Effectiveness and Safety of Vedolizumab in Anti-TNF-Naïve Patients With Inflammatory Bowel Disease-A Multicenter Retrospective European Study

Uri Kopylov, Bram Verstockt, Luc Biedermann, Shaji Sebastian, Daniela Pugliese, Elena Sonnenberg, Peter Steinhagen, Naila Arebi, Yulia Ron, Torsten Kucharzik, Xavier Roblin, Bella Ungar, Ariella Bar Gil Shitrit, Sandro Ardizzone, Pauliina Molander, Marina Coletta, Laurent Peyrin-Biroulet, Peter Bossuyt, Irit Avni-Biron, Emmanouela TsoukaliMariangela Allocca, Konstantinos Katsanos, Tim Raine, Taina Sipponen, Gionata Fiorino, Shomron Ben-Horin, Rami Eliakim, Alessandro Armuzzi, Britta Siegmund, Daniel C. Baumgart, Nikolaos Kamperidis, Nitsan Maharshak, Christian Maaser, Gerassimos Mantzaris, Henit Yanai, Dimitrious K. Christodoulou, Iris Dotan, Marc Ferrante

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Background: Vedolizumab (VDZ) is effective for treatment of ulcerative colitis (UC) and Crohn's disease (CD). In GEMINI trials, anti-tumor necrosis factor (anti-TNF)-naïve patients had a superior response compared with anti-TNF-exposed patients. In real-world experience (RWE), the number of included anti-TNF-naïve patients was low. We aimed to evaluate the effectiveness and safety of VDZ in anti-TNF-naïve patients in an RWE setting.

Methods: This retrospective multicenter European pooled cohort study included consecutive active anti-TNF-naïve IBD patients treated with VDZ. The primary end point was clinical response at week 14. Patients with follow-up beyond week 14 and those discontinuing VDZ at any time were included for maintenance outcomes analysis.

Results: Since January 2015, 184 anti-TNF-naïve patients from 23 centers initiated VDZ treatment (Crohn's disease [CD], 50; ulcerative colitis [UC], 134). In CD, 42/50 (82%) patients responded by week 14 and 32 (64%) were in clinical remission; 26/50 (52%) achieved corticosteroid-free remission (CSFR). At last follow-up (44 weeks; interquartile range [IQR], 30-52 weeks), 27/35 (77.1%) patients with available data responded to treatment; 24/35 (68.6%) were in clinical remission, 21/35 (60%) were in CSFR. For UC, 116/134 (79.1%) responded to treatment by week 14, including 53 (39.5%) in clinical remission; 49/134 (36.6%) achieved CSFR. At last follow-up (42.5 weeks; IQR, 30-52 weeks), 79/103 (76.7%) patients responded to treatment, 69/103 (67.0%) were in remission, and 61/103 (59.2%) were in CSFR. Adverse effects were reported in 20 (11%) of the patients, leading to treatment discontinuation in 6 (3.3%).

Conclusions: VDZ is similarly effective in ant-TNF-naïve CD and UC patients. The efficacy is higher than reported in anti-TNF-experienced patients and is comparable to that of anti-TNF biologics in this population.

Original languageEnglish
Pages (from-to)2442-2451
Number of pages10
JournalInflammatory Bowel Diseases
Volume24
Issue number11
DOIs
Publication statusPublished - Oct 12 2018

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Inflammatory Bowel Diseases
Retrospective Studies
Safety
Tumor Necrosis Factor-alpha
Ulcerative Colitis
Crohn Disease
Adrenal Cortex Hormones
vedolizumab
Therapeutics
Ants
Biological Products
Cohort Studies
Maintenance

ASJC Scopus subject areas

  • Immunology and Allergy
  • Gastroenterology

Cite this

Kopylov, U., Verstockt, B., Biedermann, L., Sebastian, S., Pugliese, D., Sonnenberg, E., ... Ferrante, M. (2018). Effectiveness and Safety of Vedolizumab in Anti-TNF-Naïve Patients With Inflammatory Bowel Disease-A Multicenter Retrospective European Study. Inflammatory Bowel Diseases, 24(11), 2442-2451. https://doi.org/10.1093/ibd/izy155

Effectiveness and Safety of Vedolizumab in Anti-TNF-Naïve Patients With Inflammatory Bowel Disease-A Multicenter Retrospective European Study. / Kopylov, Uri; Verstockt, Bram; Biedermann, Luc; Sebastian, Shaji; Pugliese, Daniela; Sonnenberg, Elena; Steinhagen, Peter; Arebi, Naila; Ron, Yulia; Kucharzik, Torsten; Roblin, Xavier; Ungar, Bella; Shitrit, Ariella Bar Gil; Ardizzone, Sandro; Molander, Pauliina; Coletta, Marina; Peyrin-Biroulet, Laurent; Bossuyt, Peter; Avni-Biron, Irit; Tsoukali, Emmanouela; Allocca, Mariangela; Katsanos, Konstantinos; Raine, Tim; Sipponen, Taina; Fiorino, Gionata; Ben-Horin, Shomron; Eliakim, Rami; Armuzzi, Alessandro; Siegmund, Britta; Baumgart, Daniel C.; Kamperidis, Nikolaos; Maharshak, Nitsan; Maaser, Christian; Mantzaris, Gerassimos; Yanai, Henit; Christodoulou, Dimitrious K.; Dotan, Iris; Ferrante, Marc.

In: Inflammatory Bowel Diseases, Vol. 24, No. 11, 12.10.2018, p. 2442-2451.

Research output: Contribution to journalArticle

Kopylov, U, Verstockt, B, Biedermann, L, Sebastian, S, Pugliese, D, Sonnenberg, E, Steinhagen, P, Arebi, N, Ron, Y, Kucharzik, T, Roblin, X, Ungar, B, Shitrit, ABG, Ardizzone, S, Molander, P, Coletta, M, Peyrin-Biroulet, L, Bossuyt, P, Avni-Biron, I, Tsoukali, E, Allocca, M, Katsanos, K, Raine, T, Sipponen, T, Fiorino, G, Ben-Horin, S, Eliakim, R, Armuzzi, A, Siegmund, B, Baumgart, DC, Kamperidis, N, Maharshak, N, Maaser, C, Mantzaris, G, Yanai, H, Christodoulou, DK, Dotan, I & Ferrante, M 2018, 'Effectiveness and Safety of Vedolizumab in Anti-TNF-Naïve Patients With Inflammatory Bowel Disease-A Multicenter Retrospective European Study', Inflammatory Bowel Diseases, vol. 24, no. 11, pp. 2442-2451. https://doi.org/10.1093/ibd/izy155
Kopylov, Uri ; Verstockt, Bram ; Biedermann, Luc ; Sebastian, Shaji ; Pugliese, Daniela ; Sonnenberg, Elena ; Steinhagen, Peter ; Arebi, Naila ; Ron, Yulia ; Kucharzik, Torsten ; Roblin, Xavier ; Ungar, Bella ; Shitrit, Ariella Bar Gil ; Ardizzone, Sandro ; Molander, Pauliina ; Coletta, Marina ; Peyrin-Biroulet, Laurent ; Bossuyt, Peter ; Avni-Biron, Irit ; Tsoukali, Emmanouela ; Allocca, Mariangela ; Katsanos, Konstantinos ; Raine, Tim ; Sipponen, Taina ; Fiorino, Gionata ; Ben-Horin, Shomron ; Eliakim, Rami ; Armuzzi, Alessandro ; Siegmund, Britta ; Baumgart, Daniel C. ; Kamperidis, Nikolaos ; Maharshak, Nitsan ; Maaser, Christian ; Mantzaris, Gerassimos ; Yanai, Henit ; Christodoulou, Dimitrious K. ; Dotan, Iris ; Ferrante, Marc. / Effectiveness and Safety of Vedolizumab in Anti-TNF-Naïve Patients With Inflammatory Bowel Disease-A Multicenter Retrospective European Study. In: Inflammatory Bowel Diseases. 2018 ; Vol. 24, No. 11. pp. 2442-2451.
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title = "Effectiveness and Safety of Vedolizumab in Anti-TNF-Na{\"i}ve Patients With Inflammatory Bowel Disease-A Multicenter Retrospective European Study",
abstract = "Background: Vedolizumab (VDZ) is effective for treatment of ulcerative colitis (UC) and Crohn's disease (CD). In GEMINI trials, anti-tumor necrosis factor (anti-TNF)-na{\"i}ve patients had a superior response compared with anti-TNF-exposed patients. In real-world experience (RWE), the number of included anti-TNF-na{\"i}ve patients was low. We aimed to evaluate the effectiveness and safety of VDZ in anti-TNF-na{\"i}ve patients in an RWE setting.Methods: This retrospective multicenter European pooled cohort study included consecutive active anti-TNF-na{\"i}ve IBD patients treated with VDZ. The primary end point was clinical response at week 14. Patients with follow-up beyond week 14 and those discontinuing VDZ at any time were included for maintenance outcomes analysis.Results: Since January 2015, 184 anti-TNF-na{\"i}ve patients from 23 centers initiated VDZ treatment (Crohn's disease [CD], 50; ulcerative colitis [UC], 134). In CD, 42/50 (82{\%}) patients responded by week 14 and 32 (64{\%}) were in clinical remission; 26/50 (52{\%}) achieved corticosteroid-free remission (CSFR). At last follow-up (44 weeks; interquartile range [IQR], 30-52 weeks), 27/35 (77.1{\%}) patients with available data responded to treatment; 24/35 (68.6{\%}) were in clinical remission, 21/35 (60{\%}) were in CSFR. For UC, 116/134 (79.1{\%}) responded to treatment by week 14, including 53 (39.5{\%}) in clinical remission; 49/134 (36.6{\%}) achieved CSFR. At last follow-up (42.5 weeks; IQR, 30-52 weeks), 79/103 (76.7{\%}) patients responded to treatment, 69/103 (67.0{\%}) were in remission, and 61/103 (59.2{\%}) were in CSFR. Adverse effects were reported in 20 (11{\%}) of the patients, leading to treatment discontinuation in 6 (3.3{\%}).Conclusions: VDZ is similarly effective in ant-TNF-na{\"i}ve CD and UC patients. The efficacy is higher than reported in anti-TNF-experienced patients and is comparable to that of anti-TNF biologics in this population.",
author = "Uri Kopylov and Bram Verstockt and Luc Biedermann and Shaji Sebastian and Daniela Pugliese and Elena Sonnenberg and Peter Steinhagen and Naila Arebi and Yulia Ron and Torsten Kucharzik and Xavier Roblin and Bella Ungar and Shitrit, {Ariella Bar Gil} and Sandro Ardizzone and Pauliina Molander and Marina Coletta and Laurent Peyrin-Biroulet and Peter Bossuyt and Irit Avni-Biron and Emmanouela Tsoukali and Mariangela Allocca and Konstantinos Katsanos and Tim Raine and Taina Sipponen and Gionata Fiorino and Shomron Ben-Horin and Rami Eliakim and Alessandro Armuzzi and Britta Siegmund and Baumgart, {Daniel C.} and Nikolaos Kamperidis and Nitsan Maharshak and Christian Maaser and Gerassimos Mantzaris and Henit Yanai and Christodoulou, {Dimitrious K.} and Iris Dotan and Marc Ferrante",
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month = "10",
day = "12",
doi = "10.1093/ibd/izy155",
language = "English",
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journal = "Inflammatory Bowel Diseases",
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TY - JOUR

T1 - Effectiveness and Safety of Vedolizumab in Anti-TNF-Naïve Patients With Inflammatory Bowel Disease-A Multicenter Retrospective European Study

AU - Kopylov, Uri

AU - Verstockt, Bram

AU - Biedermann, Luc

AU - Sebastian, Shaji

AU - Pugliese, Daniela

AU - Sonnenberg, Elena

AU - Steinhagen, Peter

AU - Arebi, Naila

AU - Ron, Yulia

AU - Kucharzik, Torsten

AU - Roblin, Xavier

AU - Ungar, Bella

AU - Shitrit, Ariella Bar Gil

AU - Ardizzone, Sandro

AU - Molander, Pauliina

AU - Coletta, Marina

AU - Peyrin-Biroulet, Laurent

AU - Bossuyt, Peter

AU - Avni-Biron, Irit

AU - Tsoukali, Emmanouela

AU - Allocca, Mariangela

AU - Katsanos, Konstantinos

AU - Raine, Tim

AU - Sipponen, Taina

AU - Fiorino, Gionata

AU - Ben-Horin, Shomron

AU - Eliakim, Rami

AU - Armuzzi, Alessandro

AU - Siegmund, Britta

AU - Baumgart, Daniel C.

AU - Kamperidis, Nikolaos

AU - Maharshak, Nitsan

AU - Maaser, Christian

AU - Mantzaris, Gerassimos

AU - Yanai, Henit

AU - Christodoulou, Dimitrious K.

AU - Dotan, Iris

AU - Ferrante, Marc

PY - 2018/10/12

Y1 - 2018/10/12

N2 - Background: Vedolizumab (VDZ) is effective for treatment of ulcerative colitis (UC) and Crohn's disease (CD). In GEMINI trials, anti-tumor necrosis factor (anti-TNF)-naïve patients had a superior response compared with anti-TNF-exposed patients. In real-world experience (RWE), the number of included anti-TNF-naïve patients was low. We aimed to evaluate the effectiveness and safety of VDZ in anti-TNF-naïve patients in an RWE setting.Methods: This retrospective multicenter European pooled cohort study included consecutive active anti-TNF-naïve IBD patients treated with VDZ. The primary end point was clinical response at week 14. Patients with follow-up beyond week 14 and those discontinuing VDZ at any time were included for maintenance outcomes analysis.Results: Since January 2015, 184 anti-TNF-naïve patients from 23 centers initiated VDZ treatment (Crohn's disease [CD], 50; ulcerative colitis [UC], 134). In CD, 42/50 (82%) patients responded by week 14 and 32 (64%) were in clinical remission; 26/50 (52%) achieved corticosteroid-free remission (CSFR). At last follow-up (44 weeks; interquartile range [IQR], 30-52 weeks), 27/35 (77.1%) patients with available data responded to treatment; 24/35 (68.6%) were in clinical remission, 21/35 (60%) were in CSFR. For UC, 116/134 (79.1%) responded to treatment by week 14, including 53 (39.5%) in clinical remission; 49/134 (36.6%) achieved CSFR. At last follow-up (42.5 weeks; IQR, 30-52 weeks), 79/103 (76.7%) patients responded to treatment, 69/103 (67.0%) were in remission, and 61/103 (59.2%) were in CSFR. Adverse effects were reported in 20 (11%) of the patients, leading to treatment discontinuation in 6 (3.3%).Conclusions: VDZ is similarly effective in ant-TNF-naïve CD and UC patients. The efficacy is higher than reported in anti-TNF-experienced patients and is comparable to that of anti-TNF biologics in this population.

AB - Background: Vedolizumab (VDZ) is effective for treatment of ulcerative colitis (UC) and Crohn's disease (CD). In GEMINI trials, anti-tumor necrosis factor (anti-TNF)-naïve patients had a superior response compared with anti-TNF-exposed patients. In real-world experience (RWE), the number of included anti-TNF-naïve patients was low. We aimed to evaluate the effectiveness and safety of VDZ in anti-TNF-naïve patients in an RWE setting.Methods: This retrospective multicenter European pooled cohort study included consecutive active anti-TNF-naïve IBD patients treated with VDZ. The primary end point was clinical response at week 14. Patients with follow-up beyond week 14 and those discontinuing VDZ at any time were included for maintenance outcomes analysis.Results: Since January 2015, 184 anti-TNF-naïve patients from 23 centers initiated VDZ treatment (Crohn's disease [CD], 50; ulcerative colitis [UC], 134). In CD, 42/50 (82%) patients responded by week 14 and 32 (64%) were in clinical remission; 26/50 (52%) achieved corticosteroid-free remission (CSFR). At last follow-up (44 weeks; interquartile range [IQR], 30-52 weeks), 27/35 (77.1%) patients with available data responded to treatment; 24/35 (68.6%) were in clinical remission, 21/35 (60%) were in CSFR. For UC, 116/134 (79.1%) responded to treatment by week 14, including 53 (39.5%) in clinical remission; 49/134 (36.6%) achieved CSFR. At last follow-up (42.5 weeks; IQR, 30-52 weeks), 79/103 (76.7%) patients responded to treatment, 69/103 (67.0%) were in remission, and 61/103 (59.2%) were in CSFR. Adverse effects were reported in 20 (11%) of the patients, leading to treatment discontinuation in 6 (3.3%).Conclusions: VDZ is similarly effective in ant-TNF-naïve CD and UC patients. The efficacy is higher than reported in anti-TNF-experienced patients and is comparable to that of anti-TNF biologics in this population.

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