PMID- 37419726
OWN - NLM
STAT- MEDLINE
DCOM- 20231229
LR  - 20240106
IS  - 1878-3562 (Electronic)
IS  - 1590-8658 (Linking)
VI  - 56
IP  - 1
DP  - 2024 Jan
TI  - Clinical efficacy and nocebo effect following non-medical biosimilar switch in 
      patients with inflammatory bowel disease: A prospective observational study.
PG  - 35-42
LID - S1590-8658(23)00720-X [pii]
LID - 10.1016/j.dld.2023.06.022 [doi]
AB  - BACKGROUND: We aimed to evaluate clinical efficacy, biomarker activity, 
      therapeutic drug monitoring (TDM), adverse events (AEs), and nocebo effect in 
      inflammatory bowel disease (IBD) patients who underwent non-medical biosimilar 
      switching. METHODS: A prospective observational study of consecutive IBD patients 
      who underwent biosimilar switch. Disease activity, biomarkers, TDM, and AEs, 
      including the nocebo effect were captured 8 weeks before switch, at the time of 
      switch (baseline),12 and 24 weeks after the switch. RESULTS: 210 patients were 
      included [81.4% had Crohn's disease (CD), the median age at inclusion: 42 years 
      (IQR 29-61)]. There was no significant difference in the rates of clinical 
      remission at week 8 before switch, baseline, week12, and 24 after switch: 
      89.0%,93.4%,86.3%,and 90.8%,p = 0.129. The biomarker remission rates were not 
      significantly different; CRP:81.3%,74.7%,81.2%,73.0%,p = 0.343; fecal 
      calprotectin: 78.3%,74.5%,71.7%,76.3%,p = 0.829. The rates of maintaining 
      therapeutic levels (84.7%,83.9%,83.0%,85.3%,p = 0.597) and prevalence of positive 
      anti-drug antibodies remained unchanged. Drug persistence at 12 week of switch 
      was 97.1%, regardless of disease phenotype and originator. The nocebo effect was 
      observed in 13.3%. The discontinuation rate was 4.8%. CONCLUSION: Despite a 
      significant number of early nocebo complaints within the first 6 months after the 
      biosimilar switch, no significant changes were found in clinical efficacy, 
      biomarkers, therapeutic drug level, or anti-drug antibodies.
CI  - Copyright (c) 2023 Editrice Gastroenterologica Italiana S.r.l. Published by 
      Elsevier Ltd. All rights reserved.
FAU - Wetwittayakhlang, Panu
AU  - Wetwittayakhlang P
AD  - Division of Gastroenterology and Hepatology, McGill University Health Centre, 
      Montreal, QC H3G 1A4, Canada; Gastroenterology and Hepatology Unit, Division of 
      Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, 
      Songkhla 90110, Thailand.
FAU - Karkout, Khaled
AU  - Karkout K
AD  - Division of Internal Medicine McGill University Health Centre, Montreal, Quebec 
      H3G 1A4, Canada.
FAU - Wongcha-Um, Arti
AU  - Wongcha-Um A
AD  - Division of Gastroenterology and Hepatology, McGill University Health Centre, 
      Montreal, QC H3G 1A4, Canada.
FAU - Tselekouni, Paraskevi
AU  - Tselekouni P
AD  - Division of Gastroenterology and Hepatology, McGill University Health Centre, 
      Montreal, QC H3G 1A4, Canada.
FAU - Al-Jabri, Reem
AU  - Al-Jabri R
AD  - Division of Gastroenterology and Hepatology, McGill University Health Centre, 
      Montreal, QC H3G 1A4, Canada.
FAU - Afif, Waqqas
AU  - Afif W
AD  - Division of Gastroenterology and Hepatology, McGill University Health Centre, 
      Montreal, QC H3G 1A4, Canada.
FAU - Wild, Gary
AU  - Wild G
AD  - Division of Gastroenterology and Hepatology, McGill University Health Centre, 
      Montreal, QC H3G 1A4, Canada.
FAU - Bitton, Alain
AU  - Bitton A
AD  - Division of Gastroenterology and Hepatology, McGill University Health Centre, 
      Montreal, QC H3G 1A4, Canada.
FAU - Bessissow, Talat
AU  - Bessissow T
AD  - Division of Gastroenterology and Hepatology, McGill University Health Centre, 
      Montreal, QC H3G 1A4, Canada.
FAU - Lakatos, Peter L
AU  - Lakatos PL
AD  - Division of Gastroenterology and Hepatology, McGill University Health Centre, 
      Montreal, QC H3G 1A4, Canada; Department of Internal Medicine and Oncology, 
      Semmelweis University, Budapest H-1085, Hungary. Electronic address: 
      Peter.Lakatos@muhc.mcgill.ca.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20230705
PL  - Netherlands
TA  - Dig Liver Dis
JT  - Digestive and liver disease : official journal of the Italian Society of 
      Gastroenterology and the Italian Association for the Study of the Liver
JID - 100958385
RN  - B72HH48FLU (Infliximab)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (Gastrointestinal Agents)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Biomarkers)
SB  - IM
MH  - Humans
MH  - Adult
MH  - Middle Aged
MH  - Infliximab/therapeutic use
MH  - *Biosimilar Pharmaceuticals/therapeutic use
MH  - Nocebo Effect
MH  - Gastrointestinal Agents/therapeutic use
MH  - Antibodies, Monoclonal/therapeutic use
MH  - Drug Substitution
MH  - *Inflammatory Bowel Diseases/drug therapy
MH  - Treatment Outcome
MH  - Biomarkers
OTO - NOTNLM
OT  - Anti-tumor necrosis factor
OT  - Biosimilar
OT  - Efficacy
OT  - Inflammatory bowel disease
OT  - Nocebo
EDAT- 2023/07/08 10:42
MHDA- 2023/12/29 06:43
CRDT- 2023/07/07 21:59
PHST- 2023/05/10 00:00 [received]
PHST- 2023/06/04 00:00 [revised]
PHST- 2023/06/20 00:00 [accepted]
PHST- 2023/12/29 06:43 [medline]
PHST- 2023/07/08 10:42 [pubmed]
PHST- 2023/07/07 21:59 [entrez]
AID - S1590-8658(23)00720-X [pii]
AID - 10.1016/j.dld.2023.06.022 [doi]
PST - ppublish
SO  - Dig Liver Dis. 2024 Jan;56(1):35-42. doi: 10.1016/j.dld.2023.06.022. Epub 2023 
      Jul 5.