title: Efficacy and safety of adalimumab in Japanese patients with moderately to severely active ulcerative colitis.
abstract: BACKGROUND
  Adalimumab is a fully human, monoclonal antibody against tumor necrosis factor that is approved in Western countries for the treatment of moderately to severely active ulcerative colitis (UC).
  
  
  METHODS
  This 52-week, phase 2/3, randomized, double-blind study evaluated adalimumab for induction and maintenance treatment in 273 anti-TNF-naive Japanese patients with UC who were refractory to corticosteroids, immunomodulators, or both. Patients received placebo, adalimumab 80/40 (80 mg at week 0, then 40 mg every other week), or adalimumab 160/80 (160/80 mg at weeks 0/2, then 40 mg every other week) in addition to background UC therapy.
  
  
  RESULTS
  At week 8, remission rates were similar among treatment arms, but more patients treated with adalimumab 160/80 achieved response (placebo, 35 %; 80/40, 43 %; 160/80, 50 %; P = 0.044 for 160/80 vs placebo) and mucosal healing (placebo, 30 %; 80/40, 39 %; 160/80, 44 %; P = 0.045 for 160/80 vs placebo) compared with placebo. At week 52, more patients receiving adalimumab 40 mg every other week achieved response (18 vs 31 %; P = 0.021), remission (7 vs 23 %; P = 0.001), and mucosal healing (16 vs 29 %; P = 0.015) compared with placebo. Week 8 response to adalimumab was associated with greater rates of response (61 %), remission (46 %), and mucosal healing (57 %) at week 52 relative to the overall population. Rates of serious adverse events were similar between treatment arms.
  
  
  CONCLUSIONS
  Induction with adalimumab 160/80 mg led to early response and mucosal healing. Maintenance adalimumab had greater rates of long-term response, remission, and mucosal healing compared with placebo. No new safety signals were identified.
authors.affiliation: Toho University Medical Center Sakura Hospital, Chiba, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Suzuki
authors.forename: Satoshi
authors.initials: S
authors.lastname: Motoya
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Hanai
authors.forename: Takayuki
authors.initials: T
authors.lastname: Matsumoto
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
authors.forename: Anne M
authors.initials: AM
authors.lastname: Robinson
authors.forename: Nael M
authors.initials: NM
authors.lastname: Mostafa
authors.forename: Jingdong
authors.initials: J
authors.lastname: Chao
authors.forename: Vipin
authors.initials: V
authors.lastname: Arora
authors.forename: Anne
authors.initials: A
authors.lastname: Camez
authors.forename: Roopal B
authors.initials: RB
authors.lastname: Thakkar
authors.forename: Mamoru
authors.initials: M
authors.lastname: Watanabe
mesh_terms: D000068879:Adalimumab; D000305:Adrenal Cortex Hormones; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004311:Double-Blind Method; D004351:Drug Resistance; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents; D007564:Japan; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D000068879:Adalimumab