WEDNESDAY, Dec. 7, 2005 (HealthDay News) -- Individuals struggling with the chronic discomfort of ulcerative colitis may gain relief from the drug Remicade, a new study suggests.
"Patients with ulcerative colitis who are not helped with medications such as cortisone, 5-ASA or azathioprine have a good chance of responding to Remicade [infliximab] and, in that manner, avoiding the side effects of the former therapies or even escaping colectomy," said study author Dr. Paul Rutgeerts, a professor of medicine at University Hospital Gasthuisberg in Leuven, Belgium.
The drug was recently approved for use in patients with ulcerative colitis largely based on this data, which was presented earlier this year at a large scientific meeting and appears this week in the Dec. 8 issue of the New England Journal of Medicine.
"It certainly is a landmark in the treatment of patients with ulcerative colitis, there's no question about that," added Dr. Shiva Kumar, co-director of the Inflammatory Bowel Disease Center at the Ochsner Clinic Foundation in New Orleans. "This is the first study looking at biological agents in ulcerative colitis and the first to be approved, so it represents a significant advance."
Ulcerative colitis is an inflammatory bowel disease, one of a group of diseases that involve inflammation in the small intestine and colon. Symptoms are similar to those of Crohn's disease and can include bloody diarrhea, abdominal cramps and fatigue.
Doctors currently turn to a number of drugs to treat the disorder. However, patients can become dependent on some these medicines, some of which can eventually fail. When that occurs, patients are forced to undergo a colectomy -- a complete or partial removal of the colon.
"Conventional medicines in colitis have been around for 20 or 30 years and there has been no major significant advance, so we've had a relatively low threshold for sending patients to surgery for lack of alternative options," Kumar explained. "This fills a big gap in the treatment of patients with ulcerative colitis between conventional medicines and surgery."
Remicade is a monoclonal antibody-type drug that binds to a pro-inflammatory protein called tumor necrosis factor alpha (TNF alpha). TNF alpha is found in patients with Crohn's disease, and may also play a part in ulcerative colitis. Remicade essentially incapacitates TNF alpha and is already an established treatment for Crohn's patients.
The few small studies that had previously examined Remicade's effectiveness in patients with active ulcerative colitis had produced conflicting results, however.
Here, the study authors conducted two randomized, double-blind, placebo-controlled studies to evaluate the efficacy of Remicade in adults with moderate-to-severe ulcerative colitis.
Each study involved 364 patients who were also taking other drugs. In the first trial, participants were given either Remicade or a placebo intravenously at weeks 0, two and six, and then every eight weeks thereafter through week 46. They were followed for 54 weeks.
In the second trial, the patients were given Remicade or a placebo through week 22 and followed for 30 weeks.
In the first trial, 69 percent of participants who received 5 milligrams of Remicade and 61 percent of those who received 10 milligrams had a response at week eight, vs. only 37 percent of those who received a placebo.
In the second trial, 64 percent of those who received 5 milligrams of Remicade and 69 percent of those who received 10 milligrams had a response at week eight, compared with 29 percent of those on the placebo.
There were no major differences in the two doses, although the lower dose would be preferred, the study authors stated.
Participants taking Remicade were also more likely to have mucosal healing, or healing of the lining of the colon. There has been a suggestion that mucosal healing leads to a reduced risk of cancer, but there is no hard data on this yet.
Also, 22 percent of participants taking Remicade had discontinued their corticosteroids by the end of the study.
Finally, the fact that Remicade worked in patients with ulcerative colitis suggests that TNF-alpha is, in fact, a player in this disease.
"We were positively surprised by the findings because some former small studies did not show convincing data, and because ulcerative colitis is believed to be different from Crohn's disease immunologically with a less important role for TNF," Rutgeerts said. "There is a great need to investigate the mechanism of action of infliximab further."
More information
You can learn about ulcerative colitis from the National Digestive Diseases Clearinghouse.
