Fiche publication
Date publication
septembre 2022
Journal
World journal of gastroenterology
Auteurs
Membres identifiés du Cancéropôle Est :
Pr PEYRIN-BIROULET Laurent
Tous les auteurs :
Bessissow T, Nguyen GC, Tarabain O, Peyrin-Biroulet L, Foucault N, McHugh K, Ruel J
Lien Pubmed
Résumé
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.
Mots clés
Adalimumab, Depressive symptoms, Disease burden, Patient-reported outcome, Real-world data, Ulcerative colitis
Référence
World J Gastroenterol. 2022 09 14;28(34):5058-5075
