Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn’s Disease: Results From the VISIBLE 2 Randomised Trial

BACKGROUND AND AIMS: To report results from VISIBLE 2, a randomised, double-blind, placebo-controlled, phase 3 trial evaluating a new subcutaneous [SC] vedolizumab formulation as maintenance treatment in adults with moderately to severely active Crohn’s disease [CD]. METHODS: Following open-label ve...

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Autores principales: Vermeire, Séverine, D’Haens, Geert, Baert, Filip, Danese, Silvio, Kobayashi, Taku, Loftus, Edward V, Bhatia, Siddharth, Agboton, Christian, Rosario, Maria, Chen, Chunlin, Zhang, Wenwen, Kisfalvi, Krisztina, Sandborn, William J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8797168/
https://www.ncbi.nlm.nih.gov/pubmed/34402887
http://dx.doi.org/10.1093/ecco-jcc/jjab133
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author Vermeire, Séverine
D’Haens, Geert
Baert, Filip
Danese, Silvio
Kobayashi, Taku
Loftus, Edward V
Bhatia, Siddharth
Agboton, Christian
Rosario, Maria
Chen, Chunlin
Zhang, Wenwen
Kisfalvi, Krisztina
Sandborn, William J
author_facet Vermeire, Séverine
D’Haens, Geert
Baert, Filip
Danese, Silvio
Kobayashi, Taku
Loftus, Edward V
Bhatia, Siddharth
Agboton, Christian
Rosario, Maria
Chen, Chunlin
Zhang, Wenwen
Kisfalvi, Krisztina
Sandborn, William J
author_sort Vermeire, Séverine
collection PubMed
description BACKGROUND AND AIMS: To report results from VISIBLE 2, a randomised, double-blind, placebo-controlled, phase 3 trial evaluating a new subcutaneous [SC] vedolizumab formulation as maintenance treatment in adults with moderately to severely active Crohn’s disease [CD]. METHODS: Following open-label vedolizumab 300 mg intravenous induction therapy at Weeks 0 and 2, Week 6 clinical responders (≥70-point decrease in CD Activity Index [CDAI] score from baseline) were randomised 2:1 to receive double-blind maintenance vedolizumab 108 mg SC or placebo every 2 weeks until Week 50. Assessments at Week 52 included clinical remission [primary endpoint; CDAI ≤150], enhanced clinical response [≥100-point decrease in CDAI from baseline], corticosteroid-free clinical remission among patients using a corticosteroid at baseline, clinical remission in anti-tumour necrosis factor [anti-TNF]-naïve patients, and safety. RESULTS: Following vedolizumab intravenous induction, 275 patients were randomised to vedolizumab SC and 135 to placebo maintenance. At Week 52, 48.0% of patients receiving vedolizumab SC versus 34.3% receiving placebo were in clinical remission [p = 0.008]. Enhanced clinical response at Week 52 was achieved by 52.0% versus 44.8% of patients receiving vedolizumab SC versus placebo, respectively [p = 0.167]. At Week 52, 45.3% and 18.2% of patients receiving vedolizumab SC and placebo, respectively, were in corticosteroid-free clinical remission, and 48.6% of anti-TNF-naïve patients receiving vedolizumab SC and 42.9% receiving placebo were in clinical remission. Injection site reaction was the only new safety finding observed for vedolizumab SC [2.9%]. CONCLUSIONS: Vedolizumab SC is an effective and safe maintenance therapy in patients with CD who responded to two infusions of vedolizumab intravenous induction therapy.
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spelling pubmed-87971682022-01-31 Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn’s Disease: Results From the VISIBLE 2 Randomised Trial Vermeire, Séverine D’Haens, Geert Baert, Filip Danese, Silvio Kobayashi, Taku Loftus, Edward V Bhatia, Siddharth Agboton, Christian Rosario, Maria Chen, Chunlin Zhang, Wenwen Kisfalvi, Krisztina Sandborn, William J J Crohns Colitis Original Articles BACKGROUND AND AIMS: To report results from VISIBLE 2, a randomised, double-blind, placebo-controlled, phase 3 trial evaluating a new subcutaneous [SC] vedolizumab formulation as maintenance treatment in adults with moderately to severely active Crohn’s disease [CD]. METHODS: Following open-label vedolizumab 300 mg intravenous induction therapy at Weeks 0 and 2, Week 6 clinical responders (≥70-point decrease in CD Activity Index [CDAI] score from baseline) were randomised 2:1 to receive double-blind maintenance vedolizumab 108 mg SC or placebo every 2 weeks until Week 50. Assessments at Week 52 included clinical remission [primary endpoint; CDAI ≤150], enhanced clinical response [≥100-point decrease in CDAI from baseline], corticosteroid-free clinical remission among patients using a corticosteroid at baseline, clinical remission in anti-tumour necrosis factor [anti-TNF]-naïve patients, and safety. RESULTS: Following vedolizumab intravenous induction, 275 patients were randomised to vedolizumab SC and 135 to placebo maintenance. At Week 52, 48.0% of patients receiving vedolizumab SC versus 34.3% receiving placebo were in clinical remission [p = 0.008]. Enhanced clinical response at Week 52 was achieved by 52.0% versus 44.8% of patients receiving vedolizumab SC versus placebo, respectively [p = 0.167]. At Week 52, 45.3% and 18.2% of patients receiving vedolizumab SC and placebo, respectively, were in corticosteroid-free clinical remission, and 48.6% of anti-TNF-naïve patients receiving vedolizumab SC and 42.9% receiving placebo were in clinical remission. Injection site reaction was the only new safety finding observed for vedolizumab SC [2.9%]. CONCLUSIONS: Vedolizumab SC is an effective and safe maintenance therapy in patients with CD who responded to two infusions of vedolizumab intravenous induction therapy. Oxford University Press 2021-08-17 /pmc/articles/PMC8797168/ /pubmed/34402887 http://dx.doi.org/10.1093/ecco-jcc/jjab133 Text en © European Crohn’s and Colitis Organisation 2021. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Articles
Vermeire, Séverine
D’Haens, Geert
Baert, Filip
Danese, Silvio
Kobayashi, Taku
Loftus, Edward V
Bhatia, Siddharth
Agboton, Christian
Rosario, Maria
Chen, Chunlin
Zhang, Wenwen
Kisfalvi, Krisztina
Sandborn, William J
Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn’s Disease: Results From the VISIBLE 2 Randomised Trial
title Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn’s Disease: Results From the VISIBLE 2 Randomised Trial
title_full Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn’s Disease: Results From the VISIBLE 2 Randomised Trial
title_fullStr Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn’s Disease: Results From the VISIBLE 2 Randomised Trial
title_full_unstemmed Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn’s Disease: Results From the VISIBLE 2 Randomised Trial
title_short Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn’s Disease: Results From the VISIBLE 2 Randomised Trial
title_sort efficacy and safety of subcutaneous vedolizumab in patients with moderately to severely active crohn’s disease: results from the visible 2 randomised trial
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8797168/
https://www.ncbi.nlm.nih.gov/pubmed/34402887
http://dx.doi.org/10.1093/ecco-jcc/jjab133
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