Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver · 2026
Comparative effectiveness and safety of first-line anti-TNF, vedolizumab, and ustekinumab in biologic-naïve Crohn's disease: Analysis from a real-world cohort.
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Shani Uria, Yaakobi Hadas, Leibovitzh Haim, Maharshak Nitsan, Regev Ohad, Abitbol Haya Mushka, Goldman Adam, Ungar Bella, Albshesh Ahmad, Okashi Offir, Ben-Horin Shomron, Kopylov Uri
Аннотация
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.
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.