PMID- 31204314
OWN - NLM
STAT- MEDLINE
DCOM- 20210722
LR  - 20210722
IS  - 2210-741X (Electronic)
IS  - 2210-7401 (Linking)
VI  - 44
IP  - 2
DP  - 2020 Apr
TI  - Effectiveness and safety of biologics in pediatric inflammatory boweldisease: 
      Real-life data from the Sicilian Network.
PG  - 223-229
LID - S2210-7401(19)30105-6 [pii]
LID - 10.1016/j.clinre.2019.05.008 [doi]
AB  - 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.
CI  - Copyright (c) 2019 Elsevier Masson SAS. All rights reserved.
FAU - Romeo, Anna Claudia
AU  - Romeo AC
AD  - Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human 
      Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Via 
      Consolare Valeria 1, 98124 Messina, Italy.
FAU - Ventimiglia, Marco
AU  - Ventimiglia M
AD  - Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human 
      Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Via 
      Consolare Valeria 1, 98124 Messina, Italy.
FAU - Dipasquale, Valeria
AU  - Dipasquale V
AD  - Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human 
      Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Via 
      Consolare Valeria 1, 98124 Messina, Italy.
FAU - Orlando, Ambrogio
AU  - Orlando A
AD  - Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human 
      Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Via 
      Consolare Valeria 1, 98124 Messina, Italy.
FAU - Citrano, Michele
AU  - Citrano M
AD  - Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human 
      Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Via 
      Consolare Valeria 1, 98124 Messina, Italy.
FAU - Pellegrino, Salvatore
AU  - Pellegrino S
AD  - Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human 
      Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Via 
      Consolare Valeria 1, 98124 Messina, Italy.
FAU - Accomando, Salvatore
AU  - Accomando S
AD  - Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human 
      Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Via 
      Consolare Valeria 1, 98124 Messina, Italy.
FAU - Cottone, Mario
AU  - Cottone M
AD  - Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human 
      Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Via 
      Consolare Valeria 1, 98124 Messina, Italy.
FAU - Romano, Claudio
AU  - Romano C
AD  - Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human 
      Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Via 
      Consolare Valeria 1, 98124 Messina, Italy. Electronic address: romanoc@unime.it.
LA  - eng
PT  - Journal Article
DEP - 20190614
PL  - France
TA  - Clin Res Hepatol Gastroenterol
JT  - Clinics and research in hepatology and gastroenterology
JID - 101553659
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Biological Products)
RN  - 0 (Gastrointestinal Agents)
RN  - 91X1KLU43E (golimumab)
RN  - B72HH48FLU (Infliximab)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
MH  - Adalimumab/*therapeutic use
MH  - Adolescent
MH  - Anti-Inflammatory Agents/*therapeutic use
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Biological Products/*therapeutic use
MH  - Child
MH  - Colitis, Ulcerative/*drug therapy
MH  - Crohn Disease/*drug therapy
MH  - Female
MH  - Gastrointestinal Agents/*therapeutic use
MH  - Humans
MH  - Infliximab/*therapeutic use
MH  - Male
MH  - Retrospective Studies
MH  - Sicily
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Biologics
OT  - Child
OT  - Efficacy
OT  - Inflammatory bowel disease
OT  - Safety
EDAT- 2019/06/18 06:00
MHDA- 2021/07/23 06:00
CRDT- 2019/06/18 06:00
PHST- 2019/02/12 00:00 [received]
PHST- 2019/05/07 00:00 [revised]
PHST- 2019/05/09 00:00 [accepted]
PHST- 2019/06/18 06:00 [pubmed]
PHST- 2021/07/23 06:00 [medline]
PHST- 2019/06/18 06:00 [entrez]
AID - S2210-7401(19)30105-6 [pii]
AID - 10.1016/j.clinre.2019.05.008 [doi]
PST - ppublish
SO  - Clin Res Hepatol Gastroenterol. 2020 Apr;44(2):223-229. doi: 
      10.1016/j.clinre.2019.05.008. Epub 2019 Jun 14.