Title :

Effectiveness and safety of ustekinumab for crohn''s disease; systematic review and pooled analysis of real-world evidence

Author(s) :

Engel, Tal [Auteur]
Yung, Diana E. [Auteur]
Ma, Christopher [Auteur]
Pariente, Benjamin [Auteur]
Wils, Pauline [Auteur]
Eliakim, Rami [Auteur]
Ungar, Bella [Auteur]
Ben-Horin, Shomron [Auteur]
Kopylov, Uri [Auteur]

Journal title :

Digestive and liver disease . official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver

Abbreviated title :

Dig Liver Dis

Publication date :

2019-06-12

ISSN :

1878-3562

English keyword(s) :

Ustekinumab
Real-world experience
Crohns disease

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Ustekinumab [UST] is effective in Crohn's disease (CD) in the UNITI studies. Several real-world experience (RWE) studies with UST have been published to date. Our aim was to summarize the available RWE data for UST ...
Show more >Ustekinumab [UST] is effective in Crohn's disease (CD) in the UNITI studies. Several real-world experience (RWE) studies with UST have been published to date. Our aim was to summarize the available RWE data for UST effectiveness and safety. A systematic review of the available RWE studies of UST for CD and pooled analysis of the available effectiveness and safety data was performed. Eight relevant studies of 6 RWE were included for analysis. Data from 578 patients were pooled for analysis. Most patients (97.7%) were anti-TNF experienced. Pooled clinical response rate was 60%, 62%, 49% at 12, 24 and 52 weeks respectively (95% CI (0.42-0.77), (0.48-0.75), (0.37-0.62)). Pooled remission rate was 39% (95% CI (0.18-0.65)) at 24 weeks and pooled endoscopic response rate was 63% (95% CI (0.53-0.72)) after approximately one year of UST; 134 adverse events (AE) were reported in total, pooled proportion 21% (95% CI (0.12-0.35)). Serious AE were reported in 19 patients, pooled proportion 5% (95% CI (0.03-0.08)). Infections were reported in 38, pooled proportion 6% (95% CI (0.04-0.11)). Pooled analysis of the RWE data suggests that the real-world effectiveness and safety are comparable to that reported in the randomized control trials.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Submission date :

2024-01-30T10:27:53Z