Risk factors for cutaneous complications of advanced therapies in paediatric inflammatory bowel disease patients.
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BACKGROUND: Observational data suggest comparable efficacy of different advanced therapies in paediatric inflammatory bowel disease (pIBD). Cutaneous adverse effects (cAEs) of tumour necrosis factor antagonists (anti-TNF) may lead to treatment discontinuation. Identifying risk factors for these adverse effects could improve treatment sustainability. METHODS: We conducted a prospective, multicentre observational study using Czech registry data. pIBD patients treated with anti-TNF, vedolizumab or ustekinumab were enroled. The primary outcome assessed was time to the onset of cAEs. The secondary outcome was time to the onset of severe cAEs. Multivariate Cox proportional hazards models with mixed effects were used with predefined clinically important confounders. RESULTS: We analysed 546 treatment courses from 423 patients across four centres. cAEs were reported in 19.8% of therapy courses and were associated with female sex [hazard ratio (HR) 1.82, 95% confidence interval (CI): 1.18-2.81], a family history of atopic diseases (HR: 1.82, 95% CI: 1.13-2.91) and anti-TNF therapy (HR: 6.84, 95% CI 1.98-23.63). CONCLUSION: We demonstrated a strong association between cAEs and anti-TNF treatment, female sex and a family history of atopic diseases. Non-anti-TNF advanced therapy may be considered early for patients at risk for cAEs. IMPACT: Cutaneous adverse effects occur in up to 20% of advanced therapy courses in paediatric inflammatory bowel disease, with approximately half being severe. Female sex and a family history of atopic disease are associated with an increased risk of cutaneous adverse effects. Among patients requiring a change in advanced therapy due to cutaneous adverse effects, switching to ustekinumab is associated with higher odds of resolution compared with switching to another anti-TNF agent. Early use of non-anti-TNF agents may be considered in paediatric patients at higher risk of cutaneous adverse effects.