Very Early Biologic Therapy within Six Months of Crohn’s Disease Diagnosis Improves One-Year Steroid-Free Clinical Remission: A Retrospective Cohort Study

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INTRODUCTION: Early use of biologics improves outcomes for Crohn's disease (CD). Evidence now indicates that initiating therapy within 6 months of diagnosis - the "very early" window - may yield additional benefits over the traditional ≤2-year target. We therefore compared 1-year outcomes after very early (<6 months) versus early (6-24 months) biologic initiation in routine practice. METHODS: In this retrospective cohort (March 2018 to June 2025), biologic-naïve adults with CD and ≥52 weeks of follow-up were stratified by time from diagnosis to first biologic: very early (<6 months) or early (6-24 months). The primary endpoint was steroid-free clinical remission at week 52. Multivariate logistic regression identified variables independently associated with remission. RESULTS: Ninety-six patients were analyzed (very early = 52; early = 44). Baseline characteristics were comparable except for a higher proportion of corticosteroid use in the very early group (67.3% vs. 43.2%; p = 0.018). At week 52, very early initiation was associated with a lower mean CD Activity Index (64.82 ± 6.79 vs. 96.10 ± 13.03; p = 0.038) and a higher steroid-free clinical remission rate (71.2% vs. 45.5%; p = 0.011). Concomitant corticosteroid use fell to 11.4% in the very early group versus 30.6% in the early group (p = 0.033). Very early initiation remained the strongest independent predictor of steroid-free remission (adjusted OR 3.537, 95% CI: 1.417-8.824; p = 0.007). CONCLUSIONS: Initiating biologic therapy within 6 months of CD diagnosis significantly increases 1-year steroid-free clinical remission and reduces corticosteroid dependence compared with initiation at 6-24 months. These real-world data support adopting a standardized "very early" biologic treatment strategy to optimize clinical outcomes in newly diagnosed, biologic-naïve CD.

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