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Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease

Bergqvist, Viktoria LU ; Kadivar, Mohammad LU ; Molin, Daniel; Angelison, Leif LU ; Hammarlund, Per; Olin, Marie LU ; Torp, Jörgen; Grip, Olof LU ; Nilson, Stefan and Hertervig, Erik LU , et al. (2018) In Therapeutic Advances in Gastroenterology 11.
Abstract

Background: As the patents of originator biologics are expiring, biosimilar versions are becoming available for the treatment of inflammatory bowel disease (IBD). However, published switch studies of the first infliximab biosimilar, CT-P13, have delivered ambiguous results that could be interpreted as showing a trend towards inferior effectiveness in Crohn’s disease (CD) compared with ulcerative colitis (UC). The aim of this study was to investigate the effectiveness and safety of switching IBD patients from treatment with Remicade to CT-P13. Methods: In this prospective observational cohort study, all adult IBD patients on Remicade treatment, at four hospitals, were switched to CT-P13. The primary endpoint was change in clinical... (More)

Background: As the patents of originator biologics are expiring, biosimilar versions are becoming available for the treatment of inflammatory bowel disease (IBD). However, published switch studies of the first infliximab biosimilar, CT-P13, have delivered ambiguous results that could be interpreted as showing a trend towards inferior effectiveness in Crohn’s disease (CD) compared with ulcerative colitis (UC). The aim of this study was to investigate the effectiveness and safety of switching IBD patients from treatment with Remicade to CT-P13. Methods: In this prospective observational cohort study, all adult IBD patients on Remicade treatment, at four hospitals, were switched to CT-P13. The primary endpoint was change in clinical disease activity at 2, 6, and 12 months after the switch. Secondary endpoints were subgroup analyses of patients with and without concomitant immunomodulators; changes in biomarkers, quality of life, drug trough levels and anti-drug antibodies (ADAbs); and adverse events. Results: A total of 313 IBD patients were switched (195 CD; 118 UC). There were no significant changes in clinical disease activity, quality of life, biomarkers (except a small but significant increase in albumin in CD) including F-calprotectin, drug trough levels, or proportion of patients in remission. Disease worsening rates were 14.0% for CD and 13.8% for UC; and 2.7% developed ADAbs and 2.2% developed serious adverse events. Conclusions: This is the largest study of switched IBD patients published to date, and it demonstrates that switching from Remicade to CT-P13 may be done with preserved therapeutic effectiveness and safety in both CD and UC.

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publication status
published
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keywords
biosimilar, Crohn’s disease, infliximab, switch, ulcerative colitis
in
Therapeutic Advances in Gastroenterology
volume
11
publisher
SAGE Publications Inc.
external identifiers
  • scopus:85054813502
ISSN
1756-283X
DOI
10.1177/1756284818801244
language
English
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yes
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c717548b-f6ac-4333-a552-25f8fb2809fa
date added to LUP
2018-11-08 09:45:46
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2019-03-17 05:10:15
@article{c717548b-f6ac-4333-a552-25f8fb2809fa,
  abstract     = {<p>Background: As the patents of originator biologics are expiring, biosimilar versions are becoming available for the treatment of inflammatory bowel disease (IBD). However, published switch studies of the first infliximab biosimilar, CT-P13, have delivered ambiguous results that could be interpreted as showing a trend towards inferior effectiveness in Crohn’s disease (CD) compared with ulcerative colitis (UC). The aim of this study was to investigate the effectiveness and safety of switching IBD patients from treatment with Remicade to CT-P13. Methods: In this prospective observational cohort study, all adult IBD patients on Remicade treatment, at four hospitals, were switched to CT-P13. The primary endpoint was change in clinical disease activity at 2, 6, and 12 months after the switch. Secondary endpoints were subgroup analyses of patients with and without concomitant immunomodulators; changes in biomarkers, quality of life, drug trough levels and anti-drug antibodies (ADAbs); and adverse events. Results: A total of 313 IBD patients were switched (195 CD; 118 UC). There were no significant changes in clinical disease activity, quality of life, biomarkers (except a small but significant increase in albumin in CD) including F-calprotectin, drug trough levels, or proportion of patients in remission. Disease worsening rates were 14.0% for CD and 13.8% for UC; and 2.7% developed ADAbs and 2.2% developed serious adverse events. Conclusions: This is the largest study of switched IBD patients published to date, and it demonstrates that switching from Remicade to CT-P13 may be done with preserved therapeutic effectiveness and safety in both CD and UC.</p>},
  articleno    = {175628481880124},
  author       = {Bergqvist, Viktoria and Kadivar, Mohammad and Molin, Daniel and Angelison, Leif and Hammarlund, Per and Olin, Marie and Torp, Jörgen and Grip, Olof and Nilson, Stefan and Hertervig, Erik and Lillienau, Jan and Marsal, Jan},
  issn         = {1756-283X},
  keyword      = {biosimilar,Crohn’s disease,infliximab,switch,ulcerative colitis},
  language     = {eng},
  month        = {10},
  publisher    = {SAGE Publications Inc.},
  series       = {Therapeutic Advances in Gastroenterology},
  title        = {Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease},
  url          = {http://dx.doi.org/10.1177/1756284818801244},
  volume       = {11},
  year         = {2018},
}