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Research Article: Real-world effectiveness and safety of dupilumab therapy in children ?6 years with uncontrolled persistent asthma: a propensity-matched retrospective cohort study

Date Published: 2026-06-15

Abstract:
Asthma is common in children. Dupilumab is a biological agent that showed effectiveness in older children with uncontrolled asthma; however, its efficacy and safety are lacking among the very young children (?6) who were excluded from clinical trials. Using TriNetX, children ?6 years old with persistent asthma who received a concomitant prescription for dupilumab for any indication, in addition to standard asthma treatment, were compared with those on standard treatment alone. Using 1:1 propensity score matching across 35 covariates, outcomes such as acute exacerbations, status asthmaticus, need for oral corticosteroid (OCS), emergency room (ER) visits, anaphylaxis, infections, and inpatient admissions were assessed at 6 and 12 months. Of 44,952 patients analyzed, 301 patients were matched per group. Asthmatic children with concomitant dupilumab prescriptions were associated with a reduction in acute exacerbations at 6 and 12 months (RR 0.53 and 0.46, respectively; p <?0.05), OCS use (RR 0.67 and 0.66; p <?0.05), ER visits, and infections (all p <?0.05). However, the risk of anaphylaxis was higher in cohort one at 6 and 12 months (RR 1.80 and 1.74; p <?0.05). Other outcomes, such as status asthmaticus, eosinophilia, and inpatient admissions, were similar between the cohorts. This real-world analysis shows dupilumab therapy alongside standard treatment in children ?6 years with persistent asthma is significantly associated with reduced acute exacerbations, OCS use, and ER visits. These findings support dupilumab's clinical benefit for this vulnerable group, aiding clinical decisions.

Introduction:
Asthma is common in children. Dupilumab is a biological agent that showed effectiveness in older children with uncontrolled asthma; however, its efficacy and safety are lacking among the very young children (?6) who were excluded from clinical trials.

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