Pediatric RISK Stratification Study

We have long understood that children with inflammatory bowel disease (IBD) require diagnostics and treatments that are tailored to their unique needs, rather than what may work best for adults.

The Crohn’s & Colitis Foundation launched its Pediatric RISK Stratification Study to document and examine Crohn’s disease in children in hopes of finding a diagnostic predictor of which children will later develop serious complications requiring surgery.

About the RISK Stratification Study

The Pediatric RISK Stratification Study is the largest, new-onset study completed on pediatric Crohn’s disease patients.

The study enrolled 1,800 patients from 28 clinics in the United States and Canada, and focused on 913 children newly diagnosed with Crohn’s disease. Each of the children were free of complications for 90 days after their diagnosis.

This 36-month prospective inception cohort study included collections of well-documented clinical, demographic, and biological samples every six months on all patients for three years, with continuing follow up for five years.

RISK Stratification Study Outcomes

Researchers successfully identified biological signatures that are capable of predicting if  a child newly diagnosed with Crohn’s disease will develop disease-related complications that will require major surgery within three to five years.

Pediatric RISK Stratification Study

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Pediatric RISK Stratification Study

The study also found that early biological therapy treatment, given within 90 days of diagnosis, was effective in preventing penetrating complications, such as fistulae. That same treatment, however, did not seem to have an impact on patients likely to develop strictures. The data highlighted the unmet need to find new treatments for children likely to develop strictures.

The outcomes of this study revealed a potential new approach for precision medicine in pediatric patients — medical treatment tailored to the individual characteristics of each patient, including biologic therapy.

In the future, researchers are hoping to use these findings to create a risk diagnostic tool that could use the biological signatures as biomarkers to help clinicians make therapeutic decisions at diagnosis.