Infliximab Does Not Boost Mortality Risk with Crohn's Disease

August 30, 2012

NEW YORK (Reuters Health) - In patients with Crohn's disease, the tumor necrosis factor alpha antagonist infliximab does not increase mortality compared to use of conventional treatments, registry data suggest.

It did seem to increase patients' risk of serious infection, but higher risks were seen with prednisone, narcotic painkillers, and more severe disease. In an August 14th online paper in the American Journal of Gastroenterology, Dr. Gary R. Lichtenstein of the University of Pennsylvania in Philadelphia and colleagues note that all therapies for Crohn's disease can have adverse side effects. But early use of immunomodulators along with biological therapies has been shown to induce more rapid remission.

In an earlier study, the researchers found that mortality rates across treatments seem to be similar. In the current study the team extended their evaluation of registry data from a mean of about 1.9 years to 5.2 years. In all, 6,273 patients were involved, roughly half of whom (54.5%) received infliximab. The remainder received other treatments only.

More patients in the infliximab group had moderate to severe disease (30.6% vs 10.7%) or severe-to-fulminant disease (2.5% vs 0.6%). In the year before enrollment, more infliximab-treated patients required surgical intervention (17.4% vs 13.6%) and hospitalization (14.2% vs 8.8%). They were also more likely to need prednisone, immunomodulators and narcotic analgesics.

The mortality rate was similar in infliximab-treated patients and the control group. In multivariate analyses, mortality was linked with prednisone, narcotic analgesics and age, but not with infliximab or immunomodulator treatment.

A higher incidence of infections in general was observed in the infliximab-treated patients relative to patients receiving other treatments only. However, infliximab-treated patients had more severe disease at registry entry and also were more likely to be using other immunosuppressive agents or prednisone. In addition, there was no evidence of an increase in the occurrence of serious infections with an increasing number of infliximab infusions. Factors independently associated with serious infections included moderate to severe disease activity (hazard ratio, 2.24), narcotic analgesic treatment (HR 1.98), prednisone therapy (HR 1.57) and infliximab treatment (HR 1.43).

The researchers believe it is "likely that infliximab lessened the disease burden and thus counterbalanced any mortality risk that might have been associated with other causes such as serious infection."

Also, they point out, "There has been no indication that infliximab is associated with an increased risk of neoplasia or an increased risk of fetal malformation."

Dr. Lichtenstein did not respond to requests for comments.

Am J Gastroenterol 2012

Crohn's & Colitis Foundation

The Crohn's & Colitis Foundation's mission is to cure Crohn's disease and ulcerative colitis, and to improve the quality of life of children and adults affected by these diseases. The Foundation ranks third among leading health non-profits in the percentage of expense devoted to research toward a cure, with more than 80 cents of every dollar the Foundation spends going to mission-critical programs. The Foundation consistently meets the standards of organizations that monitor charities, including the Better Business Bureau's Wise Giving Alliance ( and the American Institute of Philanthropy (

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