Vedolizumab for Ulcerative Colitis: Treatment Outcomes from the VICTORY Consortium

Neeraj Narula, Farhad Peerani, Joseph Meserve, Gursimran Kochhar, Khadija Chaudrey, Justin Hartke, Prianka Chilukuri, Jenna Koliani-Pace, Adam Winters, Leah Katta, Eugenia Shmidt, Robert Hirten, David Faleck, Malav P. Parikh, Diana Whitehead, Brigid S. Boland, Siddharth Singh, Sashidhar Varma Sagi, Monika Fischer, Shannon ChangMorris Barocas, Michelle Luo, Karen Lasch, Matthew Bohm, Dana Lukin, Keith Sultan, Arun Swaminath, David Hudesman, Nitin Gupta, Bo Shen, Sunanda Kane, Edward Vincent Loftus, Jr, Corey A. Siegel, Bruce E. Sands, Jean Frederic Colombel, William J. Sandborn, Parambir S. Dulai

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Objectives: We aimed to quantify the safety and effectiveness of vedolizumab (VDZ) when used for UC, and to identify predictors of response to treatment. Methods: Retrospective review (May 2014–December 2016) of VICTORY Consortium data. Adults with follow-up after starting VDZ for clinically active UC were included. Primary effectiveness outcomes were cumulative rates of clinical remission (resolution of all UC-related symptoms) and endoscopic remission (Mayo endoscopic sub-score 0). Key secondary effectiveness outcomes included cumulative rates of corticosteroid-free remission and deep remission (clinical remission and endoscopic remission). Cox proportional hazard analyses were used to identify independent predictors of treatment effectiveness. Non-response imputation (NRI) sensitivity analyses were performed for effectiveness outcomes. Key safety outcomes were rates of serious infection, serious adverse events, and colectomy. Results: We included 321 UC patients (71% prior TNFα antagonist exposure, median follow-up 10 months). The 12-month cumulative rates of clinical remission and endoscopic remission were 51% and 41%, respectively. Corresponding rates for corticosteroid-free remission and deep remission were 37% and 30%, respectively. Using NRI, 12-month rates were 20% (n = 64/321) for clinical remission, 17% (n = 35/203) for endoscopic remission, 15% (n = 30/195) for corticosteroid-free remission, and 14% (n = 28/203) for deep remission. A majority of the patients without adequate follow-up at 12 months who were deemed non-responders using NRI had already achieved clinical remission (n = 70) or a significant clinical response (n = 36) prior to 12 months. VDZ discontinuation prior to 12 months was observed in 91 patients, for lack of response (n = 56), need for surgery (n = 29), or adverse event (n = 6). On multivariable analyses, prior exposure to a TNFα antagonist was associated with a reduced probability of achieving clinical remission (HR 0.53, 95% CI 0.38–0.75) and endoscopic remission (HR 0.51, 95% CI 0.29–0.88). Serious adverse events and serious infections were reported in 6% and 4% of patients, respectively. Overall cumulative rates of colectomy over 12 months were 13%, with lower rates observed in patients naive to TNFα antagonist therapy (2%) than those who had been exposed to TNFα antagonists (19%). Conclusion: In this large real-world cohort we observed that VDZ was well tolerated and effective in achieving key clinical outcomes.

Original languageEnglish (US)
Pages (from-to)1345-1354
Number of pages10
JournalAmerican Journal of Gastroenterology
Volume113
Issue number9
DOIs
StatePublished - Sep 1 2018

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Ulcerative Colitis
Adrenal Cortex Hormones
Colectomy
Safety
Infection
vedolizumab
Therapeutics

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Narula, N., Peerani, F., Meserve, J., Kochhar, G., Chaudrey, K., Hartke, J., ... Dulai, P. S. (2018). Vedolizumab for Ulcerative Colitis: Treatment Outcomes from the VICTORY Consortium. American Journal of Gastroenterology, 113(9), 1345-1354. https://doi.org/10.1038/s41395-018-0162-0

Vedolizumab for Ulcerative Colitis : Treatment Outcomes from the VICTORY Consortium. / Narula, Neeraj; Peerani, Farhad; Meserve, Joseph; Kochhar, Gursimran; Chaudrey, Khadija; Hartke, Justin; Chilukuri, Prianka; Koliani-Pace, Jenna; Winters, Adam; Katta, Leah; Shmidt, Eugenia; Hirten, Robert; Faleck, David; Parikh, Malav P.; Whitehead, Diana; Boland, Brigid S.; Singh, Siddharth; Sagi, Sashidhar Varma; Fischer, Monika; Chang, Shannon; Barocas, Morris; Luo, Michelle; Lasch, Karen; Bohm, Matthew; Lukin, Dana; Sultan, Keith; Swaminath, Arun; Hudesman, David; Gupta, Nitin; Shen, Bo; Kane, Sunanda; Loftus, Jr, Edward Vincent; Siegel, Corey A.; Sands, Bruce E.; Colombel, Jean Frederic; Sandborn, William J.; Dulai, Parambir S.

In: American Journal of Gastroenterology, Vol. 113, No. 9, 01.09.2018, p. 1345-1354.

Research output: Contribution to journalArticle

Narula, N, Peerani, F, Meserve, J, Kochhar, G, Chaudrey, K, Hartke, J, Chilukuri, P, Koliani-Pace, J, Winters, A, Katta, L, Shmidt, E, Hirten, R, Faleck, D, Parikh, MP, Whitehead, D, Boland, BS, Singh, S, Sagi, SV, Fischer, M, Chang, S, Barocas, M, Luo, M, Lasch, K, Bohm, M, Lukin, D, Sultan, K, Swaminath, A, Hudesman, D, Gupta, N, Shen, B, Kane, S, Loftus, Jr, EV, Siegel, CA, Sands, BE, Colombel, JF, Sandborn, WJ & Dulai, PS 2018, 'Vedolizumab for Ulcerative Colitis: Treatment Outcomes from the VICTORY Consortium', American Journal of Gastroenterology, vol. 113, no. 9, pp. 1345-1354. https://doi.org/10.1038/s41395-018-0162-0
Narula, Neeraj ; Peerani, Farhad ; Meserve, Joseph ; Kochhar, Gursimran ; Chaudrey, Khadija ; Hartke, Justin ; Chilukuri, Prianka ; Koliani-Pace, Jenna ; Winters, Adam ; Katta, Leah ; Shmidt, Eugenia ; Hirten, Robert ; Faleck, David ; Parikh, Malav P. ; Whitehead, Diana ; Boland, Brigid S. ; Singh, Siddharth ; Sagi, Sashidhar Varma ; Fischer, Monika ; Chang, Shannon ; Barocas, Morris ; Luo, Michelle ; Lasch, Karen ; Bohm, Matthew ; Lukin, Dana ; Sultan, Keith ; Swaminath, Arun ; Hudesman, David ; Gupta, Nitin ; Shen, Bo ; Kane, Sunanda ; Loftus, Jr, Edward Vincent ; Siegel, Corey A. ; Sands, Bruce E. ; Colombel, Jean Frederic ; Sandborn, William J. ; Dulai, Parambir S. / Vedolizumab for Ulcerative Colitis : Treatment Outcomes from the VICTORY Consortium. In: American Journal of Gastroenterology. 2018 ; Vol. 113, No. 9. pp. 1345-1354.
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abstract = "Objectives: We aimed to quantify the safety and effectiveness of vedolizumab (VDZ) when used for UC, and to identify predictors of response to treatment. Methods: Retrospective review (May 2014–December 2016) of VICTORY Consortium data. Adults with follow-up after starting VDZ for clinically active UC were included. Primary effectiveness outcomes were cumulative rates of clinical remission (resolution of all UC-related symptoms) and endoscopic remission (Mayo endoscopic sub-score 0). Key secondary effectiveness outcomes included cumulative rates of corticosteroid-free remission and deep remission (clinical remission and endoscopic remission). Cox proportional hazard analyses were used to identify independent predictors of treatment effectiveness. Non-response imputation (NRI) sensitivity analyses were performed for effectiveness outcomes. Key safety outcomes were rates of serious infection, serious adverse events, and colectomy. Results: We included 321 UC patients (71{\%} prior TNFα antagonist exposure, median follow-up 10 months). The 12-month cumulative rates of clinical remission and endoscopic remission were 51{\%} and 41{\%}, respectively. Corresponding rates for corticosteroid-free remission and deep remission were 37{\%} and 30{\%}, respectively. Using NRI, 12-month rates were 20{\%} (n = 64/321) for clinical remission, 17{\%} (n = 35/203) for endoscopic remission, 15{\%} (n = 30/195) for corticosteroid-free remission, and 14{\%} (n = 28/203) for deep remission. A majority of the patients without adequate follow-up at 12 months who were deemed non-responders using NRI had already achieved clinical remission (n = 70) or a significant clinical response (n = 36) prior to 12 months. VDZ discontinuation prior to 12 months was observed in 91 patients, for lack of response (n = 56), need for surgery (n = 29), or adverse event (n = 6). On multivariable analyses, prior exposure to a TNFα antagonist was associated with a reduced probability of achieving clinical remission (HR 0.53, 95{\%} CI 0.38–0.75) and endoscopic remission (HR 0.51, 95{\%} CI 0.29–0.88). Serious adverse events and serious infections were reported in 6{\%} and 4{\%} of patients, respectively. Overall cumulative rates of colectomy over 12 months were 13{\%}, with lower rates observed in patients naive to TNFα antagonist therapy (2{\%}) than those who had been exposed to TNFα antagonists (19{\%}). Conclusion: In this large real-world cohort we observed that VDZ was well tolerated and effective in achieving key clinical outcomes.",
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TY - JOUR

T1 - Vedolizumab for Ulcerative Colitis

T2 - Treatment Outcomes from the VICTORY Consortium

AU - Narula, Neeraj

AU - Peerani, Farhad

AU - Meserve, Joseph

AU - Kochhar, Gursimran

AU - Chaudrey, Khadija

AU - Hartke, Justin

AU - Chilukuri, Prianka

AU - Koliani-Pace, Jenna

AU - Winters, Adam

AU - Katta, Leah

AU - Shmidt, Eugenia

AU - Hirten, Robert

AU - Faleck, David

AU - Parikh, Malav P.

AU - Whitehead, Diana

AU - Boland, Brigid S.

AU - Singh, Siddharth

AU - Sagi, Sashidhar Varma

AU - Fischer, Monika

AU - Chang, Shannon

AU - Barocas, Morris

AU - Luo, Michelle

AU - Lasch, Karen

AU - Bohm, Matthew

AU - Lukin, Dana

AU - Sultan, Keith

AU - Swaminath, Arun

AU - Hudesman, David

AU - Gupta, Nitin

AU - Shen, Bo

AU - Kane, Sunanda

AU - Loftus, Jr, Edward Vincent

AU - Siegel, Corey A.

AU - Sands, Bruce E.

AU - Colombel, Jean Frederic

AU - Sandborn, William J.

AU - Dulai, Parambir S.

PY - 2018/9/1

Y1 - 2018/9/1

N2 - Objectives: We aimed to quantify the safety and effectiveness of vedolizumab (VDZ) when used for UC, and to identify predictors of response to treatment. Methods: Retrospective review (May 2014–December 2016) of VICTORY Consortium data. Adults with follow-up after starting VDZ for clinically active UC were included. Primary effectiveness outcomes were cumulative rates of clinical remission (resolution of all UC-related symptoms) and endoscopic remission (Mayo endoscopic sub-score 0). Key secondary effectiveness outcomes included cumulative rates of corticosteroid-free remission and deep remission (clinical remission and endoscopic remission). Cox proportional hazard analyses were used to identify independent predictors of treatment effectiveness. Non-response imputation (NRI) sensitivity analyses were performed for effectiveness outcomes. Key safety outcomes were rates of serious infection, serious adverse events, and colectomy. Results: We included 321 UC patients (71% prior TNFα antagonist exposure, median follow-up 10 months). The 12-month cumulative rates of clinical remission and endoscopic remission were 51% and 41%, respectively. Corresponding rates for corticosteroid-free remission and deep remission were 37% and 30%, respectively. Using NRI, 12-month rates were 20% (n = 64/321) for clinical remission, 17% (n = 35/203) for endoscopic remission, 15% (n = 30/195) for corticosteroid-free remission, and 14% (n = 28/203) for deep remission. A majority of the patients without adequate follow-up at 12 months who were deemed non-responders using NRI had already achieved clinical remission (n = 70) or a significant clinical response (n = 36) prior to 12 months. VDZ discontinuation prior to 12 months was observed in 91 patients, for lack of response (n = 56), need for surgery (n = 29), or adverse event (n = 6). On multivariable analyses, prior exposure to a TNFα antagonist was associated with a reduced probability of achieving clinical remission (HR 0.53, 95% CI 0.38–0.75) and endoscopic remission (HR 0.51, 95% CI 0.29–0.88). Serious adverse events and serious infections were reported in 6% and 4% of patients, respectively. Overall cumulative rates of colectomy over 12 months were 13%, with lower rates observed in patients naive to TNFα antagonist therapy (2%) than those who had been exposed to TNFα antagonists (19%). Conclusion: In this large real-world cohort we observed that VDZ was well tolerated and effective in achieving key clinical outcomes.

AB - Objectives: We aimed to quantify the safety and effectiveness of vedolizumab (VDZ) when used for UC, and to identify predictors of response to treatment. Methods: Retrospective review (May 2014–December 2016) of VICTORY Consortium data. Adults with follow-up after starting VDZ for clinically active UC were included. Primary effectiveness outcomes were cumulative rates of clinical remission (resolution of all UC-related symptoms) and endoscopic remission (Mayo endoscopic sub-score 0). Key secondary effectiveness outcomes included cumulative rates of corticosteroid-free remission and deep remission (clinical remission and endoscopic remission). Cox proportional hazard analyses were used to identify independent predictors of treatment effectiveness. Non-response imputation (NRI) sensitivity analyses were performed for effectiveness outcomes. Key safety outcomes were rates of serious infection, serious adverse events, and colectomy. Results: We included 321 UC patients (71% prior TNFα antagonist exposure, median follow-up 10 months). The 12-month cumulative rates of clinical remission and endoscopic remission were 51% and 41%, respectively. Corresponding rates for corticosteroid-free remission and deep remission were 37% and 30%, respectively. Using NRI, 12-month rates were 20% (n = 64/321) for clinical remission, 17% (n = 35/203) for endoscopic remission, 15% (n = 30/195) for corticosteroid-free remission, and 14% (n = 28/203) for deep remission. A majority of the patients without adequate follow-up at 12 months who were deemed non-responders using NRI had already achieved clinical remission (n = 70) or a significant clinical response (n = 36) prior to 12 months. VDZ discontinuation prior to 12 months was observed in 91 patients, for lack of response (n = 56), need for surgery (n = 29), or adverse event (n = 6). On multivariable analyses, prior exposure to a TNFα antagonist was associated with a reduced probability of achieving clinical remission (HR 0.53, 95% CI 0.38–0.75) and endoscopic remission (HR 0.51, 95% CI 0.29–0.88). Serious adverse events and serious infections were reported in 6% and 4% of patients, respectively. Overall cumulative rates of colectomy over 12 months were 13%, with lower rates observed in patients naive to TNFα antagonist therapy (2%) than those who had been exposed to TNFα antagonists (19%). Conclusion: In this large real-world cohort we observed that VDZ was well tolerated and effective in achieving key clinical outcomes.

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