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4CPS-240 Biologics in paediatric severe asthma: real-world evidence from a specialised unit in a tertiary paediatric hospital

ejhpharm · 2026-03-18 · canonical JSON source

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Background and Importance Severe paediatric asthma is associated with frequent exacerbations, healthcare burden, and impaired quality of life. Biologic therapies have changed the management of these patients, but real-world paediatric evidence remains limited. Hospital-based specialised severe asthma units are multidisciplinary teams in which pharmacists play a key role in treatment optimisation, safety monitoring, and adherence support. In Spain, paediatric specialised units are scarce.Aim and Objectives To describe real-world characteristics and outcomes of paediatric patients receiving biologic therapy in a Paediatric Severe Asthma Unit (PSAU), including pharmacist-led pharmaceutical care activity, adherence, adverse reactions, and healthcare utilisation before and after initiation.Material and Methods Retrospective observational study. It included all patients with severe asthma treated with biologics in a PSAU of a tertiary paediatric hospital from January/2017 to June/2025.Collected variables: demographics (sex, age, weight, comorbidities), biologic therapy (type, adherence, adverse reactions), pharmacist-led follow-up (pharmaceutical care consultations), and healthcare utilisation in the year prior to and after initiation (emergency visits and hospital admissions). Descriptive statistics are reported as median (range).Results 44 patients were included, 59.1% female. Median age at initiation was 11.3 years (3.0–18.1) and median weight 41.6 kg (13.5–101.7). Almost all patients (97.7%) presented at least one comorbidity: 58.1% allergy, 41.9% allergy and atopic dermatitis. Biologics prescribed were omalizumab (61.4%), dupilumab (22.7%), mepolizumab (11.4%), and tezepelumab (4.5%). 308 pharmaceutical care consultations were carried out. Adherence was high, with median of 100% (84.85–100). Adverse reactions were reported in 6 patients (13.6%), including local injection site reactions, pruritus and headache. Healthcare utilisation decreased after initiation: annual emergency visits fell from 1(0–13) to 0(0–7), and hospital admissions from 0(0–6) to 0(0–4).Conclusion and Relevance In this real-world paediatric cohort, biologic therapy initiation was associated with high adherence and a marked reduction in exacerbation-related emergency visits and hospital admissions, with few, non-severe adverse reactions. Nearly all patients had relevant comorbidities, predominantly allergy with or without atopic dermatitis. These findings reinforce the benefit of biologics in severe paediatric asthma and highlight the critical role of hospital pharmacists, in a PSAU, in patient monitoring and support. Further studies should incorporate long-term outcomes, lung function, and patient-reported measures to strengthen evidence for clinical practice.Conflict of Interest No conflict of interest