Abstract
Background
The effectiveness of Ustekinumab (UST) and Vedolizumab (VDZ) in patients with Crohn's
disease (CD) as third-line biologic therapies is unclear.
Aims
We performed a multicentre, real-world assessment of the effectiveness of UST and
VDZ among highly-refractory patients with CD.
Methods
Data of consecutive patients with CD treated with UST and VDZ as third-line biologic
therapy until December 2021 were extracted from the cohort of the Sicilian Network
for Inflammatory Bowel Disease (SN-IBD).
Results
143 patients (UST: n = 113; VDZ: n = 30) were included. At the end of induction, the rates of clinical response (CR)
were 61.9% for UST and 60.0% for VDZ (p = 1.00), with steroid-free clinical remission (SFCR) achieved in 38.1% of patients
in the UST group and 43.3% of patients in the VDZ group (p = 0.75). After 52 weeks of observation, the rates of CR were 65.9% for UST and 71.4%
for VDZ (p = 0.77), while the rates of SFCR were 51.8% for UST and 57.1% for VDZ (p = 0.78). At multiple Cox proportional hazard regression model, age (HR 0.98; p = 0.04) and need for systemic steroids at baseline (HR 3.29; p = 0.003) were found to be independent predictors of treatment discontinuation.
Conclusions
Both VDZ and UST showed high effectiveness as third-line biologic therapy in CD, without
significant differences between them.
Keywords
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References
- Positioning biologics in the treatment of IBD: a practical guide - which mechanism of action for whom?.Curr Res Pharmacol Drug Discov. 2022; 3100104
- Effectiveness and safety of Ustekinumab for the treatment of Crohn's disease in real-life experiences: a meta-analysis of observational studies.Expert Opin Biol Ther. 2020; 20: 193-203
- Systematic review with meta-analysis: real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease.J Gastroenterol. 2018; 53: 1048-1064
- Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience.Therap Adv Gastroenterol. 2021; 1417562848211010668
- The PROSIT cohort of infliximab biosimilar in IBD: a prolonged follow-up on the effectiveness and safety across Italy.Inflamm Bowel Dis. 2019; 25: 568-579
- The SPOSIB SB2 sicilian cohort: safety and effectiveness of infliximab biosimilar SB2 in inflammatory bowel diseases, including multiple switches.Inflamm Bowel Dis. 2021; 27: 182-189
- SPOSAB ABP 501: a sicilian prospective observational study of patients with inflammatory bowel disease treated with adalimumab biosimilar ABP 501.J Gastroenterol Hepatol. 2021; 36: 3041-3049
- Systematic review with meta-analysis: the effectiveness of either ustekinumab or vedolizumab in patients with Crohn's disease refractory to anti-tumour necrosis factor.Aliment Pharmacol Ther. 2022; 55: 380-388
- The effectiveness of either ustekinumab or vedolizumab in 239 patients with Crohn's disease refractory to anti-tumour necrosis factor.Aliment Pharmacol Ther. 2020; 51: 948-957
- Comparison of short- and long-term effectiveness between ustekinumab and vedolizumab in patients with Crohn's disease refractory to anti-tumour necrosis factor therapy.Aliment Pharmacol Ther. 2021; 53: 1289-1299
- Dutch Initiative on Crohn and Colitis (ICC). Ustekinumab is associated with superior effectiveness outcomes compared to vedolizumab in Crohn's disease patients with prior failure to anti-TNF treatment.Aliment Pharmacol Ther. 2020; 52: 123-134
- Comparative effectiveness of ustekinumab or vedolizumab after one year in 130 patients with anti-TNF-refractory Crohn's disease.Aliment Pharmacol Ther. 2020; 52: 1341-1352
- Vedolizumab vs. ustekinumab as second-line therapy in Crohn's disease in clinical practice.Gastroenterol Hepatol. 2019; 73: 25-31
- A propensity score-matched, real-world comparison of ustekinumab vs vedolizumab as a second-line treatment for Crohn's disease. The Cross Pennine study II.Aliment Pharmacol Ther. 2021;
- Objective comparison of vedolizumab and ustekinumab effectiveness in Crohn's disease patients failure to TNF-alpha inhibitors.Am J Gastroenterol. 2022; https://doi.org/10.14309/ajg.0000000000001773
- Effectiveness of third-class biologic treatment in Crohn's disease: a multi-center retrospective cohort study.J Clin Med. 2021; 10: 2914
- The outcome of Crohn's disease patients refractory to anti-TNF and either vedolizumab or ustekinumab.Dig Liver Dis. 2020; 52: 1148-1155
- Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn's disease: a systematic review and network meta-analysis.Lancet Gastroenterol Hepatol. 2021; 6: 1002-1014
Article info
Publication history
Published online: September 17, 2022
Accepted:
August 16,
2022
Received:
June 21,
2022
Publication stage
In Press Corrected ProofIdentification
Copyright
© 2022 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
