title: Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: Data from ULTRA 1, 2, and 3.
abstract: OBJECTIVE
  The safety and efficacy of adalimumab for patients with moderately to severely active ulcerative colitis (UC) has been reported up to week 52 from the placebo-controlled trials ULTRA (Ulcerative Colitis Long-Term Remission and Maintenance with Adalimumab) 1 and 2. Up to 4 years of data for adalimumab-treated patients from ULTRA 1, 2, and the open-label extension ULTRA 3 are presented.
  
  
  METHODS
  Remission per partial Mayo score, remission per Inflammatory Bowel Disease Questionnaire (IBDQ) score, and mucosal healing rates were assessed in adalimumab-randomized patients from ULTRA 1 and 2 up to week 208. Corticosteroid-free remission was assessed in adalimumab-randomized patients who used corticosteroids at lead-in study baseline. Maintenance of remission per partial Mayo score and mucosal healing was assessed in patients who entered ULTRA 3 in remission per full Mayo score and with mucosal healing, respectively. As observed, last observation carried forward (LOCF) and nonresponder imputation (NRI) were used to report efficacy. Adverse events were reported for any adalimumab-treated patient.
  
  
  RESULTS
  A total of 600/1,094 patients enrolled in ULTRA 1 or 2 were randomized to receive adalimumab and included in the intent-to-treat analyses of the studies. Of these, 199 patients remained on adalimumab after 4 years of follow-up. Rates of remission per partial Mayo score, remission per IBDQ score, mucosal healing, and corticosteroid discontinuation at week 208 were 24.7%, 26.3%, 27.7% (NRI), and 59.2% (observed), respectively. Of the patients who were followed up in ULTRA 3 (588/1,094), a total of 360 patients remained on adalimumab 3 years later. Remission per partial Mayo score and mucosal healing after ULTRA 1 or 2 to year 3 of ULTRA 3 were maintained by 63.6% and 59.9% of patients, respectively (NRI). Adverse event rates were stable over time.
  
  
  CONCLUSIONS
  Remission, mucosal healing, and improved quality of life were maintained in patients with moderately to severely active UC with long-term adalimumab therapy, for up to 4 years. No new safety signals were reported.
authors.affiliation: Department of Gastroenterology, Icahn School of Medicine at Mt Sinai, New York, New York, USA.
authors.forename: Jean-Frederic
authors.initials: JF
authors.lastname: Colombel
authors.affiliation: Division of Gastroenterology, Inflammatory Bowel Disease Center, University of California San Diego, La Jolla, California, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.affiliation: Department of Medicine, Division of Gastroenterology, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Subrata
authors.initials: S
authors.lastname: Ghosh
authors.affiliation: Atlanta Gastroenterology Associates, Atlanta, Georgia, USA.
authors.forename: Douglas C
authors.initials: DC
authors.lastname: Wolf
authors.affiliation: Department of Medicine, Division of Gastroenterology, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Remo
authors.initials: R
authors.lastname: Panaccione
authors.affiliation: Robarts Research Institute and University of Western Ontario, London, Ontario, Canada.
authors.forename: Brian
authors.initials: B
authors.lastname: Feagan
authors.affiliation: Department of Medicine, Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Walter
authors.initials: W
authors.lastname: Reinisch
authors.affiliation: AbbVie, North Chicago, Illinois, USA.
authors.forename: Anne M
authors.initials: AM
authors.lastname: Robinson
authors.affiliation: AbbVie Deutschland, Ludwigshafen, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Lazar
authors.affiliation: AbbVie Deutschland, Ludwigshafen, Germany.
authors.forename: Martina
authors.initials: M
authors.lastname: Kron
authors.affiliation: AbbVie, North Chicago, Illinois, USA.
authors.forename: Bidan
authors.initials: B
authors.lastname: Huang
authors.affiliation: AbbVie, North Chicago, Illinois, USA.
authors.forename: Martha
authors.initials: M
authors.lastname: Skup
authors.affiliation: AbbVie, North Chicago, Illinois, USA.
authors.forename: Roopal B
authors.initials: RB
authors.lastname: Thakkar
mesh_terms: D000068879:Adalimumab; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D060046:Maintenance Chemotherapy / Q000379:methods*; D008297:Male; D011788:Quality of Life; D012074:Remission Induction; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab