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 - 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 -