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

Lauranne A.A.P. Derikx*, Nikolas Plevris, Shanna Su, Beatriz Gros, Mathew Lyons, Spyros I. Siakavellas, Nathan Constantine-Cooke, Philip Jenkinson, Claire O'Hare, Colin Noble, Ian D. Arnott, Gareth Rhys Jones, Charlie W. Lees

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


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.

Original languageEnglish
JournalDigestive and Liver Disease
Publication statusE-pub ahead of print - 22 Oct 2022
Externally publishedYes

Bibliographical note

Funding Information:
Professor Lees is funded by a UK Research and Innovation Future Leaders Fellowship “Predicting outcomes in IBD”. Gareth-Rhys Jones is funded by a Wellcome Trust Clinical Research Career Development Fellowship.

Publisher Copyright:
© 2022


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