PMID- 32743840
OWN - NLM
STAT- MEDLINE
DCOM- 20210901
LR  - 20210901
IS  - 1365-2710 (Electronic)
IS  - 0269-4727 (Linking)
VI  - 45
IP  - 6
DP  - 2020 Dec
TI  - Biosimilar infliximab in paediatric inflammatory bowel disease: Efficacy, 
      immunogenicity and safety.
PG  - 1228-1234
LID - 10.1111/jcpt.13239 [doi]
AB  - WHAT IS KNOWN AND OBJECTIVE: Based on extrapolation, biosimilar infliximab (IFX) 
      was approved to treat inflammatory bowel disease (IBD). The first studies in 
      adults have shown similar efficacy and safety in comparison with reference drug. 
      The aim of this review was to collect and evaluate all the literature data 
      regarding the use of biosimilar IFX in paediatric IBD. METHODS: This article 
      reviewed efficacy, immunogenicity and safety profile of biosimilar IFX in IBD 
      paediatric patients through a comprehensive search of the published literature. 
      RESULTS AND DISCUSSION: Eight papers were extracted and critically reviewed. Four 
      paediatric studies (prospective, n = 3; retrospective, n = 1) assessed the 
      induction efficacy of the biosimilar IFX. Clinical response and remission rates 
      reported were 86%-90% and 67%-68%, respectively. No significant difference in 
      clinical response and remission rates between the reference and biosimilar IFX 
      groups was found at follow-up (range: 3-13 months). Similar findings were shown 
      in the prospective studies (n = 4) conducted on patients elected to switch from 
      reference IFX to its biosimilar. The most frequently reported adverse events 
      (AEs) of biosimilar IFX were mild upper respiratory tract infections. Taking into 
      account of all AEs coming from published data, biosimilar IFX seems to be as safe 
      as its originator. Immunogenicity has not been significantly impacted by the 
      switch from the reference drug. WHAT IS NEW AND CONCLUSION: To date, treatment 
      with (or switch to) biosimilar IFX in paediatric patients with IBD have been 
      successful, without affecting efficacy, immunogenicity or safety. However, 
      further studies are warranted, including clinical trials and pharmacovigilance 
      studies.
CI  - (c) 2020 John Wiley & Sons Ltd.
FAU - Dipasquale, Valeria
AU  - Dipasquale V
AD  - Unit of Pediatric Gastroenterology and Cystic Fibrosis, Department of Human 
      Pathology in Adulthood and Childhood 'G. Barresi', University of Messina, 
      Messina, Italy.
FAU - Romano, Claudio
AU  - Romano C
AUID- ORCID: 0000-0001-8827-2091
AD  - Unit of Pediatric Gastroenterology and Cystic Fibrosis, Department of Human 
      Pathology in Adulthood and Childhood 'G. Barresi', University of Messina, 
      Messina, Italy.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Review
DEP - 20200802
PL  - England
TA  - J Clin Pharm Ther
JT  - Journal of clinical pharmacy and therapeutics
JID - 8704308
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (Gastrointestinal Agents)
RN  - B72HH48FLU (Infliximab)
SB  - IM
MH  - Biosimilar Pharmaceuticals/*administration & dosage/adverse effects
MH  - Child
MH  - Drug Substitution
MH  - Gastrointestinal Agents/administration & dosage/adverse effects
MH  - Humans
MH  - Inflammatory Bowel Diseases/*drug therapy
MH  - Infliximab/*administration & dosage/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - CT-P13
OT  - biosimilar
OT  - inflammatory bowel disease
OT  - paediatrics
EDAT- 2020/08/04 06:00
MHDA- 2021/09/02 06:00
CRDT- 2020/08/04 06:00
PHST- 2020/03/28 00:00 [received]
PHST- 2020/06/09 00:00 [revised]
PHST- 2020/06/28 00:00 [accepted]
PHST- 2020/08/04 06:00 [pubmed]
PHST- 2021/09/02 06:00 [medline]
PHST- 2020/08/04 06:00 [entrez]
AID - 10.1111/jcpt.13239 [doi]
PST - ppublish
SO  - J Clin Pharm Ther. 2020 Dec;45(6):1228-1234. doi: 10.1111/jcpt.13239. Epub 2020 
      Aug 2.