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Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: a systematic review and meta-analysis

BACKGROUND: The application of vedolizumab (VDZ) subcutaneous (SC) formulation has brought more convenience and hope to patients with moderate-to-severe inflammatory bowel diseases (IBDs) in the coronavirus disease 2019 context. OBJECTIVE: This study aimed to systematically evaluate all previous stu...

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Autores principales: Hu, Qiong, Tang, Xing-zhou, Liu, Fang, Liu, De-wu, Cao, Bo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10141260/
https://www.ncbi.nlm.nih.gov/pubmed/37124368
http://dx.doi.org/10.1177/17562848231166227
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author Hu, Qiong
Tang, Xing-zhou
Liu, Fang
Liu, De-wu
Cao, Bo
author_facet Hu, Qiong
Tang, Xing-zhou
Liu, Fang
Liu, De-wu
Cao, Bo
author_sort Hu, Qiong
collection PubMed
description BACKGROUND: The application of vedolizumab (VDZ) subcutaneous (SC) formulation has brought more convenience and hope to patients with moderate-to-severe inflammatory bowel diseases (IBDs) in the coronavirus disease 2019 context. OBJECTIVE: This study aimed to systematically evaluate all previous studies that used VDZ SC formulation for maintenance therapy in patients with IBD. DESIGN: Systematic review and meta-analysis. DATA SOURCES AND METHODS: The search was conducted using the subject and free terms related to ‘Vedolizumab’, ‘Subcutaneous’, and ‘IBD’, in Embase, PubMed, Web of Science, Cochrane, and at ClinicalTrials.gov databases between 2008 and 2022. The methodological quality of randomized controlled trials (RCTs) and cohort studies was assessed using the Cochrane Handbook of Systematic Reviews and the Newcastle–Ottawa Scale, respectively. The endpoints included efficacy, safety, and immunogenicity. RESULTS: A total of 60 studies and 2 completed clinical registry trials were retrieved, of which 3 RCTs with high methodological quality, and 3 cohort studies with large heterogeneity were included in the meta-analysis. In the RCT study design, patients with ulcerative colitis (UC) under different conditions after treated with VDZ SC were significantly distinct than those for placebo (PBO) in clinical remission, endoscopic remission, and biochemical remission. In Crohn’s disease (CD), the aforementioned parameters were slightly higher than those for PBO, but there was not statistically significant in endoscopic remission and the efficacy of anti-tumor necrosis factor-naive patients. The clinical remission, endoscopic remission, and biochemical remission in patients with UC after VDZ SC treatment were similar to those after intravenous (IV) treatment. The risk ratios in patients experiencing adverse events (AEs) and serious AEs after VDZ SC and PBO treatments were 86% and 89% in UC, and 96% and 80% in CD, respectively. Compared with IV, safety was not statistically different. The risk of developing anti-VDZ antibody after VDZ SC treatment was only 20% of that after PBO in patients with UC, but it was 9.38 times in CD. CONCLUSION: VDZ SC treatment maintained the clinical efficacy of IV induction in patients with IBD without increasing the safety risk, and the efficacy was more pronounced in patients with UC. Immunogenicity might be a potential factor for the decrease in efficacy rate in patients with IBD. REGISTRATION: INPLASY 2022120115
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spelling pubmed-101412602023-04-29 Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: a systematic review and meta-analysis Hu, Qiong Tang, Xing-zhou Liu, Fang Liu, De-wu Cao, Bo Therap Adv Gastroenterol Systematic Review BACKGROUND: The application of vedolizumab (VDZ) subcutaneous (SC) formulation has brought more convenience and hope to patients with moderate-to-severe inflammatory bowel diseases (IBDs) in the coronavirus disease 2019 context. OBJECTIVE: This study aimed to systematically evaluate all previous studies that used VDZ SC formulation for maintenance therapy in patients with IBD. DESIGN: Systematic review and meta-analysis. DATA SOURCES AND METHODS: The search was conducted using the subject and free terms related to ‘Vedolizumab’, ‘Subcutaneous’, and ‘IBD’, in Embase, PubMed, Web of Science, Cochrane, and at ClinicalTrials.gov databases between 2008 and 2022. The methodological quality of randomized controlled trials (RCTs) and cohort studies was assessed using the Cochrane Handbook of Systematic Reviews and the Newcastle–Ottawa Scale, respectively. The endpoints included efficacy, safety, and immunogenicity. RESULTS: A total of 60 studies and 2 completed clinical registry trials were retrieved, of which 3 RCTs with high methodological quality, and 3 cohort studies with large heterogeneity were included in the meta-analysis. In the RCT study design, patients with ulcerative colitis (UC) under different conditions after treated with VDZ SC were significantly distinct than those for placebo (PBO) in clinical remission, endoscopic remission, and biochemical remission. In Crohn’s disease (CD), the aforementioned parameters were slightly higher than those for PBO, but there was not statistically significant in endoscopic remission and the efficacy of anti-tumor necrosis factor-naive patients. The clinical remission, endoscopic remission, and biochemical remission in patients with UC after VDZ SC treatment were similar to those after intravenous (IV) treatment. The risk ratios in patients experiencing adverse events (AEs) and serious AEs after VDZ SC and PBO treatments were 86% and 89% in UC, and 96% and 80% in CD, respectively. Compared with IV, safety was not statistically different. The risk of developing anti-VDZ antibody after VDZ SC treatment was only 20% of that after PBO in patients with UC, but it was 9.38 times in CD. CONCLUSION: VDZ SC treatment maintained the clinical efficacy of IV induction in patients with IBD without increasing the safety risk, and the efficacy was more pronounced in patients with UC. Immunogenicity might be a potential factor for the decrease in efficacy rate in patients with IBD. REGISTRATION: INPLASY 2022120115 SAGE Publications 2023-04-27 /pmc/articles/PMC10141260/ /pubmed/37124368 http://dx.doi.org/10.1177/17562848231166227 Text en © The Author(s), 2023 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Systematic Review
Hu, Qiong
Tang, Xing-zhou
Liu, Fang
Liu, De-wu
Cao, Bo
Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: a systematic review and meta-analysis
title Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: a systematic review and meta-analysis
title_full Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: a systematic review and meta-analysis
title_fullStr Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: a systematic review and meta-analysis
title_full_unstemmed Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: a systematic review and meta-analysis
title_short Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: a systematic review and meta-analysis
title_sort vedolizumab subcutaneous formulation maintenance therapy for patients with ibd: a systematic review and meta-analysis
topic Systematic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10141260/
https://www.ncbi.nlm.nih.gov/pubmed/37124368
http://dx.doi.org/10.1177/17562848231166227
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