A study was performed to investigate the long-term efficacy and safety of orally administered ozanimod in individuals having moderate-to-severe ulcerative colitis with ≥four years of follow-up in phase II, randomized, placebo-controlled, TOUCHSTONE open-label extension. 

Participants treated with ozanimod HCl 0.5 mg or 1 mg or placebo during the double-blind therapy period could enter an open-label extension trial (ozanimod HCl 1 mg daily). Evaluation of Partial Mayo score clinical response and remission were done through open-label extension week 200. Utilizing the observed cases and non-responder imputation (NRI), the findings were summarized descriptively.

At open-label extension week 56 and therapy end, endoscopy was required. The parameters linked with endoscopy were suitably summarized at weeks 56 and 104 (observed cases), and week 56 (NRI). Evaluation of C-reactive protein and fecal calprotectin were done. Monitoring of adverse events was done throughout the trial.

Of 197 subjects treated with double-blind therapy, 170 entered open-label extension trial. At year 1, the discontinuation rates were 28% and 15%-18% annually through year 4.  At open-label extension week 200, the partial mayo measures demonstrated clinical response and remission rates of 93.3% and 82.7% respectively, utilizing observed cases and 41% and 37% with the more conservative NRI analysis.

At weeks 56 and 104, respectively, the histologic remission rates and endoscopic improvement rates (observed cases) is shown in the below table:

No novel safety signals were recognized during the ≥4 years of follow-up. An elevated rate of continued study participation was also noted. 

In ulcerative colitis patients, the consistent efficacy outcomes across clinical, endoscopic, histologic, and biomarker measures indicate that long-term usage of ozanimod may alleviate inflammation and lead to histologic and endoscopic disease remission, manifested as sustained improvement in clinical symptoms of the disease.