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
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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 -