Effectiveness of ustekinumab in patients with refractory Crohn's disease: a multicentre real-life study in Italy.
Crohn’s disease
effectiveness
refractory
ustekinumab
Journal
Therapeutic advances in gastroenterology
ISSN: 1756-283X
Titre abrégé: Therap Adv Gastroenterol
Pays: England
ID NLM: 101478893
Informations de publication
Date de publication:
2022
2022
Historique:
received:
13
08
2021
accepted:
20
12
2021
entrez:
21
2
2022
pubmed:
22
2
2022
medline:
22
2
2022
Statut:
epublish
Résumé
The effectiveness of ustekinumab in patients with refractory Crohn's disease (CD) has been investigated in several real-world studies. However, very few data concerning the real-life experience in Italy have been reported. Therefore, this study assessed the effectiveness of ustekinumab in a large cohort of Italian patients with refractory CD. All patients who had started on ustekinumab after failure of or intolerance to antitumour necrosis factor-α (TNF-α) treatment at five tertiary centres between November 2018 and February 2020 were retrospectively enrolled. The coprimary outcome was corticosteroid-free clinical remission, defined as a Harvey-Bradshaw Index (HBI) score of ⩽4, at weeks 26 and 52. The secondary outcomes were changes in the HBI and C-reactive protein (CRP) values at weeks 8, 26, and 52 from baseline and the normalization of CRP in patients with initially abnormal values. Totally, 140 patients who had previously received at least one anti-TNF-α agent were enrolled; 40.0% received two anti-TNF-α agents and 20.0% received vedolizumab. At baseline, 108 patients (77.1%) had HBI scores of >4; of these, 56.5% and 58.3% achieved corticosteroid-free clinical remission at weeks 26 and 52, respectively. Significant decreases in HBI and CRP values were observed at weeks 8, 26, and 52 in the entire study cohort (all Our study findings confirm the effectiveness and safety of ustekinumab in patients with CD after failure of or intolerance to anti-TNF-α therapy.
Sections du résumé
BACKGROUND
BACKGROUND
The effectiveness of ustekinumab in patients with refractory Crohn's disease (CD) has been investigated in several real-world studies. However, very few data concerning the real-life experience in Italy have been reported. Therefore, this study assessed the effectiveness of ustekinumab in a large cohort of Italian patients with refractory CD.
METHODS
METHODS
All patients who had started on ustekinumab after failure of or intolerance to antitumour necrosis factor-α (TNF-α) treatment at five tertiary centres between November 2018 and February 2020 were retrospectively enrolled. The coprimary outcome was corticosteroid-free clinical remission, defined as a Harvey-Bradshaw Index (HBI) score of ⩽4, at weeks 26 and 52. The secondary outcomes were changes in the HBI and C-reactive protein (CRP) values at weeks 8, 26, and 52 from baseline and the normalization of CRP in patients with initially abnormal values.
RESULTS
RESULTS
Totally, 140 patients who had previously received at least one anti-TNF-α agent were enrolled; 40.0% received two anti-TNF-α agents and 20.0% received vedolizumab. At baseline, 108 patients (77.1%) had HBI scores of >4; of these, 56.5% and 58.3% achieved corticosteroid-free clinical remission at weeks 26 and 52, respectively. Significant decreases in HBI and CRP values were observed at weeks 8, 26, and 52 in the entire study cohort (all
CONCLUSION
CONCLUSIONS
Our study findings confirm the effectiveness and safety of ustekinumab in patients with CD after failure of or intolerance to anti-TNF-α therapy.
Identifiants
pubmed: 35186121
doi: 10.1177/17562848211072412
pii: 10.1177_17562848211072412
pmc: PMC8848093
doi:
Types de publication
Journal Article
Langues
eng
Pagination
17562848211072412Informations de copyright
© The Author(s), 2022.
Déclaration de conflit d'intérêts
Conflict of interest statement: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MLS: advisory board and/or lecture fees from AbbVie, Celltrion, Janssen, Pfizer, and Takeda. CB: lecture fees from Takeda, AbbVie, and Janssen. SS: advisory board and lecture fees from Arena, Gilead, Janssen, Takeda, and AbbVie. CP: consultancy fees and/or educational grants from AbbVie, MSD, Takeda, Pfizer, Janssen-Cilag, Chiesi, Sofar, Ferring, and Zambon. LB: speaker fees from Ferring, AbbVie, Janssen, and Zambon. The other authors declare no conflict of interest.
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