Crohn's Drug Works Longer in Drug Combo
Immune-Suppressing Drugs Make Remicade More Effective
Feb. 12, 2003 -- Doctors once had little to offer patients with
Crohn's disease, but that changed five years ago with the introduction of
Remicade -- the first drug specifically designed to treat the chronic irritable
bowel condition. The drug's promise has not been fulfilled for many patients
who have experienced side effects and dwindling responses to it, but new
treatment approaches may change that.
In a study published in the Feb. 13 issue of TheNew
England Journal of Medicine, Belgian researchers report that patients who
took immune-suppressing drugs along with Remicade had far fewer side effects
and better response to it than patients who were given Remicade alone.
The researchers found that 61% of the patients in their
125-person treatment group developed antibodies against the drug, also known as
infliximab. Higher levels of these antibodies were associated with a much
shorter response to treatment -- an average of 35 days compared with 71 days
for patients who had lower antibody levels. Patients who developed antibodies
were also more than twice as likely to have moderate to severe side effects
associated with Remicade.
"We found that immunosuppressive treatment prevented the
formation of antibodies, and reduced the incidence of [treatment]
reactions," researcher Paul Rutgeerts, MD, PhD, tells WebMD.
Crohn's is an inflammatory disease that causes diarrhea, which
may be severe and bloody, along with abdominal pain. Complications can lead to
bowel obstruction or large abscess formation. Although the cause is unknown,
there is evidence that it may be inherited.
Given intravenously, Remicade works by attacking a protein
known as tumor necrosis factor (TNF), believed to cause the inflammation
associated with Crohn's disease. The drug is approved for use in patients with
moderate to severe disease who have failed other treatment or have specific
In the Belgian study, patients received an average of four
doses of Remicade over roughly 10 months. Just over a quarter of the patients
had reactions such as skin rashes, shortness of breath, or a potentially
dangerous lowering of blood pressure. These patients responded well to the drug
for an average of just 38 days, compared with 65 days for patients without
reactions. Those who had lower antibodies levels and less severe reactions had
been on immunosuppressive treatment.
Rutgeerts and colleagues used Remicade to treat patients who
were experiencing symptom flare-ups, but specialists in the United States are
now using the drug to prevent these symptoms from occurring. Last May,
researchers at the University of Chicago reported that patients frequently
stayed in remission when they were given the drug every eight weeks to keep
blood levels of the drug high.
Keeping drug levels high prevents antibodies from developing,
says Stephen Hanauer, MD, who led the University of Chicago research team. But
he tells WebMD that most of his Crohn's patients are also on immunomodulating
treatments to ensure that antibody levels remain low.
"What we have shown is that if patients respond for one
year and they stay on this therapy, it continues to work for them," he
says. "We also know that if we stop treatment, symptoms tend to come back,
even if patients have been on this drug for two or three years."