Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study

INTRODUCTION: This ongoing post-marketing surveillance monitors the long-term safety and effectiveness of vedolizumab in routine clinical practice in patients with moderate-to-severe ulcerative colitis (UC) in Japan. This interim analysis assessed induction-phase data, covering the initial three dos...

Descripción completa

Detalles Bibliográficos
Autores principales: Matsuoka, Katsuyoshi, Hisamatsu, Tadakazu, Mikami, Yohei, Yamamoto, Takayuki, Motoya, Satoshi, Shinzaki, Shinichiro, Iwakiri, Ryuichi, Sugiura, Kenkichi, Nishimura, Kunihiko, Kajita, Mika, Fernandez, Jovelle L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10220148/
https://www.ncbi.nlm.nih.gov/pubmed/37140705
http://dx.doi.org/10.1007/s12325-023-02500-6
_version_ 1785049155278733312
author Matsuoka, Katsuyoshi
Hisamatsu, Tadakazu
Mikami, Yohei
Yamamoto, Takayuki
Motoya, Satoshi
Shinzaki, Shinichiro
Iwakiri, Ryuichi
Sugiura, Kenkichi
Nishimura, Kunihiko
Kajita, Mika
Fernandez, Jovelle L.
author_facet Matsuoka, Katsuyoshi
Hisamatsu, Tadakazu
Mikami, Yohei
Yamamoto, Takayuki
Motoya, Satoshi
Shinzaki, Shinichiro
Iwakiri, Ryuichi
Sugiura, Kenkichi
Nishimura, Kunihiko
Kajita, Mika
Fernandez, Jovelle L.
author_sort Matsuoka, Katsuyoshi
collection PubMed
description INTRODUCTION: This ongoing post-marketing surveillance monitors the long-term safety and effectiveness of vedolizumab in routine clinical practice in patients with moderate-to-severe ulcerative colitis (UC) in Japan. This interim analysis assessed induction-phase data, covering the initial three doses of vedolizumab. METHODS: Patients were enrolled via a web-based electronic data capture system from approximately 250 institutions. Incidence of adverse events and treatment responses were assessed by the physicians after the patient had received three doses of vedolizumab or when the drug was discontinued, whichever occurred first. Therapeutic response was defined as any treatment response, including remission or improvement of complete or partial Mayo score, and was assessed in the total and stratified patient populations according to prior tumor necrosis factor alpha (TNFα) inhibitor treatments and/or baseline partial Mayo score. RESULTS: The total incidence of adverse drug reactions (ADRs) was 4.10% (11/268). Common ADRs were dizziness, nausea, and arthralgia, each reported in 0.75% of patients (2/268). Serious ADRs were herpes zoster oticus and UC, each reported in 0.37% of patients (1/268). Therapeutic response was reported in 84.5% (218/258) of all patients, 85.8% (127/148) of TNFα inhibitor-naïve patients, and 82.7% (91/110) of TNFα inhibitor-experienced patients. Among patients with partial Mayo score of ≥ 4 at baseline, partial Mayo score remission in patients without or with prior TNFα inhibitor treatment was 62.5% (60/96) and 45.6% (36/79), respectively. CONCLUSION: The results confirm a safety and effectiveness profile of vedolizumab consistent with that observed in previous trials. CLINICAL TRIAL REGISTRATION: JapicCTI-194603, NCT03824561. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-023-02500-6.
format Online
Article
Text
id pubmed-10220148
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Springer Healthcare
record_format MEDLINE/PubMed
spelling pubmed-102201482023-05-28 Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study Matsuoka, Katsuyoshi Hisamatsu, Tadakazu Mikami, Yohei Yamamoto, Takayuki Motoya, Satoshi Shinzaki, Shinichiro Iwakiri, Ryuichi Sugiura, Kenkichi Nishimura, Kunihiko Kajita, Mika Fernandez, Jovelle L. Adv Ther Original Research INTRODUCTION: This ongoing post-marketing surveillance monitors the long-term safety and effectiveness of vedolizumab in routine clinical practice in patients with moderate-to-severe ulcerative colitis (UC) in Japan. This interim analysis assessed induction-phase data, covering the initial three doses of vedolizumab. METHODS: Patients were enrolled via a web-based electronic data capture system from approximately 250 institutions. Incidence of adverse events and treatment responses were assessed by the physicians after the patient had received three doses of vedolizumab or when the drug was discontinued, whichever occurred first. Therapeutic response was defined as any treatment response, including remission or improvement of complete or partial Mayo score, and was assessed in the total and stratified patient populations according to prior tumor necrosis factor alpha (TNFα) inhibitor treatments and/or baseline partial Mayo score. RESULTS: The total incidence of adverse drug reactions (ADRs) was 4.10% (11/268). Common ADRs were dizziness, nausea, and arthralgia, each reported in 0.75% of patients (2/268). Serious ADRs were herpes zoster oticus and UC, each reported in 0.37% of patients (1/268). Therapeutic response was reported in 84.5% (218/258) of all patients, 85.8% (127/148) of TNFα inhibitor-naïve patients, and 82.7% (91/110) of TNFα inhibitor-experienced patients. Among patients with partial Mayo score of ≥ 4 at baseline, partial Mayo score remission in patients without or with prior TNFα inhibitor treatment was 62.5% (60/96) and 45.6% (36/79), respectively. CONCLUSION: The results confirm a safety and effectiveness profile of vedolizumab consistent with that observed in previous trials. CLINICAL TRIAL REGISTRATION: JapicCTI-194603, NCT03824561. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-023-02500-6. Springer Healthcare 2023-05-04 2023 /pmc/articles/PMC10220148/ /pubmed/37140705 http://dx.doi.org/10.1007/s12325-023-02500-6 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Matsuoka, Katsuyoshi
Hisamatsu, Tadakazu
Mikami, Yohei
Yamamoto, Takayuki
Motoya, Satoshi
Shinzaki, Shinichiro
Iwakiri, Ryuichi
Sugiura, Kenkichi
Nishimura, Kunihiko
Kajita, Mika
Fernandez, Jovelle L.
Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study
title Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study
title_full Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study
title_fullStr Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study
title_full_unstemmed Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study
title_short Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study
title_sort safety and effectiveness of vedolizumab in patients with moderate-to-severe ulcerative colitis: an interim analysis of a japanese post-marketing surveillance study
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10220148/
https://www.ncbi.nlm.nih.gov/pubmed/37140705
http://dx.doi.org/10.1007/s12325-023-02500-6
work_keys_str_mv AT matsuokakatsuyoshi safetyandeffectivenessofvedolizumabinpatientswithmoderatetosevereulcerativecolitisaninterimanalysisofajapanesepostmarketingsurveillancestudy
AT hisamatsutadakazu safetyandeffectivenessofvedolizumabinpatientswithmoderatetosevereulcerativecolitisaninterimanalysisofajapanesepostmarketingsurveillancestudy
AT mikamiyohei safetyandeffectivenessofvedolizumabinpatientswithmoderatetosevereulcerativecolitisaninterimanalysisofajapanesepostmarketingsurveillancestudy
AT yamamototakayuki safetyandeffectivenessofvedolizumabinpatientswithmoderatetosevereulcerativecolitisaninterimanalysisofajapanesepostmarketingsurveillancestudy
AT motoyasatoshi safetyandeffectivenessofvedolizumabinpatientswithmoderatetosevereulcerativecolitisaninterimanalysisofajapanesepostmarketingsurveillancestudy
AT shinzakishinichiro safetyandeffectivenessofvedolizumabinpatientswithmoderatetosevereulcerativecolitisaninterimanalysisofajapanesepostmarketingsurveillancestudy
AT iwakiriryuichi safetyandeffectivenessofvedolizumabinpatientswithmoderatetosevereulcerativecolitisaninterimanalysisofajapanesepostmarketingsurveillancestudy
AT sugiurakenkichi safetyandeffectivenessofvedolizumabinpatientswithmoderatetosevereulcerativecolitisaninterimanalysisofajapanesepostmarketingsurveillancestudy
AT nishimurakunihiko safetyandeffectivenessofvedolizumabinpatientswithmoderatetosevereulcerativecolitisaninterimanalysisofajapanesepostmarketingsurveillancestudy
AT kajitamika safetyandeffectivenessofvedolizumabinpatientswithmoderatetosevereulcerativecolitisaninterimanalysisofajapanesepostmarketingsurveillancestudy
AT fernandezjovellel safetyandeffectivenessofvedolizumabinpatientswithmoderatetosevereulcerativecolitisaninterimanalysisofajapanesepostmarketingsurveillancestudy