Several studies have demonstrated the efficacy of infliximab in inflammatory bowel disease (IBD). However, potential toxicity of infliximab has been less studied.
In this study, researchers from Sweden assessed the use of infliximab in IBD in a population based cohort.
The team evaluated 217 patients with IBD (mean age 37.6 years) who were treated with infliximab between 1999 and 2001 in Stockholm County.
The team retrospectively analyzed possible adverse events that occurred in relation to infliximab treatment. Any adverse events requiring pharmacological treatment or hospitalization were defined as severe.
Of the 217 patients, 191 patients had Crohn’s disease, 22 had ulcerative colitis, and 4 indeterminate colitis.
Overall, patients received a mean of 2.6 infliximab infusions.
|Three patients with Crohn's disease developed lymphoma.|
The researchers found that 42 severe adverse events occurred in 41 patients (35 with Crohn's disease).
Eleven of the severe adverse events occurred postoperatively, 6 in patients with Crohn's disease.
Three patients with Crohn's disease developed lymphoma.
Furthermore, the team found that opportunistic infections occurred in 2 patients, and 2 patients died due to sepsis.
An additional patient with ulcerative colitis died from pulmonary embolism after colectomy.
The team determined that the overall response rate was 75%. This did not differ between the patient groups.
Dr Ljung and colleagues concluded, "Infliximab was efficacious as an anti-inflammatory treatment when assessed in a population based cohort of patients with IBD".
"However, there appear to be a significant risk of deleterious and fatal adverse events, particularly in elderly patients with severe attacks of IBD".
"Off label use of infliximab in ulcerative colitis and indeterminate colitis should be avoided until efficacy is proven in randomized controlled trials".
"The underlying risk of developing malignancies among patients with severe or chronically active Crohn's disease in need of infliximab treatment is not known".