Patient-Reported Ocular Disorders and Symptoms in Adults with Moderate-to-Severe Atopic Dermatitis: Screening and Baseline Survey Data from a Clinical Trial

Abstract

Introduction: Patients with atopic dermatitis (AD) have a greater risk of conjunctivitis and other ocular surface disorders than the general population. We evaluated the burden of ocular surface disorders and related symptoms prior to treatment initiation in adults with moderate-tosevere AD. Methods: Patients were enrolled in a randomized, placebo-controlled, double-blinded, phase 3 trial of dupilumab administered with concomitant topical corticosteroids. At the beginning of the screening period, all enrolled patients completed a survey of ocular disorder diagnoses received in the past year; at baseline, patients completed a survey of frequency and severity of ocular symptoms (discomfort, itching, redness, and tearing) experienced in the past month. Results: A total of 712 of 740 patients enrolled in the trial provided responses to the survey. At screening, 286 of 740 patients (38.6%) reported having at least one ocular disorder in the past year. At baseline, 499 of 712 respondents (70.1%) reported having at least one symptom within the past month. Of these patients, 4.4%, 6.0%, 5.5%, and 4.4%, respectively, reported having discomfort, itching, redness, and tearing all of the time. Mild discomfort, itching, redness, and tearing were reported by 26.1%, 33.7%, 30.8%, and 31.6% of patients, respectively, while 7.3%, 7.7%, 6.2%, and 4.2%, reported severe discomfort, itching, redness, and tearing, respectively. Conclusions: These data demonstrate a high burden of ocular surface disorders and related symptoms in a population of adults with moderate-to-severe AD. Dermatologists should be aware of increased incidence of these disorders in AD and query their patients for signs and symptoms of eye disease. ClinicalTrials.gov Registration Number: NCT0 2260986.

Dupilumab ocular side effects in patients with atopic dermatitis: a systematic review

“…Rates of conjunctivitis were higher in AD patients treated with dupilumab than in those receiving placebo, in adult, as well as in adolescent and children clinical trials. 7,11,[17][18][19][20][21][22][23] Most cases of conjunctivitis were mild-to-moderate forms and responded to topical eye drops with corticosteroids, antibiotics, antihistamines, or mast cell stabilizers without necessitating dupilumab discontinuation. 11 Severe cases were only reported in less than 1% of the patients.…”

Dupilumab‐associated ocular surface disease: An interdisciplinary decision framework for prescribers in the Australian setting

“…Compared with the general population, patients with AD have a high baseline prevalence of ophthalmological comorbidity prior to dupilumab treatment 18–20 . Analysis of baseline screening data from the phase 3 study LIBERTY AD CHRONOS demonstrated a high burden of ocular surface disorders 20 .…”

“…Compared with the general population, patients with AD have a high baseline prevalence of ophthalmological comorbidity prior to dupilumab treatment. 18 , 19 , 20 Analysis of baseline screening data from the phase 3 study LIBERTY AD CHRONOS demonstrated a high burden of ocular surface disorders. 20 Overall, 38.6% of patients enrolled reported having at least one eye disorder in the past year (dry eye 20.5%, perennial allergic conjunctivitis 15.0%, atopic keratoconjunctivitis 12.2%, ophthalmic herpes simplex 4.2%, ophthalmological rosacea 2.7% and keratoconus 2.1%).…”

“…18 , 19 , 20 Analysis of baseline screening data from the phase 3 study LIBERTY AD CHRONOS demonstrated a high burden of ocular surface disorders. 20 Overall, 38.6% of patients enrolled reported having at least one eye disorder in the past year (dry eye 20.5%, perennial allergic conjunctivitis 15.0%, atopic keratoconjunctivitis 12.2%, ophthalmic herpes simplex 4.2%, ophthalmological rosacea 2.7% and keratoconus 2.1%). The majority (70.1%) reported having at least one ocular symptom in the month prior to enrolling in the trial; these symptoms were mostly mild (discomfort, 26.1%, itching 33.7%, redness 30.8% and tearing 31.6% of patients) with less than 10% of patients reporting severe symptoms.…”

“…The majority (70.1%) reported having at least one ocular symptom in the month prior to enrolling in the trial; these symptoms were mostly mild (discomfort, 26.1%, itching 33.7%, redness 30.8% and tearing 31.6% of patients) with less than 10% of patients reporting severe symptoms. 20 The incidence of ocular surface disorders increases with AD severity. For example, the estimated annual incidence of keratoconus, a corneal disease related to eyerubbing, is reported to be 0.5-39% among patients with AD (vs. 0.05% in the general population), but is not usually observed in patients with milder disease (defined as patients with low Severity Scoring of Atopic Dermatitis [SCORAD, 0-103 scale] index scores of ≤25).…”