PMID- 33416268
OWN - NLM
STAT- MEDLINE
DCOM- 20210618
LR  - 20220531
IS  - 1536-4801 (Electronic)
IS  - 0277-2116 (Linking)
VI  - 72
IP  - 5
DP  - 2021 May 1
TI  - Safety of Biological Therapy in Children With Inflammatory Bowel Disease.
PG  - 736-741
LID - 10.1097/MPG.0000000000003044 [doi]
AB  - 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.
CI  - Copyright (c) 2021 by European Society for Pediatric Gastroenterology, Hepatology, 
      and Nutrition and North American Society for Pediatric Gastroenterology, 
      Hepatology, and Nutrition.
FAU - D'Arcangelo, Giulia
AU  - D'Arcangelo G
AD  - Pediatric Gastroenterology and Liver Unit, Department of Maternal and Child 
      Health, Sapienza University of Rome, Rome, Italy.
FAU - Distante, Manuela
AU  - Distante M
FAU - Raso, Tonia
AU  - Raso T
FAU - Rossetti, Danilo
AU  - Rossetti D
FAU - Catassi, Giulia
AU  - Catassi G
FAU - Aloi, Marina
AU  - Aloi M
LA  - eng
PT  - Journal Article
PT  - Observational Study
PL  - United States
TA  - J Pediatr Gastroenterol Nutr
JT  - Journal of pediatric gastroenterology and nutrition
JID - 8211545
RN  - B72HH48FLU (Infliximab)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
MH  - Adalimumab/adverse effects
MH  - Biological Therapy/adverse effects
MH  - *COVID-19
MH  - Child
MH  - Cohort Studies
MH  - Humans
MH  - *Inflammatory Bowel Diseases/drug therapy
MH  - Infliximab/adverse effects
MH  - Retrospective Studies
MH  - SARS-CoV-2
MH  - Treatment Outcome
COIS- The authors report no conflicts of interest.
EDAT- 2021/01/09 06:00
MHDA- 2021/06/22 06:00
CRDT- 2021/01/08 10:44
PHST- 2021/01/09 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2021/01/08 10:44 [entrez]
AID - 00005176-202105000-00022 [pii]
AID - 10.1097/MPG.0000000000003044 [doi]
PST - ppublish
SO  - J Pediatr Gastroenterol Nutr. 2021 May 1;72(5):736-741. doi: 
      10.1097/MPG.0000000000003044.