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The Safety of Extended Use of Infliximab for Crohn's Disease: Presented at DDW

By Bruce Sylvester

WASHINGTON, DC -- May 22, 2007 -- Greater infliximab (Remicade ®) exposure is not associated with an increased risk of mortality or serious infections, and even among more severe Crohn's disease patients, those treated continuously or intermittently with infliximab have mortality rates similar to Crohn's patients not treated with the drug.

Investigators reported these findings here at the Digestive Diseases Week (DDW) annual meeting.

"The important issue here is that individuals who are treated with infliximab over time do not have a higher rate of serious complications, particularly death, related to its continued use," said presenter and lead investigator Gary Lichtenstein, MD, professor of medicine, University of Pennsylvania School of Medicine, and director of the Center for Inflammatory Bowel Disease, Hospital of the University of Pennsylvania, Philadelphia, United States.

"Associated with the use of infliximab is the possibility of inducing and maintaining remission in these patients, which is not only advantageous to their quality of life -- such that in many cases quality of life even normalizes -- but, in addition, this can occur in a safe fashion with ongoing treatment," Dr. Lichtenstein added.

The new study is an analysis of ongoing data from TREAT (the Crohn's Therapy Resource Evaluation and Assessment Tool), a prospective registry established to study the long-term safety of infliximab and other therapies used to treat Crohn's disease.

The investigators classified subjects who received an average of 5 or more infusions per year as "continuous" treatment subjects. Those who received an average less than 5 infusions per year were defined as "intermittent" treatment subjects. Only those who had contributed a year or more of follow-up data to the registry were eligible for participation in this study.

The investigators evaluated the data specifically for risks of serious infection and mortality associated with the intermittent and continuous use of infliximab.

As of August of 2006, 6,273 subjects were enrolled in the study, of which 3,334 had received infliximab (10,796 patient-years). Of these, 873 were continuous infliximab users for 2 years or more, and 958 were intermittent infliximab users for 2 years or more.

The investigators found that 2,939 had received other therapies (8,277 patient years), with a mean follow-up of 3.4 years.

The researchers reported a significant difference in Crohn's disease severity at enrollment between treatment groups (P <.0001). More infliximab-treated subjects were diagnosed with moderate-to-severe (31.1% vs 10.7%, P <.0001) or severe-fulminant (2.6% vs 0.6%, P <.0001) Crohn's disease at enrollment.

Also, more infliximab-treated subjects had been hospitalised (27.3% vs 19.0%, P <.0001) during the year prior to enrollment, and more were taking prednisone (27.1% vs 15.9%, P <.0001) or immunomodulators (49.1% vs 31.6%, P <.0001) at enrollment.

"All of these factors may contribute to an increased risk of infection and mortality," the authors noted.

The researchers reported that mortality was similar for continuous infliximab-treated subjects and non-infliximab-treated subjects (.22 per 100 patient years vs.37).

They found that mortality was similar for intermittent infliximab-treated subjects and non-infliximab-treated subjects (.44 per 100 patient years vs.37).

The unadjusted rate of serious infections for continuous infliximab subjects was higher than the rate for non-infliximab subjects (1.38 per 100 patient years vs 0.63), and it was similar to that of intermittent infliximab-treated subjects (1.56 per 100 patient years).

Importantly, the investigators found, through a standard statistical analysis of the data, that neither continuous nor intermittent use of infliximab "remained statistically significant predictors of an increased risk of [serious infections] relative to other treatments."

They concluded that, "infliximab-treated patients have an increased risk of serious infections but multivariate Cox proportional hazard analysis suggests that this increased risk is associated with prednisone and narcotic use, and not with infliximab therapy."

The study was supported by Centocor, Inc.

[Presentation title: Greater Exposure to Infliximab Is Not Associated With Increase in Mortality and Serious Infections -- TREAT? Registry Data With Nearly 20,000 Patient-Years of Follow-Up. Abstract 1123]

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