Are we using biological therapy properly?

According to a study published by the authors, the introduction of infliximab (Remicade), the first biological treatment approved for the treatment of inflammatory bowel disease (IBD), has not resulted in drop in hospitalization rates or intestinal surgery in patients living with IBD in Ontario. from several Canadian hospitals and ICES in the newspaper Intestine.

The authors investigated trends in hospitalizations, surgical operations and drug costs in people with Crohn's disease and ulcerative colitis, collectively known as IBD, residing in Ontario between 1995 and 2012. They compared expected trends after the introduction of infliximab in Ontario with expected trends the drug was not introduced.

Infliximab is a type of anti-immune treatment (anti-TNF) that blocks inflammation in the intestines and other organs. Used to treat a variety of inflammatory diseases, it became available in Ontario for Crohn's disease in 2001 and for ulcerative colitis in 2006.

The researchers found that even among people with Crohn's disease who received infliximab, there was no significant reduction in the rate of hospitalization or surgery related to the disease compared with what we would have expected with conventional treatments alone. People with ulcerative colitis who received infliximab also did not experience lower surgery rates, but found some improvement in hospitalization rates following treatment. introduction of infliximab.

"These results are disappointing for a clbad of treatment that has been shown to reduce the number of hospitalizations and IBD-related surgeries in clinical trials," said Dr. Sanjay Murthy, author Principal Investigator, ITN Specialist and Research Associate at The Ottawa Hospital.

"We were expecting to see a greater decline in these adverse health effects because they are more common in IBD patients with severe illness.These are the same patients we should target with this treatment. early in their illness to prevent hospitalizations and surgeries. "

The study did not take into account the impact of this therapy on other important health outcomes, such as quality of life, attendance at work and the time of day. productivity.

"Clinicians have figured out how anti-TNF therapy can dramatically improve the symptoms of their patients and even, in many cases, lead to complete bowel healing," said Dr. Murthy, also an badistant professor at the University of Toronto. University of Ottawa. "But even if the drug clearly helps some people, we do not see some of the important benefits that we might expect from a larger population, which suggests that we may need to improve the way we use this. drug in clinical practice for better benefits. "

Approximately 270,000 Canadians live with IBD and the rate of IBD is increasing in Canada and around the world. In Canada, the cost of health care for IBD is estimated at $ 1.28 billion annually. Some of the most important effects of ITNs on health are hospitalizations for serious complications and intestinal resection surgery to remove diseased intestines that are resistant to treatment.

The study also showed that the average costs of drugs for ITNs per patient had increased significantly since the introduction of infliximab, especially in people with Crohn's disease. For patients whose infliximab is taken by Chron, the average annual cost of publicly funded drugs rose from around $ 1,000 before the introduction of infliximab in 2001 to more than 14,000 dollars in 2012. For patients with ulcerative colitis taking infliximab, the average cost of drugs rose from about 2,500 dollars before the introduction of infliximab in 2006. to more than $ 10,000 by 2012.

The researchers estimate that 25% of patients with Crohn 's disease and 8% of patients with ulcerative colitis would have received infliximab at the end of their study follow – up. TNF treatments are much more expensive than conventional treatments for IBD – as a clbad, they account for the largest proportion of public drug program spending in Canada at 8.7%.

The researchers hypothesized that choosing the wrong patients, delaying the start of treatment by not recognizing the severity of the disease or facilitating access to treatment, and incorrectly optimizing the dosage of the drug could all limit real impact of anti-TNF treatment on a population level. Reimbursement criteria by public or private health insurance can also limit timely access to treatment.

However, the researchers also noted a persistent decline in hospitalization rates and intestinal surgery in the IBD population long before the introduction of infliximab, suggesting that improvements made traditional care already had a significant impact.

In addition, annual intestinal resection rates in patients with IBD were already low in Ontario at the time of introduction of infliximab – about 4% for Crohn's disease patients and 2% for patients with ulcerative colitis – which might have left little room for improvement.

"Even though it may be disappointing that this treatment did not have any effect on hospitalization or surgery rates related to IBD in Ontario, this does not mean that this will have no impact on patients, "said Dr. Murthy. "More research is needed to study the quality of life and productivity in the workplace to understand the impact of this treatment in Ontario and other provinces." However, our results suggest that 39, further training of clinicians and patients is needed before this treatment can realize its full potential. "

Provided by
The Ottawa Hospital