Effectiveness and safety of biologics in pediatric inflammatory boweldisease: Real-life data from the Sicilian Network.
Adalimumab
/ therapeutic use
Adolescent
Anti-Inflammatory Agents
/ therapeutic use
Antibodies, Monoclonal
/ therapeutic use
Biological Products
/ therapeutic use
Child
Colitis, Ulcerative
/ drug therapy
Crohn Disease
/ drug therapy
Female
Gastrointestinal Agents
/ therapeutic use
Humans
Infliximab
/ therapeutic use
Male
Retrospective Studies
Sicily
Treatment Outcome
Biologics
Child
Efficacy
Inflammatory bowel disease
Safety
Journal
Clinics and research in hepatology and gastroenterology
ISSN: 2210-741X
Titre abrégé: Clin Res Hepatol Gastroenterol
Pays: France
ID NLM: 101553659
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
12
02
2019
revised:
07
05
2019
accepted:
09
05
2019
pubmed:
18
6
2019
medline:
23
7
2021
entrez:
18
6
2019
Statut:
ppublish
Résumé
Biological therapies have modified the disease course of pediatric inflammatory bowel disease (IBD) and are routinely used in clinical practice. Our observational study aims to evaluate effectiveness and safety of biologics in IBD. Clinical benefit and safety data of 93 children with IBD, receiving biologics (Infliximab - IFX, Adalimumab - ADA, Golimumab - GOL) from January 2013 to December 2017, were extracted from the cohort of the Sicilian Network of IBD. Among 87 children aged 7-17 years (63 Crohn's disease [CD], 24 Ulcerative colitis [UC]), 101 out of 108 biologic treatments were considered. Evaluation of 74 biologic treatments in CD patients at 26, 52, 104 weeks showed clinical benefit rates of 84.2%, 93.3%, 66.7% with IFX (n= 38) and 88.9%, 84.4%, 65.2% with ADA (n= 36). Biologic treatments (n=27) evaluated in the UC group at 26, 52, 104 weeks, led to clinical benefit rates of 85.7%, 83.3%, 50% in IFX subgroup (n=21) and 40%, 50%, 33% in the ADA subgroup (n=5), respectively. One patient treated with GOL showed 100% clinical benefit at 26 and 52 weeks. Overall adverse events (AEs) rate was 9.25%. Six younger children, <6 years, receiving 8 treatments (4 ADA, 4 IFX) presented a clinical remission rate of 75% at 12 weeks and 25% at 52 weeks. AEs rate was 25% in this group. Our data show that biologic therapy in children, even at a younger age, is effective in allowing long-term remission with a good safety profile.
Sections du résumé
BACKGROUND
Biological therapies have modified the disease course of pediatric inflammatory bowel disease (IBD) and are routinely used in clinical practice. Our observational study aims to evaluate effectiveness and safety of biologics in IBD.
METHOD
Clinical benefit and safety data of 93 children with IBD, receiving biologics (Infliximab - IFX, Adalimumab - ADA, Golimumab - GOL) from January 2013 to December 2017, were extracted from the cohort of the Sicilian Network of IBD.
RESULTS
Among 87 children aged 7-17 years (63 Crohn's disease [CD], 24 Ulcerative colitis [UC]), 101 out of 108 biologic treatments were considered. Evaluation of 74 biologic treatments in CD patients at 26, 52, 104 weeks showed clinical benefit rates of 84.2%, 93.3%, 66.7% with IFX (n= 38) and 88.9%, 84.4%, 65.2% with ADA (n= 36). Biologic treatments (n=27) evaluated in the UC group at 26, 52, 104 weeks, led to clinical benefit rates of 85.7%, 83.3%, 50% in IFX subgroup (n=21) and 40%, 50%, 33% in the ADA subgroup (n=5), respectively. One patient treated with GOL showed 100% clinical benefit at 26 and 52 weeks. Overall adverse events (AEs) rate was 9.25%. Six younger children, <6 years, receiving 8 treatments (4 ADA, 4 IFX) presented a clinical remission rate of 75% at 12 weeks and 25% at 52 weeks. AEs rate was 25% in this group.
CONCLUSION
Our data show that biologic therapy in children, even at a younger age, is effective in allowing long-term remission with a good safety profile.
Identifiants
pubmed: 31204314
pii: S2210-7401(19)30105-6
doi: 10.1016/j.clinre.2019.05.008
pii:
doi:
Substances chimiques
Anti-Inflammatory Agents
0
Antibodies, Monoclonal
0
Biological Products
0
Gastrointestinal Agents
0
golimumab
91X1KLU43E
Infliximab
B72HH48FLU
Adalimumab
FYS6T7F842
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
223-229Informations de copyright
Copyright © 2019 Elsevier Masson SAS. All rights reserved.