ArticleDigestive diseases and sciences2025
IFX Is Associated with Higher Rates of 2-Year Mucosal Healing in Biologic-Naïve CD Patients Compared to UST.
Article in Digestive diseases and sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
BACKGROUND AND
objectiveThe selection of optimal first-line biologic therapy for treatment-naïve Crohn's disease (CD) patients continues to present a clinical dilemma. Existing evidence remains limited by its predominant focus on anti-TNF-exposed populations or reliance on clinical endpoints alone. Our investigation provides a comprehensive comparative effectiveness analysis of ustekinumab (UST) versus infliximab (IFX) as first-line therapies in biologic-naïve CD, incorporating advanced cross-sectional imaging characteristics and specifically evaluating differential rates of endoscopic mucosal healing (MH) across longitudinal follow-up.
methodsThis retrospective cohort study enrolled 210 biologic-naïve CD patients. Primary outcome was MH at 1, 1.5, and 2 years. Subgroup analyses were performed to explore potential treatment heterogeneity among different patient subgroups. Furthermore, logistic regression analyses were conducted to identify MH-related factors.
resultsWhile 1-year and 1.5-year MH rates were comparable (27.8%/33.3% UST vs 30%/35.5% IFX; P = 0.726/0.788 unadjusted, P = 0.056/0.401 adjusted), IFX demonstrated significantly higher 2-year MH rates (59.5% vs 38.9%; adjusted P = 0.028). Patients with baseline BWT of 4-6 mm derived particular benefit from IFX, showing greater likelihood of achieving MH at both 1 year (OR 8.57, 95% CI 2.08-35.32; P = 0.003) and 1.5 years (OR 6.22, 95% CI 1.21-31.94; P = 0.028). Limberg > 2 consistently predicted worse MH outcomes across all time points (1-year OR 0.03, P < 0.001; 1.5-year OR 0.08, P = 0.008; 2-year OR 0.13, P = 0.024). Sustained MH correlated with lower 1-year HBI scores, and SES-CD. Notably, IFX treatment showed a strong independent association with 2-year MH achievement (OR 18.45, P = 0.002). Safety profiles were similar overall (P = 0.079), though IFX showed increased infection-related hospitalizations (P = 0.033) and immune-mediated adverse events, particularly drug-induced lupus (P = 0.033).
conclusionUST and IFX showed comparable efficacy and safety, but IFX demonstrated superior MH at 2 years. Patients with baseline BWT of 4-6 mm may benefit more from IFX.
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