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 complications.
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."