Comparative effectiveness and safety of first-line anti-TNF, vedolizumab, and ustekinumab in biologic-naïve Crohn's disease: Analysis from a real-world cohort
In brief
Three first-line Crohn's biologics show similar clinical outcomes at one year
In a two-center cohort of 448 adults starting biologic treatment for Crohn's disease, anti-TNF drugs, vedolizumab, and ustekinumab had similar clinical response and steroid-free remission at one year, with no detected differences in persistence, hospitalizations, or safety. Anti-TNF treatment was linked to more early biomarker normalization, but this retrospective study found no lasting differences, supporting individualized treatment choice.
- Journal
- Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver (Q1)
- Published
- 3 October 2026
- Study design
- Retrospective cohort
- Evidence level
- Level 3, Low (CEBM 3b)
- Authors
- Uria Shani, Hadas Yaakobi, Haim Leibovitzh, Nitsan Maharshak, Ohad Regev, Haya Mushka Abitbol, et al.
- PMID
- 42829277
- DOI
- 10.1016/j.dld.2026.09.009
Why clinicians should know about it
- Picked for Gastroenterology (paper of the day, 5 October 2026): Comparative effectiveness of first‑line biologics in Crohn's
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.