When Crohn’s disease is diagnosed in childhood, it can often be more severe than when diagnosed in adults. That is why it is essential to get children diagnosed and on the right therapy quickly. “We have learned from previous pediatric IBD research studies that if we can heal the Crohn's afflicted bowel with medical therapy, the risks of complications from Crohn’s disease decrease dramatically,” says Neal LeLeiko, MD, PhD, Director of the Pediatric Inflammatory Bowel Disease (IBD) Program at NewYork-Presbyterian/Columbia.
Under Dr. LeLeiko’s leadership, NewYork-Presbyterian/
Although there are a handful of medications approved for the treatment of pediatric Crohn’s disease, there are still questions about the best way to optimize treatment to achieve mucosal healing and prevent complications. “We're at a point now where we're trying to determine what's the optimal drug, what's the optimal dose, and who needs to be treated more aggressively because of their higher potential for a bad outcome,” says Dr. LeLeiko.
Across the country and in Canada, pediatric IBD specialists are working together on the next large pediatric Crohn’s disease research study. “Up until around 2000, there were very few major studies conducted about pediatric Crohn’s disease,” he says. “Since then, several important studies have been completed that have helped identify biomarkers that can predict future complications requiring surgery. However, we still need more studies to help us predict who will have a more difficult disease course and therefore should receive stronger medications earlier in their disease journey.”
A New National Standard of Care Study for Pediatric Crohn’s Treatment
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Through the CAMEO Study, Dr. LeLeiko and the other investigators seek to enroll new Crohn's patients prior to confirmation of their diagnosis and understand why some children with Crohn’s disease who are treated with anti-TNF therapy achieve mucosal healing and some do not. “CAMEO will provide us with a better understanding of the biology of how the bowel achieves healing with treatment with critical anti-tumor necrosis factor medicines,” says Dr. LeLeiko. “What we learn will point the way not only to improving our use of our current best medicines, but we hope it will inform us how to design and implement newer therapies as they become available to children.”
There are two phases to the CAMEO Study: The first phase begins when a child is being evaluated for Crohn’s disease and a colonoscopy is scheduled. The child will undergo stool studies, a colonoscopy, and an MRE to assess for the presence of inflammation and diagnosis of Crohn’s disease. If a diagnosis of Crohn’s disease is made and the patient begins anti-TNF therapy within six months, they can continue into the second phase of the study. During the second phase, a specialized computer program will suggest optimal anti-TNF dosing. The patient and physician may decide to follow the program or treat as if they were not in the study. Additional blood and stool samples will be tested periodically for inflammation. If the child does well on the anti-TNF therapy, then at one year, a repeat colonoscopy and MRE are performed to see if their intestinal lining has healed.
“A critical part of CAMEO is carefully monitoring the amounts of anti-TNF medication in our patients’ blood to see how it relates to all other aspects of healing,” says Dr. LeLeiko. “Since CAMEO is performed as part of the patients regular individualized therapy, the study supported therapeutic drug monitoring occurs when routine bloodwork is performed. We are hopeful that the information obtained will not only answer a great many questions about Crohn’s but will also provide a mechanism for predicting and improving outcomes of therapy for children who are being treated with anti-TNFs.”
Hope for the Future
Dr. LeLeiko believes that the CAMEO Study will yield crucial information that will help improve the treatment of pediatric Crohn’s disease in the future. “The patients we see are at risk for significant complications, and participating in a study like CAMEO will allow us to further optimize the care we provide to these patients and provide more personalized therapeutic recommendations based on individualized data,” he says.
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