Impact of adalimumab on disease burden in moderate-to-severe ulcerative colitis patients: The one-year, real-world UCanADA study.

ABSTRACT:

Background

A gap remains in documenting the impact of anti-tumor necrosis factor therapy on disease burden in ulcerative colitis (UC) patients treated in a real-world setting. The use of patient-reported outcomes (PROs) has been discussed as a primary endpoint in the context of the FDA PRO Guidance, for labelling purposes. Specifically, the efficacy and safety of adalimumab have been demonstrated in pivotal trials; however, data are needed to understand how clinical results translate into improvements in key aspects of the daily lives of UC patients, such as symptoms, health-related quality of life (HRQoL), and disability.

Aim

To assess real-world effectiveness of adalimumab on PRO measures in patients with moderate-to-severe UC.

Methods

UCanADA was a single arm, pros

SUBMITTER: Bessissow T 

PROVIDER: S-EPMC9494926 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature