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Publications

Journal Article Ahead of print

PubMed: 42829277 DOI: 10.1016/j.dld.2026.09.009

Comparative effectiveness and safety of first-line anti-TNF, vedolizumab, and ustekinumab in biologic-naïve Crohn's disease: Analysis from a real-world cohort.

Dig Liver Dis

Authors: Uria Shani, Hadas Yaakobi, Haim Leibovitzh, Nitsan Maharshak, Ohad Regev, Haya Mushka Abitbol, Adam Goldman, Bella Ungar, Ahmad Albshesh, Offir Okashi, Shomron Ben-Horin, Uri Kopylov

Affiliations

  • Department of Gastroenterology, Sheba Medical Center, Tel-Hashomer, Ramat-Gan, Israel.
  • IBD Unit, Department of Gastroenterology and Liver Diseases, Tel Aviv Sourasky University Medical Center, Tel Aviv, Israel; Gray Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.
  • Tel Aviv Sourasky University Medical Center, Tel Aviv, Israel.
  • Department of Gastroenterology, Sheba Medical Center, Tel-Hashomer, Ramat-Gan, Israel.
  • Department of Gastroenterology, Sheba Medical Center, Tel-Hashomer, Ramat-Gan, Israel; Gray Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.

Abstract

BACKGROUND

Comparative first-line biologic data in biologic-naïve Crohn's disease (CD) remain limited. Anti-tumor necrosis factor (anti-TNF) agents, vedolizumab (VDZ), and ustekinumab (UST) were compared in routine care.

METHODS

This retrospective cohort study included biologic-naïve adults with CD treated at two tertiary inflammatory bowel disease (IBD) centers. The primary outcome was clinical response at 48-52 weeks; secondary outcomes were early clinical response (12-16 weeks), corticosteroid-free remission, biomarker normalization, composite remission, persistence, hospitalizations, and safety. Inverse probability of treatment weighting (IPTW) was applied.

RESULTS

Among 448 patients, 204/448 (45.5%) received anti-TNF, 159/448 (35.5%) VDZ, and 85/448 (19.0%) UST. Clinical response and corticosteroid-free remission did not differ significantly at 12-16 or 48-52 weeks. At 12-16 weeks, biomarker normalization was higher with anti-TNF (adjusted odds ratio [aOR] 2.51, 95% confidence interval [CI] 1.34-4.71; p=0.004; each agent vs. the other two combined), lower with VDZ (aOR 0.44, 95% CI 0.24-0.83; p=0.01), and not significantly different with UST (aOR 0.91, 95% CI 0.45-1.83; p=0.79). By 48-52 weeks, no significant differences were detected in biomarker normalization, composite remission, discontinuation, hospitalizations, or safety.

CONCLUSION

First-line anti-TNF, VDZ, and UST showed no significant differences in 52-week clinical effectiveness or treatment persistence, supporting individualized treatment selection.

MeSH

Ustekinumab, Safety, Hospitalization, Crohn Disease, Adrenal Cortex Hormones, Biomarkers, Therapeutics