S1342 Impact of Baseline Disease Duration on Ozanimod Efficacy in Patients With Moderately to Severely Active Ulcerative Colitis: A Post Hoc Analysis of the Phase 3 True North Study

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Introduction: Ozanimod (OZA) is approved for patients (pts) with moderately to severely active ulcerative colitis (UC) based on results from the pivotal phase 3 True North (TN) trial. Methods: This analysis evaluated the impact of disease duration at TN baseline (BL) on OZA efficacy during the TN induction period (IP). In the 10-wk TN IP, pts were randomized to receive in a double-blind fashion either placebo (PBO) or OZA in Cohort 1 or open-label OZA in Cohort 2. All Cohort 1 pts were included in this analysis and stratified by disease duration at TN BL; subgroups included pts with < 2, 2 to < 5, 5 to < 10, or ≥10 y since UC diagnosis. Symptomatic remission and response were assessed through Week (W) 10 within these subgroups using PBO-adjusted difference in proportions; treatment differences and P values for comparisons between OZA and PBO were based on the Cochran-Mantel-Haenszel test, stratified by corticosteroid use at screening and prior anti–tumor necrosis factor use. Clinical response and remission at W10 were also analyzed. A stepwise logistic regression model was used to adjust for potential BL pt characteristic confounders. Results: A total of 645 pts were included in Cohort 1 of the TN IP (PBO, N=216; OZA, N=429). At TN BL, 158 pts had a disease duration of < 2 y (PBO, n=55; OZA, n=103), 178 had 2 to < 5 y (PBO, n=64; OZA, n=114), 163 had 5 to < 10 y (PBO, n=52; OZA, n=111), and 146 had ≥10 y (PBO, n=45; OZA, n=101). BL pt characteristics were generally similar in all subgroups of the OZA and PBO treatment arms. As expected, more pts with longer disease duration had prior exposure to biologic therapies. Pts with disease duration < 2 y achieved greater symptomatic clinical response by W4 (P < 0.001) compared to other subgroups, but differences were similar across other subgroups by W10; symptomatic remission rates were also generally similar across subgroups by W10. The proportions of pts achieving clinical remission and response after 10 wk of OZA treatment were comparable, regardless of TN BL disease duration (Figure 1). Finally, a logistic regression model demonstrated that BL disease duration did not affect OZA efficacy. Conclusion: OZA efficacy at the end of induction was not affected by duration of disease in pts with UC. These results suggest that OZA is an optimal oral therapeutic option for newly diagnosed pts and for those with long-standing UC disease.Figure 1.: Clinical (A) remissiona and (B) responseb at W10 in all pts in Cohort 1 of the TN IP by BL disease duration. All P values are nominal. aClinical remission: RBS = 0, SFS ≤1 point (and a decrease of ≥1 point from BL SFS), and MES ≤1 point. bClinical response: decrease from BL in the 3-component Mayo score (sum of RBS, SFS, and MES) of ≥2 points and ≥35% and a reduction of ≥1 point in RBS or absolute RBS of ≤1 point. BL, baseline; IP, induction period; MES, Mayo endoscopy subscore; OZA, ozanimod; PBO, placebo; pt, patient; RBS, rectal bleeding subscore; SFS, stool frequency subscore; TN, True North; W, Week.

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