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

Abstract

Background: Dupilumab-associated ocular surface disease (DAOSD) is a common side effect in paediatric atopic dermatitis (AD) patients treated with dupilumab. However, long-term real-world safety data is limited. Therefore, this study investigates the incidence of DAOSD in paediatric AD patients treated with dupilumab and identifies associated risk factors.

Methods: This prospective study included paediatric AD patients (aged 3-17 years) treated with dupilumab. Ocular symptoms were assessed every 4-12 weeks. DAOSD was initially treated with lubricating eye drops, antihistamine eye drops, and/or tacrolimus ointment for the external eyelids. Persistent symptoms were treated with ocular anti-inflammatory therapy. Ophthalmological examination was performed in patients with DAOSD requiring ocular anti-inflammatory therapy. Univariable and multivariable regression analyses were conducted to identify predictors for developing DAOSD.

Results: A total of 104 patients (11.7 ± 4.0 years) with a median follow-up of 70.5 weeks were included. Overall, 34.6% (36/104) of patients developed DAOSD, of which 30.6% (11/36) required ocular anti-inflammatory therapy. The development of DAOSD was not age-dependent, nor was it associated with pre-existing allergic conjunctivitis. The most common ocular symptoms were pruritus (75.0%), redness (72.2%), and tearing (58.3%). Ophthalmological examination revealed tarsal conjunctivitis in all patients with DAOSD requiring ocular anti-inflammatory therapy. Baseline serum IgE levels of ≥ 3000 kU/L were independently associated with the development of DAOSD (OR 4.65; 95% CI 1.43-15.11, p = 0.011). DAOSD led to dupilumab discontinuation in 3.8% (4/104) of patients.

Conclusions: This prospective, long-term, real-world study shows that 34.6% of paediatric AD patients treated with dupilumab develop DAOSD. Elevated baseline serum IgE (≥ 3000 kU/L) may predict the development of DAOSD. The high incidence of DAOSD underscores the importance of awareness of ocular symptoms during dupilumab treatment, especially in (young) paediatric patients, where reporting ocular symptoms can be challenging and may lead to delayed diagnosis.