Dupilumab-Associated Ocular Surface Disease in Paediatric Atopic Dermatitis Patients: Results From the BioDay Registry

This study aimed to evaluate long-term incidence and severity of dupilumab-associated ocular surface disease (DAOSD) in pediatric patients diagnosed with moderate to severe atopic dermatitis and to identify possible predictors that could increase risk of developing DAOSD throughout treatment.This study included 104 pediatric patients, aged 3 to 17 years, diagnosed with moderate to severe atopic dermatitis and treated with dupilumab, an interleukin 4 (IL-4) and IL-13 inhibitory monoclonal antibody. All patients were enrolled in the Netherlands-based BioDay registry between 2019 and 2024.This was a prospective observational cohort study. Patients began biologic treatment based on age- and weight-adjusted dosing of dupilumab. The enrolled patients were maintained on a follow-up schedule every 4 to 12 weeks and assessed for self-reported or objectively observed ocular symptoms, AD severity, and any treatment changes or side effects. If ocular symptoms presented, the patient was first treated by a dermatologist with lubricating or antihistamine eye drops as well as tacrolimus ointment as needed. If symptoms worsened or persisted, the patient was then referred for an ophthalmology evaluation, at which time inflammation was quantified and followed by subsequent intraocular anti-inflammatory drops.DAOSD occurred in 34.6% of patients, with 30.6% of those patients requiring ophthalmology assessment and intraocular anti-inflammatory therapy. Of the total reported DAOSD cases, 86% developed within the first year of treatment. Of the symptoms reported throughout treatment, pruritus, redness, and tearing were the most common. Regarding possible laboratory predictors, an elevated baseline immunoglobulin E (IgE) level greater than or equal to 3000 kU/L was the only individual predictor of DAOSD, whereas age, sex, and history of allergic conjunctivitis were not statistically significant. Four patients (3.8%) discontinued the medication due to persistent ocular symptomsAlthough typically mild, DAOSD is a common side effect reported in pediatric patients who are prescribed dupilumab for the treatment of atopic dermatitis. Nearly one-third of patients who clinically developed DAOSD required ophthalmologic intervention. Elevated baseline IgE was determined to be a predictor for the risk of developing DAOSD. Increased awareness, close-focused follow-up, and a long follow-up period (median 70.5 weeks) may have contributed to increased incidence in this specific pediatric population when compared with adult studies involving AD.This real-world longitudinal study provides valuable insight into pediatric DAOSD, where current literature is limited. When pediatric patients are unable to verbalize ocular symptoms, commonly resembling allergic conjunctivitis in early stages, this poses a risk of vision-compromising complications in the future. Using baseline IgE levels, physicians can use specific laboratory and clinical information to counsel families and plan close follow-up to effectively anticipate and treat early stages of DAOSD. The findings of this study suggest that more than 95% of patients are able to continue treatment with dupilumab after treatment of ocular symptoms.