Long-term Efficacy of Vedolizumab for Crohn's Disease

Severine Vermeire, Edward V. Loftus, Jean-Frédéric Colombel, Brian G. Feagan, William J. Sandborn, Bruce E. Sands, Silvio Danese, Geert R D'Haens, Arthur Kaser, Remo Panaccione, David T. Rubin, Ira Shafran, Megan McAuliffe, Arpeat Kaviya, Serap Sankoh, Reema Mody, Brihad Abhyankar, Michael A. Smyth

Research output: Contribution to journalArticle

Abstract

BACKGROUND AND AIMS: Vedolizumab is a gut-selective α4β7 integrin antagonist therapy for ulcerative colitis and Crohn's disease. The GEMINI long-term safety [LTS] trial is an ongoing open-label study investigating the safety of vedolizumab. We present interim exploratory analyses of efficacy in patients with Crohn's disease.

METHODS: Patients from the C13004, GEMINI 2 and GEMINI 3 studies and vedolizumab-naïve patients could enrol in GEMINI LTS and received vedolizumab every 4 weeks. Data were collected from May 22, 2009 to June 27, 2013. Outcomes of clinical response and remission, defined by the Harvey-Bradshaw Index, and health-related quality of life [HRQL] were assessed for up to 152 weeks of treatment in the efficacy population.

RESULTS: Among patients with response at week 6 in GEMINI 2 who received vedolizumab continuously, 83% [n=100/120] and 89% [n=62/70] of patients with available data were in remission after 104 and 152 weeks, respectively. Increased dosing frequency from every 8 weeks [GEMINI 2] to every 4 weeks [GEMINI LTS] improved outcomes in patients who had withdrawn early from GEMINI 2, with 47% [n=27/57] experiencing clinical response and 32% [n=18/57] in remission at week 52 of GEMINI LTS [up from 39% and 4% before the dose increase]. Similar improvements were observed regardless of prior tumour necrosis factor [TNF] antagonist exposure. Long-term benefits of HRQL were also observed.

CONCLUSIONS: The clinical benefits of vedolizumab continued with long-term treatment regardless of prior TNF antagonist exposure. Increased dosing frequency might improve outcomes in patients who lose response to conventional 8-weekly dosing.

Original languageEnglish
JournalJournal of Crohn's & colitis
DOIs
Publication statusE-pub ahead of print - Sep 28 2016

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Crohn Disease
Safety
Tumor Necrosis Factor-alpha
Quality of Life
vedolizumab
Ulcerative Colitis
Integrins
Therapeutics
Population

Keywords

  • Journal Article

Cite this

Vermeire, S., Loftus, E. V., Colombel, J-F., Feagan, B. G., Sandborn, W. J., Sands, B. E., ... Smyth, M. A. (2016). Long-term Efficacy of Vedolizumab for Crohn's Disease. Journal of Crohn's & colitis. https://doi.org/10.1093/ecco-jcc/jjw176

Long-term Efficacy of Vedolizumab for Crohn's Disease. / Vermeire, Severine; Loftus, Edward V.; Colombel, Jean-Frédéric; Feagan, Brian G.; Sandborn, William J.; Sands, Bruce E.; Danese, Silvio; D'Haens, Geert R; Kaser, Arthur; Panaccione, Remo; Rubin, David T.; Shafran, Ira; McAuliffe, Megan; Kaviya, Arpeat; Sankoh, Serap; Mody, Reema; Abhyankar, Brihad; Smyth, Michael A.

In: Journal of Crohn's & colitis, 28.09.2016.

Research output: Contribution to journalArticle

Vermeire, S, Loftus, EV, Colombel, J-F, Feagan, BG, Sandborn, WJ, Sands, BE, Danese, S, D'Haens, GR, Kaser, A, Panaccione, R, Rubin, DT, Shafran, I, McAuliffe, M, Kaviya, A, Sankoh, S, Mody, R, Abhyankar, B & Smyth, MA 2016, 'Long-term Efficacy of Vedolizumab for Crohn's Disease', Journal of Crohn's & colitis. https://doi.org/10.1093/ecco-jcc/jjw176
Vermeire S, Loftus EV, Colombel J-F, Feagan BG, Sandborn WJ, Sands BE et al. Long-term Efficacy of Vedolizumab for Crohn's Disease. Journal of Crohn's & colitis. 2016 Sep 28. https://doi.org/10.1093/ecco-jcc/jjw176
Vermeire, Severine ; Loftus, Edward V. ; Colombel, Jean-Frédéric ; Feagan, Brian G. ; Sandborn, William J. ; Sands, Bruce E. ; Danese, Silvio ; D'Haens, Geert R ; Kaser, Arthur ; Panaccione, Remo ; Rubin, David T. ; Shafran, Ira ; McAuliffe, Megan ; Kaviya, Arpeat ; Sankoh, Serap ; Mody, Reema ; Abhyankar, Brihad ; Smyth, Michael A. / Long-term Efficacy of Vedolizumab for Crohn's Disease. In: Journal of Crohn's & colitis. 2016.
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T1 - Long-term Efficacy of Vedolizumab for Crohn's Disease

AU - Vermeire, Severine

AU - Loftus, Edward V.

AU - Colombel, Jean-Frédéric

AU - Feagan, Brian G.

AU - Sandborn, William J.

AU - Sands, Bruce E.

AU - Danese, Silvio

AU - D'Haens, Geert R

AU - Kaser, Arthur

AU - Panaccione, Remo

AU - Rubin, David T.

AU - Shafran, Ira

AU - McAuliffe, Megan

AU - Kaviya, Arpeat

AU - Sankoh, Serap

AU - Mody, Reema

AU - Abhyankar, Brihad

AU - Smyth, Michael A.

N1 - Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

PY - 2016/9/28

Y1 - 2016/9/28

N2 - BACKGROUND AND AIMS: Vedolizumab is a gut-selective α4β7 integrin antagonist therapy for ulcerative colitis and Crohn's disease. The GEMINI long-term safety [LTS] trial is an ongoing open-label study investigating the safety of vedolizumab. We present interim exploratory analyses of efficacy in patients with Crohn's disease.METHODS: Patients from the C13004, GEMINI 2 and GEMINI 3 studies and vedolizumab-naïve patients could enrol in GEMINI LTS and received vedolizumab every 4 weeks. Data were collected from May 22, 2009 to June 27, 2013. Outcomes of clinical response and remission, defined by the Harvey-Bradshaw Index, and health-related quality of life [HRQL] were assessed for up to 152 weeks of treatment in the efficacy population.RESULTS: Among patients with response at week 6 in GEMINI 2 who received vedolizumab continuously, 83% [n=100/120] and 89% [n=62/70] of patients with available data were in remission after 104 and 152 weeks, respectively. Increased dosing frequency from every 8 weeks [GEMINI 2] to every 4 weeks [GEMINI LTS] improved outcomes in patients who had withdrawn early from GEMINI 2, with 47% [n=27/57] experiencing clinical response and 32% [n=18/57] in remission at week 52 of GEMINI LTS [up from 39% and 4% before the dose increase]. Similar improvements were observed regardless of prior tumour necrosis factor [TNF] antagonist exposure. Long-term benefits of HRQL were also observed.CONCLUSIONS: The clinical benefits of vedolizumab continued with long-term treatment regardless of prior TNF antagonist exposure. Increased dosing frequency might improve outcomes in patients who lose response to conventional 8-weekly dosing.

AB - BACKGROUND AND AIMS: Vedolizumab is a gut-selective α4β7 integrin antagonist therapy for ulcerative colitis and Crohn's disease. The GEMINI long-term safety [LTS] trial is an ongoing open-label study investigating the safety of vedolizumab. We present interim exploratory analyses of efficacy in patients with Crohn's disease.METHODS: Patients from the C13004, GEMINI 2 and GEMINI 3 studies and vedolizumab-naïve patients could enrol in GEMINI LTS and received vedolizumab every 4 weeks. Data were collected from May 22, 2009 to June 27, 2013. Outcomes of clinical response and remission, defined by the Harvey-Bradshaw Index, and health-related quality of life [HRQL] were assessed for up to 152 weeks of treatment in the efficacy population.RESULTS: Among patients with response at week 6 in GEMINI 2 who received vedolizumab continuously, 83% [n=100/120] and 89% [n=62/70] of patients with available data were in remission after 104 and 152 weeks, respectively. Increased dosing frequency from every 8 weeks [GEMINI 2] to every 4 weeks [GEMINI LTS] improved outcomes in patients who had withdrawn early from GEMINI 2, with 47% [n=27/57] experiencing clinical response and 32% [n=18/57] in remission at week 52 of GEMINI LTS [up from 39% and 4% before the dose increase]. Similar improvements were observed regardless of prior tumour necrosis factor [TNF] antagonist exposure. Long-term benefits of HRQL were also observed.CONCLUSIONS: The clinical benefits of vedolizumab continued with long-term treatment regardless of prior TNF antagonist exposure. Increased dosing frequency might improve outcomes in patients who lose response to conventional 8-weekly dosing.

KW - Journal Article

U2 - 10.1093/ecco-jcc/jjw176

DO - 10.1093/ecco-jcc/jjw176

M3 - Article

JO - Journal of Crohn's and Colitis

JF - Journal of Crohn's and Colitis

SN - 1873-9946

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