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:
The findings suggest that while both infliximab and adalimumab are effective in managing pediatric IBD, the associated infection risks need careful consideration. The lack of direct comparative studies highlights the need for further research to establish clearer safety profiles for these biologics in the pediatric population. Clinicians should weigh the benefits of therapy against the potential for increased infection risk, particularly in children with underlying health issues or those who have previously received other immunosuppressive treatments.
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 found that while both infliximab and adalimumab are associated with an increased risk of infections in pediatric IBD patients, the risk appears to be similar between the two medications. This suggests that clinicians can consider either option while monitoring for infections, emphasizing the importance of individualized patient assessment and management strategies. The findings contribute valuable insights into the safety profiles of these biologics in the pediatric population. ---
