The safety profile of infliximab in patients with Crohn's disease: the Mayo clinic experience in 500 patients

Gastroenterology. 2004 Jan;126(1):19-31. doi: 10.1053/j.gastro.2003.10.047.


Background and aims: The aim of this study was to evaluate the short- and long-term safety of infliximab in patients with Crohn's disease in clinical practice.

Methods: The medical records of 500 consecutive patients treated with infliximab at the Mayo Clinic were reviewed and abstracted for demographic features and adverse events. The likelihood of a causal relationship to infliximab for each adverse event was determined by calculating an intrinsic likelihood (imputability) score.

Results: The 500 patients received a median of 3 infusions and had a median follow-up of 17 months. Forty-three patients (8.6%) experienced a serious adverse event, of which 30 (6%) were related to infliximab. Acute infusion reactions occurred in 19 of 500 patients (3.8%). Serum sickness-like disease occurred in 19 of 500 patients and was attributed to infliximab in 14 (2.8%). Three patients developed drug-induced lupus. One patient developed a new demyelination disorder. Forty-eight patients had an infectious event, of which 41 (8.2%) were attributed to infliximab. Twenty patients had a serious infection: 2 had fatal sepsis, 8 had pneumonia (of which 2 cases were fatal), 6 had viral infections, 2 had abdominal abscesses requiring surgery, one had arm cellulitis, and one had histoplasmosis. Nine patients had a malignant disorder, 3 of which were possibly related to infliximab. A total of 10 deaths were observed. For 5 of these patients (1%), the events leading to death were possibly related to infliximab.

Conclusions: Short- and long-term infliximab therapy is generally well tolerated. However, clinicians must be vigilant for the occurrence of infrequent but serious events, including serum sickness-like reaction, opportunistic infection and sepsis, and autoimmune disorders.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal / adverse effects*
  • Autoimmune Diseases / chemically induced
  • Child
  • Child, Preschool
  • Crohn Disease / drug therapy*
  • Crohn Disease / mortality
  • Female
  • Gastrointestinal Agents / adverse effects*
  • Humans
  • Infections / chemically induced
  • Infections / mortality
  • Infliximab
  • Likelihood Functions
  • Lupus Vulgaris / chemically induced
  • Male
  • Middle Aged
  • Neoplasms / chemically induced
  • Retrospective Studies
  • Serum Sickness / chemically induced


  • Antibodies, Monoclonal
  • Gastrointestinal Agents
  • Infliximab