By Ed Susman
KISSIMMEE, Fla -- October 8, 2008 -- The incidence of cancer or infection does not appear higher in patients with Crohn's disease who are treated with infliximab compared with those who are treated with other drugs, according to an analysis of the Therapy Resource, Evaluation and Assessment Tool (TREAT) registry.
However, treatment employing narcotic analgesics or prednisone was associated with higher risks of mortality and infections, said the researchers in a plenary session here on October 8 at the American College of Gastroenterology (ACG) 73rd Annual Scientific Meeting.
"Despite having more severe Crohn's disease at entry into the registry, infliximab-treated patients have similar rates of mortality, neoplasm, and lymphoma as do patients not treated with infliximab," said Gary Lichtenstein, MD, University of Pennsylvania, Philadelphia, Pennsylvania.
In addition, he said, "infliximab safety appears to be similar to that of conventional immunomodulators."
Dr. Lichtenstein and colleagues conducted an analysis of the 6,273-patient Crohn's TREAT registry to assess the long-term safety of infliximab in patients with Crohn's disease.
He said that disease severity appeared to be a significant predictor of mortality, with moderate to severe disease increasing the risk of mortality in patients by 51% compared with patients who were not as ill at the time they entered the registry.
Use of infliximab, methotrexate, 6-mercaptopurine, and azathioprine did not appear to have statistical significance in cause or protection against mortality. However, use of prednisone increased the mortality risk by 86% and the use of narcotic analgesics more than doubled the risk of mortality (HR 2.11; P < .01 for both prednisone and narcotics).
Patients receiving infliximab were significantly more likely to have moderate to severe disease (30.7% vs 10.8%, P < .0001) and were more likely to have severe to fulminant disease (2.5% vs 0.6%, P < .0001) compared with patients not receiving the drug.
Patients on infliximab were also more likely to be receiving concomitant immunomodulators or steroids and were more likely to have been hospitalised or to have undergone surgery within the previous year compared with those who were not receiving infliximab.
In a multivariate analysis, the researchers found that serious infections were most likely reported in patients with moderate to severe Crohn's disease (HR 2.46, P < .001). In addition, use of prednisone or narcotics (P < .001) more than doubled the risk of a serious infection.
Of the 43,806 infliximab infusions, about 3.3% resulted in reactions and 0.08% in serious reactions. Death occurred in 83 patients on infliximab (0.62 per 100 patient-years) and in 74 patients not on infliximab (0.58 per 100 patient-years), a statistically nonsignificant difference.
Dr. Lichtenstein said that the TREAT registry "is a real-world experience, with 80% of patients in the registry coming from community practices and 20% from academic settings. Approximately half of the patients in the registry have received infliximab, usually in combination with other Crohn's disease treatments."
The adult Crohn's disease patients were enrolled in the TREAT registry from July 1999 to February 2008. Dr. Lichtenstein reported that 3,396 patients have received infliximab (14,184 patient-years of use) and that 2,877 patients received agents other than infliximab (10,391 patient-years of use). The mean length of time patients were enrolled in the registry was 4.3 years. Of the patients who received infliximab, 86.7% received 2 or more infusions.
Funding for the TREAT registry is provided by Centocor.
[Presentation title: Safety of Infliximab and Other Crohn's Disease Therapies: TREAT(TM) Registry Data With 24,575 Patient-Years of Follow-Up. Abstract 14]
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