Analysis of possible baseline and treatment-course factors associated with non-remission in patients with Crohn’s disease treated with ustekinumab: a retrospective real-life analysis

Background: Factors predicting persistent failure to achieve long-term clinical remission with ustekinumab (UST) in Crohn’s disease (CD) are poorly defined, limiting early identification of patients unlikely to benefit from continuation of an ineffective treatment. Methods: A multicentre retrospective registry was established comprising adult patients with CD treated with UST (induction as per guidelines and maintenance 90 mg every 8 weeks), including clinico-demographic variables and disease activity parameters. These variables were retrospectively collected at baseline (T0) and at 2 (T1), 3 (T2), 6 (T3) and 12 (T4) months. The primary endpoint was the identification of factors associated with failure to achieve clinical remission (defined as an HBI ≥ 5) at T3, with the same assessment performed at T4 as a secondary endpoint. Results: A total of 254 patients were included in the T3 analysis and 143 in the T4 analysis. At T3, lack of remission was associated with prior exposure to 5-ASA (aOR 2.704, 95%CI 1.423–5.137), appendectomy (aOR 1.965, 95%CI 1.008–3.829) and CD diagnosis before the age of 40 (aOR 2.03, 95%CI 1.072–3.834). At T4, appendectomy confirmed the association (aOR 2.938, 95%CI 1.212–7.124). A baseline FC cut-off ≥ 250 µg/g predicted lack of remission at six months (aOR 3.57, 95%CI 1.686–7.561). Conclusion: Several anamnestic and on-treatment variables warrant evaluation in this setting, pending confirmation in larger datasets.