Drug Tied to Lower Colectomy Rate in Ulcerative Colitis
Despite benefits, infliximab is associated with high rate of serious side effects, including infections
FRIDAY, Oct. 2 (HealthDay News) -- In patients with moderate-to-severe ulcerative colitis, treatment with infliximab is associated with a significantly lower likelihood of undergoing colectomy within one year, according to a study published in the October Gastroenterology.
In two studies, William J. Sandborn, M.D., of the Mayo Clinic in Rochester, Minn., and colleagues randomly assigned 728 patients to receive either placebo or infliximab at a dosage of 5 or 10 mg/kg intravenously at weeks zero, two, and six, and then every eight weeks through week 46 (first study) or 22 (second study).
The authors note that 87 percent of patients had complete follow-up and 13 percent of patients had a median follow-up of 6.2 months. The cumulative incidence of colectomy through 54 weeks was significantly lower in those treated with infliximab than those who received placebo (10 versus 17 percent). In addition, compared with placebo, there were fewer ulcerative colitis-related hospitalizations and procedures per 100 patient-years of treatment with infliximab (40 versus 20 and 34, respectively). However, the researchers found that side effects associated with infliximab included serious infections, tuberculosis, histoplasmosis, listeriosis, and malignancy.
"While the colectomy rate in patients with moderate-to-severe ulcerative colitis was reduced with infliximab therapy in this study, more evidence-based use of infliximab is needed to evaluate the short- and long-term clinical outcomes," the authors write. "Recently, a long-term, retrospective review of colectomy rates in 314 patients with acute severe ulcerative colitis showed that urgent colectomy was avoided in steroid-refractory patients, but the long-term risk of elective colectomy was not reduced."
This study was supported by Centocor Inc. and Schering Plough; several authors reported financial relationships with Centocor.