title: Adalimumab in active ulcerative colitis: a "real-life" observational study.
abstract: OBJECTIVE
  The effectiveness of adalimumab in the treatment of ulcerative colitis is under debate. Although controlled trials have shown that adalimumab is significantly better than placebo, the absolute clinical benefit is modest. We report data on the effectiveness of adalimumab in a cohort of ulcerative colitis patients treated in 22 Italian centres.
  
  
  METHODS
  All patients with active disease treated with adalimumab were retrospectively reviewed. Co-primary endpoints were clinical remission at weeks 4, 12, 24 and 54. Secondary endpoints were sustained clinical remission, steroid discontinuation, endoscopic remission and need for colectomy.
  
  
  RESULTS
  Eighty-eight patients were included. Most patients had received previous infliximab treatment. Clinical remission rates were 17%, 28.4%, 36.4% and 43.2% at 4, 12, 24 and 54 weeks respectively. Twenty-two patients required colectomy. Clinical remission and low C-reactive protein at week 12 predicted clinical remission at week 54 (OR 4.17, 95% CI 2.36-19.44; OR 2.63, 95% CI 2.32-14.94, respectively). Previous immunosuppressant use was associated with a lower probability of clinical remission at week 54 (OR 0.67, 95% CI 0.08-0.66) and with a higher rate of colectomy (HR 9.7, 95% CI 1.46-9.07).
  
  
  CONCLUSIONS
  In this large "real-life" experience adalimumab appears effective in patients with otherwise medically refractory ulcerative colitis. Patients achieving early remission can expect a better long-term outcome.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Armuzzi
authors.forename: Livia
authors.initials: L
authors.lastname: Biancone
authors.forename: Marco
authors.initials: M
authors.lastname: Daperno
authors.forename: Alessandra
authors.initials: A
authors.lastname: Coli
authors.forename: Daniela
authors.initials: D
authors.lastname: Pugliese
authors.forename: Vito
authors.initials: V
authors.lastname: Annese
authors.forename: Annalisa
authors.initials: A
authors.lastname: Aratari
authors.forename: Sandro
authors.initials: S
authors.lastname: Ardizzone
authors.forename: Paola
authors.initials: P
authors.lastname: Balestrieri
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Bossa
authors.forename: Maria
authors.initials: M
authors.lastname: Cappello
authors.forename: Fabiana
authors.initials: F
authors.lastname: Castiglione
authors.forename: Michele
authors.initials: M
authors.lastname: Cicala
authors.forename: Silvio
authors.initials: S
authors.lastname: Danese
authors.forename: Renata
authors.initials: R
authors.lastname: D'Incà
authors.forename: Pietro
authors.initials: P
authors.lastname: Dulbecco
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Feliciangeli
authors.forename: Walter
authors.initials: W
authors.lastname: Fries
authors.forename: Stefania
authors.initials: S
authors.lastname: Genise
authors.forename: Paolo
authors.initials: P
authors.lastname: Gionchetti
authors.forename: Stefano
authors.initials: S
authors.lastname: Gozzi
authors.forename: Anna
authors.initials: A
authors.lastname: Kohn
authors.forename: Roberto
authors.initials: R
authors.lastname: Lorenzetti
authors.forename: Monica
authors.initials: M
authors.lastname: Milla
authors.forename: Sara
authors.initials: S
authors.lastname: Onali
authors.forename: Ambrogio
authors.initials: A
authors.lastname: Orlando
authors.forename: Luigi Giovanni
authors.initials: LG
authors.lastname: Papparella
authors.forename: Sara
authors.initials: S
authors.lastname: Renna
authors.forename: Chiara
authors.initials: C
authors.lastname: Ricci
authors.forename: Fernando
authors.initials: F
authors.lastname: Rizzello
authors.forename: Raffaello
authors.initials: R
authors.lastname: Sostegni
authors.forename: Luisa
authors.initials: L
authors.lastname: Guidi
authors.forename: Claudio
authors.initials: C
authors.lastname: Papi
mesh_terms: D000068879:Adalimumab; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D015331:Cohort Studies; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D012074:Remission Induction; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D000068879:Adalimumab
keywords: Adalimumab; Ulcerative colitis; “Real-life” study