Infliximab and Adalimumab Show Similar Serious Infection Risk in Pediatric IBD, Finds JAMA Study
USA: Researchers have found in a new cohort study of children and adolescents with inflammatory bowel disease (IBD) that serious infections were uncommon during treatment with either infliximab or adalimumab. No significant difference in the risk of serious infections was observed between the two biologic agents, suggesting they have comparable infection safety profiles in pediatric IBD. However, the study could not rule out the possibility of clinically meaningful differences, underscoring the need for continued long-term safety monitoring.
Infliximab and adalimumab are the only biologic therapies approved by the US Food and Drug Administration for children with inflammatory bowel disease. Still, direct comparisons of their infection risk in routine clinical practice have been limited. To address this evidence gap, researchers led by Ning Lyu from the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, evaluated the comparative safety of these two agents using nationwide healthcare claims data.
The cohort study, published in JAMA Network Open, analyzed data collected between January 2016 and February 2025 from two large US healthcare claims databases. The study included 4,239 children and adolescents aged 6 to 17 years with Crohn's disease or ulcerative colitis who were newly started on infliximab or adalimumab. After propensity score matching to balance baseline characteristics, 1,533 patients remained in each treatment group.
The primary outcome was the occurrence of serious infections requiring hospitalization over 180 days of follow-up. Researchers also assessed outpatient infections, defined as an outpatient infection diagnosis accompanied by a targeted antimicrobial prescription within one day.
Key findings from the study include:
- Serious infections were rare in both treatment groups during follow-up.
- No significant difference in the risk of serious infections was observed between adalimumab and infliximab.
- Outpatient infections occurred more frequently than serious infections but were also comparable between the two biologic therapies.
- Multiple sensitivity analyses—including restriction to biologic monotherapy, first-line biologic users, originator products only, exclusion of gastrointestinal infections, and extension of follow-up to one year—produced findings consistent with the primary analysis.
- No cases of mycobacterial infection were identified in the overall study population.
The researchers found that infliximab and adalimumab have similar infection safety profiles as initial biologic therapies for pediatric IBD. While outpatient infections were relatively common, serious infections requiring hospitalization were rare with both treatments.
The authors noted that residual confounding and possible outcome misclassification cannot be entirely excluded. They also acknowledged that the low number of serious infections limited analyses of specific infection types, and that findings from commercially insured patients may not be fully generalizable to publicly insured populations.
The researchers concluded that both biologics carry comparable risks of serious and outpatient infections in children with IBD. However, clinically meaningful differences cannot be completely ruled out, underscoring the need for continued long-term safety monitoring.
Reference:
Lyu N, Tracy M, Schneeweiss S, Savage TJ. Risk of Infections With Infliximab vs Adalimumab Among Children With Inflammatory Bowel Disease. JAMA Netw Open. 2026;9(7):e2622684. doi:10.1001/jamanetworkopen.2026.22684
Next Story