Inflammatory Bowel Diseases

Inflammatory bowel diseases (IBD) is the overarching term for both ulcerative colitis and Crohn’s disease.

In Canada, there are around 270,000 individuals living with the one of these diseases and unfortunately, the number of people affected by IBD is only increasing. Healthcare costs in the country associated with the condition add up to approximately 1.28 billion dollars each year.

The very first biologic therapy to become available as a treatment for IBD patients in Ontario, Canada, was infliximab (Remicade). It first became available for Crohn’s disease patients in 2001 and then for ulcerative colitis patients in 2006. Infliximab is an anti-TNF therapy which works to block inflammation.

In the years following its approval, Canadian researchers began to wonder just how effective this therapy was for patients. In a recent study published in Gut, a group of scientists examined the effect of the drug on rates of hospitalizations (due to IBD complications) and intestinal resection surgeries (removal of the diseased bowel that is not responding to the treatment). These two effects are some of the most severe complications that IBD patients have to face.

Unfortunately, what they found was not glowingly positive.

The Study

The lead author of this study was Sanjay Murthy, who is an IBD specialist working at The Ottawa Hospital. The investigation specifically looked at ulcerative colitis and Crohn’s disease patients in Ontario, Canada. They examined the patient population in the city between the years of 1995 and 2012. They compared this real data to the trends they had expected following the drugs introduction.

The researchers found that individuals with ulcerative colitis taking the drug did see improved hospitalization rates, but those with Crohn’s disease did not see the same result. Neither group showed significant reductions in surgery rates. Considering the fact that both of these factors had been improved significantly during clinical trials, these findings were nothing short of disappointing.

This is especially disheartening because the research team knew that these two adverse events are more likely to occur in patients with severe disease. Those with such high levels of disease progression are also more likely to be the patients prescribed the novel infliximab treatment.

So why were these results not the results expected? These are the hypotheses.

• The wrong patients are being selected to receive the treatment
• The initiation of treatment has been delayed too long (severity wasn’t recognized quickly enough or the treatment was simply inaccessible)
• The optimal dose of the treatment has not been prescribed correctly
• Reimbursement criteria may correlate to limited access
• Traditional care has been improved in recent years, minimizing the dramatic effect this treatment may have had a few years prior

It is essential to note that this study also did not analyze the effect of this therapy on patient’s quality of life or factors such as their ability to attend work and be productive. These factors are critical components which are essential for a comprehensive evaluation.

The researchers did however look at the cost of the therapies.

Before infliximab was introduced, the average drug costs were 2,500 dollars for ulcerative colitis patients and 1,000 dollars for Crohn’s disease patients. After infliximab’s introduction, these costs ramped up to 10,000 dollars and 14,000 dollars respectively. The number of patients using the drug is still steadily increasing. By the end of the follow-up period for this study, the research team estimated that 25% of Crohn’s disease patients and 8% of ulcerative colitis patients would be taking the drug.

Looking Forward

The researchers ultimate conclusion was this:

“Even though the drug clearly helps some individuals, we are not seeing some of the important benefits we would expect at a broader population level.”

It is not that this drug has not proved efficacious for some patients; it would have never been approved as a biologic therapy for IBD if it had not shown that it could provide dramatic benefit. However, this study does indicate that we need to work to improve how the drug is prescribed in order to ensure it is being utilized to its full potential.

The researchers emphasize that these results should not discourage patients. The fact of the matter is that this therapy could still be impacting patients in a significant way. Things like the ability to be productive at work are influential factors that this study critically failed to evaluate. Research on quality of life factors is therefore highly needed in both Ontario as well as other areas.

But regardless, this study does indicate that more education regarding this therapy is necessary for both clinicians and their patients.

You can read more about this investigation of infliximab here.