Long-term safety data for infliximab and other therapies in Crohn's disease are needed.
Dr Gary Lichtenstein and colleagues prospectively evaluated patients for prespecified safety-related outcomes.
The research team enrolled 6290 patients in 2004.
Of these patients, 3179 received infliximab, and 87% received at least 2 infusions.
The team reported that 3111 patients received other therapies.
The mean length of follow-up evaluation was 2 years.
The researchers found that 31% of infliximab-treated patients had moderate-to-severe Crohn's disease vs 10% with other therapies.
|14% receiving infliximab had medical hospitalizations vs 9% taking other therapies|
|Clinical Gastroenterology & Hepatology|
About 3% treated with infliximab had severe-fulminant Crohn's disease compared with less than 1% receiving other therapies.
The team noted that 18% of infliximab patients had surgical hospitalizations in the previous year vs 14% with other therapies.
During the previous year, the researchers also observed that 14% with infliximab had medical hospitalizations, vs 9% with other therapies.
More infliximab patients were taking prednisone, immunomodulators, or narcotic analgesics when compared with those receiving other therapies.
The team found that the mortality rates were similar for infliximab- and non-infliximab-treated patients.
In multivariate logistic regression analysis, only prednisone was associated with an increased mortality risk.
The team showed an increased risk for infection with infliximab use, using unadjusted analysis.
However, multivariate logistic regression analysis suggested that infliximab was not an independent predictor of serious infections.
Factors independently associated with serious infections included prednisone use, narcotic analgesic use, and moderate-to-severe disease activity.
Dr Lichtenstein's team commented, “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.”