Effectiveness and factors associated with response to golimumab in Japanese patients with ulcerative colitis in real clinical practice: Phoenix Study

Abstract Introduction: There have been limited reports on the clinical efficacy of golimumab (GLM) in Japanese patients with ulcerative colitis (UC) in real clinical practice. This study aimed to explore the real-life effectiveness and factors associated with response to GLM in Japanese patients wit...

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Main Authors: Daisuke Hirayama, Satoshi Motoya, Toshifumi Ashida, Katsuyoshi Ando, Mikihiro Fujiya, Takahiro Ito, Shigeru Furukawa, Atsuo Maemoto, Takehiko Katsurada, Shiro Hinotsu, Noriko Sato, Naomi Mizuno, Yoshiko Ikawa, Hiroshi Nakase
Format: Article
Language:English
Published: Karger Publishers 2023-08-01
Series:Inflammatory Intestinal Diseases
Online Access:https://beta.karger.com/Article/FullText/533871
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author Daisuke Hirayama
Satoshi Motoya
Toshifumi Ashida
Katsuyoshi Ando
Mikihiro Fujiya
Takahiro Ito
Shigeru Furukawa
Atsuo Maemoto
Takehiko Katsurada
Shiro Hinotsu
Noriko Sato
Naomi Mizuno
Yoshiko Ikawa
Hiroshi Nakase
author_facet Daisuke Hirayama
Satoshi Motoya
Toshifumi Ashida
Katsuyoshi Ando
Mikihiro Fujiya
Takahiro Ito
Shigeru Furukawa
Atsuo Maemoto
Takehiko Katsurada
Shiro Hinotsu
Noriko Sato
Naomi Mizuno
Yoshiko Ikawa
Hiroshi Nakase
author_sort Daisuke Hirayama
collection DOAJ
description Abstract Introduction: There have been limited reports on the clinical efficacy of golimumab (GLM) in Japanese patients with ulcerative colitis (UC) in real clinical practice. This study aimed to explore the real-life effectiveness and factors associated with response to GLM in Japanese patients with UC. Methods: This observational, retrospective, multicenter study was conducted in hospitals with expertise in inflammatory bowel disease treatment. Sixty-three patients treated with GLM and active UC were included in the analysis. Clinical remission (CR) (partial Mayo score ≤2) in the induction and maintenance phases after GLM treatment and associated factors were evaluated. Results: The proportion of patients achieving CR in the induction and maintenance phases was 41.3% (26/63) and 46.0% (29/63, the last observation carried forward method was used for patients who discontinued treatment for reasons other than inadequate response), respectively. The median partial Mayo score was 5 (IQR 4-6) at baseline, 3 (IQR 1-5) in the induction phase, and 1 (IQR 0-3) in the maintenance phase. Hemoglobin, platelet, and C-reactive protein levels changed, consistent with the partial Mayo score. Multivariate logistic analysis revealed that biologic-naive status was an independent factor associated with CR in the induction (p=0.0200) and maintenance (p=0.0459) phases, and a disease duration of >60 months until GLM initiation was associated with CR in the induction phase (p=0.0427). Conclusions: The effectiveness of GLM in daily clinical practice has been confirmed in Japanese patients with active UC. Biologic-naive patients responded more to GLM in the induction and maintenance phases, and patients with a disease duration of >60 months until initiation of GLM were more responsive in the induction phase.
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spelling doaj.art-4c68dbc870ca4af0b49a58164f4bdb7d2023-09-07T07:56:39ZengKarger PublishersInflammatory Intestinal Diseases2296-93652023-08-0110.1159/000533871533871Effectiveness and factors associated with response to golimumab in Japanese patients with ulcerative colitis in real clinical practice: Phoenix StudyDaisuke HirayamaSatoshi MotoyaToshifumi AshidaKatsuyoshi AndoMikihiro FujiyaTakahiro ItoShigeru FurukawaAtsuo MaemotoTakehiko KatsuradaShiro HinotsuNoriko SatoNaomi MizunoYoshiko IkawaHiroshi NakaseAbstract Introduction: There have been limited reports on the clinical efficacy of golimumab (GLM) in Japanese patients with ulcerative colitis (UC) in real clinical practice. This study aimed to explore the real-life effectiveness and factors associated with response to GLM in Japanese patients with UC. Methods: This observational, retrospective, multicenter study was conducted in hospitals with expertise in inflammatory bowel disease treatment. Sixty-three patients treated with GLM and active UC were included in the analysis. Clinical remission (CR) (partial Mayo score ≤2) in the induction and maintenance phases after GLM treatment and associated factors were evaluated. Results: The proportion of patients achieving CR in the induction and maintenance phases was 41.3% (26/63) and 46.0% (29/63, the last observation carried forward method was used for patients who discontinued treatment for reasons other than inadequate response), respectively. The median partial Mayo score was 5 (IQR 4-6) at baseline, 3 (IQR 1-5) in the induction phase, and 1 (IQR 0-3) in the maintenance phase. Hemoglobin, platelet, and C-reactive protein levels changed, consistent with the partial Mayo score. Multivariate logistic analysis revealed that biologic-naive status was an independent factor associated with CR in the induction (p=0.0200) and maintenance (p=0.0459) phases, and a disease duration of >60 months until GLM initiation was associated with CR in the induction phase (p=0.0427). Conclusions: The effectiveness of GLM in daily clinical practice has been confirmed in Japanese patients with active UC. Biologic-naive patients responded more to GLM in the induction and maintenance phases, and patients with a disease duration of >60 months until initiation of GLM were more responsive in the induction phase.https://beta.karger.com/Article/FullText/533871
spellingShingle Daisuke Hirayama
Satoshi Motoya
Toshifumi Ashida
Katsuyoshi Ando
Mikihiro Fujiya
Takahiro Ito
Shigeru Furukawa
Atsuo Maemoto
Takehiko Katsurada
Shiro Hinotsu
Noriko Sato
Naomi Mizuno
Yoshiko Ikawa
Hiroshi Nakase
Effectiveness and factors associated with response to golimumab in Japanese patients with ulcerative colitis in real clinical practice: Phoenix Study
Inflammatory Intestinal Diseases
title Effectiveness and factors associated with response to golimumab in Japanese patients with ulcerative colitis in real clinical practice: Phoenix Study
title_full Effectiveness and factors associated with response to golimumab in Japanese patients with ulcerative colitis in real clinical practice: Phoenix Study
title_fullStr Effectiveness and factors associated with response to golimumab in Japanese patients with ulcerative colitis in real clinical practice: Phoenix Study
title_full_unstemmed Effectiveness and factors associated with response to golimumab in Japanese patients with ulcerative colitis in real clinical practice: Phoenix Study
title_short Effectiveness and factors associated with response to golimumab in Japanese patients with ulcerative colitis in real clinical practice: Phoenix Study
title_sort effectiveness and factors associated with response to golimumab in japanese patients with ulcerative colitis in real clinical practice phoenix study
url https://beta.karger.com/Article/FullText/533871
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