title: Effectiveness of adalimumab for ambulatory ulcerative colitis patients after failure of infliximab treatment: a first "real-life" experience in primary gastroenterology centers in Italy.
abstract: BACKGROUND
  Adalimumab (ADA) is the key treatment for ulcerative colitis (UC) unresponsive or intolerant to standard treatments. Our aim was to assess the efficacy and safety of ADA in treating ambulatory UC patients in primary gastroenterology centers.
  
  
  METHODS
  Fifteen patients (6 male, median age 29.9 years, range 22.8-39.9 years) were enrolled. All were previously treated with infliximab (IFX). Clinical activity and endoscopic severity were scored according to the Crohn's disease activity index (CDAI) score and Mayo subscore for endoscopy, respectively. Patients were clinically assessed at weeks 4, 8, and thereafter at weeks 16, 24, 32, 40, 48, and 54. Colonoscopy was performed before starting treatment, at weeks 24 and 54. The co-primary endpoints were clinical remission at 24 and 54 weeks. The secondary endpoints included: 1) sustained clinical remission; 2) steroid-sparing effect; 3) mucosal healing; 4) need for colectomy. Induction dose of ADA was 160 mg at week 0, and then 80 mg at week 2, while ADA maintenance treatment was 40 mg every two weeks.
  
  
  RESULTS
  Clinical remission was obtained in 11 (73.3%) and 15 (100%) patients at weeks 24 and 54 respectively. Ten patients (66.7%) were able to discontinue steroids and were under corticosteroid-free remission at week 54. No patients underwent to colectomy. Eight patients (53.33%) at week 24 and 9 patients (60%) at week 54 achieved complete mucosal healing (Mayo endoscopic score 0). Side effects were reported in 2 of 15 patients (13.3%); none of those patients stopped treatment.
  
  
  CONCLUSIONS
  ADA seems to be effective and safe in UC outpatients affected by UC, and previously treated with IFX.
authors.affiliation: Gastroenterology Service, ASL BAT, Andria, BT (Antonio Tursi), Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Tursi
authors.affiliation: Division of Gastroenterology, ASL Roma H, Albano Laziale, Rome (Walter Elisei), Italy.
authors.forename: Walter
authors.initials: W
authors.lastname: Elisei
authors.affiliation: Division of Surgery, "P. Colombo" Hospital, Velletri, Rome (Marcello Picchio), Italy.
authors.forename: Marcello
authors.initials: M
authors.lastname: Picchio
authors.affiliation: Division of Gastroenterology, "San Paolo" Hospital, Bari (Antonio Penna), Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Penna
authors.affiliation: Digestive Endoscopy Unit, "Santa Maria Goretti" Hospital, Latina (Giacomo Forti), Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Forti
authors.affiliation: Digestive Endoscopy and Nutrition Unit, "S. Eugenio" Hospital, Rome (Gian Marco Giorgetti), Italy.
authors.forename: Gian Marco
authors.initials: GM
authors.lastname: Giorgetti
authors.affiliation: Division of Gastroenterology, "Belcolle Hospital", Viterbo (Roberto Faggiani, Costantino Zampaletta, Giorgio Pelecca), Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Faggiani
authors.affiliation: Division of Gastroenterology, "Belcolle Hospital", Viterbo (Roberto Faggiani, Costantino Zampaletta, Giorgio Pelecca), Italy.
authors.forename: Costantino
authors.initials: C
authors.lastname: Zampaletta
authors.affiliation: Division of Gastroenterology, "Belcolle Hospital", Viterbo (Roberto Faggiani, Costantino Zampaletta, Giorgio Pelecca), Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Pelecca
authors.affiliation: Division of Gastroenterology, "Cristo Re" Hospital, Rome (Giovanni Brandimarte), Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Brandimarte
keywords: Adalimumab; clinical practice; clinical remission; mucosal healing; ulcerative colitis