Long-Term Relief Seen for Symptoms of Crohn’s Disease

When Crohn’s disease is hard to treat, patients are more likely to achieve long-term remission if they get regular infusions of the drug Remicade, new research confirms.

Doctors usually give people with moderate or severe forms of the bowel ailment a single infusion of the anti-swelling drug to treat acute attacks, but the effect wears off after a while.

Remicade, the first drug approved specifically for Crohn’s disease, has not been recommended for ongoing use, but experts say research published this week in the Lancet medical journal provides evidence that it is safe and effective enough to keep taking Remicade, generically known as infliximab.

The study, the largest ever conducted on Crohn’s disease, found that patients who got injections every eight weeks were half as likely to suffer a relapse over seven months as those who got a dummy drug.

“At last we have a therapy that truly allows us to manage this disease over time, rather than just treating flare-ups,” said lead investigator Dr. Stephen Hanauer, professor of medicine at the University of Chicago.

“Ongoing treatment with infliximab decreased disease activity, prevented sudden attacks and enabled patients to reduce or, in many cases, completely eliminate steroids.”

Dr. William Sandborn, a Crohn’s expert in the Inflammatory Bowel Disease Clinic at the Mayo Clinic, who was not involved in the research, said the findings represent an important advance for Crohn’s patients.

“It should change practice for this group of patients, but I think investigators should keep looking to combine infliximab with other drugs and should keep looking for other therapies so that we can get remission rates at a year at 75% or 80%,” Sandborn said.

The prevalence of Crohn’s disease varies from 28 people per 100,000 in some countries to 108 cases per 100,000 in others. It afflicts more than 500,000 people in the United States.

It causes severe diarrhea, bleeding, fever and malnutrition. There is no cure.

Researchers believe that immune cells in the gut overreact to the presence of bacteria. The resulting inflammation causes the wall of the digestive tract to shred and break down.

It is managed by diet restrictions and medication to suppress the immune system and calm inflammation. In severe cases, damaged portions of the intestine are cut out.

Remicade is a bioengineered drug that roams patients’ blood to sop up an immune system protein called tumor necrosis factor, responsible for much of the swelling.

The medication is also used for rheumatoid arthritis, another immune system disease.

In Crohn’s it is used mostly for patients with moderate or severe cases who do not do well on the traditional medication, which includes immune-suppressing drugs, steroids and other anti-inflammatories.

The experiment involved 355 patients whose symptoms had improved within two weeks of a flare-up dose. They were divided into three groups. Every eight weeks for a year, the patients were given an intravenous infusion of either 5 milligrams per kilogram of body weight, 10 milligrams per kilogram or a fake injection.

After 30 weeks, people getting Remicade were twice as likely to still be in remission as those getting the dummy drug.

The drug worked for 54 weeks in the high-dose group and 38 weeks in the low-dose group, while those on the dummy injection started getting worse after only 19 weeks.

The risk of serious infections such as tuberculosis or sepsis--the main side effect from immune-suppressing drugs such as Remicade--was the same among the three groups, the study said.