Rates, predictive factors and effectiveness of ustekinumab intensification to 4- or 6-weekly intervals in Crohn's disease

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, a...

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Published in:Digestive and liver disease 2023-08, Vol.55 (8), p.1034-1041
Main Authors: Derikx, Lauranne A.A.P., Plevris, Nikolas, Su, Shanna, Gros, Beatriz, Lyons, Mathew, Siakavellas, Spyros I., Constantine-Cooke, Nathan, Jenkinson, Philip, O'Hare, Claire, Noble, Colin, Arnott, Ian D., Jones, Gareth-Rhys, Lees, Charlie W
Format: Article
Language:English
Subjects:
Adolescent
Adult
Crohn Disease - drug therapy
Crohn's disease
Dermatologic Agents - therapeutic use
Dose escalation
Dose optimisation
Female
Humans
Male
Real world evidence
Retrospective Studies
Treatment Outcome
Ustekinumab
Ustekinumab - therapeutic use
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Summary: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.
ISSN:1590-8658
1878-3562
DOI:10.1016/j.dld.2022.10.002