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Effectiveness and safety of vedolizumab in inflammatory bowel disease patients aged 60 and over: an observational multicenter UK experience

BACKGROUND: The GEMINI trials established the efficacy of vedolizumab in moderate-to-severe inflammatory bowel disease (IBD) and demonstrated a favorable safety profile, suggesting it may be advantageous in older patients at greater risk of treatment-related complications. However, there is a paucit...

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Autores principales: Ibraheim, Hajir, Samaan, Mark A., Srinivasan, Ashish, Brain, Oliver, Digby-Bell, Jonathan, Irving, Peter M., Norman, Irena, Jawad, Issrah, Biedermann, Julia, Ibarra, Ana, Kok, Klaartje Bel, Parkes, Gareth, Rimmer, Joanna, Compot, Elisabeta, Parkes, Miles, Segal, Jonathan, Oppong, Philip, Hart, Ailsa, Hayee, Bu’Hussain, Powell, Nick
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hellenic Society of Gastroenterology 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7049246/
https://www.ncbi.nlm.nih.gov/pubmed/32127738
http://dx.doi.org/10.20524/aog.2020.0447
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author Ibraheim, Hajir
Samaan, Mark A.
Srinivasan, Ashish
Brain, Oliver
Digby-Bell, Jonathan
Irving, Peter M.
Norman, Irena
Jawad, Issrah
Biedermann, Julia
Ibarra, Ana
Kok, Klaartje Bel
Parkes, Gareth
Rimmer, Joanna
Compot, Elisabeta
Parkes, Miles
Segal, Jonathan
Oppong, Philip
Hart, Ailsa
Hayee, Bu’Hussain
Powell, Nick
author_facet Ibraheim, Hajir
Samaan, Mark A.
Srinivasan, Ashish
Brain, Oliver
Digby-Bell, Jonathan
Irving, Peter M.
Norman, Irena
Jawad, Issrah
Biedermann, Julia
Ibarra, Ana
Kok, Klaartje Bel
Parkes, Gareth
Rimmer, Joanna
Compot, Elisabeta
Parkes, Miles
Segal, Jonathan
Oppong, Philip
Hart, Ailsa
Hayee, Bu’Hussain
Powell, Nick
author_sort Ibraheim, Hajir
collection PubMed
description BACKGROUND: The GEMINI trials established the efficacy of vedolizumab in moderate-to-severe inflammatory bowel disease (IBD) and demonstrated a favorable safety profile, suggesting it may be advantageous in older patients at greater risk of treatment-related complications. However, there is a paucity of data exploring the outcomes of vedolizumab in this group. Our objective was to determine the clinical effectiveness and safety of vedolizumab in older IBD patients within a real-world multicenter UK cohort. METHODS: A retrospective review of electronic records across 6 UK hospitals was undertaken to evaluate the clinical effectiveness and safety outcomes of vedolizumab in IBD patients aged ≥60 at start of therapy. Rates of clinical response, remission and corticosteroid-free remission were assessed at weeks 14 and 52, using validated clinical indices, and were compared to historical controls from real-world vedolizumab-treated cohorts unstratified by age. RESULTS: Of 74 patients aged 60 years or above (median 66 years), 48 were included in our effectiveness analysis (29 ulcerative colitis, 19 Crohn’s disease). Rates of clinical response, remission and corticosteroid-free remission at week 14 were 64%, 48% and 30%, respectively. By week 52, the rates of clinical response, remission, and corticosteroid-free remission were 52%, 38%, and 32%, respectively. Six (8%) patients experienced adverse effects. Effectiveness and safety outcomes were comparable to those of age-unstratified vedolizumab-treated cohorts. CONCLUSION: Our 1-year outcome data suggests that vedolizumab is safe and effective in older IBD patients and broadly comparable to cohorts unselected by age.
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spelling pubmed-70492462020-03-04 Effectiveness and safety of vedolizumab in inflammatory bowel disease patients aged 60 and over: an observational multicenter UK experience Ibraheim, Hajir Samaan, Mark A. Srinivasan, Ashish Brain, Oliver Digby-Bell, Jonathan Irving, Peter M. Norman, Irena Jawad, Issrah Biedermann, Julia Ibarra, Ana Kok, Klaartje Bel Parkes, Gareth Rimmer, Joanna Compot, Elisabeta Parkes, Miles Segal, Jonathan Oppong, Philip Hart, Ailsa Hayee, Bu’Hussain Powell, Nick Ann Gastroenterol Original Article BACKGROUND: The GEMINI trials established the efficacy of vedolizumab in moderate-to-severe inflammatory bowel disease (IBD) and demonstrated a favorable safety profile, suggesting it may be advantageous in older patients at greater risk of treatment-related complications. However, there is a paucity of data exploring the outcomes of vedolizumab in this group. Our objective was to determine the clinical effectiveness and safety of vedolizumab in older IBD patients within a real-world multicenter UK cohort. METHODS: A retrospective review of electronic records across 6 UK hospitals was undertaken to evaluate the clinical effectiveness and safety outcomes of vedolizumab in IBD patients aged ≥60 at start of therapy. Rates of clinical response, remission and corticosteroid-free remission were assessed at weeks 14 and 52, using validated clinical indices, and were compared to historical controls from real-world vedolizumab-treated cohorts unstratified by age. RESULTS: Of 74 patients aged 60 years or above (median 66 years), 48 were included in our effectiveness analysis (29 ulcerative colitis, 19 Crohn’s disease). Rates of clinical response, remission and corticosteroid-free remission at week 14 were 64%, 48% and 30%, respectively. By week 52, the rates of clinical response, remission, and corticosteroid-free remission were 52%, 38%, and 32%, respectively. Six (8%) patients experienced adverse effects. Effectiveness and safety outcomes were comparable to those of age-unstratified vedolizumab-treated cohorts. CONCLUSION: Our 1-year outcome data suggests that vedolizumab is safe and effective in older IBD patients and broadly comparable to cohorts unselected by age. Hellenic Society of Gastroenterology 2020 2020-01-07 /pmc/articles/PMC7049246/ /pubmed/32127738 http://dx.doi.org/10.20524/aog.2020.0447 Text en Copyright: © Hellenic Society of Gastroenterology http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Ibraheim, Hajir
Samaan, Mark A.
Srinivasan, Ashish
Brain, Oliver
Digby-Bell, Jonathan
Irving, Peter M.
Norman, Irena
Jawad, Issrah
Biedermann, Julia
Ibarra, Ana
Kok, Klaartje Bel
Parkes, Gareth
Rimmer, Joanna
Compot, Elisabeta
Parkes, Miles
Segal, Jonathan
Oppong, Philip
Hart, Ailsa
Hayee, Bu’Hussain
Powell, Nick
Effectiveness and safety of vedolizumab in inflammatory bowel disease patients aged 60 and over: an observational multicenter UK experience
title Effectiveness and safety of vedolizumab in inflammatory bowel disease patients aged 60 and over: an observational multicenter UK experience
title_full Effectiveness and safety of vedolizumab in inflammatory bowel disease patients aged 60 and over: an observational multicenter UK experience
title_fullStr Effectiveness and safety of vedolizumab in inflammatory bowel disease patients aged 60 and over: an observational multicenter UK experience
title_full_unstemmed Effectiveness and safety of vedolizumab in inflammatory bowel disease patients aged 60 and over: an observational multicenter UK experience
title_short Effectiveness and safety of vedolizumab in inflammatory bowel disease patients aged 60 and over: an observational multicenter UK experience
title_sort effectiveness and safety of vedolizumab in inflammatory bowel disease patients aged 60 and over: an observational multicenter uk experience
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7049246/
https://www.ncbi.nlm.nih.gov/pubmed/32127738
http://dx.doi.org/10.20524/aog.2020.0447
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