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Effectiveness and Factors Associated with Response to Golimumab in Japanese Patients with Ulcerative Colitis in Real Clinical Practice: The Phoenix Study.
Hirayama, Daisuke; Motoya, Satoshi; Ashida, Toshifumi; Ando, Katsuyoshi; Fujiya, Mikihiro; Ito, Takahiro; Furukawa, Shigeru; Maemoto, Atsuo; Katsurada, Takehiko; Hinotsu, Shiro; Sato, Noriko; Mizuno, Naomi; Ikawa, Yoshiko; Nakase, Hiroshi.
Afiliación
  • Hirayama D; Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Sapporo, Japan.
  • Motoya S; IBD Center, Sapporo Kosei General Hospital, Sapporo, Japan.
  • Ashida T; Inflammatory Bowel Disease Center, Sapporo Tokushukai Hospital, Sapporo, Japan.
  • Ando K; Gastroenterology and Endoscopy, Division of Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan.
  • Fujiya M; Gastroenterology and Endoscopy, Division of Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan.
  • Ito T; Inflammatory Bowel Disease Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan.
  • Furukawa S; Inflammatory Bowel Disease Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan.
  • Maemoto A; Inflammatory Bowel Disease Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan.
  • Katsurada T; Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
  • Hinotsu S; Department of Biostatistics and Data Management, Sapporo Medical University of Medicine, Sapporo, Japan.
  • Sato N; Ikuyaku, Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
  • Mizuno N; Ikuyaku, Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
  • Ikawa Y; Ikuyaku, Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
  • Nakase H; Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Inflamm Intest Dis ; 8(3): 115-127, 2023 Dec.
Article en En | MEDLINE | ID: mdl-38098492
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 (pMayo) 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 pMayo score was 5 (interquartile range (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 pMayo 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 disease duration of >60 months until initiation of GLM were more responsive in the induction phase.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Inflamm Intest Dis Año: 2023 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Suiza

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Inflamm Intest Dis Año: 2023 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Suiza