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Background The long-term efficacy of infliximab in patients with Crohn's disease is suboptimal. Aim To study prognostic factors for real-life long-term effcacy of infliximab in Crohn's disease. Methods All consecutive Crohn's disease patients treated with infliximab at a tertiary centre were retrospectively analysed. Only patients who received scheduled infliximab maintenance treatment were considered. Patient- and disease-related factors were used to identify independent predictors of infliximab failure-free survival using Cox proportional hazards regression. Results Of 1031 patients with Crohn's disease, 261 were eligible for inclusion. Median time on infliximab was 2.4 [ IQR 1.4-4.7] years, and 65 (24.9%) patients experienced infliximab failure. Estimated 5-year infliximab failure-free survival was 65.9% (95% CI 58.3-73.5). Multivariate Cox regression identified disease duration ≥1 year ( HR 2.5 (95% CI 1.2-5.2), P = 0.02), L1 disease location [ HR 2.0 (1.1-3.5), P = 0.02], prior anti- TNF use [ HR 2.3 (1.1-4.8), P = 0.03], haemoglobin <13.5 g/dL [ HR 2.3 (1.2-4.4), P = 0.02], not using therapeutic drug monitoring [ HR 8.0 (4.1-15.6), P = 1 × 10−9], and first dose optimisation within first year [ HR 3.7 (2.1-6.6), P = 5 × 10−6] as independent predictors of infliximab failure-free survival. Stratifying patients into risk groups resulted in estimated 3-year infliximab failure-free survival rates ranging from 95.3% (94.2-96.4) to 26.3% (8.6-44.0) depending on the number of risk factors ( P = 8 × 10−13). Conclusions This study identified several easy to obtain predictors of infliximab failure in patients with Crohn's disease, and these are in line with previous reports. Those with a high-risk profile for infliximab failure in whom infliximab initiation is considered, should be treated as early as possible making use of therapeutic drug monitoring. [ABSTRACT FROM AUTHOR]