title: Infliximab safety profile and long-term applicability in inflammatory bowel disease: 9-year experience in clinical practice.
abstract: BACKGROUND
  Most available data on infliximab therapy come from large, short-term, pivotal RCTs and concerns about long-term safety profile still remain.
  
  
  OBJECTIVE
  To evaluate the long-term safety profile of infliximab in inflammatory bowel disease (IBD) in a clinical practice setting.
  
  
  METHODS
  Since 1999, all IBD patients treated with infliximab were registered and clinical outcomes prospectively recorded up to March 2008, loss of follow-up or patient's death. Infliximab regimens and preventive measures were in accordance with the prevalent guidelines or with the manufacturer's recommendations.
  
  
  RESULTS
  One hundred fifty-two patients were included (121 Crohn's disease, 24 ulcerative colitis, 7 indeterminate colitis), with a median of 5 infliximab infusions (IQR 3-8) and 87% of patients received at least three infusions. Seventy-nine per cent of them received concomitant immunomodulators and 70% were pre-medicated with hydrocortisone from the first infusion. After a median follow-up of 142 weeks, 13% presented infusion reactions, 13% viral or bacterial infections and two patients developed neoplasia. The mortality rate was 2.6% (four patients).
  
  
  CONCLUSIONS
  Infliximab therapy is safe when the recommended preventive measures are implemented, with a rate of serious adverse events less than 10%. No new safety signals were found.
authors.affiliation: Gastroenterology Department, Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Spain.
authors.forename: Y
authors.initials: Y
authors.lastname: Zabana
authors.forename: E
authors.initials: E
authors.lastname: Domènech
authors.forename: M
authors.initials: M
authors.lastname: Mañosa
authors.forename: E
authors.initials: E
authors.lastname: Garcia-Planella
authors.forename: I
authors.initials: I
authors.lastname: Bernal
authors.forename: E
authors.initials: E
authors.lastname: Cabré
authors.forename: M A
authors.initials: MA
authors.lastname: Gassull
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D003875:Drug Eruptions / Q000453:epidemiology; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006854:Hydrocortisone / Q000627:therapeutic use; D007239:Infections / Q000139:chemically induced / Q000453:epidemiology; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy* / Q000453:epidemiology; D000069285:Infliximab; D007262:Infusions, Intravenous / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000139:chemically induced / Q000453:epidemiology; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D012713:Serum Sickness / Q000139:chemically induced / Q000453:epidemiology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab; D006854:Hydrocortisone