PMID- 34523800
OWN - NLM
STAT- MEDLINE
DCOM- 20220303
LR  - 20220303
IS  - 1752-8062 (Electronic)
IS  - 1752-8054 (Print)
IS  - 1752-8054 (Linking)
VI  - 15
IP  - 1
DP  - 2022 Jan
TI  - Safety and clinical efficacy of the double switch from originator infliximab to 
      biosimilars CT-P13 and SB2 in patients with inflammatory bowel diseases 
      (SCESICS): A multicenter cohort study.
PG  - 172-181
LID - 10.1111/cts.13131 [doi]
AB  - Data regarding double switching from originator infliximab (IFX) to IFX 
      biosimilars in inflammatory bowel diseases (IBDs) are lacking. The purpose of 
      this study was to evaluate the safety and efficacy of switching from originator 
      IFX to CT-P13 and subsequently to SB2 (double switch) in patients with IBD. 
      Patients undergoing IFX-double switch in eight Centers in Lombardy (Italy) from 
      November 2018 to May 2019 were retrospectively analyzed. The IFX discontinuation 
      rate, incidence and type of adverse events (AEs), and clinical remission rate 
      were recorded. A comparison with a control group of patients with IBD 
      single-switched from originator IFX to CT-P13 was performed, before and after an 
      inverse probability of treatment weighting (IPTW)-based propensity score 
      analysis. Fifty-two double-switched patients with IBD were enrolled. The 24- and 
      52-week proportions of patients continuing on IFX therapy following the second 
      switch (CTP13 --> SB2) were 98% (95% confidence interval [CI] 94%-100%) and 90% 
      (95% CI 81%-99%), respectively. Four patients experienced a total of five AEs, 
      all graded 1-3 according to Common Terminology Criteria for Adverse Events 
      (CTCAE). No infusion reactions were observed. The 24-week and follow-up end 
      clinical remission rates following the second switch were 94% and 88%, 
      respectively. No differences were observed in the safety and efficacy outcomes by 
      comparing the double-switch group with a single-switch group of 66 patients with 
      IBD; all these results were confirmed by IPTW-adjusted analysis. The study 
      suggests both the safety and efficacy of the double switch from originator IFX to 
      CT-P13 and SB2 in patients with IBD is maintained. This strategy may be 
      associated with potential cost implications.
CI  - (c) 2021 The Authors. Clinical and Translational Science published by Wiley 
      Periodicals LLC on behalf of American Society for Clinical Pharmacology and 
      Therapeutics.
FAU - Mazza, Stefano
AU  - Mazza S
AD  - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and 
      Endoscopy Unit, Milan, Italy.
FAU - Piazza O Sed, Nicole
AU  - Piazza O Sed N
AD  - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and 
      Endoscopy Unit, Milan, Italy.
FAU - Conforti, Francesco Simone
AU  - Conforti FS
AD  - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and 
      Endoscopy Unit, Milan, Italy.
FAU - Fasci, Alberto
AU  - Fasci A
AD  - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and 
      Endoscopy Unit, Milan, Italy.
AD  - Department of Pathophysiology and Transplantation, Universita degli Studi di 
      Milano, Milan, Italy.
FAU - Rimondi, Alessandro
AU  - Rimondi A
AD  - Department of Pathophysiology and Transplantation, Universita degli Studi di 
      Milano, Milan, Italy.
FAU - Marinoni, Beatrice
AU  - Marinoni B
AD  - Department of Pathophysiology and Transplantation, Universita degli Studi di 
      Milano, Milan, Italy.
FAU - Casini, Valentina
AU  - Casini V
AD  - Gastroenterology Unit, Bolognini Hospital, Bergamo, Italy.
FAU - Ricci, Chiara
AU  - Ricci C
AD  - Department of Clinical and Experimental Sciences, University of Brescia, Spedali 
      Civili, Brescia, Italy.
FAU - Munari, Francesca
AU  - Munari F
AD  - Gastroenterology Unit, Bolognini Hospital, Bergamo, Italy.
FAU - Pirola, Lorena
AU  - Pirola L
AD  - Division of Gastroenterology and Center for Autoimmune Liver Diseases, Department 
      of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.
AD  - European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San 
      Gerardo Hospital, Monza, Italy.
FAU - Invernizzi, Pietro
AU  - Invernizzi P
AD  - Division of Gastroenterology and Center for Autoimmune Liver Diseases, Department 
      of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.
AD  - European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San 
      Gerardo Hospital, Monza, Italy.
FAU - Girelli, Carlo
AU  - Girelli C
AD  - Gastroenterology and Digestive Endoscopy Unit, Busto Arsizio Hospital, Varese, 
      Italy.
FAU - Lupinacci, Guido
AU  - Lupinacci G
AD  - Gastroenterology and Endoscopy Unit, Ospedale Maggiore, Crema, Italy.
FAU - Pastorelli, Luca
AU  - Pastorelli L
AD  - Gastroenterology and Liver Unit, ASST Santi Paolo e Carlo, Ospedale San Paolo 
      Milan, Italy.
AD  - Department of Health Sciences, Univerista degli Studi di Milano, Milan, Italy.
FAU - Cavallaro, Flaminia
AU  - Cavallaro F
AD  - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and 
      Endoscopy Unit, Milan, Italy.
FAU - Ferraris, Luca
AU  - Ferraris L
AD  - Gastroenterology and Endoscopy Unit, Gallarate Hospital, Varese, Italy.
FAU - Colucci, Alice
AU  - Colucci A
AD  - Gastroenterology and Endoscopy Unit, Gallarate Hospital, Varese, Italy.
FAU - Amato, Arnaldo
AU  - Amato A
AD  - Gastroenterology and Digestive Endoscopy Unit, Valduce Hospital, Como, Italy.
FAU - Eugenio Tontini, Gian
AU  - Eugenio Tontini G
AD  - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and 
      Endoscopy Unit, Milan, Italy.
AD  - Department of Pathophysiology and Transplantation, Universita degli Studi di 
      Milano, Milan, Italy.
FAU - Vecchi, Maurizio
AU  - Vecchi M
AD  - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and 
      Endoscopy Unit, Milan, Italy.
AD  - Department of Pathophysiology and Transplantation, Universita degli Studi di 
      Milano, Milan, Italy.
FAU - Fiorino, Gionata
AU  - Fiorino G
AD  - IBD Center, Humanitas Clinical and Research Center, Milan, Italy.
AD  - Department of Biomedical Sciences, Humanitas University, Milan, Italy.
FAU - Caprioli, Flavio
AU  - Caprioli F
AD  - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and 
      Endoscopy Unit, Milan, Italy.
AD  - Department of Pathophysiology and Transplantation, Universita degli Studi di 
      Milano, Milan, Italy.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20210915
PL  - United States
TA  - Clin Transl Sci
JT  - Clinical and translational science
JID - 101474067
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (CT-P13)
RN  - 0 (SB2 infliximab)
RN  - B72HH48FLU (Infliximab)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Monoclonal/*pharmacology/*therapeutic use
MH  - Biosimilar Pharmaceuticals/*pharmacology/*therapeutic use
MH  - Cohort Studies
MH  - *Drug Substitution
MH  - Female
MH  - Humans
MH  - Inflammatory Bowel Diseases/*drug therapy
MH  - Infliximab/*pharmacology/*therapeutic use
MH  - Male
MH  - *Treatment Outcome
MH  - Young Adult
PMC - PMC8742653
COIS- The authors declared no competing interests for this work.
EDAT- 2021/09/16 06:00
MHDA- 2022/03/04 06:00
PMCR- 2022/01/01
CRDT- 2021/09/15 09:12
PHST- 2021/06/17 00:00 [revised]
PHST- 2021/05/17 00:00 [received]
PHST- 2021/07/19 00:00 [accepted]
PHST- 2021/09/16 06:00 [pubmed]
PHST- 2022/03/04 06:00 [medline]
PHST- 2021/09/15 09:12 [entrez]
PHST- 2022/01/01 00:00 [pmc-release]
AID - CTS13131 [pii]
AID - 10.1111/cts.13131 [doi]
PST - ppublish
SO  - Clin Transl Sci. 2022 Jan;15(1):172-181. doi: 10.1111/cts.13131. Epub 2021 Sep 
      15.