Ocular Adverse Events Associated With Dupilumab: Analysis From a Real-World Database

Purpose: Dupilumab is a human monoclonal antibody used to treat various inflammatory conditions. The purpose of this study was to characterize the cumulative proportion of documented ocular adverse events after dupilumab initiation and compare outcomes between patients with atopic dermatitis (AD) and those treated for non-AD indications. Methods: This retrospective cohort study used the TriNetX electronic health record network. Patients who initiated dupilumab and had at least 2 years of available follow-up after treatment initiation were included. Patients with documented ocular adverse events within the 3 months before initiating dupilumab were excluded. Overall cumulative proportions were calculated, and propensity score–matched AD and non-AD cohorts were compared using risk ratios. Results: The overall cohort included 64,497 patients. Two-year cumulative proportions were 1.39% for conjunctivitis, 1.20% for dry eye syndrome, 0.39% for blepharitis/blepharoconjunctivitis, 0.32% for keratitis: inflammatory eye disease and cicatricial ectropion were rare. After propensity score matching, the AD cohort had higher 2-year cumulative proportions of documented blepharitis/blepharoconjunctivitis (0.46% vs. 0.22%; P < 0.01), conjunctivitis (1.97% vs. 1.52%; P = 0.01), and keratitis (0.43% vs. 0.23%; P < 0.01) than the non-AD cohort. Conclusions: Our study found a low frequency of documented ocular adverse events among patients treated with dupilumab. Although routine ophthalmic screening for all patients initiating dupilumab may not be necessary, prescribing physicians should remain vigilant for ocular surface inflammation, particularly in patients with atopic dermatitis, and promptly refer patients who develop ocular symptoms for ophthalmic evaluation.