Long-term effectiveness, safety of dupilumab demonstrated in real-world paediatric AD patients

Dupilumab appears to be effective and safe in the long-term treatment of children with atopic dermatitis (AD) in the clinical setting, according to a multicentre, prospective cohort study.

The study was part of the BioDay registry and conducted across four academic and three nonacademic hospitals in the Netherlands. A total of 309 paediatric AD patients (mean age 10.2 years, 51.5 percent male) treated with dupilumab were included in the analysis. All patients initiated dupilumab at the recommended label dose.

The main outcome of clinical effectiveness was assessed using the Eczema Area and Severity Index (EASI) and Investigator Global Assessment (IGA). Additional outcomes included the Numeric Rating Scale (NRS) for pruritus, NRS for pain, and quality of life (QoL) scores. Safety, drug survival, reasons, and factors associated with discontinuation were also evaluated.

Of the patients, 51 (16.5 percent) were aged 6 months to 5 years (median follow-up 45 weeks), 120 (38.8 percent) were aged 6–11 years (median follow-up 80 weeks), and 138 (44.7 percent) were aged 12–16 years (median follow-up 89.5 weeks) at baseline.

AD control was maintained in most patients, with mean EASI and NRS scores for pruritus remaining low after 3 years (3.4 and 3.6 points, respectively). NRS for pruritus and QoL scores over time differed across age groups, with children in the 6-months-to-5-years age group consistently having higher scores than older children.

In terms of safety, the most frequently reported adverse event (AE) was dupilumab-associated ocular surface disease (6.6 percent). Fifty patients (16.2 percent) discontinued dupilumab treatment due to ineffectiveness (38 percent) and/or AEs (30 percent) or administration problems (22 percent). Most treatment discontinuations occurred within 1.5 years.

Three-year drug survival was 80.1 percent. Factors including allergic asthma, allergic rhinitis, and age 6–11 years were associated with a lower risk of treatment discontinuation.