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. Boland; Preeti 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

doi:10.1093/ibd/izz071

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

Medicine - Gastro, Hepatology, Nutrition Division

Research output: Contribution to journal › Article › peer-review

9 Scopus citations

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 language	English (US)
Pages (from-to)	1854-1861
Number of pages	8
Journal	Inflammatory bowel diseases
Volume	25
Issue number	11
DOIs	https://doi.org/10.1093/ibd/izz071
State	Published - Oct 18 2019

Bibliographical note

Funding Information:
Conflicts of interest: J.L.K.P.: travel support from Takeda. S.S.: research support from Pfizer and support from the American College of Gastroenterology and the Crohn’s and Colitis Foundation. M.L.: employee of Takeda Pharmaceuticals U.S.A., Inc. D.L.: consulting for AbbVie, Janssen, Salix. E.S.: travel support from Takeda. J.Y.: employee of Takeda Pharmaceuticals U.S.A., Inc. Z.H.: employee of Takeda Pharmaceuticals U.S.A., Inc. B.S.B.: research support from Takeda and Janssen, consulting for AbbVie, and support from CCFA career development award and UCSD KL2 (1KL2TR001444). D.H.: consulting for AbbVie, Janssen, Takeda. K.S.: consulting for AbbVie; research support from AbbVie, Celgene, Genentech, Pfizer, Takeda. B.S.: consulting for AbbVie, Janssen, Robarts Clinical Trials, Salix, Takeda, Theravance. S.K.: consultant to AbbVie, Janssen, Merck, Spherix Health, Pfizer, UCB; research support from UCB; board member of ABIM. E.V.L.: consulting for Janssen, Takeda, AbbVie, UCB, Amgen, Pfizer, Salix, Mesoblast, Eli Lilly, Celgene, CVS Caremark; research support from Janssen, Takeda, AbbVie, UCB, Amgen, Pfizer, Genentech, Gilead, Receptos, Celgene, MedImmune, Seres Therapeutics, Robarts Clinical Trials. B.E.S.: consulting and research support from Amgen, Celgene, Janssen, Pfizer, Prometheus Laboratories, Takeda; consulting for AbbVie, Akros Pharma, Arena Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Cowen Services Company, Forest Research Institute, Forward Pharma, Immune Pharmaceuticals, Lilly, Receptos, Salix Pharmaceuticals, Shire, Synergy Pharmaceuticals, Theravance Biopharma R&D, TiGenix, TopiVert Pharma, UCB, Vivelix Pharmaceuticals, Target PharmaSolutions, Allergan. J.F.C.: consultancy/advisory board membership: AbbVie, Amgen, Boehringer Ingelheim, Celgene Corporation, Celltrion, Enterome, Ferring, Genentech, Janssen & Janssen, MedImmune, Merck & Co., Pfizer, Protagonist, Second Genome, Seres, Takeda, Theradiag; speaker for AbbVie, Ferring, Takeda, Shire; research support from AbbVie, Janssen & Janssen, Genentech, Takeda; stock options in Intestinal Biotech Development, Genfit. W.J.S.: personal fees from Actavis, ActoGeniX NV, Adheron Therapeutics, Akros Pharma, AM Pharma BV, Ardelyx Inc., Arena Pharmaceuticals, Ambrx Inc., Avaxia Biologics, Baxter Healthcare, Biogen, Catabasis Pharmaceuticals, Celgene, Cellular Therapeutics, Chiasma, Cosmo Pharmaceuticals, Dr. August Wolff, Eisai, Eli Lilly, Ferring Pharmaceuticals, Ferring Research Institute, Forward Pharma, Galapagos, Immune Pharmaceuticals, InDex Pharmaceuticals, Ironwood Pharmaceuticals, Kyowa Hakko Kirin, Lexicon Pharmaceuticals, Lipid Therapeutics GmbH, Luitpold Pharmaceuticals, MedImmune (AstraZeneca), Mesoblast, Millennium Pharmaceuticals, Nestle, Novo Nordisk, Orexigen, Palatin, Qu Biologics, Regeneron, Ritter Pharmaceuticals, Salix Pharmaceuticals, Santarus, Seattle Genetics, Seres Health, Shire, Sigmoid Biotechnologies, Teva Pharmaceuticals, Theradiag, Theravance, TiGenix, Tillotts Pharma, Toray Industries Inc., UCB Pharma, University of Western Ontario (owner of Robarts Clinical Trials), Vascular Biogenics, Vertex Pharmaceuticals, Warner Chilcott, Zyngenia; grants and personal fees from AbbVie, Amgen, Atlantic Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Gilead Sciences, GlaxoSmithKline, Nutrition Science Partners, Prometheus Laboratories, Takeda, Pfizer, Receptos; grants, personal fees, and nonfinancial support from Janssen; grants from American College of Gastroenterology, Broad Foundation, Exact Sciences. K.L.: employee of Takeda Pharmaceuticals U.S.A., Inc. C.A.S.: consulting for AbbVie, Amgen, Celgene, Janssen, Lilly, Pfizer, Prometheus, Sandoz, Takeda; speaker for CME activities for AbbVie, Janssen, Pfizer, Takeda; grant support from AbbVie, Janssen, Pfizer, Takeda. P.S.D.: research support, an honorarium, and travel support from Takeda; research support from Pfizer; advisory board for Janssen. The following authors have no disclosures: Robert Hirten, Satimai Aniwan, Gursimran Kochhar, Shannon Chang, Youran Gao, Matthew Bohm, Arun Swaminath, Nitin Gupta, Joseph Meserve, Adam Winters, Shreya Chablaney, David M. Faleck, Preeti Shashi, Aaron Weiss, Sashidhar Varma, Monika Fischer.

Publisher Copyright:
© 2019 Crohn's & Colitis Foundation. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.

Keywords

hospitalization
surgery
trends utilization
vedolizumab

Access

10.1093/ibd/izz071

OpenUrl availability

Full text

Cite this

Koliani-Pace, J. L., 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, D. M., Yang, J., Huang, Z., ... Dulai, P. S. (2019). Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated with Improved Effectiveness and Disease Outcomes. Inflammatory bowel diseases, 25(11), 1854-1861. https://doi.org/10.1093/ibd/izz071

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

@article{0871b049c3c8456fa58b3531fd026609,

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

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.",

keywords = "hospitalization, surgery, trends utilization, vedolizumab",

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

note = "Funding Information: Conflicts of interest: J.L.K.P.: travel support from Takeda. S.S.: research support from Pfizer and support from the American College of Gastroenterology and the Crohn{\textquoteright}s and Colitis Foundation. M.L.: employee of Takeda Pharmaceuticals U.S.A., Inc. D.L.: consulting for AbbVie, Janssen, Salix. E.S.: travel support from Takeda. J.Y.: employee of Takeda Pharmaceuticals U.S.A., Inc. Z.H.: employee of Takeda Pharmaceuticals U.S.A., Inc. B.S.B.: research support from Takeda and Janssen, consulting for AbbVie, and support from CCFA career development award and UCSD KL2 (1KL2TR001444). D.H.: consulting for AbbVie, Janssen, Takeda. K.S.: consulting for AbbVie; research support from AbbVie, Celgene, Genentech, Pfizer, Takeda. B.S.: consulting for AbbVie, Janssen, Robarts Clinical Trials, Salix, Takeda, Theravance. S.K.: consultant to AbbVie, Janssen, Merck, Spherix Health, Pfizer, UCB; research support from UCB; board member of ABIM. E.V.L.: consulting for Janssen, Takeda, AbbVie, UCB, Amgen, Pfizer, Salix, Mesoblast, Eli Lilly, Celgene, CVS Caremark; research support from Janssen, Takeda, AbbVie, UCB, Amgen, Pfizer, Genentech, Gilead, Receptos, Celgene, MedImmune, Seres Therapeutics, Robarts Clinical Trials. B.E.S.: consulting and research support from Amgen, Celgene, Janssen, Pfizer, Prometheus Laboratories, Takeda; consulting for AbbVie, Akros Pharma, Arena Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Cowen Services Company, Forest Research Institute, Forward Pharma, Immune Pharmaceuticals, Lilly, Receptos, Salix Pharmaceuticals, Shire, Synergy Pharmaceuticals, Theravance Biopharma R&D, TiGenix, TopiVert Pharma, UCB, Vivelix Pharmaceuticals, Target PharmaSolutions, Allergan. J.F.C.: consultancy/advisory board membership: AbbVie, Amgen, Boehringer Ingelheim, Celgene Corporation, Celltrion, Enterome, Ferring, Genentech, Janssen & Janssen, MedImmune, Merck & Co., Pfizer, Protagonist, Second Genome, Seres, Takeda, Theradiag; speaker for AbbVie, Ferring, Takeda, Shire; research support from AbbVie, Janssen & Janssen, Genentech, Takeda; stock options in Intestinal Biotech Development, Genfit. W.J.S.: personal fees from Actavis, ActoGeniX NV, Adheron Therapeutics, Akros Pharma, AM Pharma BV, Ardelyx Inc., Arena Pharmaceuticals, Ambrx Inc., Avaxia Biologics, Baxter Healthcare, Biogen, Catabasis Pharmaceuticals, Celgene, Cellular Therapeutics, Chiasma, Cosmo Pharmaceuticals, Dr. August Wolff, Eisai, Eli Lilly, Ferring Pharmaceuticals, Ferring Research Institute, Forward Pharma, Galapagos, Immune Pharmaceuticals, InDex Pharmaceuticals, Ironwood Pharmaceuticals, Kyowa Hakko Kirin, Lexicon Pharmaceuticals, Lipid Therapeutics GmbH, Luitpold Pharmaceuticals, MedImmune (AstraZeneca), Mesoblast, Millennium Pharmaceuticals, Nestle, Novo Nordisk, Orexigen, Palatin, Qu Biologics, Regeneron, Ritter Pharmaceuticals, Salix Pharmaceuticals, Santarus, Seattle Genetics, Seres Health, Shire, Sigmoid Biotechnologies, Teva Pharmaceuticals, Theradiag, Theravance, TiGenix, Tillotts Pharma, Toray Industries Inc., UCB Pharma, University of Western Ontario (owner of Robarts Clinical Trials), Vascular Biogenics, Vertex Pharmaceuticals, Warner Chilcott, Zyngenia; grants and personal fees from AbbVie, Amgen, Atlantic Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Gilead Sciences, GlaxoSmithKline, Nutrition Science Partners, Prometheus Laboratories, Takeda, Pfizer, Receptos; grants, personal fees, and nonfinancial support from Janssen; grants from American College of Gastroenterology, Broad Foundation, Exact Sciences. K.L.: employee of Takeda Pharmaceuticals U.S.A., Inc. C.A.S.: consulting for AbbVie, Amgen, Celgene, Janssen, Lilly, Pfizer, Prometheus, Sandoz, Takeda; speaker for CME activities for AbbVie, Janssen, Pfizer, Takeda; grant support from AbbVie, Janssen, Pfizer, Takeda. P.S.D.: research support, an honorarium, and travel support from Takeda; research support from Pfizer; advisory board for Janssen. The following authors have no disclosures: Robert Hirten, Satimai Aniwan, Gursimran Kochhar, Shannon Chang, Youran Gao, Matthew Bohm, Arun Swaminath, Nitin Gupta, Joseph Meserve, Adam Winters, Shreya Chablaney, David M. Faleck, Preeti Shashi, Aaron Weiss, Sashidhar Varma, Monika Fischer. Publisher Copyright: {\textcopyright} 2019 Crohn's & Colitis Foundation. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.",

year = "2019",

month = oct,

day = "18",

doi = "10.1093/ibd/izz071",

language = "English (US)",

volume = "25",

pages = "1854--1861",

journal = "Inflammatory bowel diseases",

issn = "1078-0998",

publisher = "John Wiley and Sons Inc.",

number = "11",

}

TY - JOUR

T1 - Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated with Improved Effectiveness and Disease Outcomes

AU - Koliani-Pace, Jenna L.

AU - Singh, Siddharth

AU - Luo, Michelle

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.

AU - Lasch, Karen

AU - Siegel, Corey A.

AU - Dulai, Parambir S.

N1 - Funding Information: Conflicts of interest: J.L.K.P.: travel support from Takeda. S.S.: research support from Pfizer and support from the American College of Gastroenterology and the Crohn’s and Colitis Foundation. M.L.: employee of Takeda Pharmaceuticals U.S.A., Inc. D.L.: consulting for AbbVie, Janssen, Salix. E.S.: travel support from Takeda. J.Y.: employee of Takeda Pharmaceuticals U.S.A., Inc. Z.H.: employee of Takeda Pharmaceuticals U.S.A., Inc. B.S.B.: research support from Takeda and Janssen, consulting for AbbVie, and support from CCFA career development award and UCSD KL2 (1KL2TR001444). D.H.: consulting for AbbVie, Janssen, Takeda. K.S.: consulting for AbbVie; research support from AbbVie, Celgene, Genentech, Pfizer, Takeda. B.S.: consulting for AbbVie, Janssen, Robarts Clinical Trials, Salix, Takeda, Theravance. S.K.: consultant to AbbVie, Janssen, Merck, Spherix Health, Pfizer, UCB; research support from UCB; board member of ABIM. E.V.L.: consulting for Janssen, Takeda, AbbVie, UCB, Amgen, Pfizer, Salix, Mesoblast, Eli Lilly, Celgene, CVS Caremark; research support from Janssen, Takeda, AbbVie, UCB, Amgen, Pfizer, Genentech, Gilead, Receptos, Celgene, MedImmune, Seres Therapeutics, Robarts Clinical Trials. B.E.S.: consulting and research support from Amgen, Celgene, Janssen, Pfizer, Prometheus Laboratories, Takeda; consulting for AbbVie, Akros Pharma, Arena Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Cowen Services Company, Forest Research Institute, Forward Pharma, Immune Pharmaceuticals, Lilly, Receptos, Salix Pharmaceuticals, Shire, Synergy Pharmaceuticals, Theravance Biopharma R&D, TiGenix, TopiVert Pharma, UCB, Vivelix Pharmaceuticals, Target PharmaSolutions, Allergan. J.F.C.: consultancy/advisory board membership: AbbVie, Amgen, Boehringer Ingelheim, Celgene Corporation, Celltrion, Enterome, Ferring, Genentech, Janssen & Janssen, MedImmune, Merck & Co., Pfizer, Protagonist, Second Genome, Seres, Takeda, Theradiag; speaker for AbbVie, Ferring, Takeda, Shire; research support from AbbVie, Janssen & Janssen, Genentech, Takeda; stock options in Intestinal Biotech Development, Genfit. W.J.S.: personal fees from Actavis, ActoGeniX NV, Adheron Therapeutics, Akros Pharma, AM Pharma BV, Ardelyx Inc., Arena Pharmaceuticals, Ambrx Inc., Avaxia Biologics, Baxter Healthcare, Biogen, Catabasis Pharmaceuticals, Celgene, Cellular Therapeutics, Chiasma, Cosmo Pharmaceuticals, Dr. August Wolff, Eisai, Eli Lilly, Ferring Pharmaceuticals, Ferring Research Institute, Forward Pharma, Galapagos, Immune Pharmaceuticals, InDex Pharmaceuticals, Ironwood Pharmaceuticals, Kyowa Hakko Kirin, Lexicon Pharmaceuticals, Lipid Therapeutics GmbH, Luitpold Pharmaceuticals, MedImmune (AstraZeneca), Mesoblast, Millennium Pharmaceuticals, Nestle, Novo Nordisk, Orexigen, Palatin, Qu Biologics, Regeneron, Ritter Pharmaceuticals, Salix Pharmaceuticals, Santarus, Seattle Genetics, Seres Health, Shire, Sigmoid Biotechnologies, Teva Pharmaceuticals, Theradiag, Theravance, TiGenix, Tillotts Pharma, Toray Industries Inc., UCB Pharma, University of Western Ontario (owner of Robarts Clinical Trials), Vascular Biogenics, Vertex Pharmaceuticals, Warner Chilcott, Zyngenia; grants and personal fees from AbbVie, Amgen, Atlantic Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Gilead Sciences, GlaxoSmithKline, Nutrition Science Partners, Prometheus Laboratories, Takeda, Pfizer, Receptos; grants, personal fees, and nonfinancial support from Janssen; grants from American College of Gastroenterology, Broad Foundation, Exact Sciences. K.L.: employee of Takeda Pharmaceuticals U.S.A., Inc. C.A.S.: consulting for AbbVie, Amgen, Celgene, Janssen, Lilly, Pfizer, Prometheus, Sandoz, Takeda; speaker for CME activities for AbbVie, Janssen, Pfizer, Takeda; grant support from AbbVie, Janssen, Pfizer, Takeda. P.S.D.: research support, an honorarium, and travel support from Takeda; research support from Pfizer; advisory board for Janssen. The following authors have no disclosures: Robert Hirten, Satimai Aniwan, Gursimran Kochhar, Shannon Chang, Youran Gao, Matthew Bohm, Arun Swaminath, Nitin Gupta, Joseph Meserve, Adam Winters, Shreya Chablaney, David M. Faleck, Preeti Shashi, Aaron Weiss, Sashidhar Varma, Monika Fischer. Publisher Copyright: © 2019 Crohn's & Colitis Foundation. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.

PY - 2019/10/18

Y1 - 2019/10/18

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.

AB - 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.

KW - hospitalization

KW - surgery

KW - trends utilization

KW - vedolizumab

UR - http://www.scopus.com/inward/record.url?scp=85073584583&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85073584583&partnerID=8YFLogxK

U2 - 10.1093/ibd/izz071

DO - 10.1093/ibd/izz071

M3 - Article

C2 - 31050734

AN - SCOPUS:85073584583

SN - 1078-0998

VL - 25

SP - 1854

EP - 1861

JO - Inflammatory bowel diseases

JF - Inflammatory bowel diseases

IS - 11

ER -

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

Abstract

Bibliographical note

Keywords

Access

OpenUrl availability

Other files and links

Fingerprint

Cite this