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Dr Gary Lichtenstein and colleagues from Pennsylvania, USA contributed long-term safety data for infliximab and other therapies in Crohn's disease. The research team prospectively evaluated Crohn's disease patients enrolled in the large, observational Crohn's Therapy, Resource, Evaluation, and Assessment Tool registry, established to compare infliximab safety with conventional nonbiological medications in Crohn's disease. A total of 6,273 patients were enrolled and evaluated on or before 2010. The team noted that 3,420 received infliximab, and 2,853 received other-treatments-only. Mean length of patient follow-up was 5 years.  | | Treatment with prednisone was associated with increased mortality risk | | American Journal of Gastroenterology |
More infliximab- than other-treatments-only-treated patients had moderate-to-severe or severe-to-fulminant disease severity. The researchers found that in the year before enrollment, more infliximab- than other-treatments-only-treated patients required surgical intervention, medical hospitalization, prednisone, immunomodulators, and narcotic analgesics. The research team noted that patient mortality was similar for infliximab- and other-treatments-only-treated patients. In multivariate logistic regression analyses, treatment with prednisone or narcotic analgesics and age were associated with increased mortality risk. The team found that neither infliximab nor immunomodulator treatment was associated with increased mortality risk. Factors independently associated with serious infections included moderate-to-severe disease activity, narcotic analgesic treatment, prednisone therapy, and infliximab treatment. Dr Lichtenstein's team commented, "Mortality was similar between infliximab- and other-treatments-only-treated Crohn's disease patients." "An increased risk of serious infection with infliximab was observed, although Crohn's disease severity and use of prednisone or narcotic analgesics carried higher risks."
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