Long-term Efficacy of Vedolizumab for Ulcerative Colitis

Edward V. Loftus, Jean-Frédéric Colombel, Brian G. Feagan, Severine Vermeire, 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: The GEMINI long-term safety [LTS] study is a continuing phase 3 trial investigating the safety and efficacy of vedolizumab, an α4β7 integrin antagonist for ulcerative colitis [UC] and Crohn's disease. We provide an interim analysis of efficacy in patients with UC.

METHODS: Patients from the C13004 and GEMINI 1 studies and a cohort of vedolizumab-naïve patients received open-label vedolizumab every 4 weeks. Interim data were collected from May 22, 2009 to June 27, 2013. Clinical response and remission, evaluated using partial Mayo scores, and health-related quality of life [HRQL] were assessed for up to 152 weeks of cumulative treatment in the efficacy population.

RESULTS: As of June 27, 2013, 63% of the efficacy population [n = 532/845] were continuing treatment. Among patients who responded to vedolizumab induction and had data available, 88% [n = 120/136] were in remission after 104 weeks of exposure (96% [n = 70/73] after 152 weeks). Among patients who withdrew from every-8-week vedolizumab maintenance in GEMINI 1 [n = 32] before week 52, increased dosing to every 4 weeks in GEMINI LTS resulted in response and remission rates of 41% and 28%, respectively, after 52 weeks, an increase from 19% and 6%, respectively, from before the dose increase. Similar benefits were demonstrated regardless of prior tumour necrosis factor-antagonist exposure. Durable benefits on HRQL were also observed.

CONCLUSIONS: Patients with UC experienced clinical and HRQL improvements with continued vedolizumab treatment. Increased dosing frequency to every 4 weeks was beneficial in patients who had loss of response to 8-weekly dosing.

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

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

Keywords

  • Journal Article

Cite this

Loftus, E. V., Colombel, J-F., Feagan, B. G., Vermeire, S., Sandborn, W. J., Sands, B. E., ... Smyth, M. A. (2016). Long-term Efficacy of Vedolizumab for Ulcerative Colitis. Journal of Crohn's & colitis. https://doi.org/10.1093/ecco-jcc/jjw177

Long-term Efficacy of Vedolizumab for Ulcerative Colitis. / Loftus, Edward V.; Colombel, Jean-Frédéric; Feagan, Brian G.; Vermeire, Severine; 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

Loftus, EV, Colombel, J-F, Feagan, BG, Vermeire, S, 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 Ulcerative Colitis', Journal of Crohn's & colitis. https://doi.org/10.1093/ecco-jcc/jjw177
Loftus EV, Colombel J-F, Feagan BG, Vermeire S, Sandborn WJ, Sands BE et al. Long-term Efficacy of Vedolizumab for Ulcerative Colitis. Journal of Crohn's & colitis. 2016 Sep 28. https://doi.org/10.1093/ecco-jcc/jjw177
Loftus, Edward V. ; Colombel, Jean-Frédéric ; Feagan, Brian G. ; Vermeire, Severine ; 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 Ulcerative Colitis. In: Journal of Crohn's & colitis. 2016.
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T1 - Long-term Efficacy of Vedolizumab for Ulcerative Colitis

AU - Loftus, Edward V.

AU - Colombel, Jean-Frédéric

AU - Feagan, Brian G.

AU - Vermeire, Severine

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: The GEMINI long-term safety [LTS] study is a continuing phase 3 trial investigating the safety and efficacy of vedolizumab, an α4β7 integrin antagonist for ulcerative colitis [UC] and Crohn's disease. We provide an interim analysis of efficacy in patients with UC.METHODS: Patients from the C13004 and GEMINI 1 studies and a cohort of vedolizumab-naïve patients received open-label vedolizumab every 4 weeks. Interim data were collected from May 22, 2009 to June 27, 2013. Clinical response and remission, evaluated using partial Mayo scores, and health-related quality of life [HRQL] were assessed for up to 152 weeks of cumulative treatment in the efficacy population.RESULTS: As of June 27, 2013, 63% of the efficacy population [n = 532/845] were continuing treatment. Among patients who responded to vedolizumab induction and had data available, 88% [n = 120/136] were in remission after 104 weeks of exposure (96% [n = 70/73] after 152 weeks). Among patients who withdrew from every-8-week vedolizumab maintenance in GEMINI 1 [n = 32] before week 52, increased dosing to every 4 weeks in GEMINI LTS resulted in response and remission rates of 41% and 28%, respectively, after 52 weeks, an increase from 19% and 6%, respectively, from before the dose increase. Similar benefits were demonstrated regardless of prior tumour necrosis factor-antagonist exposure. Durable benefits on HRQL were also observed.CONCLUSIONS: Patients with UC experienced clinical and HRQL improvements with continued vedolizumab treatment. Increased dosing frequency to every 4 weeks was beneficial in patients who had loss of response to 8-weekly dosing.

AB - BACKGROUND AND AIMS: The GEMINI long-term safety [LTS] study is a continuing phase 3 trial investigating the safety and efficacy of vedolizumab, an α4β7 integrin antagonist for ulcerative colitis [UC] and Crohn's disease. We provide an interim analysis of efficacy in patients with UC.METHODS: Patients from the C13004 and GEMINI 1 studies and a cohort of vedolizumab-naïve patients received open-label vedolizumab every 4 weeks. Interim data were collected from May 22, 2009 to June 27, 2013. Clinical response and remission, evaluated using partial Mayo scores, and health-related quality of life [HRQL] were assessed for up to 152 weeks of cumulative treatment in the efficacy population.RESULTS: As of June 27, 2013, 63% of the efficacy population [n = 532/845] were continuing treatment. Among patients who responded to vedolizumab induction and had data available, 88% [n = 120/136] were in remission after 104 weeks of exposure (96% [n = 70/73] after 152 weeks). Among patients who withdrew from every-8-week vedolizumab maintenance in GEMINI 1 [n = 32] before week 52, increased dosing to every 4 weeks in GEMINI LTS resulted in response and remission rates of 41% and 28%, respectively, after 52 weeks, an increase from 19% and 6%, respectively, from before the dose increase. Similar benefits were demonstrated regardless of prior tumour necrosis factor-antagonist exposure. Durable benefits on HRQL were also observed.CONCLUSIONS: Patients with UC experienced clinical and HRQL improvements with continued vedolizumab treatment. Increased dosing frequency to every 4 weeks was beneficial in patients who had loss of response to 8-weekly dosing.

KW - Journal Article

U2 - 10.1093/ecco-jcc/jjw177

DO - 10.1093/ecco-jcc/jjw177

M3 - Article

C2 - 27683800

JO - Journal of Crohn's and Colitis

JF - Journal of Crohn's and Colitis

SN - 1873-9946

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