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:

  1. 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.
  2. To evaluate long-term clinical outcomes of pediatric patients initiated on an infliximab biosimilars vs the originator.
  3. 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

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