WebMD Medical News
Louise Chang, MD
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
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
“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
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
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.
SOURCES: 72nd Annual Meeting of the American College of Gastroenterology,
Philadelphia, Oct. 12-17, 2007. William Sanburn, MD, professor of medicine,
Mayo Clinic College of Medicine, Rochester, Minn. Phillip Jaffee MD, ACG Public
Relations Committee; Gastroenterology Center of Connecticut, Hamden, Conn.
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