Endoscopic and Clinical Efficacy Demonstrated With Oral Ozanimod in Moderately to Severely Active Crohnʼs Disease

Introduction: Ozanimod, an oral, once-daily immunomodulator designed to selectively targets S1P1R and S1P5R, has demonstrated clinical efficacy in ulcerative colitis (UC) [1] and is being evaluated in active Crohn's Disease (CD). This Phase 2 open-label study in CD examined endoscopic and clinical outcomes following treatment with ozanimod 1 mg daily for 12 weeks. Methods: Patients with active CD (Crohn's Disease Activity Index [CDAI] score 220-450, total simple endoscopic score for CD [SES-CD] ≥6 [or in isolated ileum disease SES-CD ≥4]) were dosed with ozanimod 1 mg daily. All endoscopic assessments were read in a blinded manner by an imaging core lab. Daily electronic diary records were used to collect CD symptoms (including abdominal pain and soft/loose stool frequency). SES-CD was evaluated at baseline and Week 12, and CDAI was assessed at baseline and Weeks 4, 8, and 12. Results: Sixty-nine patients were enrolled. At baseline, mean age was 37.7 years, mean SES-CD was 13.3, and mean CDAI was 320. Mean CD duration was 10.0 years, with 54% of patients having had prior exposure to biologic therapy (i.e., TNF-α, vedolizumab). Patients with available data at baseline and Week 12 were included in the analyses, including SES-CD matched endoscopic segments (n=60) and CDAI (n=59). SES-CD score reductions of ≥25% and ≥50% from baseline were seen in 43.3% and 26.7% of patients, respectively. Patients with less endoscopic disease activity (baseline SES-CD ≤12) had a greater endoscopic response, with 50.0% of patients and 35.7% having a reduction of ≥25% and ≥50%, respectively. In line with the improvements in SES-CD, reductions in mean CDAI scores from baseline were seen as early as Week 4 (first post-baseline assessment) with further reductions through Week 12. CDAI response (CDAI decrease ≥100) was demonstrated in 66% of patients, and CDAI remission (CDAI < 150) was demonstrated in 46% of patients, with a mean reduction at Week 12 of 130 points. Adverse event (AE) and serious AE rates appeared to be related to underlying moderate to severe CD. The overall safety profile in CD was similar to that observed in UC. Conclusion: Oral ozanimod demonstrated meaningful clinical improvements as early as Week 4 and endoscopic improvements at Week 12 in patients with moderate to severe CD. No new safety signals were identified.

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