BACKGROUND AND AIMS: This analysis examined the long-term safety and efficacy of 
ozanimod in patients with moderately to severely active ulcerative colitis [UC] 
with ≥ 4 years of follow-up in the phase 2 TOUCHSTONE open-label extension 
[OLE].
METHODS: Patients receiving placebo or ozanimod HCl 0.5 mg or 1 mg during the 
double-blind period could enter the OLE [ozanimod HCl 1 mg daily]. Partial Mayo 
score [pMS] clinical response and remission were assessed through OLE week 200 
and summarized descriptively using observed cases [OC] and non-responder 
imputation [NRI]. Endoscopy was required at OLE week 56 and the end of 
treatment. Parameters associated with endoscopy were summarized at weeks 56 and 
104 [OC], and week 56 [NRI]. C-reactive protein and faecal calprotectin were 
assessed. Adverse events were monitored throughout the study.
RESULTS: Of 197 patients receiving double-blind treatment, 170 entered the OLE. 
Discontinuation rates were 28% at year 1 and 15-18% annually through year 4. 
Partial Mayo measures indicated clinical response and remission rates at OLE 
week 200 of 93.3% and 82.7%, respectively, using OC and 41% and 37% with the 
more conservative NRI analysis. At weeks 56 and 104, respectively, histological 
remission rates were 46.3% and 38.5%, and endoscopic improvement rates were 
46.4% and 46.5% [OC]. No new safety signals were identified during ≥ 4 years of 
follow-up.
CONCLUSIONS: There was a high rate of continued study participation and 
long-term benefit with ozanimod HCl 1 mg daily based on clinical, histological 
and biomarker measures in patients with moderately to severely active UC in the 
TOUCHSTONE OLE. [NCT02531126].