Safety of Biological Therapy in Children With Inflammatory Bowel Disease.

J Pediatr Gastroenterol Nutr

Pediatric Gastroenterology and Liver Unit, Department of Maternal and Child Health, Sapienza University of Rome, Rome, Italy.

Published: May 2021

AI Article Synopsis

  • This study analyzed the safety of biological therapies in children with inflammatory bowel disease (IBD) through a retrospective observational cohort approach.
  • It involved 185 pediatric patients treated with drugs like infliximab and adalimumab for at least two months, examining adverse events (AEs) related to these therapies.
  • Results indicated that while 49% of patients experienced AEs, most were mild to moderate, with only a small percentage leading to treatment discontinuation, confirming a generally positive safety profile for biologic treatments.

Article Abstract

Objectives: Retrospective, observational, single-center, cohort study investigating the safety profile of biological therapy in children with inflammatory bowel disease (IBD).

Methods: Retrospective, observational, cohort study of pediatric patients with IBD, receiving infliximab, adalimumab, vedolizumab, or ustekinumab for at least 2 months. Data related to the immediate and delayed adverse events (AEs) were collected, focusing on the reaction type and severity, the time of onset, the outcome and the temporary or definitive therapy discontinuation secondary to the AE. Number of suspected and confirmed coronavirus disease-209 (COVID-19) cases and their outcomes, as well as flu vaccination coverage were collected.

Results: One hundred eighty-five children were included (101 [55%] CD, 82 [44%] UC, and 2 [1%] IBDU): 149 received infliximab (IFX) (81%), 88 (48%) adalimumab (ADA), 18 (21%) vedolizumab, and 4 (2%) ustekinumab. The overall AE rates were 49%, 67% of whom likely medication-related. Eleven (6%) patients experienced more than 1 AE, 18 patients (10%) presented an immediate reaction, and 82 (45%) a delayed AE. Among the 90 patients experiencing at least 1 AE, 97% had mild-to-moderate AEs. Only 4 SAEs were reported (4%). Treatment discontinuation because of AE occurred in 25 patients (14%). Four COVID-19 cases were reported, all with a mild course.

Conclusions: Our findings confirm a good safety profile of biologics. Infusion reactions to IFX administration remain one of the main issues, significantly linked to its immunogenicity and consequently with an impact on its efficacy and durability.

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Source
http://dx.doi.org/10.1097/MPG.0000000000003044DOI Listing

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