Robarts clinical trial finds better treatment option

Friday, February 22, 2008

An international research study, published today in The Lancet, has thrown into question the current method of treating Crohn's disease - opening the door to a safer and more effective treatment option for sufferers of the chronic disease.

"Our study clearly demonstrated that this alternative treatment method was more effective at inducing disease remission than the conventional method," said Brian Feagan, Director of Robarts Clinical Trials at Robarts Research Institute at The University of Western Ontario. Feagan coordinated the research trial and is an author on the study.

"Not only were patients more likely to get their disease under control, but they were also spared exposure to steroids - the extended use of which is linked with metabolic disease and even increased mortality. It's simply a safer, more effective treatment method."

Called a "step-up" approach, the conventional treatment for Crohn's disease involves first administering steroids in order to control the patient's symptoms (abdominal pain and bloody diarrhea); the next step involves administering immune-suppressing drugs, which prepare the body to receive the third medication - an antibody that curbs the inflammatory response at the root of the disease.

The alternative strategy, called "top-down" therapy, employs early use of immune-suppressing drugs combined with an antibody in order to address the disease from the start. Symptom-treating steroids may never even be needed.

The two-year study was conducted at research centres in Belgium, Holland, and Germany and involved 129 subjects with active Crohn's disease. Sixty-four patients received the conventional step-up treatment and 65 the combined immune-suppressing method (top-down). In all, 60 per cent of the top-down subjects were symptom-free by the 26th week of the study, compared to only 36 per cent of the step-up subjects.

"This study is a milestone in the management of Crohn's disease," said lead author Geert D'Haens, of the Imelda GI Clinical Research Centre at the Imelda Hospital in Bonheiden, Belgium. "It does not look at the effects of single drug intervention but at strategies to alter the natural history of this chronic destructive condition. All 'classic' paradigms for the management of Crohn's disease need to be questioned."

The impact of the study goes beyond Crohn's disease.

"We've seen similar results in top-down, step-up studies of rheumatoid arthritis," said Feagan, "suggesting that the top-down approach could be the best treatment method for other chronic auto-immune diseases such as ulcerative colitis."

Feagan is a Professor of Medicine and Epidemiology & Biostatistics at the Schulich School of Medicine & Dentistry at Western. He holds cross-appointments in the divisions of Internal Medicine, Clinical Pharmacology and Gastroenterology.