Remicade Treats Ulcerative Colitis
Better Results Than With Fake Drug, Researchers Report
Dec. 7, 2005 -- The rheumatoid arthritis drug Remicade may help treat
moderate-to-severe ulcerative colitis, a new study shows.
WebMD first reported the news in May, when The New England Journal of
were presented at a
medical conference. Now, more details appear in
The researchers included Paul Rutgeerts, MD. He works in Leuven, Belgium, at
the University Hospital Gasthuisberg.
Ulcerative colitis is an inflammatory bowel disease that primarily affects
the colon and rectum with inflammation and ulcers leading to bleeding and
abdominal pain. The disease generally follows a course of flare-ups that can be
difficult to manage. In some circumstances, surgery may be necessary to remove
the affected area.
Remicade is aCrohn's disease (another
inflammatory bowel disease) and ankylosing spondylitis, a form of
given by infusion. It targets the immune system and
blocks an inflammatory chemical called tumor necrosis factor (TNF). Besides
rheumatoid arthritis, it's also used to treat
Remicade was recently tested in two studies, which included 728 patients
with moderate to severe ulcerative colitis. The patients' colitis hadn't
responded to other drugs.
In each study, patients were split into three groups. One group got a low
Remicade dose (5 milligrams). Another got a higher dose of Remicade (10
milligrams). A third group got a fake drug containing no medicine
Patients got three treatments within six weeks, followed by less-frequent
maintenance doses for several months.
In both studies, more people taking Remicade showed improvement in
ulcerative colitis symptoms than did those who got the fake drug.
The first study lasted for about a year. By eight weeks, 64% of patients
taking the low dose of Remicade and 69% of those taking the higher dose met the
researchers' target for reduced ulcerative colitis symptoms. When it finished,
more than four in 10 patients taking Remicade met the goal. In the placebo
group, 20% showed the same response.
The second study was shorter, lasting for 30 weeks. By eight weeks, 69% of
patients taking the low Remicade dose and 61% of those taking the higher dose
met the goal. That's compared with 37% of the placebo group. At 30 weeks, both
study groups showed better response in those patients taking Remicade.
The results show that TNF plays a role in ulcerative colitis and makes a
good treatment target, write Rutgeerts and colleagues.
Remicade's Side Effects
Reports of adverse effects came from similar percentages of patients taking
Remicade or the placebo.
However, the Remicade groups had slightly more cases of serious infections,
lupus-like reactions, and neurologic diseases, write the researchers.
Those cases included:
- 1 patient taking Remicade who had a lupus-like reaction
- 16 taking Remicade who had serious infections (compared with six taking
- 1 taking Remicade who had tuberculosis
- 1 taking Remicade who died after getting a type of pneumonia