Infection risk with infliximab (Remicade) and adalimumab (Humira) is similar in pediatric inflammatory bowel disease

1. Among children with inflammatory bowel disease, there were no significant differences in serious or outpatient infection risk between initiating infliximab (Remicade) and adalimumab (Humira).

Evidence Rating Level: 2 (Good)

Study Rundown: Pediatric Inflammatory Bowel Disease (IBD) includes Crohn disease (CD), ulcerative colitis (UC), and IBD-unclassified (IBD-U), and its prevalence is increasing in the US. Infliximab and adalimumab were the first biologics approved by the US Food and Drug Administration for pediatric IBD. While both agents have been found to be effective in children with IBD, their comparative safety, including the risk of infections, remains unclear. This study thus compared the risk of infections with infliximab vs adalimumab among pediatric patients with IBD using nationwide claims data. This study included children and adolescents aged 6 to 17 years diagnosed with CD or UC who newly initiated infliximab or adalimumab and had >180 days of prior continuous enrollment. The primary outcomes were serious infections requiring hospitalization and outpatient infections requiring treatment. Among the 4239 patients in the study cohort, 2467 initiated infliximab and 1772 initiated adalimumab. After 1:1 propensity score matching, each group included 1,533 patients. Over an 180-day follow-up period, the incidence of serious infections was 29 per 1,000 person-years for infliximab and 34 per 1,000 person-years for adalimumab. There was no significant difference in risk of serious infections between initiating infliximab and adalimumab. The incidence of outpatient infections was 358 per 1,000 person-years for infliximab and 386 per 1,000 person-years for adalimumab. There was also no significant difference in risk of outpatient infections between initiating infliximab and adalimumab. Overall, this study found that among children and adolescents with IBD, serious infections were rare and there were no differences in serious or outpatient infection risk between initiating infliximab and adalimumab. 

Click to read the study in JAMA Network Open

Relevant reading: Comparative effectiveness and safety of infliximab and adalimumab in patients with ulcerative colitis

In-Depth [retrospective cohort study]:

This study analyzed data from two nationwide health care claims databases between January 1, 2016, and February 28, 2025. The study included children and adolescents aged 6 to 17 years diagnosed with CD or UC who newly initiated infliximab or adalimumab and had >180 days of prior continuous enrollment. The exposure was initiation of adalimumab vs infliximab. The primary outcomes were serious infections requiring hospitalization and outpatient infections with a targeted antimicrobial therapy dispensed within 1 day. Among the 4239 patients in the study cohort, 2467 initiated infliximab (mean [SD] age, 13.3 [2.9] years; 1005 girls [40.7%]; 1502 with CD [60.9%]) and 1772 initiated adalimumab (mean [SD] age, 14.0 [2.7] years; 725 girls [40.9%]; 1068 with CD [60.3%]). After 1:1 propensity score matching, each group included 1,533 patients. Over an 180-day follow-up period, the incidence of serious infections was 29 per 1,000 person-years for infliximab and 34 per 1,000 person-years for adalimumab. There was no significant difference in risk of serious infections between initiating infliximab (reference) vs adalimumab (pooled HR, 1.15; 95% CI, 0.63-2.11). The incidence of outpatient infections was 358 per 1,000 person-years for infliximab and 386 per 1,000 person-years for adalimumab. There was also no significant difference in risk of outpatient infections between initiating infliximab vs adalimumab (pooled HR, 1.08; 95% CI, 0.90-1.29). Similar results were found in sensitivity analyses restricted to patients receiving monotherapy, originator-only use, first-line users only, exclusion of gastrointestinal infections from the outcome, and extending follow-up to 365 days. Overall, this study found that among children and adolescents with IBD, serious infections were rare and there were no differences in serious or outpatient infection risk between initiating infliximab and adalimumab. These results suggest that infliximab and adalimumab have similar infection risk profiles in children with IBD. Strengths of this study include being the first study to compare adalimumab and infliximab among pediatric patients, having the largest cohort of either medication studied in children, and conducting sensitivity analyses that confirm primary findings. Limitations of this study include the presence of residual confounding, infrequent cases of serious infections that could limit precision of estimates, and inclusion of only commercially insured patients that may limit generalizability. Future studies should confirm study findings, determine whether clinically meaningful differences exist, and address these study limitations.

Image: PD

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