Principal Investigator: Ross Maltz, MD; Nationwide Children's Hospital
Overall Study Question: Evaluate variation in prescribing habits of IV anti-TNF therapies across the pediatric IBD community. Evaluate the safety and efficacy of non-medical switches from the originator to a biosimilar
Specific Aims:
- To evaluate infliximab use over time for patients who are anti-TNF naïve, to determine if biosimilar use is increasing nationally, variation amongst practices, geographic regions, by commercial vs Medicaid insurance, and race.
- To evaluate long-term clinical outcomes of pediatric patients initiated on an infliximab biosimilars vs the originator.
- Evaluate how often switching from the originator to a biosimilar are occurring within the ICN Network. Determine if non-medical switching adversely affects clinical outcomes in pediatric IBD patients including the impact upon clinical remission in addition to anti-TNF drug and antibody levels. Evaluate how often patients are switching back to the originator or to a different therapy class.
Study Period: Beginning in May 2022
Contact: Ross Maltz, MD