P544 Histological remission following ozanimod treatment is associated with concurrent clinical remission and endoscopic mucosal healing: Results from the TOUCHSTONE study

TOUCHSTONE was a randomised, double-blind, placebo-controlled phase 2 trial of ozanimod 1 and 0.5 mg vs. placebo in patients with moderate-to-severe ulcerative colitis (UC). In this trial, a significantly greater proportion of patients on ozanimod 1 mg vs. placebo achieved clinical remission, response, and endoscopic mucosal healing based on Mayo score at Weeks 8 and 32. We also assessed whether ozanimod leads to histologic improvement and healing. 197 patients were randomised (1: 1: 1) to ozanimod 1 mg (n = 67), 0.5 mg (n = 65), or placebo (n = 65), with 103 (52.3%) entering a maintenance period and 91 (88.3%) completing. Baseline, Weeks 8 and 32 biopsies were scored by a central pathologist blinded to treatment and visit. Histologic improvement was based on the change from baseline in Geboes score (range 0–22). Histologic remission was defined as Geboes <2. Endoscopic remission was defined as endoscopic score ≤1. Clinical remission was defined as total Mayo score ≤2, with no subscore >1. Baseline mean Geboes score was similar in the 1 mg, 0.5 mg, and placebo groups (12.92, 14.36, and 13.94, respectively). Histologic improvement as measured by mean change in Geboes score was greater in the 1 mg group than placebo at both Week 8 (−4.37 vs. −2.20, p = 0.0345) and Week 32 (−5.50 vs. 2.24, p = 0.0033). The 0.5 mg group showed the same trend but the difference vs. placebo was not significant at Week 8 (−3.31 vs. −2.20, p = 0.5885) or Week 32 (−4.31 vs. −2.24, p = 0.2448). Histologic remission (Geboes <2) at Week 8 occurred in 15 of 67 (22.4%) for 1 mg (p = 0.0705 vs. placebo), 9 of 65 (13.8%) for 0.5 mg (p = 0.6294, vs. placebo) and 7 of 65 (10.8%) for placebo, and for Week 32 in 21 of 67 (31.3%) for 1 mg (p = 0.0006, vs. placebo), 15 of 65 (23.1%) for 0.5 mg (p = 0.0164 vs. placebo), and 5 of 65 (7.7%) for placebo. In patients treated with ozanimod, endoscopic remission and clinical remission were highly concordant with histologic remission (87.1% and 82.6%, respectively) at Week 32. Concordance between endoscopic remission and histologic remission at Week 32 was high in both the 1 and 0.5 mg groups (83.6% and 90.8%, respectively). Across ozanimod patients, concordance between histologic remission and normalised Physician Global Assessment (PGA = 0) was 75.8%, the absence of diarrhoea (SFS = 0) was 73.5%, and rectal bleeding (RBS = 0) was 65.2%. Ozanimod was effective in the induction of clinical, endoscopic, and histologic remission at Week 32 in patients with moderate-to-severe UC. Histologic remission at Week 32 following treatment with ozanimod is highly concordant with endoscopic and clinical remission.

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