PROTECT Study Produces New Model for Treating Children with Ulcerative Colitis
Top Breakthrough Discovery | Published March 2019 in The Lancet
Lee Denson, MD
While most children diagnosed with ulcerative colitis respond well to existing medications, some do not, which results in about 26% of patients needing colectomy surgery within five years.
Now the co-authors of the 29-center PROTECT study, led by co-principal investigator Lee Denson, MD, propose a fundamental shift in treatment approach. Using DNA genotyping, RNA sequencing and microbial analysis of more than 400 patient biopsy samples, the team reveals a collection of results that can help clinicians predict which children need earlier interventions and who is most likely to respond well to treatment.
“Our results show that you can predict who will achieve the primary outcome of corticosteroid-free remission at 52 weeks based on certain clinical factors,” says Denson, director of the Schubert-Martin Inflammatory Bowel Disease Center. “Early prediction could lead to more timely introduction of additional medical therapy when needed.”
Current protocols lack precision
When treating children with newly diagnosed ulcerative colitis, physicians typically choose between corticosteroids and mesalazine (a locally acting anti-inflammatory) for those presenting with mild symptoms. Many prescribe infliximab (a potent monoclonal antibody) for those with more severe symptoms.
However, outcomes have not been so clearly stratified. Some patients with mild symptoms do not respond to mesalazine, yet they linger on the drug. Meanwhile, others with moderate to severe symptoms sometimes do respond to mesalazine, suggesting that more intense treatments may not always be necessary.
Much of this inconsistency, Denson says, has reflected clinicians relying on adult-driven protocols because they have lacked evidence-based outcomes data—until now.