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Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated With Improved Effectiveness and Disease Outcomes

BACKGROUND: Vedolizumab effectiveness estimates immediately after Food and Drug Administration (FDA) approval for ulcerative colitis (UC) and Crohn’s disease (CD) are limited by use in refractory populations. We aimed to compare treatment patterns and outcomes of vedolizumab in 2 time frames after F...

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Autores principales: Koliani-Pace, Jenna L, Singh, Siddharth, Luo, Michelle, Hirten, Robert, Aniwan, Satimai, Kochhar, Gursimran, Chang, Shannon, Lukin, Dana, Gao, Youran, Bohm, Matthew, Swaminath, Arun, Gupta, Nitin, Shmidt, Eugenia, Meserve, Joseph, Winters, Adam, Chablaney, Shreya, Faleck, David M, Yang, Jiao, Huang, Zhongwen, Boland, Brigid S, Shashi, Preeti, Weiss, Aaron, Hudesman, David, Varma, Sashidhar, Fischer, Monika, Sultan, Keith, Shen, Bo, Kane, Sunanda, Loftus, Edward V, Sands, Bruce E, Colombel, Jean-Frederic, Sandborn, William J, Lasch, Karen, Siegel, Corey A, Dulai, Parambir S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6799947/
https://www.ncbi.nlm.nih.gov/pubmed/31050734
http://dx.doi.org/10.1093/ibd/izz071
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author Koliani-Pace, Jenna L
Singh, Siddharth
Luo, Michelle
Hirten, Robert
Aniwan, Satimai
Kochhar, Gursimran
Chang, Shannon
Lukin, Dana
Gao, Youran
Bohm, Matthew
Swaminath, Arun
Gupta, Nitin
Shmidt, Eugenia
Meserve, Joseph
Winters, Adam
Chablaney, Shreya
Faleck, David M
Yang, Jiao
Huang, Zhongwen
Boland, Brigid S
Shashi, Preeti
Weiss, Aaron
Hudesman, David
Varma, Sashidhar
Fischer, Monika
Sultan, Keith
Shen, Bo
Kane, Sunanda
Loftus, Edward V
Sands, Bruce E
Colombel, Jean-Frederic
Sandborn, William J
Lasch, Karen
Siegel, Corey A
Dulai, Parambir S
author_facet Koliani-Pace, Jenna L
Singh, Siddharth
Luo, Michelle
Hirten, Robert
Aniwan, Satimai
Kochhar, Gursimran
Chang, Shannon
Lukin, Dana
Gao, Youran
Bohm, Matthew
Swaminath, Arun
Gupta, Nitin
Shmidt, Eugenia
Meserve, Joseph
Winters, Adam
Chablaney, Shreya
Faleck, David M
Yang, Jiao
Huang, Zhongwen
Boland, Brigid S
Shashi, Preeti
Weiss, Aaron
Hudesman, David
Varma, Sashidhar
Fischer, Monika
Sultan, Keith
Shen, Bo
Kane, Sunanda
Loftus, Edward V
Sands, Bruce E
Colombel, Jean-Frederic
Sandborn, William J
Lasch, Karen
Siegel, Corey A
Dulai, Parambir S
author_sort Koliani-Pace, Jenna L
collection PubMed
description BACKGROUND: Vedolizumab effectiveness estimates immediately after Food and Drug Administration (FDA) approval for ulcerative colitis (UC) and Crohn’s disease (CD) are limited by use in refractory populations. We aimed to compare treatment patterns and outcomes of vedolizumab in 2 time frames after FDA approval. METHODS: We used 2 data sets for time trend analysis, an academic multicenter vedolizumab consortium (VICTORY) and the Truven MarketScan database, and 2 time periods, May 2014–June 2015 (Era 1) and July 2015–June 2017 (Era 2). VICTORY cumulative 12-month clinical remission, corticosteroid-free remission, and mucosal healing rates, and Truven 12-month hospitalization and surgery rates, were compared between Eras 1 and 2 using time-to-event analyses. RESULTS: A total of 3661 vedolizumab-treated patients were included (n = 1087 VICTORY, n = 2574 Truven). In both cohorts, CD and UC patients treated during Era 2 were more likely to be biologic naïve. Compared with Era 1, Era 2 CD patients in the VICTORY consortium had higher rates of clinical remission (31% vs 40%, P = 0.03) and mucosal healing (42% vs 58%, P < 0.01). These trends were not observed for UC. In the Truven database, UC patients treated during Era 2 had lower rates of inflammatory bowel disease–related hospitalization (22.4% vs 9.6%, P < 0.001) and surgery (17.2% vs 9.4%, P = 0.008), which was not observed for CD. CONCLUSION: Since FDA approval, remission and mucosal healing rates have increased for vedolizumab-treated CD patients, and vedolizumab-treated UC patients have had fewer hospitalizations and surgeries. This is likely due to differences between patient populations treated immediately after drug approval and those treated later.
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spelling pubmed-67999472019-10-24 Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated With Improved Effectiveness and Disease Outcomes Koliani-Pace, Jenna L Singh, Siddharth Luo, Michelle Hirten, Robert Aniwan, Satimai Kochhar, Gursimran Chang, Shannon Lukin, Dana Gao, Youran Bohm, Matthew Swaminath, Arun Gupta, Nitin Shmidt, Eugenia Meserve, Joseph Winters, Adam Chablaney, Shreya Faleck, David M Yang, Jiao Huang, Zhongwen Boland, Brigid S Shashi, Preeti Weiss, Aaron Hudesman, David Varma, Sashidhar Fischer, Monika Sultan, Keith Shen, Bo Kane, Sunanda Loftus, Edward V Sands, Bruce E Colombel, Jean-Frederic Sandborn, William J Lasch, Karen Siegel, Corey A Dulai, Parambir S Inflamm Bowel Dis Clinical Research BACKGROUND: Vedolizumab effectiveness estimates immediately after Food and Drug Administration (FDA) approval for ulcerative colitis (UC) and Crohn’s disease (CD) are limited by use in refractory populations. We aimed to compare treatment patterns and outcomes of vedolizumab in 2 time frames after FDA approval. METHODS: We used 2 data sets for time trend analysis, an academic multicenter vedolizumab consortium (VICTORY) and the Truven MarketScan database, and 2 time periods, May 2014–June 2015 (Era 1) and July 2015–June 2017 (Era 2). VICTORY cumulative 12-month clinical remission, corticosteroid-free remission, and mucosal healing rates, and Truven 12-month hospitalization and surgery rates, were compared between Eras 1 and 2 using time-to-event analyses. RESULTS: A total of 3661 vedolizumab-treated patients were included (n = 1087 VICTORY, n = 2574 Truven). In both cohorts, CD and UC patients treated during Era 2 were more likely to be biologic naïve. Compared with Era 1, Era 2 CD patients in the VICTORY consortium had higher rates of clinical remission (31% vs 40%, P = 0.03) and mucosal healing (42% vs 58%, P < 0.01). These trends were not observed for UC. In the Truven database, UC patients treated during Era 2 had lower rates of inflammatory bowel disease–related hospitalization (22.4% vs 9.6%, P < 0.001) and surgery (17.2% vs 9.4%, P = 0.008), which was not observed for CD. CONCLUSION: Since FDA approval, remission and mucosal healing rates have increased for vedolizumab-treated CD patients, and vedolizumab-treated UC patients have had fewer hospitalizations and surgeries. This is likely due to differences between patient populations treated immediately after drug approval and those treated later. Oxford University Press 2019-11 2019-05-03 /pmc/articles/PMC6799947/ /pubmed/31050734 http://dx.doi.org/10.1093/ibd/izz071 Text en © 2019 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Clinical Research
Koliani-Pace, Jenna L
Singh, Siddharth
Luo, Michelle
Hirten, Robert
Aniwan, Satimai
Kochhar, Gursimran
Chang, Shannon
Lukin, Dana
Gao, Youran
Bohm, Matthew
Swaminath, Arun
Gupta, Nitin
Shmidt, Eugenia
Meserve, Joseph
Winters, Adam
Chablaney, Shreya
Faleck, David M
Yang, Jiao
Huang, Zhongwen
Boland, Brigid S
Shashi, Preeti
Weiss, Aaron
Hudesman, David
Varma, Sashidhar
Fischer, Monika
Sultan, Keith
Shen, Bo
Kane, Sunanda
Loftus, Edward V
Sands, Bruce E
Colombel, Jean-Frederic
Sandborn, William J
Lasch, Karen
Siegel, Corey A
Dulai, Parambir S
Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated With Improved Effectiveness and Disease Outcomes
title Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated With Improved Effectiveness and Disease Outcomes
title_full Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated With Improved Effectiveness and Disease Outcomes
title_fullStr Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated With Improved Effectiveness and Disease Outcomes
title_full_unstemmed Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated With Improved Effectiveness and Disease Outcomes
title_short Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated With Improved Effectiveness and Disease Outcomes
title_sort changes in vedolizumab utilization across us academic centers and community practice are associated with improved effectiveness and disease outcomes
topic Clinical Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6799947/
https://www.ncbi.nlm.nih.gov/pubmed/31050734
http://dx.doi.org/10.1093/ibd/izz071
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