Conventional wisdom about the treatment of Crohn's disease is being turned on its head by a new study.
Traditionally, patients diagnosed with the devastating inflammatory bowel disease are treated with a "step-up" approach, a series of drugs given sequentially as their health deteriorates.
First, they get corticosteroids to control symptoms like abdominal pain and bloody diarrhea. They are then prescribed a powerful immune-suppressing drug, which prepares them for a third medication, an antibody that curbs the inflammation at the root of the disease.
But a group of European and Canadian researchers decided to see what would happen if they treated newly diagnosed Crohn's patients immediately with a combination of an immune-suppressing drug, azathioprine, and an antibody, infliximab, simultaneously. Patients were only treated with steroids if they had symptoms.
In the study, published in today's edition of The Lancet, this "step-down" approach proved to be markedly more effective.
At six months, 60 per cent of patients treated with this method were in remission, compared with 36 per cent in the step-up group.
After a year, 62 per cent of the step-down patients were in remission from Crohn's, compared with 42 per cent of the other group. But the numbers in the latter group rose only because so many had progressed to taking infliximab.
"The conventional approach was far inferior," said Brian Feagan, director of clinical trials at the Robarts Research Institute of the University of Western Ontario in London, Ont., and co-author of the study.
He said that treatment methods for Crohn's have developed over time but have never really been tested in this manner before.
"There's a lot of therapeutic inertia, and physicians tend to use the most effective drugs only as a last resort," Dr. Feagan said.
While the new study is compelling, the researcher said that instituting the step-down approach in practice will be a tough sell because drugs such as infliximab (brand name Remicade) are far more expensive than steroids.
"The third-party payers [insurance providers] would be horrified if we started treating everyone with biologics like Remicade," Dr. Feagan said.
But he noted that doing so would pay off because fast and prolonged remission would reduce other treatment costs, and would result in better quality of life. While steroids are cheap, they are toxic in high doses, and Crohn's patients who take them frequently have a much higher death rate.
Monica Price was diagnosed with Crohn's just before Christmas, 2005, at the age of 50. She suffered from bloating and severe abdominal pain, and then developed welts on her shins (called erythema nodosum) that are a telltale sign of Crohn's.
She was prescribed steroids but suffered troublesome side effects including insomnia, facial puffiness and a voracious appetite that translated into significant weight gain.
Because she was a participant in a study - not the same one whose results are published today but similar in nature - Ms. Price began taking azathioprine (brand name Imuran) and Remicade after only three weeks on steroids.
"I started feeling better as soon as the infusion began," she said.
Ms. Price has been in remission ever since. "All my symptoms are gone. It's amazing," she said.
Ms. Price gets infusions of the drug once every 10 weeks.
The new research involved 133 patients in Belgium, the Netherlands and Germany, half of whom were treated with the traditional step-up approach and half with the step-down approach over a two-year period.
Geert D'Haens of the Imelda Gastrointestinal Clinical Research Centre in Bonheiden, Belgium, and lead author of the study, called the findings a milestone in the management of Crohn's.
"All classic paradigms for the management of Crohn's disease need to be questioned," he said.
Dr. D'Haens said the findings should also inspire researchers and clinicians to rethink their treatment of other conditions such as ulcerative colitis and rheumatoid arthritis that are also treated with biologics like Remicade.
About 170,000 Canadians suffer from inflammatory bowel disease - which includes two similar but distinct conditions: Crohn's and ulcerative colitis - according to the Crohn's and Colitis Foundation of Canada.
People are most frequently diagnosed between the ages of 15 and 25, or 45 and 55.
These diseases affect the digestive system and cause the intestinal tissue to become inflamed, form sores and bleed easily. Many patients also suffer extra-intestinal problems, including joint, skin and eye problems.
There is no known cure for inflammatory bowel disease. It is treated with drugs, as well as surgery to remove parts of the bowel.
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