TY - JOUR
T1 - Dupilumab-Associated Ocular Surface Disease in Paediatric Atopic Dermatitis Patients
T2 - Results From the BioDay Registry
AU - van der Rijst, Lisa P
AU - van Luijk, Chantal M
AU - van der Kamp, Sara
AU - Zuithoff, Nicolaas P A
AU - de Boer, Joke H
AU - de Bruin-Weller, Marjolein S
AU - de Graaf, Marlies
N1 - Publisher Copyright:
© 2025 The Author(s). Clinical & Experimental Allergy published by John Wiley & Sons Ltd.
PY - 2025/5
Y1 - 2025/5
N2 - 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.
AB - 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.
KW - atopic dermatitis
KW - children
KW - conjunctivitis
KW - dupilumab
KW - ocular surface
KW - paediatric
KW - type 2 inflammation
UR - http://www.scopus.com/inward/record.url?scp=105000825580&partnerID=8YFLogxK
U2 - 10.1111/cea.70025
DO - 10.1111/cea.70025
M3 - Article
C2 - 40103206
SN - 0954-7894
VL - 55
SP - 391
EP - 402
JO - Clinical and Experimental Allergy
JF - Clinical and Experimental Allergy
IS - 5
ER -