Observational studyPharmacological reports : PR2026
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.
Observational study in Pharmacological reports : PR, 2026. 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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10 authors.
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Abstract
backgroundFactors 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.
methodsA 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.
resultsA 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).
conclusionSeveral anamnestic and on-treatment variables warrant evaluation in this setting, pending confirmation in larger datasets.
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