Separate Studies Test Infliximab as Treatment for Ulcerative Colitis, Pediatric Crohn's

Winter 2000

Interest in infliximab – one of the latest drugs to be developed for the treatment of adult Crohn's disease -- is expanding as researchers test its effectiveness in other conditions.

Infliximab is an monoclonal antibody which blocks the activity of a key inflammatory agent called tumour necrosis factor. Delivered via intravenous infusion, the drug has shown dramatic effectiveness in some patients with moderate to severe Crohn's disease which had not responded to other treatments.

The drug was approved as a treatment for Crohn's disease in the United States in 1999 and is currently being reviewed by Health Canada for release in this country.

Infliximab in ulcerative colitis
Researchers at the University of Rochester Medical Center in New York used infliximab to treat 17 patients whose ulcerative colitis was unresponsive to other treatments. Sixteen of the patients exhibited dramatic and significant improvements, according to an abstract published in the American Journal of Gastroenterology (Vol. 95, No. 9, 2000). The study was led William Y. Chey.

The improvements in patients' conditions occurred in about six days in most cases and lasted two to 10 months. Those patients who had been prednisone-dependant were able to go off the steroid. No significant side effects were observed.

Among the 17 patients studied, eight were in hospital at the time of treatment and nine were treated in an ambulatory setting. The results suggest that infliximab helped all but one of the hospitalized patients avoid surgery and helped the ambulatory patients avoid subsequent hospitalization.

Researchers concluded that infliximab is an effective agent for inducing remission of patients with ulcerative colitis. The observations suggest that the treatment avoids surgical intervention in most hospitalized ulcerative colitis patients and minimizes the number of ulcerative colitis patients who require hospitalization. The researchers suggest large multi-centre trials are warranted.

Infliximab use in children
A small study by researchers at the Medical College of Wisconsin suggests infliximab is effective in treating some children with Crohn's.

The study, reported in the American Journal of Gastroenterology (November), involved 15 pediatric patients who had severe Crohn's disease which had not responded to conventional therapy. Nearly half of the children has such severe cases of Crohn's that they could not attend school or were hospitalized.

Within a month of receiving a single infusion of infliximab, the children showed significant improvements and were able to taper off steroids within weeks of receiving a single infliximab infusion. Within four weeks of the infusion, 94 per cent of the patients had experienced significant decreases in their disease activity. By the 10th week, 67 per cent were in remission.

Researchers observed that the children who had been diagnosed for two years or less had a longer response to the drug compared to those who had been diagnosed for longer than two years.

The ability of infliximab to reduce dependence on steroids is an important finding. Corticosteroids are effective in controlling inflammation but there are certain side effects associated with long term use, including delayed puberty, bone damage and osteoporosis and appearance-related side effects. Physicians typically try to limit steroid use and to taper patients off steroids while using immunomodulating drugs. Some patients, however, such as those in this study, were unable to taper off steroids.

Dr.Subra Kugathasan, lead investigator and Assistant Professor of Pediatrics at the Medical College of Wisconsin, said the early use of infliximab in children can help get the children off steroids more quickly and offer a fast and effective alternative treatment.

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