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The monoclonal antibody demonstrates the ability to reduce the incidence and improve symptoms related to sleep disorders and psychiatric disorders such as anxiety.
In patients with atopic dermatitis (AD) who were prescribed dupilumab (Dupixent; Regeneron, Sanofi), investigators observed a lower risk of psychiatric and sleep disorders, with effects more prominent within a subgroup of Black or African American patients, according to retrospective cohort study results published in Annals of Allergy, Asthma & Immunology.1
Typically linked to a history or family history of allergies, AD can result in significant disability due to its chronic nature and associated complications, including mental illness and sleep disturbances, which are well-documented comorbidities. AD and allergies remain associated following a diagnosis of the condition, with patients at higher risk of developing food allergies, allergic contact dermatitis, and asthma.1,2
Previous investigations have documented an increased risk of AD with various psychiatric conditions, including affective disorders and stress-related conditions. Similarly, sleep disturbances are reported in 47% to 80% of children with AD, and 87.1% of adults.1,3
Problems with sleep are ranked as the second most impactful factor in quality of life, after itching. Dysregulated cytokines and sustained inflammation due to AD contribute to disrupted circadian rhythm and neuropsychological dysfunction. The relationship between sleep disturbances, mental illness, and AD can form a cycle that is difficult to break out of, combining to create a debilitating health burden for patients.1,3
Dupilumab, a human monoclonal antibody, can effectively manage AD and has multiple FDA-approved indications. It was approved for AD in 2022 and has shown the ability to improve patient-observed outcomes, including sleep disorders, in clinical trials. Still, evidence is limited due to existing data stemming from trials of short duration without using real-world population data. Furthermore, previous trials have centered on patient-reported symptom relief, instead of providing fact-based evidence of reductions in specific disorders.1,4
In this trial, the investigators sought to assess how dupilumab alters the risk of incident psychiatric and sleep disorders in patients with AD, compared with standard drugs known to mitigate sleep disturbance and mental illness. Specific diagnoses of psychiatric disorders analyzed included anxiety, adjustment disorders, depressive disorders, and attention deficit hyperactivity disorder (ADHD), in addition to sleep disorders overall.1
Both the dupilumab (DUPI)-cohort and conventional (CONV)-cohort included 6114 patients. Throughout the observation period, patients in the DUPI-cohort had fewer incident diagnoses compared with the CONV-cohort for anxiety (4.2% vs 4.8%; P = .097), depressive disorders (2.8% vs 3.4%; P = .041), adjustment disorders (0.7% vs 1.2%; P = .011), and sleep disorders (3.4% vs 3.8%; P = .226), but slightly more cases of ADHD (0.8% vs 0.7%; P = .834), according to the investigators. Additionally, a series of Kaplan-Meier analyses showed that the 3-year cumulative incidence of these 4 conditions was significantly lower in the DUPI-cohort compared with the CONV-cohort.1
Subgroup analyses were also conducted. A notable observation was the lack of trend indicating a decreased sleep of disorders among patients with AD older than 65 years treated with dupilumab compared with conventionally treated patients. Further, among Black or African American subgroups, dupilumab had a more pronounced protective effect for anxiety, depressive disorders, adjustment disorders, and sleep disorders.1
IL-4 and IL-13, both targets of dupilumab treatment, have been linked to symptoms of psychiatric disorders in previous research, being associated with anxiety symptoms and processes related to self-harm. Continuing, dupilumab’s inhibition of IL-4 and IL-13 modulates dysregulated cytokine signaling and circadian processes that are involved in sleep disturbances. These aspects demonstrate dupilumab’s effectiveness in treating both itch-related symptoms of AD and managing psychiatric and sleep disorders.1
“Despite the significantly reduced risks, the only slightly decreased incidence of outcome events with dupilumab still suggests that factors beyond AD treatment must also be considered in addressing these issues,” the study authors concluded.1