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

Abstract

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.