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Oct. 16, 2007 (Philadelphia) -- For the first time, a drug has been shown to cut the chance that a person with ulcerative colitis will need to have their colon removed.
In a study of 630 people with moderate-to-severe ulcerative colitis, the drug Remicade, originally approved to treat rheumatoid arthritis, significantly reduced the number of people that needed colon removal surgery.
The study was presented here at the annual meeting of the American College of Gastroenterology.
“This is huge. Losing their colon is something most people would like to avoid,” Phillip Jaffee, MD, of the Gastroenterology Center of Connecticut in Hamden, tells WebMD. “No drug has ever been shown to do this before.” Jaffee, a member of the committee that chose which stories to highlight at the meeting, was not involved with the research.
Marked by bloody diarrhea and rectal bleeding, ulcerative colitis affects about half a million people in the U.S., according to researcher William Sanburn, MD, professor of medicine at the Mayo Clinic College of Medicine in Rochester, Minn.
Since it is an inflammatory bowel disease, anti-inflammatory medications are the first drugs of choice, but about half of sufferers don’t respond, he says. That’s where steroids, immunosuppression agents and Remicade, approved in 2005 for the treatment of ulcerative colitis, come in.
Still, about half of these people do not get relief, continuing to suffer from flare-ups that are difficult to manage, he says. They’re referred to surgery to have the colon removed.
Remicade is a biologic drug given by infusion -- the only biologic approved for the treatment of moderate to severe ulcerative colitis. It targets the immune system and blocks an inflammatory chemical called tumor necrosis factor (TNF). Besides rheumatoid arthritis, it's also used to treat Crohn's disease (another inflammatory bowel disease), plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis, a rheumatic disease.
Remicade’s approval for use in the treatment of people with moderate to severe ulcerative colitis who haven't completely responded to other treatments was based on two studies of 728 patients.? In both studies, more people taking Remicade showed more improvement in ulcerative colitis symptoms than did those who got a placebo.
But the participants weren’t followed for long enough to determine whether the drug also cut the need for surgery, Sanburn says. The new study involves 630 participants in those studies who have now been followed for 54 weeks.
By the end of that period, 9.5% of people taking Remicade had to have surgery to have their colons removed vs. 14.8% given placebo.
There have been reports of serious infections (including tuberculosis, sepsis, and pneumonia) and rare reports of serious liver problems, blood disorders, and nervous system problems in people taking Remicade, according to Centocor, which makes Remicade and funded the study. Remicade's web site states that some of these infections have been fatal.
Remicade's web site also notes that the drug shouldn't be taken by people with heart failure and that there have been rare and sometimes fatal cases of blood disorders in people taking Remicade.