P719 Symptomatic improvement and long-term stability of ulcerative colitis symptoms over 3 years of ozanimod treatment

Abstract Background The phase 3 True North (TN) study demonstrated the efficacy and safety of ozanimod over 52 weeks in patients (pts) with moderately to severely active ulcerative colitis (UC). Pts completing TN were eligible for ongoing open-label extension (OLE) assessing long-term ozanimod. Presented here is interim analysis OLE focused on symptomatic pts approximately years continuous treatment. Methods who achieved clinical response after receiving during subsequently entered evaluated (data cutoff: 10 January 2022, at which point Week 94 disposition was available pts). Patient-reported (rectal bleeding subscore [RBS] stool frequency [SFS]) clinician-reported (Physician’s Global Assessment) outcomes determined. Symptomatic (partial Mayo score [PMS] ≥1 ≥30% reduction PMS ≥1-point decrease RBS or absolute ≤1) remission (RBS=0 SFS ≤1 [and from baseline SFS]) 5 through (146 treatment) using observed case (OC) nonresponder imputation (NRI) analyses. PMS, RBS, assessed 94. Results In all, 131 achieving following TN. At data cutoff, 87.0% completed 46 (98 ozanimod) 71.8% ozanimod). had a mean age 44 52% female. Most (68%) left-sided UC disease, 24% concomitant corticosteroid use baseline, 32% prior exposure tumor necrosis factor inhibitors. 100.0% (Figure 1A) 84.4% 2A) pts, respectively, OC (93.1% [Figure 1B] 78.6% 2B] NRI analysis). Rates maintained decreased slightly time analysis. Reductions sustained 3) 4) also Conclusion This focusing endpoints found that most 1 year symptom control another 2 years.