Infectious complications of TNF-α inhibitor monotherapy versus combination therapy with immunomodulators in inflammatory bowel disease: analysis of the Food and Drug Administration Adverse Event Reporting System.

@article{Deepak2013InfectiousCO,
  title={Infectious complications of TNF-α inhibitor monotherapy versus combination therapy with immunomodulators in inflammatory bowel disease: analysis of the Food and Drug Administration Adverse Event Reporting System.},
  author={Parakkal Deepak and Derrick J. Stobaugh and Eli Daniel Ehrenpreis},
  journal={Journal of gastrointestinal and liver diseases : JGLD},
  year={2013},
  volume={22 3},
  pages={269-76}
}
BACKGROUND & AIM Incremental increase in the risk of serious infections with combinations of tumor necrosis factor-alpha (TNF-α) inhibitors and immunomodulators compared to monotherapy with these agents in inflammatory bowel disease (IBD) is unclear. Our aim was to analyze whether there is such an incremental increase in the odds of serious infections. METHODS The FDA Adverse Event Reporting System (2003 - June 2011) was queried for 'Primary Suspect' reports of various infections with TNF… CONTINUE READING

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Patients enrolled in randomized controlled trials do not represent the inflammatory bowel disease patient population.

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