Long-term Clinical Effectiveness of Ustekinumab in Patients with Crohn's Disease Who Failed Biologic Therapies: A National Cohort Study.
Adolescent
Adult
Aged
Arthralgia
/ drug therapy
Belgium
/ epidemiology
Biological Therapy
/ adverse effects
Body Mass Index
Child
Cohort Studies
Crohn Disease
/ drug therapy
Female
Gastrointestinal Agents
/ therapeutic use
Glucocorticoids
/ therapeutic use
Humans
Male
Middle Aged
Remission Induction
Retrospective Studies
Tumor Necrosis Factor-alpha
/ antagonists & inhibitors
Ustekinumab
/ therapeutic use
Young Adult
Clinical effectiveness
Crohn’s disease
real-life cohort
ustekinumab
Journal
Journal of Crohn's & colitis
ISSN: 1876-4479
Titre abrégé: J Crohns Colitis
Pays: England
ID NLM: 101318676
Informations de publication
Date de publication:
28 Oct 2019
28 Oct 2019
Historique:
pubmed:
17
4
2019
medline:
31
3
2020
entrez:
17
4
2019
Statut:
ppublish
Résumé
Ustekinumab [UST] was recently approved in Europe for the treatment of moderate to severe Crohn's disease [CD]. Long-term real-world data are currently scarce for CD patients previously exposed to several biologics. This is an observational, national, retrospective multicentre study. Patients received intravenous UST ~6 mg/kg at baseline, with 90 mg subcutaneously thereafter every 8 weeks. Response and remission rates were assessed at Weeks 8, 16, and 52. Data from 152 patients were analysed. All patients were exposed to at least one anti-TNFα agent, with 69.7% were exposed to even two anti-TNFα and vedolizumab. After 1 year, 42.1% and 25.7% of patients had experienced clinical response and clinical remission, respectively, and 38.8% and 24.3% had achieved steroid-free clinical response and remission, respectively; 38.8% of patients discontinued therapy during the 12 months of follow-up. Colonic location was predictive of clinical response at 1 year, and low body mass index [BMI] at baseline was a negative predictor of clinical remission. Resolution of arthralgia was associated with clinical response over time. De novo arthralgia was reported by 17.9% of patients at Week 8 and 13.5% of patients at Week 52. No impact of UST on arthralgia was observed in patients with concomitant ankylosing spondylitis [n = 17]. Others adverse events were reported in 7.2% of patients. This real-world cohort study confirms the effectiveness of UST in CD patients previously exposed to several biologics. Ustekinumab was well tolerated with respect to adverse events. This article has an associated podcast which can be accessed at https://academic.oup.com/ecco-jcc/pages/podcast.
Sections du résumé
BACKGROUND
BACKGROUND
Ustekinumab [UST] was recently approved in Europe for the treatment of moderate to severe Crohn's disease [CD]. Long-term real-world data are currently scarce for CD patients previously exposed to several biologics.
METHODS
METHODS
This is an observational, national, retrospective multicentre study. Patients received intravenous UST ~6 mg/kg at baseline, with 90 mg subcutaneously thereafter every 8 weeks. Response and remission rates were assessed at Weeks 8, 16, and 52.
RESULTS
RESULTS
Data from 152 patients were analysed. All patients were exposed to at least one anti-TNFα agent, with 69.7% were exposed to even two anti-TNFα and vedolizumab. After 1 year, 42.1% and 25.7% of patients had experienced clinical response and clinical remission, respectively, and 38.8% and 24.3% had achieved steroid-free clinical response and remission, respectively; 38.8% of patients discontinued therapy during the 12 months of follow-up. Colonic location was predictive of clinical response at 1 year, and low body mass index [BMI] at baseline was a negative predictor of clinical remission. Resolution of arthralgia was associated with clinical response over time. De novo arthralgia was reported by 17.9% of patients at Week 8 and 13.5% of patients at Week 52. No impact of UST on arthralgia was observed in patients with concomitant ankylosing spondylitis [n = 17]. Others adverse events were reported in 7.2% of patients.
CONCLUSIONS
CONCLUSIONS
This real-world cohort study confirms the effectiveness of UST in CD patients previously exposed to several biologics. Ustekinumab was well tolerated with respect to adverse events.
PODCAST
UNASSIGNED
This article has an associated podcast which can be accessed at https://academic.oup.com/ecco-jcc/pages/podcast.
Identifiants
pubmed: 30989232
pii: 5467237
doi: 10.1093/ecco-jcc/jjz080
doi:
Substances chimiques
Gastrointestinal Agents
0
Glucocorticoids
0
Tumor Necrosis Factor-alpha
0
Ustekinumab
FU77B4U5Z0
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1401-1409Informations de copyright
Copyright © 2019 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.