# Safety and Efficacy of Ozanimod in Patients With Moderately to Severely Active Ulcerative Colitis Stratified by Age

## TL;DR

The study found that ozanimod is generally safe and effective for treating ulcerative colitis in older adults, similar to younger patients.

## Contribution

This study evaluates the safety and efficacy of ozanimod in ulcerative colitis patients stratified by age, focusing on older adults.

## Key findings

- Ozanimod showed consistent safety and efficacy across age groups in ulcerative colitis patients.
- Rates of serious infections and other adverse events increased with age during long-term treatment.
- No cases of progressive multifocal leukoencephalopathy were observed in over 242 weeks of ozanimod exposure.

## Abstract

Older adults with ulcerative colitis (UC) have unique treatment challenges. Ozanimod is approved for the treatment of moderately to severely active UC in adults based on the phase 3 True North (TN) study results. Here, we analyzed the impact of patient age on ozanimod safety and efficacy in TN and during the open-label extension (OLE).

Patients were stratified by age at TN baseline: <40, 40 to 60, and >60 years (cutoff: 75 years). Safety was evaluated in all patients during TN and the OLE; efficacy was assessed at weeks 10 and 52 in TN and up to OLE week 190 in patients who entered as TN week 52 ozanimod clinical responders.

Of 1012 patients analyzed, 492 were <40 years of age, 404 were 40 to 60 years of age, and 116 were >60 years of age. Infection, malignancy, cardiac events, and macular edema were low throughout TN across all ages. Exposure-adjusted incidence rates (EAIRs) of opportunistic and serious infections increased with age during the OLE. Patients ≥40 years of age had higher hypertension EAIRs than those <40 years of age, but EAIRs of other cardiovascular TEAEs were low. No cases of progressive multifocal leukoencephalopathy occurred over 242 weeks of ozanimod exposure. Efficacy rates for evaluated clinical and mucosal endpoints at weeks 10 and 52 with ozanimod were generally consistent across age groups with the overall population; similar trends were observed in the OLE.

Ozanimod safety was similar and efficacy was generally comparable across age groups, although statistical significance vs placebo was not achieved in patients >60 years of age.

Immunosuppressive treatment can be associated with safety concerns in older patients with ulcerative colitis. We found that ozanimod safety and efficacy were generally consistent across age groups, supporting ozanimod as an oral treatment option for older adults with ulcerative colitis.