Real-world clinical, endoscopic and radiographic efficacy of vedolizumab for the treatment of inflammatory bowel disease

Paulo G. Kotze; Christopher Ma; Abdulelah Almutairdi; Ahmed Al-Darmaki; Shane M. Devlin; Gilaad G Kaplan; Cynthia H. Seow; Kerri L. Novak; Cathy Lu; Jose G.P. Ferraz; Michael J. Stewart; Michelle Buresi; Humberto Jijon; Meena Mathivanan; Joan Heatherington; Marie Louise Martin; Remo Panaccione

doi:10.1111/apt.14919

Real-world clinical, endoscopic and radiographic efficacy of vedolizumab for the treatment of inflammatory bowel disease

Paulo G. Kotze, Christopher Ma, Abdulelah Almutairdi, Ahmed Al-Darmaki, Shane M. Devlin, Gilaad G Kaplan, Cynthia H. Seow, Kerri L. Novak, Cathy Lu, Jose G.P. Ferraz, Michael J. Stewart, Michelle Buresi, Humberto Jijon, Meena Mathivanan, Joan Heatherington, Marie Louise Martin, Remo Panaccione

Producción científica: Contribución a una revista › Artículo › revisión exhaustiva

51 Citas (Scopus)

Resumen

Background: Vedolizumab is an α4β7 integrin antagonist with proven efficacy for inducing and maintaining clinical response and remission in Crohn's disease (CD) and ulcerative colitis (UC). Aim: To evaluate clinical and objective response and remission rates with vedolizumab in a large, real world cohort. Methods: A retrospective cohort study of adult CD and UC patients receiving vedolizumab between 2012 and 2017 was conducted. Primary outcome: clinical or objective response and remission at 3, 6 and 12 months after induction. Clinical remission was defined by complete, steroid-free absence of symptoms. Objective remission was defined by endoscopic mucosal healing or normalisation of radiographic appearance on contrast-enhanced ultrasound or CT/MR enterography. Results: The study included 222 vedolizumab patients (122 CD, 100 UC). In CD, clinical remission at 3, 6 and 12 months was achieved in 19.8% (22/111), 22.1% (21/95) and 22.1% (15/68) of patients, respectively. Objective remission occurred in 11.5% (6/52), 21.2% (14/66), and 18.9% (7/37) of patients at 3, 6 and 12 months, respectively. In UC, clinical remission at 3, 6, and 12 months was 51.0% (51/100), 61.8% (55/89) and 61.9% (39/63), respectively. Endoscopic remission occurred in 27.5% (11/40), 41.0% (16/39) and 47.8% (22/46) of patients at 3, 6 and 12 months, respectively. In multivariable analysis, patients with UC as compared to CD, and those with milder disease activity were more likely to achieve objectively defined remission at both 6 and 12 months. Conclusions: Vedolizumab was effective for induction and maintenance of clinical and objective remission, both in Crohn's disease and ulcerative colitis.

Idioma original	English
Páginas (desde-hasta)	626-637
Número de páginas	12
Publicación	Alimentary Pharmacology and Therapeutics
Volumen	48
N.º	6
DOI	https://doi.org/10.1111/apt.14919
Estado	Published - sep. 2018
Publicado de forma externa	Sí

Nota bibliográfica

Funding Information:
Declaration of personal interests: Paulo G. Kotze has received speaking or consultancy honoraria from AbbVie, Ferring, Janssen, Pfizer, and Takeda. Shane Devlin has received speaking or consultancy honoraria from AbbVie, Ferring, Janssen, Pfizer, Shire and Takeda. Cynthia Seow has received speaking or consultancy honoraria from AbbVie, Actavis, Ferring, Janssen, Pfizer, Shire, and Takeda. Gilaad Kaplan has received speaking or consultancy honoraria from AbbVie, Janssen, Pfizer, and Shire. He has received a grant from Abbvie, Janssen, Merck, and Shire. Kerri Novak has received speaking or consultancy honoraria from AbbVie, Janssen, Pendopharm, Pfizer, and Takeda. She has also received a grant from AbbVie. Cathy Lu has received consultancy honoraria from AbbVie and Ferring. Michael Stewart has received speaking or consultancy honoraria from AbbVie, Ferring, Janssen, Takeda, and Shire. Meena Mathivanana as received consultancy honoraria from AbbVie, Ferring, Janssen, Pfizer, Shire, and Takeda. Joan Heatherington has received speaker honoraria from AbbVie, Ferring, Janssen, and Takeda. Remo Panaccione has received research/educational support from AbbVie, Abbott, Bristol-Myers Squibb, Centocor, Elan, Ferring, Janssen, Millennium, Procter & Gamble, and Schering-Plough. He has served as a consultant for AbbVie, Abbott, Amgen, Aptalis, AstraZeneca, Baxter, Bristol-Myers Squibb, Celgene, Centocor, Cubist, Eisai, Elan, Ferring, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Pfizer, Schering-Plough, Shire, Takeda, UCB, and Warner Chilcott. Remo Panaccione has also participated on speaker's bureaus for AbbVie, AstraZeneca, Centocor, Elan, Ferring, Janssen, Prometheus, Schering-Plough, Shire, Takeda, and Warner Chilcott. He has attended advisory boards for AbbVie, Abbott, Amgen, Aptalis, AstraZeneca, Baxter, Bristol-Myers Squibb, Celgene, Centocor, Cubist, Eisai, Elan, Ferring, Genentech, GlaxoSmithKline, Janssen, Merck, Pfizer, Salix, Schering-Plough, Shire, Takeda, UCB, and Warner Chilcott. All other authors have no disclosure. Declaration of funding interests: This study was funded in part by the Canadian Association of Gastroenterology and the Canadian Institutes for Health Research (Christopher Ma). Funding information This study was funded in part by the Canadian Association of Gastroenterology and the Canadian Institutes for Health Research (Christopher Ma).

Publisher Copyright:
© 2018 John Wiley & Sons Ltd

ASJC Scopus Subject Areas

Hepatology
Gastroenterology
Pharmacology (medical)

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10.1111/apt.14919

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Kotze, P. G., Ma, C., Almutairdi, A., Al-Darmaki, A., Devlin, S. M., Kaplan, GG., Seow, C. H., Novak, K. L., Lu, C., Ferraz, J. G. P., Stewart, M. J., Buresi, M., Jijon, H., Mathivanan, M., Heatherington, J., Martin, M. L., & Panaccione, R. (2018). Real-world clinical, endoscopic and radiographic efficacy of vedolizumab for the treatment of inflammatory bowel disease. Alimentary Pharmacology and Therapeutics, 48(6), 626-637. https://doi.org/10.1111/apt.14919

Kotze, PG, Ma, C, Almutairdi, A, Al-Darmaki, A, Devlin, SM, Kaplan, GG, Seow, CH, Novak, KL, Lu, C, Ferraz, JGP, Stewart, MJ, Buresi, M, Jijon, H, Mathivanan, M, Heatherington, J, Martin, ML & Panaccione, R 2018, 'Real-world clinical, endoscopic and radiographic efficacy of vedolizumab for the treatment of inflammatory bowel disease', Alimentary Pharmacology and Therapeutics, vol. 48, n.º 6, pp. 626-637. https://doi.org/10.1111/apt.14919

@article{38c962a222964d789fb02287ff1727a9,

title = "Real-world clinical, endoscopic and radiographic efficacy of vedolizumab for the treatment of inflammatory bowel disease",

abstract = "Background: Vedolizumab is an α4β7 integrin antagonist with proven efficacy for inducing and maintaining clinical response and remission in Crohn's disease (CD) and ulcerative colitis (UC). Aim: To evaluate clinical and objective response and remission rates with vedolizumab in a large, real world cohort. Methods: A retrospective cohort study of adult CD and UC patients receiving vedolizumab between 2012 and 2017 was conducted. Primary outcome: clinical or objective response and remission at 3, 6 and 12 months after induction. Clinical remission was defined by complete, steroid-free absence of symptoms. Objective remission was defined by endoscopic mucosal healing or normalisation of radiographic appearance on contrast-enhanced ultrasound or CT/MR enterography. Results: The study included 222 vedolizumab patients (122 CD, 100 UC). In CD, clinical remission at 3, 6 and 12 months was achieved in 19.8% (22/111), 22.1% (21/95) and 22.1% (15/68) of patients, respectively. Objective remission occurred in 11.5% (6/52), 21.2% (14/66), and 18.9% (7/37) of patients at 3, 6 and 12 months, respectively. In UC, clinical remission at 3, 6, and 12 months was 51.0% (51/100), 61.8% (55/89) and 61.9% (39/63), respectively. Endoscopic remission occurred in 27.5% (11/40), 41.0% (16/39) and 47.8% (22/46) of patients at 3, 6 and 12 months, respectively. In multivariable analysis, patients with UC as compared to CD, and those with milder disease activity were more likely to achieve objectively defined remission at both 6 and 12 months. Conclusions: Vedolizumab was effective for induction and maintenance of clinical and objective remission, both in Crohn's disease and ulcerative colitis.",

author = "Kotze, {Paulo G.} and Christopher Ma and Abdulelah Almutairdi and Ahmed Al-Darmaki and Devlin, {Shane M.} and Gilaad G Kaplan and Seow, {Cynthia H.} and Novak, {Kerri L.} and Cathy Lu and Ferraz, {Jose G.P.} and Stewart, {Michael J.} and Michelle Buresi and Humberto Jijon and Meena Mathivanan and Joan Heatherington and Martin, {Marie Louise} and Remo Panaccione",

note = "Funding Information: Declaration of personal interests: Paulo G. Kotze has received speaking or consultancy honoraria from AbbVie, Ferring, Janssen, Pfizer, and Takeda. Shane Devlin has received speaking or consultancy honoraria from AbbVie, Ferring, Janssen, Pfizer, Shire and Takeda. Cynthia Seow has received speaking or consultancy honoraria from AbbVie, Actavis, Ferring, Janssen, Pfizer, Shire, and Takeda. Gilaad Kaplan has received speaking or consultancy honoraria from AbbVie, Janssen, Pfizer, and Shire. He has received a grant from Abbvie, Janssen, Merck, and Shire. Kerri Novak has received speaking or consultancy honoraria from AbbVie, Janssen, Pendopharm, Pfizer, and Takeda. She has also received a grant from AbbVie. Cathy Lu has received consultancy honoraria from AbbVie and Ferring. Michael Stewart has received speaking or consultancy honoraria from AbbVie, Ferring, Janssen, Takeda, and Shire. Meena Mathivanana as received consultancy honoraria from AbbVie, Ferring, Janssen, Pfizer, Shire, and Takeda. Joan Heatherington has received speaker honoraria from AbbVie, Ferring, Janssen, and Takeda. Remo Panaccione has received research/educational support from AbbVie, Abbott, Bristol-Myers Squibb, Centocor, Elan, Ferring, Janssen, Millennium, Procter & Gamble, and Schering-Plough. He has served as a consultant for AbbVie, Abbott, Amgen, Aptalis, AstraZeneca, Baxter, Bristol-Myers Squibb, Celgene, Centocor, Cubist, Eisai, Elan, Ferring, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Pfizer, Schering-Plough, Shire, Takeda, UCB, and Warner Chilcott. Remo Panaccione has also participated on speaker's bureaus for AbbVie, AstraZeneca, Centocor, Elan, Ferring, Janssen, Prometheus, Schering-Plough, Shire, Takeda, and Warner Chilcott. He has attended advisory boards for AbbVie, Abbott, Amgen, Aptalis, AstraZeneca, Baxter, Bristol-Myers Squibb, Celgene, Centocor, Cubist, Eisai, Elan, Ferring, Genentech, GlaxoSmithKline, Janssen, Merck, Pfizer, Salix, Schering-Plough, Shire, Takeda, UCB, and Warner Chilcott. All other authors have no disclosure. Declaration of funding interests: This study was funded in part by the Canadian Association of Gastroenterology and the Canadian Institutes for Health Research (Christopher Ma). Funding information This study was funded in part by the Canadian Association of Gastroenterology and the Canadian Institutes for Health Research (Christopher Ma). Publisher Copyright: {\textcopyright} 2018 John Wiley & Sons Ltd",

year = "2018",

month = sep,

doi = "10.1111/apt.14919",

language = "English",

volume = "48",

pages = "626--637",

journal = "Alimentary Pharmacology and Therapeutics",

issn = "0269-2813",

publisher = "Wiley-Blackwell",

number = "6",

}

TY - JOUR

T1 - Real-world clinical, endoscopic and radiographic efficacy of vedolizumab for the treatment of inflammatory bowel disease

AU - Kotze, Paulo G.

AU - Ma, Christopher

AU - Almutairdi, Abdulelah

AU - Al-Darmaki, Ahmed

AU - Devlin, Shane M.

AU - Kaplan, Gilaad G

AU - Seow, Cynthia H.

AU - Novak, Kerri L.

AU - Lu, Cathy

AU - Ferraz, Jose G.P.

AU - Stewart, Michael J.

AU - Buresi, Michelle

AU - Jijon, Humberto

AU - Mathivanan, Meena

AU - Heatherington, Joan

AU - Martin, Marie Louise

AU - Panaccione, Remo

N1 - Funding Information: Declaration of personal interests: Paulo G. Kotze has received speaking or consultancy honoraria from AbbVie, Ferring, Janssen, Pfizer, and Takeda. Shane Devlin has received speaking or consultancy honoraria from AbbVie, Ferring, Janssen, Pfizer, Shire and Takeda. Cynthia Seow has received speaking or consultancy honoraria from AbbVie, Actavis, Ferring, Janssen, Pfizer, Shire, and Takeda. Gilaad Kaplan has received speaking or consultancy honoraria from AbbVie, Janssen, Pfizer, and Shire. He has received a grant from Abbvie, Janssen, Merck, and Shire. Kerri Novak has received speaking or consultancy honoraria from AbbVie, Janssen, Pendopharm, Pfizer, and Takeda. She has also received a grant from AbbVie. Cathy Lu has received consultancy honoraria from AbbVie and Ferring. Michael Stewart has received speaking or consultancy honoraria from AbbVie, Ferring, Janssen, Takeda, and Shire. Meena Mathivanana as received consultancy honoraria from AbbVie, Ferring, Janssen, Pfizer, Shire, and Takeda. Joan Heatherington has received speaker honoraria from AbbVie, Ferring, Janssen, and Takeda. Remo Panaccione has received research/educational support from AbbVie, Abbott, Bristol-Myers Squibb, Centocor, Elan, Ferring, Janssen, Millennium, Procter & Gamble, and Schering-Plough. He has served as a consultant for AbbVie, Abbott, Amgen, Aptalis, AstraZeneca, Baxter, Bristol-Myers Squibb, Celgene, Centocor, Cubist, Eisai, Elan, Ferring, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Pfizer, Schering-Plough, Shire, Takeda, UCB, and Warner Chilcott. Remo Panaccione has also participated on speaker's bureaus for AbbVie, AstraZeneca, Centocor, Elan, Ferring, Janssen, Prometheus, Schering-Plough, Shire, Takeda, and Warner Chilcott. He has attended advisory boards for AbbVie, Abbott, Amgen, Aptalis, AstraZeneca, Baxter, Bristol-Myers Squibb, Celgene, Centocor, Cubist, Eisai, Elan, Ferring, Genentech, GlaxoSmithKline, Janssen, Merck, Pfizer, Salix, Schering-Plough, Shire, Takeda, UCB, and Warner Chilcott. All other authors have no disclosure. Declaration of funding interests: This study was funded in part by the Canadian Association of Gastroenterology and the Canadian Institutes for Health Research (Christopher Ma). Funding information This study was funded in part by the Canadian Association of Gastroenterology and the Canadian Institutes for Health Research (Christopher Ma). Publisher Copyright: © 2018 John Wiley & Sons Ltd

PY - 2018/9

Y1 - 2018/9

N2 - Background: Vedolizumab is an α4β7 integrin antagonist with proven efficacy for inducing and maintaining clinical response and remission in Crohn's disease (CD) and ulcerative colitis (UC). Aim: To evaluate clinical and objective response and remission rates with vedolizumab in a large, real world cohort. Methods: A retrospective cohort study of adult CD and UC patients receiving vedolizumab between 2012 and 2017 was conducted. Primary outcome: clinical or objective response and remission at 3, 6 and 12 months after induction. Clinical remission was defined by complete, steroid-free absence of symptoms. Objective remission was defined by endoscopic mucosal healing or normalisation of radiographic appearance on contrast-enhanced ultrasound or CT/MR enterography. Results: The study included 222 vedolizumab patients (122 CD, 100 UC). In CD, clinical remission at 3, 6 and 12 months was achieved in 19.8% (22/111), 22.1% (21/95) and 22.1% (15/68) of patients, respectively. Objective remission occurred in 11.5% (6/52), 21.2% (14/66), and 18.9% (7/37) of patients at 3, 6 and 12 months, respectively. In UC, clinical remission at 3, 6, and 12 months was 51.0% (51/100), 61.8% (55/89) and 61.9% (39/63), respectively. Endoscopic remission occurred in 27.5% (11/40), 41.0% (16/39) and 47.8% (22/46) of patients at 3, 6 and 12 months, respectively. In multivariable analysis, patients with UC as compared to CD, and those with milder disease activity were more likely to achieve objectively defined remission at both 6 and 12 months. Conclusions: Vedolizumab was effective for induction and maintenance of clinical and objective remission, both in Crohn's disease and ulcerative colitis.

AB - Background: Vedolizumab is an α4β7 integrin antagonist with proven efficacy for inducing and maintaining clinical response and remission in Crohn's disease (CD) and ulcerative colitis (UC). Aim: To evaluate clinical and objective response and remission rates with vedolizumab in a large, real world cohort. Methods: A retrospective cohort study of adult CD and UC patients receiving vedolizumab between 2012 and 2017 was conducted. Primary outcome: clinical or objective response and remission at 3, 6 and 12 months after induction. Clinical remission was defined by complete, steroid-free absence of symptoms. Objective remission was defined by endoscopic mucosal healing or normalisation of radiographic appearance on contrast-enhanced ultrasound or CT/MR enterography. Results: The study included 222 vedolizumab patients (122 CD, 100 UC). In CD, clinical remission at 3, 6 and 12 months was achieved in 19.8% (22/111), 22.1% (21/95) and 22.1% (15/68) of patients, respectively. Objective remission occurred in 11.5% (6/52), 21.2% (14/66), and 18.9% (7/37) of patients at 3, 6 and 12 months, respectively. In UC, clinical remission at 3, 6, and 12 months was 51.0% (51/100), 61.8% (55/89) and 61.9% (39/63), respectively. Endoscopic remission occurred in 27.5% (11/40), 41.0% (16/39) and 47.8% (22/46) of patients at 3, 6 and 12 months, respectively. In multivariable analysis, patients with UC as compared to CD, and those with milder disease activity were more likely to achieve objectively defined remission at both 6 and 12 months. Conclusions: Vedolizumab was effective for induction and maintenance of clinical and objective remission, both in Crohn's disease and ulcerative colitis.

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U2 - 10.1111/apt.14919

DO - 10.1111/apt.14919

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JO - Alimentary Pharmacology and Therapeutics

JF - Alimentary Pharmacology and Therapeutics

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Real-world clinical, endoscopic and radiographic efficacy of vedolizumab for the treatment of inflammatory bowel disease

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