Abstract Background Emerging evidence in Crohn’s disease (CD) suggests that starting biological therapy during an early therapeutic window may improve clinical outcomes and minimise structural damage. The PROFILE trial has recently challenged how early this therapeutic window should be. This real-world study aimed to assess if very early therapy provides better outcomes. Methods We conducted a multicentric retrospective study including adults with CD who started biologic therapy within three years of diagnosis. The primary outcomes were clinical remission (CR) at twelve months. Secondary outcomes included endoscopic remission (ER), transmural remission, progression of disease behaviour, and a composite outcome defined as the behaviour progression, hospitalisation, or surgery. Results A total of 317 patients met the inclusion criteria. Overall, 51.1% were male, with mean age at diagnosis was 33.3±14.6 years. Most patients had an inflammatory phenotype (65.6%), ileal disease (54.9%) and 24,3% had perianal disease. Before biologic therapy, mean PRO2 score was 12.5±7.7 and mean SES-CD score 7.87±5.3. The mean time from diagnosis to biologic initiation was 7.8±7.7 months. Biologic therapy was initiated within the first 3 months in 43.7% of the patients and between 3 and 6 months in 25.2%. The rate of clinical remission was 77%, endoscopic remission was 62.3% and transmural remission was 39.3%. Overall, 17% required hospitalisation, 18.6% required surgery, and 27.8% met the composite outcome. Starting biologic within 3 months did not increase clinical remission at 12 months, however it was associated with increased endoscopic remission compared with initiation after 6 months (p = 0.008), and prevention of developing stricturing/fistulizing disease (p = 0.013). Conclusion Early initiation of biological therapy in CD was associated with high clinical and endoscopic remission rates. Treatment initiation within the first three months of disease conferred the greatest benefit regarding ER and prevention of disease progression. References: 1. Noor NM, Lee JC, Bond S, Dowling F, Brezina B, Patel K V., et al. A biomarker-stratified comparison of top-down versusaccelerated step-up treatment strategies for patients with newly diagnosed Crohn’s disease (PROFILE): a multicentre, open-labelrandomised controlled trial. Lancet Gastroenterol Hepatol. 2024;9(5):415–27 2. Revés J, Fernandez-Clotet A, Ordás I, Buisson A, Bazoge M, Hordonneau C, et al. Early Biological Therapy Within 12 Months ofDiagnosis Leads to Higher Transmural Healing Rates in Crohn’s Disease. Clinical Gastroenterology and Hepatology Conflict of interest: Dr. Vaz Conde, Patrícia: No conflict of interest Costa, Ana Beatriz: No conflict of interest Carvalho, Tania: No conflict of interest Fernandes, Daniela: No conflict of interest Oliveira, Raquel: No conflict of interest to declare. Neves, Andre: No conflict of interest Fernandes, Samuel Raimundo: No conflict of interest Bastos, António: No conflict of interest Teixeira, Pedro: No conflict of interest Portugal, Margarida: No conflict of interest Camões Neves, Joana: No conflict of interest Damasceno, José: No conflict of interest Guimaraes, Andreia: No conflict of interest Soares, Joao: No conflict of interest Silva Mendes, Sofia: None. Goncalves, Raquel: No conflict of interest Leal, Tiago Filipe: No conflict of interest
Conde et al. (Thu,) studied this question.