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. 2022 Apr;55(7):856-866.
doi: 10.1111/apt.16742. Epub 2021 Dec 22.

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

Marco Vincenzo Lenti  1   2 , Vivien Dolby  1 , Tanya Clark  1 , Veronica Hall  3 , Suzanne Tattersall  3 , Francesca Fairhurst  3 , Catherine Kenneth  4 , Rachael Walker  4 , Karen Kemp  5 , Simon Borg-Bartolo  5 , Jimmy K Limdi  5 , Jo Taylor  5 , Tristan Townsend  6 , Sree Subramanian  6 , Daniel Storey  6 , Arash Assadsangabi  7 , Catherine Stansfield  7 , Paul Smith  8 , Debra Byrne  8 , Annalisa De Silvestri  2 , Christian P Selinger  1
Affiliations

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

Marco Vincenzo Lenti et al. Aliment Pharmacol Ther. 2022 Apr.

Abstract

Background: The optimal choice of biological agents after failure of anti-tumour-necrosis-factor-(TNF)α agent in Crohn's disease (CD) is yet to be defined.

Aims: To assess the effectiveness and safety of ustekinumab compared to vedolizumab as second-line treatment in CD patients who failed anti-TNFα therapy.

Methods: Retrospective analysis of clinical response and remission at 14 and 52 weeks to ustekinumab by physician global assessment (PGA). A propensity score-matched analysis with a cohort treated with vedolizumab was performed.

Results: Of 282 patients (mean age 40 ± 15, F:M ratio 1.7:1) treated with ustekinumab, clinical response or remission was reached by 200/282 patients (70.9%) at 14 weeks, and 162/259 patients (62.5%) at 52 weeks. Overall, 74 adverse events occurred, of which 26 were labelled as serious (8.3 per 100 person-year). After exclusion of patients without prior anti-TNFα exposure and patients previously exposed to vedolizumab or ustekinumab, we analysed 275/282 patients (97.5%) on ustekinumab and 118/135 patients (87.4%) on vedolizumab. Propensity score analysis revealed that at 14 weeks, patients treated with ustekinumab were 38% (95% CI 25%-50%; P < 0.001) more likely to achieve clinical remission, while at 52 weeks, the difference of 9% (95% CI -15% to 33%; P = 0.462) was not significant.

Conclusions: Ustekinumab was effective and well tolerated in this real-world cohort. While ustekinumab proved more effective at 14-weeks, we found no statistically significant differences at 52 weeks compared to vedolizumab.

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Figures

FIGURE 1
FIGURE 1
Rates of 14‐ and 52‐week clinical response or remission and steroid‐free response or remission (expressed as %) according to the physician global assessment
FIGURE 2
FIGURE 2
Kaplan‐Meier ustekinumab vs vedolizumab failure estimate. Of note, no significant difference was noticed between the two drugs at both 3‐ and 12‐month follow‐up
See this image and copyright information in PMC

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References

    1. Roda G, Chien Ng S, Kotze PG, et al. Crohn’s disease. Nat Rev Dis Primers. 2020;6:22. - PubMed
    1. Lenti MV, Di Sabatino A. Intestinal fibrosis. Mol Aspects Med. 2019;65:100–109. - PubMed
    1. Lenti MV, Cococcia S, Ghorayeb J, Di Sabatino A, Selinger CP. Stigmatisation and resilience in inflammatory bowel disease. Intern Emerg Med. 2020;15:211–223. - PMC - PubMed
    1. Torres J, Bonovas S, Doherty G, et al. ECCO Guidelines on therapeutics in Crohn's disease: medical treatment. J Crohns Colitis. 2020;14:4–22. - PubMed
    1. Adamina M, Bonovas S, Raine T, et al. ECCO guidelines on therapeutics in Crohn's disease: surgical treatment. J Crohns Colitis. 2020;14:155–168. - PubMed

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