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

Abstract

<b><i>Introduction:</i></b> 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. <b><i>Methods:</i></b> 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. <b><i>Results:</i></b> 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 (<i>p</i> = 0.0200) and maintenance (<i>p</i> = 0.0459) phases, and a disease duration of >60 months until GLM initiation was associated with CR in the induction phase (<i>p</i> = 0.0427). <b><i>Conclusions:</i></b> 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.

Change in systemic steroid use and surgery rate in patients with inflammatory bowel disease: a Japanese real-world database analysis

“…This was a retrospective study conducted in the Hokkaido region of Japan using a database originally developed for the P rincipal research in the H okkaido O rganization E mphasizing N utritional and therapeutic I mprovement to IBD patients’ e X pectation (Phoenix) Cohort Study (UMIN Clinical Trials Registry; UMIN000035384), which was initiated in October 2018 and aimed to collect data of patients with IBD and develop new diagnostic criteria and a treatment guideline for IBD. The Phoenix cohort database consisted of data for approximately 2100 patients with IBD who were treated at five core IBD treatment hospitals (Sapporo Medical University Hospital, Hokkaido University Hospital, Asahikawa Medical University Hospital, Sapporo-Kosei General Hospital, and Sapporo Higashi Tokushukai Hospital) between January 1, 1990, and March 31, 2021, which have been used for previous studies of IBD [ 18 , 19 ]. Patient data were collected using medical records and included clinical findings (e.g., treatment details, dosing status, treatment duration, and outcomes), blood test results, endoscopy findings, pathology, and imaging examination findings.…”

Effectiveness and Persistency of Ustekinumab Treatment for Ulcerative Colitis: A Phoenix retrospective Cohort Study

“…A principal research in the Hokkaido Organization Emphasizing Nutritional and Therapeutic Improvement to IBD Patients’ Expectation (Phoenix cohort) study group has previously revealed clinical effectiveness and its predictive factors regarding UST in CD 16 in addition to anti-TNF-α antibodies (infliximab biosimilar and golimumab) in UC and CD. 17 , 18 In this study, using our cohort, we aimed to reveal the clinical effectiveness, remission, persistency, predictive factors associated with effectiveness and persistency, and safety of UST for inducing and maintaining UC remission, thereby contributing to elucidating the appropriate positioning of UST for UC with bio-naïve and bio-failure.…”