Predicting the course of IBD

Imagine if there was a test that could predict if you’d develop severe Crohn’s disease or ulcerative colitis at the time of diagnosis. PredictImmune, a biotech spinout company from Cambridge University in the United Kingdom, is working to develop just that with its PredictSure IBD™ test. During the Crohn’s & Colitis Foundation’s Biomarkers Summit, Dr. Paul Lyons highlighted the importance of the test, which is now available in the UK and European Union for patients with Crohn’s disease and ulcerative colitis.

What does it do?

PredictSure IBD™ is the first test that has been shown in clinical trials to predict the likely course of disease for newly diagnosed patients with Crohn’s and colitis. Using a simple blood test, PredictSure IBD™ can predict, with a high degree of accuracy, whether newly diagnosed adult patients are likely to develop severe disease (and need hospitalizations and/or surgery in their first year) or are more likely to have a mild course of disease.

Why does this matter?

Until now, we’ve had no way to predict the course of IBD for a specific patient. A physician might see two newly diagnosed patients with very similar profiles (i.e., same symptoms, patient characteristics, and histories). Yet one will go on to develop severe disease within a year while the other goes into remission. 

Previous research has shown that early aggressive treatment (like with biologics) can improve the course of disease in patients with more severe disease. But until now, we haven’t had a reliable way to identify those patients. That’s why PredictSure IBD™ may be a game changer. This is the first practical step towards our goal of personalized medicine: getting the right medicine to the right patient at the right time. 

As Dr. Lyons said, this “may also help to improve drug development by reducing clinical trial costs. If we can stratify high-risk patients into clinical trials of products intended for severe disease, hopefully we’ll have more success even in high-risk patients. And equally important, we’ll avoid unnecessary treatment for the low risk patients.”

How does it work?  

PredictSure IBD™ uses a small sample of whole blood to measure the gene expression of CD8+ T cells, using a complex algorithm. Test results are available quickly and have been shown in UK trials to have a high degree of reliability.

Is it available in the USA?  It has been qualified by regulators in the UK and European Union for use in clinical practice and is now available in those countries. However, the test has not yet been studied in USA patients. That’s why the Foundation is partially funding the US study for PredictSure IBD™. The trial, called “PRECIOUS”, will recruit 200 newly diagnosed Crohn’s and colitis patients and follow them for 12 months. If the U.S. study proves as successful as the UK trials were in predicting whether patients are at high or low risk for severe disease, that would support use of the test in the US. This is an exciting and crucial step in providing personalized medicine for IBD patients.

Click here to learn more about the PRECIOUS study and PredictSure IBD™.

Sheila Roher, MPH, is a science writer for the Crohn's & Colitis Foundation.