Safety of Biological Therapy in Children With Inflammatory B
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A Study was conducted to investigate the safety profile of biological therapy in children with inflammatory bowel disease (IBD).

Retrospective, randomized cohort review was done of pediatric patients with IBD who had been treated with infliximab, adalimumab, vedolizumab, or ustekinumab for at least two months. Data on immediate and delayed adverse reactions (AEs) was obtained, with a focus on reaction form and intensity, onset duration, outcome, and temporary or permanent therapy discontinuation as a result of the AE. The number of reported and confirmed coronavirus disease-209 (COVID-19) cases, as well as their outcomes and flu vaccine coverage, was gathered.

--185 children were included (101 CD, 82 UC, and 2 IBDU): 149 received infliximab (IFX), 88 adalimumab (ADA), 18 vedolizumab, and 4 ustekinumab.

--The overall AE rates were 49%, 67% of whom likely medication-related.

--11 patients experienced more than 1 AE, 18 patients presented an immediate reaction, and 82 presented 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%). 4 COVID-19 cases were reported, all with a mild course.

In conclusion, these results show that biologics have a strong safety profile. Infusion reactions to IFX administration remain a major concern, as they are strongly related to its immunogenicity and, as a result, to its effectiveness and durability.