ArticleClinics (Sao Paulo, Brazil)2026
Cumulative thalidomide exposure, peripheral neuropathy, and clinical outcomes in pediatric and very early-onset inflammatory bowel disease: a retrospective cohort study.
Article in Clinics (Sao Paulo, Brazil), 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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Abstract
backgroundThalidomide serves as a rescue therapy for refractory pediatric Inflammatory Bowel Disease (pIBD), but its use is constrained by the risk of thalidomide-induced Peripheral Neuropathy (TiPN). The quantitative relationship between cumulative dose and TiPN, as well as the risk profile in the specific population of Very Early-Onset IBD (VEOIBD), lacks precise evaluation.
methodsWe conducted a single-center, retrospective cohort study of children with IBD treated with thalidomide from 2018 to 2025. We compared cumulative thalidomide doses between TiPN and non-TiPN groups and employed ROC curve analysis to determine a predictive dose threshold. The cohort was further stratified into VEOIBD and pIBD groups to compare dynamic inflammatory marker changes and overall drug tolerability.
resultsAmong 49 included patients, the incidence of TiPN was 26.5% (13/49). The cumulative thalidomide dose was significantly higher in the TiPN group (median 19.5 g vs. 8.35 g, p = 0.008). A cumulative dose threshold of > 15.38 g predicted TiPN with an AUC of 0.756 (sensitivity 0.722, specificity 0.692). While VEOIBD patients (n = 14) had a distinct disease treatment history, they experienced significantly fewer overall adverse events than pIBD patients (3/14 vs. 19/35, p = 0.04), with no significant difference in TiPN incidence.
conclusionsCumulative thalidomide dose is a strong predictor of TiPN in children with IBD. Despite being a more refractory population, VEOIBD patients demonstrated better overall tolerance to thalidomide. Monitoring cumulative dose is crucial for mitigating neurotoxicity and optimizing thalidomide therapy in pIBD.
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