Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry

Clin Gastroenterol Hepatol. 2006 May;4(5):621-30. doi: 10.1016/j.cgh.2006.03.002.

Abstract

Background & aims: Long-term safety data for infliximab and other therapies in Crohn's disease (CD) are needed.

Methods: We prospectively evaluated patients for prespecified safety-related outcomes.

Results: As of August 2004, 6290 patients were enrolled; 3179 received infliximab (5519 patient-years), 87% of whom received at least 2 infusions, and 3111 received other therapies (6123 patient-years). The mean length of follow-up evaluation was 1.9 years. More infliximab-treated patients had moderate-to-severe (30.8% vs 10.3%) or severe-fulminant (2.5% vs .6%) CD, and had surgical (17.5% vs 13.8%) or medical (14.4% vs 9.1%) hospitalizations in the previous year. More patients were taking prednisone (27.4% vs 16.1%), immunomodulators (49.4% vs 32.2%), or narcotic analgesics (9.8% vs 5.4%) when compared with those receiving other therapies (P<.001, all comparisons). The mortality rates were similar for infliximab- and non-infliximab-treated patients (.53 per 100 patient-years vs .43; relative risk, 1.24; 95% confidence interval [CI], .73-2.10). In multivariate logistic regression analysis, only prednisone was associated with an increased mortality risk (odds ratio [OR], 2.10; 95% CI, 1.15-3.83; P=.016). Although the unadjusted analysis showed an increased risk for infection with infliximab use, multivariate logistic regression analysis suggested that infliximab was not an independent predictor of serious infections (OR, .99; 95% CI, .64-1.54). Factors independently associated with serious infections included prednisone use (OR, 2.21; 95% CI, 1.46-3.34; P<.001), narcotic analgesic use (OR, 2.38; 95% CI, 1.56-3.63; P<.001), and moderate-to-severe disease activity (OR, 2.11; 95% CI, 1.10-4.05; P=.024).

Conclusions: Mortality rates were similar between infliximab- and non-infliximab-treated patients. The increased risk for serious infection observed with infliximab likely was owing to disease severity and prednisone use.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / therapeutic use
  • Bacterial Infections / etiology
  • Bacterial Infections / mortality*
  • Bacterial Infections / physiopathology
  • Cause of Death*
  • Colectomy / adverse effects*
  • Colectomy / methods
  • Confidence Intervals
  • Crohn Disease / diagnosis
  • Crohn Disease / mortality*
  • Crohn Disease / therapy*
  • Female
  • Gastrointestinal Agents / adverse effects
  • Gastrointestinal Agents / therapeutic use
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use
  • Incidence
  • Infliximab
  • Male
  • Middle Aged
  • Odds Ratio
  • Postoperative Complications / epidemiology
  • Postoperative Complications / pathology
  • Prednisone / adverse effects
  • Prednisone / therapeutic use
  • Probability
  • Prognosis
  • Prospective Studies
  • Registries*
  • Risk Assessment
  • Severity of Illness Index
  • Survival Rate

Substances

  • Antibodies, Monoclonal
  • Gastrointestinal Agents
  • Immunosuppressive Agents
  • Infliximab
  • Prednisone