To compare the risk of infections with adalimumab vs infliximab among pediatric patients with inflammatory bowel disease (IBD) in routine clinical practice.
Approach:
Data Sources: Utilized two nationwide US commercial claims databases: Merative MarketScan Commercial Database and Optum’s deidentified Clinformatics Data Mart Database.
Cohort Definition: Defined cohort entry as the first dispensation or administration date of adalimumab or infliximab, excluding patients with prior biologic use and specific comorbidities.
Outcome Measures: Outcomes included serious infections requiring hospitalization and outpatient infections requiring treatment, defined by specific ICD-10 codes and treatment criteria.
Follow-Up: Follow-up began 1 day after cohort entry and continued until the occurrence of the outcome, death, disenrollment, or discontinuation of treatment.
Key Findings:
Pediatric IBD prevalence is increasing, with 43% receiving biologic therapy before age 18.
No head-to-head trials have compared the safety of infliximab and adalimumab specifically for infection risks in children.
Children with IBD have a higher rate of serious infections compared to the general pediatric population.
Interpretation:
Limitations:
Study design is observational and may not account for all confounding factors.
Data is limited to claims databases, which may not capture all clinical outcomes.
Conclusion:
The study aims to fill the evidence gap regarding infection risks associated with infliximab and adalimumab in pediatric IBD patients.
