TY - JOUR
T1 - Rates, predictive factors and effectiveness of ustekinumab intensification to 4- or 6-weekly intervals in Crohn's disease
AU - Derikx, Lauranne A A P
AU - Plevris, Nikolas
AU - Su, Shanna
AU - Gros, Beatriz
AU - Lyons, Mathew
AU - Siakavellas, Spyros I
AU - Constantine-Cooke, Nathan
AU - Jenkinson, Philip
AU - O'Hare, Claire
AU - Noble, Colin
AU - Arnott, Ian D
AU - Jones, Gareth-Rhys
AU - Lees, Charlie W
N1 - Copyright © 2022. Published by Elsevier Ltd.
PY - 2023/8/1
Y1 - 2023/8/1
N2 - 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.
AB - 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.
KW - Crohn Disease/drug therapy
KW - Ustekinumab/therapeutic use
KW - Dermatologic Agents/therapeutic use
KW - Humans
KW - Retrospective Studies
KW - Treatment Outcome
KW - Male
KW - Female
KW - Adolescent
KW - Adult
U2 - 10.1016/j.dld.2022.10.002
DO - 10.1016/j.dld.2022.10.002
M3 - Article
C2 - 36283944
SN - 1590-8658
VL - 55
SP - 1034
EP - 1041
JO - Digestive and Liver Disease
JF - Digestive and Liver Disease
IS - 8
ER -