Section 2 of 4
Methods
Sandra Elmasry, Shabana Pasha, Manreet Kaur, Jonathan A Leighton, Suryakanth R Gurudu, and Christina Ha · about 1 minutes
We performed a retrospective cohort study of adult patients with moderate to severe UC presenting to a tertiary IBD referral center for diagnosis or adjustment of medical therapy from January 2022 to August 2024. Patients were included if they had a total Mayo score of ≥6 and a Mayo endoscopic subscore of 2 (moderate) or 3 (severe), with a disease duration of at least 3 months, which was a major inclusion criterion across all trials. Seven published phase III RCTs for moderate to severe UC from 2012 to 2022 were included in this analysis: TRUE NORTH, U-ACCOMPLISH & U-ACHIEVE,3 OCTAVE,4 ELEVATE,5 UNIFI,6 VARSITY,7 and LUCENT.8 A summary of each trial, including the medication studied, design, and trial years is provided in Table S2. Inclusion and exclusion criteria from these trials were identified and represented in Table S3. This was systematically applied to our study population to assess overall patient eligibility. Patients were evaluated for eligibility at the time of referral based on available recent laboratory results, endoscopic findings, and symptom assessment. For patients who did not meet eligibility criteria, the most common exclusion variables were identified.