Principal Investigator: Steven Steiner, MD – Riley Hospital for Children
Purpose:
The selected medication for IBD depends primarily on the severity of active disease, the patient's tolerance, observed clinical response, and cost. Timely access to selected medications is critical to prevent complications from untreated disease such as strictures, infection, or need for surgical intervention. Of the approximately 13 biologics/small molecules approved for adult IBD, only 2 are currently approved in children: infliximab and adalimumab.
Pediatric patients often receive non-FDA approved biologics/small molecules with prior authorization after failing other FDA-approved medications or if they present with severe disease that necessitates urgent use of a non-FDA approved medication.
Aims:
- Identify the number/ percentage of patients who were exposed to a biologic/small molecule without FDA approval
- Identify the number/ percentage of patients who were exposed to specific number of biologic/small molecule without FDA approval (i.e. # exposed to 1 drug, # exposed to 2 drugs, etc.)
- Identify the average age of first exposure to non-FDA approved biologic/small molecule
- Identify the time from diagnosis toto first exposure to non-FDA approved biologic/small molecule (will consider time to second, third exposure as well)
- Identify variations, if any, of non-FDA approved biologic/small molecule medication use within gender and race/ethnicity subgroups
Funding Source (Year Awarded): 2022 - IU Pediatric GI Departmental Funding during fellowship
Study Period: July 2023 – June 2025
Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.
Contact: [email protected]