title: Efficacy and safety of infliximab and adalimumab in Crohn's disease: a single centre study.
abstract: BACKGROUND
  Infliximab and adalimumab are highly effective in Crohn's Disease (CD). This is supported by clinical trials and open-label studies using either infliximab or adalimumab, thus not allowing a proper comparison between these anti-TNFs in CD.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of infliximab and adalimumab in active CD.
  
  
  METHODS
  In a longitudinal study, CD patients with indication for anti-TNFs were treated with infliximab or adalimumab.
  
  
  RESULTS
  Ninety-three patients were treated with infliximab (n = 44) or adalimumab (n = 49). In the infliximab group, the induction was completed by 77.3% of patients, due to no response (n = 2), delayed hypersensitivity reactions (DHR) or infusion reactions (n = 8). Maintenance with infliximab was completed by 60% of patients, due to clinical worsening or loss of efficacy (n = 5), DHR or infusion reactions (n = 5). In the adalimumab group, all patients completed the induction, while maintenance was completed by 67% of patients, due to clinical worsening or loss of efficacy (n = 8), DHR (n = 1), other causes (n = 7). In both groups, the CDAI significantly reduced at baseline vs. each visit (P < 0.04). The Kaplan-Meier survival analysis performed to evaluate the risk of steroid-free remission in patients treated with infliximab vs. adalimumab detected no differences (log-rank test P = 0.4). Cox proportional-hazards regression identified two predictors of steroid-free remission using anti-TNFs: no smokers [HR = 2.94 (1.52-5.70), P = 0.001] and non stricturing non penetrating behaviour [HR = 3.116 (1.06-9.13), P = 0.03826].
  
  
  CONCLUSIONS
  Infliximab and adalimumab showed a similar efficacy. No smoking and non-stricturing non-penetrating behaviour were predictors of steroid-free remission.
authors.affiliation: Unità di Gastroenterologia, Dipartimento di Medicina Interna, Università di Roma 'Tor Vergata', Rome, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Zorzi
authors.forename: S
authors.initials: S
authors.lastname: Zuzzi
authors.forename: S
authors.initials: S
authors.lastname: Onali
authors.forename: E
authors.initials: E
authors.lastname: Calabrese
authors.forename: G
authors.initials: G
authors.lastname: Condino
authors.forename: C
authors.initials: C
authors.lastname: Petruzziello
authors.forename: M
authors.initials: M
authors.lastname: Ascolani
authors.forename: F
authors.initials: F
authors.lastname: Pallone
authors.forename: L
authors.initials: L
authors.lastname: Biancone
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000069285:Infliximab; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab