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

Jenna L. Koliani-Pace, Siddharth Singh, Michelle Luo, Robert Hirten, Satimai Aniwan, Gursimran Kochhar, Shannon Chang, Dana Lukin, Youran Gao, Matthew Bohm, Arun Swaminath, Nitin Gupta, Eugenia Shmidt, Joseph Meserve, Adam Winters, Shreya Chablaney, David M. Faleck, Jiao Yang, Zhongwen Huang, Brigid S. BolandPreeti Shashi, Aaron Weiss, David Hudesman, Sashidhar Varma, Monika Fischer, Keith Sultan, Bo Shen, Sunanda Kane, Edward V. Loftus, Bruce E. Sands, Jean Frederic Colombel, William J. Sandborn, Karen Lasch, Corey A. Siegel, Parambir S. Dulai

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1854-1861
Number of pages8
JournalInflammatory bowel diseases
Volume25
Issue number11
DOIs
StatePublished - Oct 18 2019

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Drug Approval
Ulcerative Colitis
Crohn Disease
United States Food and Drug Administration
Hospitalization
Databases
vedolizumab
Inflammatory Bowel Diseases
Population
Adrenal Cortex Hormones

Keywords

  • hospitalization
  • surgery
  • trends utilization
  • vedolizumab

ASJC Scopus subject areas

  • Immunology and Allergy
  • Gastroenterology

Cite this

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.

In: Inflammatory bowel diseases, Vol. 25, No. 11, 18.10.2019, p. 1854-1861.

Research output: Contribution to journalArticle

Koliani-Pace, JL, Singh, S, Luo, M, Hirten, R, Aniwan, S, Kochhar, G, Chang, S, Lukin, D, Gao, Y, Bohm, M, Swaminath, A, Gupta, N, Shmidt, E, Meserve, J, Winters, A, Chablaney, S, Faleck, DM, Yang, J, Huang, Z, Boland, BS, Shashi, P, Weiss, A, Hudesman, D, Varma, S, Fischer, M, Sultan, K, Shen, B, Kane, S, Loftus, EV, Sands, BE, Colombel, JF, Sandborn, WJ, Lasch, K, Siegel, CA & Dulai, PS 2019, 'Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated with Improved Effectiveness and Disease Outcomes', Inflammatory bowel diseases, vol. 25, no. 11, pp. 1854-1861. https://doi.org/10.1093/ibd/izz071
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. In: Inflammatory bowel diseases. 2019 ; Vol. 25, No. 11. pp. 1854-1861.
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abstract = "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 na{\"i}ve. 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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AU - Koliani-Pace, Jenna L.

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AU - Hirten, Robert

AU - Aniwan, Satimai

AU - Kochhar, Gursimran

AU - Chang, Shannon

AU - Lukin, Dana

AU - Gao, Youran

AU - Bohm, Matthew

AU - Swaminath, Arun

AU - Gupta, Nitin

AU - Shmidt, Eugenia

AU - Meserve, Joseph

AU - Winters, Adam

AU - Chablaney, Shreya

AU - Faleck, David M.

AU - Yang, Jiao

AU - Huang, Zhongwen

AU - Boland, Brigid S.

AU - Shashi, Preeti

AU - Weiss, Aaron

AU - Hudesman, David

AU - Varma, Sashidhar

AU - Fischer, Monika

AU - Sultan, Keith

AU - Shen, Bo

AU - Kane, Sunanda

AU - Loftus, Edward V.

AU - Sands, Bruce E.

AU - Colombel, Jean Frederic

AU - Sandborn, William J.

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N2 - 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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KW - surgery

KW - trends utilization

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