Risk of Infections With Infliximab vs Adalimumab Among Children With Inflammatory Bowel Disease

Area of Science:

• Pediatric Gastroenterology
• Immunology
• Pharmacovigilance

Background:

• Infliximab and adalimumab are FDA-approved biologics for pediatric inflammatory bowel disease (IBD).
• Comparative infection risks between these two treatments in children have not been well-established in clinical practice.

Purpose of the Study:

• To compare the risk of serious and outpatient infections in pediatric patients with IBD initiating infliximab versus adalimumab.
• To evaluate the safety profiles of these biologics in a real-world clinical setting.

Main Methods:

• A cohort study utilizing nationwide healthcare claims data from January 2016 to February 2025.
• Inclusion of children and adolescents (6-17 years) with Crohn disease or ulcerative colitis newly starting infliximab or adalimumab.
• Propensity score matching and meta-analysis to compare serious and outpatient infections over a 180-day follow-up period.

Main Results:

• The study identified 4239 children with IBD, with 1533 patients in each matched exposure group (infliximab vs. adalimumab).
• Incidence of serious infections was similar (29 vs. 34 per 1000 person-years; HR, 1.15), as were outpatient infections (358 vs. 386 per 1000 person-years; HR, 1.08).
• Sensitivity analyses confirmed these findings, and no mycobacterial infections were observed.

Conclusions:

• Serious infections are rare in pediatric IBD patients treated with infliximab or adalimumab.
• This study found no evidence of a difference in infection risk between infliximab and adalimumab.
• The findings suggest comparable infection risk profiles for these biologics in pediatric IBD, though subtle differences cannot be excluded.