WebMD first reported the news in May, when findings were presented at a medical conference. Now, more details appear in The New England Journal of Medicine.
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 abiologic drug 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 Crohn's disease (another inflammatory bowel disease) and ankylosing spondylitis, a form of arthritis.
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 (placebo).
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:
Remicade's effects on the immune system can bring a risk of infection, the researchers note. Most of their patients didn't have such problems.
Serious side effects of Remicade include increased risk for serious and life-threatening infections, lupus-like syndrome, lymphoma, seizures, liver damage, and blood problems. Most common side effects include rash, dizziness, fatigue, and allergic reactions.
The risk for infection isn't new. Remicade's web site states, "There are reports of serious infections, including tuberculosis (TB), sepsis, and pneumonia. Some of these infections have been fatal."
Remicade's 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 and serious liver injury in people taking Remicade.
The study was funded by drug companies Centocor Inc. and Schering-Plough. Centocor markets Remicade in the U.S.; Schering-Plough markets Remicade in most other countries.