By Bruce Sylvester
WASHINGTON, DC—At Digestive Disease Week, several presentations focused on the benefits of infliximab therapy, showing that patients with moderate-to-severe ulcerative colitis continue to respond to infliximab for up to 2 years, and that extended exposure to this drug is also safe in Crohn's disease.
Walter Reinisch, MD, of the University Hospital of the University of Vienna, Austria, presented results of a study that included data from long-term extensions of the Active Ulcerative Colitis (ACT) 1 and 2 trials, conducted in the United States and Europe.
"We found that infliximab is showing efficacy as a long-term treatment," Dr Reinisch told . "Patients with moderate-to-severe disease maintained a therapeutic benefit for 2 years, and, notably, most of them were off corticosteroids after 2 years."
At the beginning of the extension period, 76% of the 229 responders to active treatment in the original trials had achieved mild or no disease activity; 41% showed no disease activity.
The number of patients with mildor no disease activity continued to increase with prolonged use. By 104 weeks, most patients had either mild or no disease.
A total of 80%, 88%, and 98% of the patients became corticosteroid-free at weeks 8, 56, and 104, respectively. Infliximab therapy was generally well- tolerated, with a <5% discontinuation rate.
Extended infliximab exposure does not increase the risk of mortality or of serious infections in patients with Crohn's disease, according to results presented at the meeting. And, among patients with more severe disease, mortality rates in those treated with infliximab are similar to those among patients with less-severe disease.
"Patients who are treated with infliximab over time do not have a higher rate of serious complications, in particular death, related to its ongoing use," lead investigator Gary Lichtenstein, MD, director of the Center for Inflammatory Bowel Disease at the Hospital of the University of Pennsylvania, Philadelphia, told .
He and colleagues are analyzing data from an ongoing registry established to study the long-term safety of therapies used to treat Crohn's disease.
Participants are classified as continuous-treatment patients (receiving an average of %ge;5 infusions/yr) or as intermittent-treatment patients (average of <5 infusions/yr). Of the 6273 patients enrolled as of August 2006, 3334 had received infliximab (10,796 patient-years): 873 were continuous and 958 were intermittent infliximab users for ≥2 years (mean follow-up, 3.4 yrs).
Significantly more infliximab-treated patients were diagnosed with moderate-to-severe or severe-fulminant Crohn's at enrollment than those receiving other agents; more infliximab-treated patients had been hospitalized during the year before enrollment, and more were likely to also be taking prednisone or immunomodulators at enrollment.
The investigators stressed that, "Infliximab-treated patients have an increased risk of serious infections, but multivariate?analysis suggests thatthis increased risk is associated with prednisone and narcotic use, and not with infliximab therapy."