Open AccessImpact of adalimumab on disease burden in moderate-to-severe ulcerative colitis patients: The one-year, real-world UCanADA study
Author(s) -
Talat Bessissow,
Geoffrey C. Nguyen,
Osman Tarabain,
L Peyrin-Biroulet,
Nathalie Foucault,
Kevin J. McHugh,
Joannie Ruel
Publication year - 2022
Publication title -
world journal of gastroenterology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.427
H-Index - 155
eISSN - 2219-2840
pISSN - 1007-9327
DOI - 10.3748/wjg.v28.i34.5058
Subject(s) - medicine , adalimumab , ulcerative colitis , context (archaeology) , quality of life (healthcare) , clinical endpoint , depression (economics) , adverse effect , distress , clinical trial , observational study , physical therapy , disease , paleontology , clinical psychology , nursing , macroeconomics , economics , biology
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.