The goal of this study is to confirm that Mirikizumab therapy may provide clinical, endoscopic, and histopathologic improvements in patients with moderate to severe UC refractory to maintenance therapy when high neutrophilic infiltration in epithelium of the colonic mucosa (Geboes score Grade ≥3.2) on endoscopic biopsy is found.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Mirikizmgab will be administered based on the result of Geboes score Grade ≥ 3.2.
Vedolizmab will be administered based on the result of Geboes score Grade 3.1.
Showa Inan General Hospital
Komagane, Nagano, Japan
Changes in clinical activities before and after mirikizumab or vedolizumab treatment.
Clinical activity is graded using the clinical activity index (0, best - 15, worst).
Time frame: 2 weeks
Changes in endoscopic activities before and after mirikizumab or vedolizumab administration.
Mayo endoscopic subscore (0, best - 3, worst) and ulcerative colitis endoscopic index of severity (UCEIS) score are assessed at the site with the maximum endoscopic activity, (0, best - 8, worst).
Time frame: 2 months
Changes in pathological activity
Pathological activity was graded using Geboes biopsy histology scores, which were classified on a scale from 0 to 5, with higher scores indicating more severe histologic inflammation.
Time frame: 2 months
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