New Study to Test Infliximab Precision Dosing Strategy at 10 Centers Nationwide
Optimizing infliximab therapy for children with inflammatory bowel disease is critically important and notoriously challenging. A new, web-based decision support dashboard designed by experts at Cincinnati Children’s standardizes the calculation. Called RoadMAB, the dashboard allows physicians to determine a patient’s optimal infliximab (REMICADE®) dose with the click of a button, whether establishing a starting dose or adjusting the treatment plan during the maintenance phase. It is available to patients at the Schubert-Martin Inflammatory Bowel Disease Center at Cincinnati Children’s.
RoadMAB received the Technology Innovation Award at NASPGHAN in October 2022 and was featured during the conference’s Single Topic Symposium.
Pediatric gastroenterologist Phillip Minar, MD, MS, and his Cincinnati Children’s colleagues in pediatric gastroenterology, pharmacokinetics and information systems began developing the RoadMAB dashboard in 2019. In 2021, Minar did a chart review of patients who received infliximab dose optimizations using the dashboard in 2019-2021. He found that 16 of 19 study participants (84%) achieved the desired drug target. Now, he is following that up with a multisite, randomized clinical trial comparing the outcomes of dashboard-driven infliximab dosing to the current standard of care dosing strategy for children and young adults with Crohn’s disease.
The objective is to identify which method is most effective in delivering the right dose to the right patient to achieve optimal drug levels, improve patient-reported outcomes and attain gut healing with minimal side effects. A total of 10 institutions are participating in the pragmatic research study, which is sponsored by the National Institutes of Health.
The unique trial design uses a novel continuous learning approach that involves systematically checking drug levels, evaluating patient reported outcomes and monitoring stool and blood biomarkers to optimize drug therapy before gastrointestinal symptoms worsen.
“We’re excited about the study design because it allows us to personalize dosing as we go along,” Minar says. “Every two months, we’ll look at patient-reported outcomes and biomarkers and make individual dose adjustments based not on drug clearance, but on whether the patient achieved the treatment target of endoscopic healing.”
Anti-TNF biologics, such as infliximab, are the only approved biologic for children with moderate to severe Crohn’s disease. Standard dosing regimens of infliximab are associated with improved outcomes, but the standard dose doesn’t work for more than half of the children who use it.
