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Superior persistence of ustekinumab compared to anti-TNF in vedolizumab-experienced inflammatory bowel diseases patients: a real-world cohort study.

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  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 100968547 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-230X (Electronic) Linking ISSN: 1471230X NLM ISO Abbreviation: BMC Gastroenterol Subsets: MEDLINE
    • Publication Information:
      Original Publication: London : BioMed Central, [2001-
    • Subject Terms:
      Ustekinumab*/therapeutic use ; Antibodies, Monoclonal, Humanized*/therapeutic use ; Gastrointestinal Agents*/therapeutic use ; Crohn Disease*/drug therapy ; Adalimumab*/therapeutic use ; Colitis, Ulcerative*/drug therapy; Humans ; Female ; Male ; Retrospective Studies ; Adult ; Middle Aged ; Infliximab/therapeutic use ; Tumor Necrosis Factor-alpha/antagonists & inhibitors ; Tumor Necrosis Factor Inhibitors/therapeutic use ; Inflammatory Bowel Diseases/drug therapy ; Treatment Outcome ; Assessment of Medication Adherence
    • Abstract:
      Background/aims: The increasing use of biologic therapies for moderate to severe inflammatory bowel disease (IBD) highlights the importance of optimal treatment sequencing, particularly after vedolizumab (VDZ) exposure. Studies comparing the effectiveness of ustekinumab (UST) and antitumor necrosis factor (anti-TNF) agents post-VDZ are limited.
      Methods: This retrospective study analyzed VDZ-experienced IBD patients treated with UST or anti-TNF (adalimumab and infliximab) from May 2019 to January 2024. We conducted a comparative analysis of the 52-week treatment persistence between UST and anti-TNF therapies, while also identifying independent predictors that influence 52-week persistence.
      Results: The study included 110 participants, with 40 diagnosed with ulcerative colitis (UC) and 70 with Crohn's disease (CD). Demographics were comparable across treatment groups. The primary discontinuation reason for VDZ was secondary non-response. Kaplan-Meier analysis revealed that UST demonstrated superior 52-week persistence in overall IBD, CD and UC patients, compared to anti-TNF. Cox regression analysis also showed UST's superiority in overall IBD (HR: 0.15, 95% CI: 0.05-0.45, p < 0.001), CD (HR: 0.09, 95% CI: 0.01-0.68, p = 0.02), and UC (HR: 0.28, 95% CI: 0.08-0.996, p = 0.049). The independent predictors for 52-week treatment persistence are Crohn's disease (Odds Ratio: 7.151, 95% CI: 1.763-28.995, p = 0.006) and UST treatment (Odds Ratio: 7.912, 95% CI: 1.789-34.992, p = 0.006). Notably, UST required more frequent dosing adjustments than anti-TNF, although both treatments exhibited comparable safety profiles.
      Conclusions: UST demonstrated superior 52-week treatment persistence in IBD patients previously treated with VDZ compared to anti-TNF agents, albeit with a need for more frequent dose adjustments.
      Competing Interests: Declarations. Ethical approval and consent to participate: The study was approved by the Institutional Review Board (IRB) of the Chang Gung Medical Foundation (approval document No. 202400030B0: “Diagnosis, Treatment, and Prognosis of Inflammatory Bowel Disease”). The IRB waived the requirement for signed informed consent from individual patients for reviewing medical records in the electronic medical record system as it was a retrospective study. Consent for publication: Not applicable. Financial disclosures: This study was not funded by grants or other financial sponsors. The authors have no financial arrangements for the company whose products are discussed in this manuscript. Competing interests: The authors declare no competing interests.
      (© 2024. The Author(s).)
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    • Contributed Indexing:
      Keywords: Anti-TNF; Inflammatory bowel disease; Persistence; Ustekinumab; Vedolizumab
    • Accession Number:
      FU77B4U5Z0 (Ustekinumab)
      9RV78Q2002 (vedolizumab)
      0 (Antibodies, Monoclonal, Humanized)
      0 (Gastrointestinal Agents)
      FYS6T7F842 (Adalimumab)
      B72HH48FLU (Infliximab)
      0 (Tumor Necrosis Factor-alpha)
      0 (Tumor Necrosis Factor Inhibitors)
    • Publication Date:
      Date Created: 20241231 Date Completed: 20241231 Latest Revision: 20250104
    • Publication Date:
      20250114
    • Accession Number:
      PMC11686934
    • Accession Number:
      10.1186/s12876-024-03577-1
    • Accession Number:
      39741232