The real-world effectiveness and safety of vedolizumab for moderate-severe Crohn's disease: Results from the US VICTORY consortium

Parambir S. Dulai, Siddharth Singh, Xiaoqian Jiang, Farhad Peerani, Neeraj Narula, Khadija Chaudrey, Diana Whitehead, David Hudesman, Dana Lukin, Arun Swaminath, Eugenia Shmidt, Shuang Wang, Brigid S. Boland, John T. Chang, Sunanda Kane, Corey A. Siegel, Edward Vincent Loftus, Jr, William J. Sandborn, Bruce E. Sands, Jean Frederic Colombel

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Abstract

OBJECTIVES: We assessed the real-world effectiveness and safety of vedolizumab (VDZ) in moderate-severe Crohn's disease (CD). METHODS: Retrospective cohort study of seven medical centers, from May 2014 to December 2015. Adults with moderate-severe CD treated with VDZ, with follow-up after initiation of therapy, were included. Using the multivariable Cox proportional hazard analyses, we identified independent predictors of clinical remission or mucosal healing with VDZ. Rates of serious infection (requiring antibiotics, resulting in discontinuation of VDZ, hospitalization or death) and serious adverse events (discontinuation of VDZ, hospitalization or death) were described quantitatively. RESULTS: We included 212 patients with moderate-severe CD (median age 34 years; 40% male; 90% tumor necrosis factor (TNF)-antagonist exposed) with a median follow-up (IQR) of 39 weeks (25-53). Twelve-month cumulative rates of clinical remission, mucosal healing, and deep remission (clinical remission+mucosal healing) were 35%, 63%, and 26%, respectively. Individuals with prior TNF-antagonist exposure (hazard ratio (HR) 0.40; 95% confidence interval (CI): 0.20-0.81), smoking history (HR 0.47; 95% CI: 0.25-0.89), active perianal disease (HR 0.49; 95% CI: 0.27-0.88), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve clinical remission. Those with prior TNF-antagonist exposure (HR 0.29; 95% CI: 0.12-0.73), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve mucosal healing. During 160 patient years of follow-up (PYF) and 1,433 VDZ infusions, 5 patients developed infusion reactions (3.5 per 1,000 infusions), 21 developed serious infections (13 per 100 PYF), and 17 developed serious adverse events (10 per 100 PYF). A minority of adverse events required discontinuation of therapy (6 per 100 PYF). CONCLUSIONS: VDZ is a safe and effective treatment option for moderate-severe CD in routine practice. Clinical remission and deep remission (clinical remission and mucosal healing) can be achieved in 1/3 of individuals, and a minority of individuals require discontinuation of therapy due to adverse events.

Original languageEnglish (US)
Pages (from-to)1147-1155
Number of pages9
JournalAmerican Journal of Gastroenterology
Volume111
Issue number8
DOIs
StatePublished - Aug 1 2016

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Crohn Disease
Safety
Confidence Intervals
Tumor Necrosis Factor-alpha
Hospitalization
Therapeutics
Infection
vedolizumab
Cohort Studies
Retrospective Studies
Smoking
History
Anti-Bacterial Agents

ASJC Scopus subject areas

  • Medicine(all)
  • Gastroenterology

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The real-world effectiveness and safety of vedolizumab for moderate-severe Crohn's disease : Results from the US VICTORY consortium. / Dulai, Parambir S.; Singh, Siddharth; Jiang, Xiaoqian; Peerani, Farhad; Narula, Neeraj; Chaudrey, Khadija; Whitehead, Diana; Hudesman, David; Lukin, Dana; Swaminath, Arun; Shmidt, Eugenia; Wang, Shuang; Boland, Brigid S.; Chang, John T.; Kane, Sunanda; Siegel, Corey A.; Loftus, Jr, Edward Vincent; Sandborn, William J.; Sands, Bruce E.; Colombel, Jean Frederic.

In: American Journal of Gastroenterology, Vol. 111, No. 8, 01.08.2016, p. 1147-1155.

Research output: Contribution to journalArticle

Dulai, PS, Singh, S, Jiang, X, Peerani, F, Narula, N, Chaudrey, K, Whitehead, D, Hudesman, D, Lukin, D, Swaminath, A, Shmidt, E, Wang, S, Boland, BS, Chang, JT, Kane, S, Siegel, CA, Loftus, Jr, EV, Sandborn, WJ, Sands, BE & Colombel, JF 2016, 'The real-world effectiveness and safety of vedolizumab for moderate-severe Crohn's disease: Results from the US VICTORY consortium', American Journal of Gastroenterology, vol. 111, no. 8, pp. 1147-1155. https://doi.org/10.1038/ajg.2016.236
Dulai, Parambir S. ; Singh, Siddharth ; Jiang, Xiaoqian ; Peerani, Farhad ; Narula, Neeraj ; Chaudrey, Khadija ; Whitehead, Diana ; Hudesman, David ; Lukin, Dana ; Swaminath, Arun ; Shmidt, Eugenia ; Wang, Shuang ; Boland, Brigid S. ; Chang, John T. ; Kane, Sunanda ; Siegel, Corey A. ; Loftus, Jr, Edward Vincent ; Sandborn, William J. ; Sands, Bruce E. ; Colombel, Jean Frederic. / The real-world effectiveness and safety of vedolizumab for moderate-severe Crohn's disease : Results from the US VICTORY consortium. In: American Journal of Gastroenterology. 2016 ; Vol. 111, No. 8. pp. 1147-1155.
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abstract = "OBJECTIVES: We assessed the real-world effectiveness and safety of vedolizumab (VDZ) in moderate-severe Crohn's disease (CD). METHODS: Retrospective cohort study of seven medical centers, from May 2014 to December 2015. Adults with moderate-severe CD treated with VDZ, with follow-up after initiation of therapy, were included. Using the multivariable Cox proportional hazard analyses, we identified independent predictors of clinical remission or mucosal healing with VDZ. Rates of serious infection (requiring antibiotics, resulting in discontinuation of VDZ, hospitalization or death) and serious adverse events (discontinuation of VDZ, hospitalization or death) were described quantitatively. RESULTS: We included 212 patients with moderate-severe CD (median age 34 years; 40{\%} male; 90{\%} tumor necrosis factor (TNF)-antagonist exposed) with a median follow-up (IQR) of 39 weeks (25-53). Twelve-month cumulative rates of clinical remission, mucosal healing, and deep remission (clinical remission+mucosal healing) were 35{\%}, 63{\%}, and 26{\%}, respectively. Individuals with prior TNF-antagonist exposure (hazard ratio (HR) 0.40; 95{\%} confidence interval (CI): 0.20-0.81), smoking history (HR 0.47; 95{\%} CI: 0.25-0.89), active perianal disease (HR 0.49; 95{\%} CI: 0.27-0.88), and severe disease activity (HR 0.54; 95{\%} CI: 0.31-0.95) were less likely to achieve clinical remission. Those with prior TNF-antagonist exposure (HR 0.29; 95{\%} CI: 0.12-0.73), and severe disease activity (HR 0.54; 95{\%} CI: 0.31-0.95) were less likely to achieve mucosal healing. During 160 patient years of follow-up (PYF) and 1,433 VDZ infusions, 5 patients developed infusion reactions (3.5 per 1,000 infusions), 21 developed serious infections (13 per 100 PYF), and 17 developed serious adverse events (10 per 100 PYF). A minority of adverse events required discontinuation of therapy (6 per 100 PYF). CONCLUSIONS: VDZ is a safe and effective treatment option for moderate-severe CD in routine practice. Clinical remission and deep remission (clinical remission and mucosal healing) can be achieved in 1/3 of individuals, and a minority of individuals require discontinuation of therapy due to adverse events.",
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T1 - The real-world effectiveness and safety of vedolizumab for moderate-severe Crohn's disease

T2 - Results from the US VICTORY consortium

AU - Dulai, Parambir S.

AU - Singh, Siddharth

AU - Jiang, Xiaoqian

AU - Peerani, Farhad

AU - Narula, Neeraj

AU - Chaudrey, Khadija

AU - Whitehead, Diana

AU - Hudesman, David

AU - Lukin, Dana

AU - Swaminath, Arun

AU - Shmidt, Eugenia

AU - Wang, Shuang

AU - Boland, Brigid S.

AU - Chang, John T.

AU - Kane, Sunanda

AU - Siegel, Corey A.

AU - Loftus, Jr, Edward Vincent

AU - Sandborn, William J.

AU - Sands, Bruce E.

AU - Colombel, Jean Frederic

PY - 2016/8/1

Y1 - 2016/8/1

N2 - OBJECTIVES: We assessed the real-world effectiveness and safety of vedolizumab (VDZ) in moderate-severe Crohn's disease (CD). METHODS: Retrospective cohort study of seven medical centers, from May 2014 to December 2015. Adults with moderate-severe CD treated with VDZ, with follow-up after initiation of therapy, were included. Using the multivariable Cox proportional hazard analyses, we identified independent predictors of clinical remission or mucosal healing with VDZ. Rates of serious infection (requiring antibiotics, resulting in discontinuation of VDZ, hospitalization or death) and serious adverse events (discontinuation of VDZ, hospitalization or death) were described quantitatively. RESULTS: We included 212 patients with moderate-severe CD (median age 34 years; 40% male; 90% tumor necrosis factor (TNF)-antagonist exposed) with a median follow-up (IQR) of 39 weeks (25-53). Twelve-month cumulative rates of clinical remission, mucosal healing, and deep remission (clinical remission+mucosal healing) were 35%, 63%, and 26%, respectively. Individuals with prior TNF-antagonist exposure (hazard ratio (HR) 0.40; 95% confidence interval (CI): 0.20-0.81), smoking history (HR 0.47; 95% CI: 0.25-0.89), active perianal disease (HR 0.49; 95% CI: 0.27-0.88), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve clinical remission. Those with prior TNF-antagonist exposure (HR 0.29; 95% CI: 0.12-0.73), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve mucosal healing. During 160 patient years of follow-up (PYF) and 1,433 VDZ infusions, 5 patients developed infusion reactions (3.5 per 1,000 infusions), 21 developed serious infections (13 per 100 PYF), and 17 developed serious adverse events (10 per 100 PYF). A minority of adverse events required discontinuation of therapy (6 per 100 PYF). CONCLUSIONS: VDZ is a safe and effective treatment option for moderate-severe CD in routine practice. Clinical remission and deep remission (clinical remission and mucosal healing) can be achieved in 1/3 of individuals, and a minority of individuals require discontinuation of therapy due to adverse events.

AB - OBJECTIVES: We assessed the real-world effectiveness and safety of vedolizumab (VDZ) in moderate-severe Crohn's disease (CD). METHODS: Retrospective cohort study of seven medical centers, from May 2014 to December 2015. Adults with moderate-severe CD treated with VDZ, with follow-up after initiation of therapy, were included. Using the multivariable Cox proportional hazard analyses, we identified independent predictors of clinical remission or mucosal healing with VDZ. Rates of serious infection (requiring antibiotics, resulting in discontinuation of VDZ, hospitalization or death) and serious adverse events (discontinuation of VDZ, hospitalization or death) were described quantitatively. RESULTS: We included 212 patients with moderate-severe CD (median age 34 years; 40% male; 90% tumor necrosis factor (TNF)-antagonist exposed) with a median follow-up (IQR) of 39 weeks (25-53). Twelve-month cumulative rates of clinical remission, mucosal healing, and deep remission (clinical remission+mucosal healing) were 35%, 63%, and 26%, respectively. Individuals with prior TNF-antagonist exposure (hazard ratio (HR) 0.40; 95% confidence interval (CI): 0.20-0.81), smoking history (HR 0.47; 95% CI: 0.25-0.89), active perianal disease (HR 0.49; 95% CI: 0.27-0.88), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve clinical remission. Those with prior TNF-antagonist exposure (HR 0.29; 95% CI: 0.12-0.73), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve mucosal healing. During 160 patient years of follow-up (PYF) and 1,433 VDZ infusions, 5 patients developed infusion reactions (3.5 per 1,000 infusions), 21 developed serious infections (13 per 100 PYF), and 17 developed serious adverse events (10 per 100 PYF). A minority of adverse events required discontinuation of therapy (6 per 100 PYF). CONCLUSIONS: VDZ is a safe and effective treatment option for moderate-severe CD in routine practice. Clinical remission and deep remission (clinical remission and mucosal healing) can be achieved in 1/3 of individuals, and a minority of individuals require discontinuation of therapy due to adverse events.

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