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Real-world outcomes associated with switching to anti-TNFs versus other biologics in Crohn’s Disease patients: A retrospective analysis using German claims data

BACKGROUND: The positioning of new biologic agents for the treatment of Crohn’s disease (CD) following failure of initial anti-tumor necrosis factor (anti-TNF) therapy remains a challenge in the real world. OBJECTIVES: This study aims to investigate the real-world outcomes associated with the sequen...

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Autores principales: Zhuleku, Evi, Antolin-Fontes, Beatriz, Borsi, Andras, Nissinen, Riikka, Bravatà, Ivana, Barthelmes, Jennifer Norma, Le Bars, Manuela, Lee, Jennifer, Passey, Alun, Maywald, Ulf, Deiters, Barthold, Bokemeyer, Bernd, Wilke, Thomas, Ghiani, Marco
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9638528/
https://www.ncbi.nlm.nih.gov/pubmed/36353736
http://dx.doi.org/10.1177/17562848221130554
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author Zhuleku, Evi
Antolin-Fontes, Beatriz
Borsi, Andras
Nissinen, Riikka
Bravatà, Ivana
Barthelmes, Jennifer Norma
Le Bars, Manuela
Lee, Jennifer
Passey, Alun
Maywald, Ulf
Deiters, Barthold
Bokemeyer, Bernd
Wilke, Thomas
Ghiani, Marco
author_facet Zhuleku, Evi
Antolin-Fontes, Beatriz
Borsi, Andras
Nissinen, Riikka
Bravatà, Ivana
Barthelmes, Jennifer Norma
Le Bars, Manuela
Lee, Jennifer
Passey, Alun
Maywald, Ulf
Deiters, Barthold
Bokemeyer, Bernd
Wilke, Thomas
Ghiani, Marco
author_sort Zhuleku, Evi
collection PubMed
description BACKGROUND: The positioning of new biologic agents for the treatment of Crohn’s disease (CD) following failure of initial anti-tumor necrosis factor (anti-TNF) therapy remains a challenge in the real world. OBJECTIVES: This study aims to investigate the real-world outcomes associated with the sequential use of biologics in CD patients that newly initiate anti-TNFs, specifically comparing those that switch to another anti-TNF versus biologics with other modes of action. DESIGN: Retrospective cohort study. METHODS: We identified CD patients who newly began anti-TNF therapy between 1 October 2014 and 31 December 2018 using two German claims databases. Patients were classified as within-class switchers (WCS) if they switched to another anti-TNF or outside-class switchers (OCS) if they switched to vedolizumab (VDZ) or ustekinumab (UST). To compare WCS and OCS, baseline covariates were adjusted through inverse probability of treatment weighting (IPTW), and time-to-event analyses were performed using Cox Proportional Hazard regressions. Results from both databases were meta-analyzed using an inverse variance model. RESULTS: Overall, 376 prevalent adult CD patients who initiated anti-TNFs and switched to another biologic were identified. After IPTW, there were 152 and 177 patients in the WCS and OCS group, respectively. WCS were more likely to receive prolonged corticosteroid therapy [hazard ratio (HR): 1.63, 95% confidence interval (CI): 1.17–2.27, p = 0.004], switch a second time to a different biologic (HR: 2.44, 95% CI: 1.63–3.66, p < 0.001), and discontinue treatment (HR: 1.71, 95% CI: 1.25–2.34, p = 0.001) than OCS. CONCLUSION: This study suggests that CD patients exhibit more favorable outcomes when switching outside the anti-TNF class to VDZ or UST after initial anti-TNF failure than switching to a second anti-TNF. With loss of response to anti-TNFs as a concern in the real world, comparative evidence from claims data assessing sequential use of biologics can help optimize treatment algorithms of patients after anti-TNF failure.
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spelling pubmed-96385282022-11-08 Real-world outcomes associated with switching to anti-TNFs versus other biologics in Crohn’s Disease patients: A retrospective analysis using German claims data Zhuleku, Evi Antolin-Fontes, Beatriz Borsi, Andras Nissinen, Riikka Bravatà, Ivana Barthelmes, Jennifer Norma Le Bars, Manuela Lee, Jennifer Passey, Alun Maywald, Ulf Deiters, Barthold Bokemeyer, Bernd Wilke, Thomas Ghiani, Marco Therap Adv Gastroenterol Original Research BACKGROUND: The positioning of new biologic agents for the treatment of Crohn’s disease (CD) following failure of initial anti-tumor necrosis factor (anti-TNF) therapy remains a challenge in the real world. OBJECTIVES: This study aims to investigate the real-world outcomes associated with the sequential use of biologics in CD patients that newly initiate anti-TNFs, specifically comparing those that switch to another anti-TNF versus biologics with other modes of action. DESIGN: Retrospective cohort study. METHODS: We identified CD patients who newly began anti-TNF therapy between 1 October 2014 and 31 December 2018 using two German claims databases. Patients were classified as within-class switchers (WCS) if they switched to another anti-TNF or outside-class switchers (OCS) if they switched to vedolizumab (VDZ) or ustekinumab (UST). To compare WCS and OCS, baseline covariates were adjusted through inverse probability of treatment weighting (IPTW), and time-to-event analyses were performed using Cox Proportional Hazard regressions. Results from both databases were meta-analyzed using an inverse variance model. RESULTS: Overall, 376 prevalent adult CD patients who initiated anti-TNFs and switched to another biologic were identified. After IPTW, there were 152 and 177 patients in the WCS and OCS group, respectively. WCS were more likely to receive prolonged corticosteroid therapy [hazard ratio (HR): 1.63, 95% confidence interval (CI): 1.17–2.27, p = 0.004], switch a second time to a different biologic (HR: 2.44, 95% CI: 1.63–3.66, p < 0.001), and discontinue treatment (HR: 1.71, 95% CI: 1.25–2.34, p = 0.001) than OCS. CONCLUSION: This study suggests that CD patients exhibit more favorable outcomes when switching outside the anti-TNF class to VDZ or UST after initial anti-TNF failure than switching to a second anti-TNF. With loss of response to anti-TNFs as a concern in the real world, comparative evidence from claims data assessing sequential use of biologics can help optimize treatment algorithms of patients after anti-TNF failure. SAGE Publications 2022-11-04 /pmc/articles/PMC9638528/ /pubmed/36353736 http://dx.doi.org/10.1177/17562848221130554 Text en © The Author(s), 2022 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Research
Zhuleku, Evi
Antolin-Fontes, Beatriz
Borsi, Andras
Nissinen, Riikka
Bravatà, Ivana
Barthelmes, Jennifer Norma
Le Bars, Manuela
Lee, Jennifer
Passey, Alun
Maywald, Ulf
Deiters, Barthold
Bokemeyer, Bernd
Wilke, Thomas
Ghiani, Marco
Real-world outcomes associated with switching to anti-TNFs versus other biologics in Crohn’s Disease patients: A retrospective analysis using German claims data
title Real-world outcomes associated with switching to anti-TNFs versus other biologics in Crohn’s Disease patients: A retrospective analysis using German claims data
title_full Real-world outcomes associated with switching to anti-TNFs versus other biologics in Crohn’s Disease patients: A retrospective analysis using German claims data
title_fullStr Real-world outcomes associated with switching to anti-TNFs versus other biologics in Crohn’s Disease patients: A retrospective analysis using German claims data
title_full_unstemmed Real-world outcomes associated with switching to anti-TNFs versus other biologics in Crohn’s Disease patients: A retrospective analysis using German claims data
title_short Real-world outcomes associated with switching to anti-TNFs versus other biologics in Crohn’s Disease patients: A retrospective analysis using German claims data
title_sort real-world outcomes associated with switching to anti-tnfs versus other biologics in crohn’s disease patients: a retrospective analysis using german claims data
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9638528/
https://www.ncbi.nlm.nih.gov/pubmed/36353736
http://dx.doi.org/10.1177/17562848221130554
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