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Adapted from D’Haens G et al. 2024.1
*This was an interim analysis of the TRUE NORTH OLE study, with the data cutoff date being 30 June, 2023. Study analysis presented for the TRUE NORTH OLE only includes patients who completed the TRUE NORTH maintenance period (Week 52) and were clinical responders.1
†The data presented are based on OC analysis. Denominators for the OC analysis were based on the number of patients who completed the OLE timepoint and had data available.1
‡Clinical remission was defined as RBS=0, SFS ≤1 (and a decrease of ≥1 point from the baseline SFS), and Mayo endoscopy subscore ≤1.1
§Corticosteroid-free remission was defined as clinical remission while off corticosteroids for ≥12 weeks.1
CS, corticosteroid; OLE, open-label extension; OC, observed case; RBS, rectal-bleeding subscore; SFS, stool-frequency subscore.
Adapted from Danese S et al. 2023 & BMS Data on File.3,4
*This was an interim analysis of the TRUE NORTH OLE study, with the data cutoff date being 10 January, 2022. Study analysis presented for the TRUE NORTH OLE only includes patients who completed the TRUE NORTH maintenance period (Week 52) and were clinical responders.3
†Partial Mayo score was defined as the sum of the RBS, SFS, and Physician’s Global Assessment subscore.3
BL, baseline; OLE, open-label extension; RBS, rectal-bleeding subscore; SFS, stool-frequency subscore.