Data on safety and long-term follow-up evaluation of population-based cohorts of inflammatory bowel disease (IBD) patients treated with infliximab are sparse.
Dr Sarah Caspersen and colleagues from Denmark described the use of infliximab in a national Danish population-based IBD cohort during 1999 and 2005.
Medical records of all infliximab-treated IBD patients were scrutinized to abstract information on patient demographics, treatment efficacy, and adverse events.
|Infusion reactions were noted in 4%|
|Clinical Gastroenterology & Hepatology
The researchers found a total of 651 patients received infliximab during 1999 and 2005.
A total of 3351 infusions were administered, with a median of 3 infusions per patient.
The research team observed a positive clinical response in 83%.
The team noted infusion reactions in 4%.
Significantly fewer infusion reactions were seen in patients also receiving azathioprine or methotrexate, compared with patients not receiving azathioprine or methotrexate.
The team found severe adverse events in 3% of infusions, and in a total of 95 patients.
The team found that 4 patients developed cancer versus 6 expected, and 13 patients died versus 7 expected.
The research team noted that 2 deaths caused by infections were possibly related to infliximab.
Dr Caspersen’s team concluded, “Infliximab seemed effective in IBD and generally was well tolerated.”
“However, rare but severe adverse events occurred, and patients receiving infliximab therefore should be selected carefully and monitored closely.”
“No lymphomas and no increased risk of cancer were observed.”