Effectiveness and Factors Associated with Response to Golimumab in Japanese Patients with Ulcerative Colitis in Real Clinical Practice: The Phoenix Study

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

doi:10.1159/000533871

Effectiveness and Factors Associated with Response to Golimumab in Japanese Patients with Ulcerative Colitis in Real Clinical Practice: The Phoenix Study

Inflamm Intest Dis. 2023 Aug 31;8(3):115-127. doi: 10.1159/000533871. eCollection 2023 Dec.

Authors

Affiliations

¹ Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Sapporo, Japan.
² IBD Center, Sapporo Kosei General Hospital, Sapporo, Japan.
³ Inflammatory Bowel Disease Center, Sapporo Tokushukai Hospital, Sapporo, Japan.
⁴ Gastroenterology and Endoscopy, Division of Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan.
⁵ Inflammatory Bowel Disease Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan.
⁶ Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
⁷ Department of Biostatistics and Data Management, Sapporo Medical University of Medicine, Sapporo, Japan.
⁸ Ikuyaku, Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.

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.

Keywords: Anti-TNF-α antibody; Golimumab; Real-world effectiveness; Ulcerative colitis.

Grants and funding

This work was funded by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical K.K. In addition, this work was partially funded by Health and Labor Sciences Research grants for research on intractable diseases from the Ministry of Health, Labor, and Welfare of Japan (Investigation and Research for intractable Inflammatory Bowel Disease to H.N.) and Japan Society for the Promotion of Science (JSPS) Grant No. JP 21K07919 (to YH).