title: Managing ambulatory ulcerative colitis patients with infliximab: a long term follow-up study in primary gastroenterology centers.
abstract: BACKGROUND
  Infliximab (IFX) is the key treatment for ulcerative colitis (UC) unresponsive to standard treatments. The aim of the present study was to assess the efficacy and safety of IFX in treating ambulatory UC patients in primary gastroenterology centers.
  
  
  METHODS
  One hundred and eighteen patients (65 M, 63 F, median age 34 years, range 19-71 years), affected by UC, were treated with IFX. Clinical efficacy, safety, mucosal healing (MH), and histological healing (HH) were assessed at a scheduled follow-up of 42 months.
  
  
  RESULTS
  Percentage of patients with clinical remission persistence at 42-month follow-up was 70.4%. Colectomy occurred in only 3 patients (2.7%). At 42-month follow-up percentage of patients with MH was 44.6%, and percentage of patients with HH was 24.3%. HH at 6-month follow-up occurred in 13 out of 34 patients (38.2%) with C-reactive protein (CRP) <3 and in 8 out of 76 patients (10.5%) with CRP ≥ 3 (p=0.002). Side effects were reported in 16 patients (13.6%): infusion reactions occurred in 7 patients, other severe side-effects occurred in 3 patients, and opportunistic infections occurred in 3 patients (2.5%). Finally, 3 cancers (2.5%) occurred during the follow-up period (1 breast, 1 kidney and 1 rectal cancer). Both univariate and multivariate analyses showed Hb <11.5 g/dL and HH at 6-month follow-up to be significantly associated with treatment failure during follow-up.
  
  
  CONCLUSIONS
  IFX seems to be effective and safe in long-term treatment of outpatients affected by UC.
authors.affiliation: Gastroenterology Service, ASL BAT, Andria, BT, Italy. Electronic address: antotursi@tiscali.it.
authors.forename: Antonio
authors.initials: A
authors.lastname: Tursi
authors.affiliation: Division of Gastroenterology, ASL Roma H, Albano Laziale, Rome, Italy.
authors.forename: Walter
authors.initials: W
authors.lastname: Elisei
authors.affiliation: Division of Surgery, "P. Colombo" Hospital, Velletri, Rome, Italy.
authors.forename: Marcello
authors.initials: M
authors.lastname: Picchio
authors.affiliation: Division of Gastroenterology, "San Paolo" Hospital, Bari, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Penna
authors.affiliation: Division of Gastroenterology, "Cristo Re" Hospital, Rome, Italy.
authors.forename: Piera Giuseppina
authors.initials: PG
authors.lastname: Lecca
authors.affiliation: Digestive Endoscopy Unit, "Santa Maria Goretti" Hospital, Latina, Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Forti
authors.affiliation: Digestive Endoscopy and Nutrition Unit, "S. Eugenio" Hospital, Rome, Italy.
authors.forename: GianMarco
authors.initials: G
authors.lastname: Giorgetti
authors.affiliation: Division of Gastroenterology, "Belcolle Hospital", Viterbo, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Faggiani
authors.affiliation: Division of Gastroenterology, "Belcolle Hospital", Viterbo, Italy.
authors.forename: Costantino
authors.initials: C
authors.lastname: Zampaletta
authors.affiliation: Division of Gastroenterology, "Belcolle Hospital", Viterbo, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Pelecca
authors.affiliation: Division of Gastroenterology, "Cristo Re" Hospital, Rome, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Brandimarte
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D005753:Gastric Mucosa / Q000473:pathology; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D012074:Remission Induction; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab
keywords: Clinical practice; Clinical remission; Histological healing; Infliximab; Mucosal healing; Ulcerative colitis