Safety of Biological Therapy in Children With Inflammatory Bowel Disease.
J Pediatr Gastroenterol Nutr
; 72(5): 736-741, 2021 05 01.
Article
in English
| MEDLINE | ID: covidwho-1015411
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 2âmonths. 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.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Inflammatory Bowel Diseases
/
COVID-19
Type of study:
Cohort study
/
Observational study
/
Prognostic study
Topics:
Vaccines
Limits:
Child
/
Humans
Language:
English
Journal:
J Pediatr Gastroenterol Nutr
Year:
2021
Document Type:
Article
Affiliation country:
MPG.0000000000003044
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