Rates, predictive factors and effectiveness of ustekinumab intensification to 4- or 6-weekly intervals in Crohn's disease.
Crohn's disease
Dose escalation
Dose optimisation
Real world evidence
Ustekinumab
Journal
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385
Informations de publication
Date de publication:
08 2023
08 2023
Historique:
received:
12
07
2022
revised:
04
10
2022
accepted:
05
10
2022
medline:
28
7
2023
pubmed:
26
10
2022
entrez:
25
10
2022
Statut:
ppublish
Résumé
The UNITI trial reports efficacy of ustekinumab (UST) dose intensification in Crohn's disease (CD) from 12- to 8-weekly, but not 4-weekly. We aimed 1) to assess the cumulative incidence of UST dose intensification to 4- or 6-weekly, 2) to identify factors associated with dose intensification, and 3) to assess the effectiveness of this strategy. We performed a retrospective, observational cohort study in NHS Lothian including all UST treated CD patients (2015-2020). 163 CD patients were treated with UST (median follow-up: 20.3 months [13.4-38.4]), of whom 55 (33.7%) underwent dose intensification to 4-weekly (n = 50, 30.7%) or 6-weekly (n = 5, 3.1%). After 1 year 29.9% were dose intensified. Prior exposure to both anti-TNF and vedolizumab (HR 9.5; 1.3-70.9), and concomitant steroid use at UST start (HR 1.8; 1.0-3.1) were associated with dose intensification. Following dose intensification, 62.6% patients (29/55) remained on UST beyond 1 year. Corticosteroid-free clinical remission was achieved in 27% at week 16 and 29.6% at last follow-up. One third of CD patients treated with UST underwent dose intensification to a 4- or 6-weekly interval within the first year. Patients who failed both anti-TNF and vedolizumab, or required steroids at initiation were more likely to dose intensify.
Sections du résumé
BACKGROUND
The UNITI trial reports efficacy of ustekinumab (UST) dose intensification in Crohn's disease (CD) from 12- to 8-weekly, but not 4-weekly. We aimed 1) to assess the cumulative incidence of UST dose intensification to 4- or 6-weekly, 2) to identify factors associated with dose intensification, and 3) to assess the effectiveness of this strategy.
METHODS
We performed a retrospective, observational cohort study in NHS Lothian including all UST treated CD patients (2015-2020).
RESULTS
163 CD patients were treated with UST (median follow-up: 20.3 months [13.4-38.4]), of whom 55 (33.7%) underwent dose intensification to 4-weekly (n = 50, 30.7%) or 6-weekly (n = 5, 3.1%). After 1 year 29.9% were dose intensified. Prior exposure to both anti-TNF and vedolizumab (HR 9.5; 1.3-70.9), and concomitant steroid use at UST start (HR 1.8; 1.0-3.1) were associated with dose intensification. Following dose intensification, 62.6% patients (29/55) remained on UST beyond 1 year. Corticosteroid-free clinical remission was achieved in 27% at week 16 and 29.6% at last follow-up.
CONCLUSION
One third of CD patients treated with UST underwent dose intensification to a 4- or 6-weekly interval within the first year. Patients who failed both anti-TNF and vedolizumab, or required steroids at initiation were more likely to dose intensify.
Identifiants
pubmed: 36283944
pii: S1590-8658(22)00734-4
doi: 10.1016/j.dld.2022.10.002
pii:
doi:
Substances chimiques
Ustekinumab
FU77B4U5Z0
Dermatologic Agents
0
Types de publication
Observational Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1034-1041Subventions
Organisme : Medical Research Council
ID : MR/S034919/1
Pays : United Kingdom
Informations de copyright
Copyright © 2022. Published by Elsevier Ltd.
Déclaration de conflit d'intérêts
Conflict of interest Lauranne Derikx has served on an advisory board for Sandoz and as a speaker for Janssen. Spyros Siakavellas has received speaker fees from Pfizer and Janssen. Nikolas Plevris has served as a speaker for Janssen, Takeda and Pfizer. Beatriz Gros has served as a speaker for Abbvie and Galapagos. Colin Noble has served on an advisory board for Galapagos. Gareth-Rhys Jones has served as a speaker for Takeda, Janssen, Abbvie and Ferring. Charlie Lees has acted as a consultant to Abbvie, Janssen, Takeda, Pfizer, Galapagos, BMS, Pharmacosmos, GSK, Gilead, Topivert, Vifor Pharma, Celltrion, Dr Falk, Oshi Health, Trellus Health and Iterative Scopes; he has received speaking fees and travel support from Pfizer, Janssen, Abbvie, Galapagos, Fresnius Kabi, Takeda, Shire, Ferring, and Dr Falk. None of the other authors reported any conflicts of interest.