mg/day in 3 divided doses was administered to 696 (46.4%) patients in remission and 473 (67.3%) patients in active stage. The remission maintenance rate at week 52 by dosage and frequency did not significantly differ between Pentasa® Tablets at 4000 mg/day in 2 divided doses (76.5%) and Asacol® Tablets at 3600 mg/day in 3 divided doses (76.1%, P = 0.7868). Factors affecting the risk of relapse in UC were identified. Significantly persistent remission maintenance was noted in patients in whom duration of remission maintenance until enrollment was 12 to <24 months or ≥24 months relative to the reference category of <3 months (12 to <24 months: HR 0.600 [0.486-0.740], p < 0.0001]; ≥24 months: HR 0.352 [0.289-0.431], p < 0.0001).
  
  
  CONCLUSIONS
  Efficacy of real life results in using oral 5-ASA products for maintaining mild to moderate UC patients was favorable. Maintaining remission for 12 months or longer after induction therapy was shown to reduce recurrence risk thereafter.
  
  
  BACKGROUND
  UMIN 000008563 (the date of registration: July 30, 2012), ClinicalTrials.gov NCT01654783 (the date of registration: July 30, 2012).
authors.affiliation: Department of Gastroenterology, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyoku, Tokyo, 113-8519, Japan. nagahori.gast@tmd.ac.jp.
authors.forename: Masakazu
authors.initials: M
authors.lastname: Nagahori
authors.affiliation: Division of Gastroenterology, Matsuyama Red Cross Hospital, 1 Bunkyocho, Matsuyama, Ehime, Japan.
authors.forename: Shuji
authors.initials: S
authors.lastname: Kochi
authors.affiliation: Center for Gastroenterology and Inflammatory Bowel Disease Research, Hamamatsu South Hospital, 26 Shirowacho, Minamiku, Hamamatsu, Shizuoka, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Hanai
authors.affiliation: Inflammatory Bowel Disease Center, Yokkaichi Hazu Medical Center, 10-8 Hazuyamacho, Yokkaichi, Mie, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yamamoto
authors.affiliation: Department of Inflammatory Bowel Disease, Division of Internal Medicine, Hyogo College of Medicine, 1-1 Mukogawacho, Nishinomiya, Hyogo, Japan.
authors.forename: Shiro
authors.initials: S
authors.lastname: Nakamura
authors.affiliation: Medical Affairs, Clinical Development Center, Kyorin Pharmaceutical Co., Ltd. 4-6 Kanda Surugadai, Chiyodaku, Tokyo, Japan.
authors.forename: Soji
authors.initials: S
authors.lastname: Omuro
authors.affiliation: Department of Gastroenterology, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyoku, Tokyo, 113-8519, Japan.
authors.forename: Mamoru
authors.initials: M
authors.lastname: Watanabe
authors.affiliation: Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, 5-9-1 Shirokane, Minatoku, Tokyo, Japan.
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004339:Drug Compounding; D005260:Female; D006801:Humans; D007564:Japan; D060046:Maintenance Chemotherapy; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use*; D008875:Middle Aged; D012008:Recurrence; D012720:Severity of Illness Index; D012460:Sulfasalazine / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D012460:Sulfasalazine; D019804:Mesalamine
keywords: Observational study; Oral 5-ASA products; Remission maintenance rate; Ulcerative colitis