New Drug Addresses Unmet Medical Need in Atopic Dermatitis Patients

Recent research presented at AMCP Nexus 2019 indicated that dupilumab may address a significant unmet medical need in patients with atopic dermatitis (AD).

Atopic dermatitis is characterized by T helper 2-mediated skin inflammation and itching that is intense, persistent, and debilitating, particularly in those with moderate-to-severe disease. Allergies, allergic rhinitis, and asthma are common type 2 inflammatory comorbidities (T2-ICs). Dupilumab, an interleukin-4 receptor α antagonist, is approved for use in moderate-to-severe AD patients aged 12 and older whose symptoms are not adequately managed by topical prescriptions, or if those therapies are not advisable. The goal of this study was to understand real-world patient demographics, clinical characteristics, and treatment prior to dupilumab (pre-dup tx) initiation in adult AD patients in the U.S.

For this study, the research team conducted descriptive analyses on data collected from March 2016 through September 2017 in the Symphony Health Integrated Dataverse (IDV®). This database integrates anonymized patient-linked claims data that captures > 80% of prescription (Rx), 60% of medical office, and 25% of hospital claims in the U.S. Patient inclusion criteria for these analyses were one or more dupilumab Rx between March 28, 2017 (dupilumab U.S. approval date), and September 30, 2017 (the index date for all patients is defined as the first dupilumab Rx after U.S. approval), 18 years or older at index date, one or more AD diagnoses, and at least one prescription/medical/healthcare claim for any condition one year pre-index date.

Demographics of the 2,472 patients in the dupilumab cohort at index indicated an average age of 46 years (±17), 53% female, and a patient ethnicity representative of the U.S. population (60% White, 14% Black/African, 14% Hispanic, and 12% other). Pre-index T2-ICs, including allergic rhinitis (25%) and asthma (24%), were the most common comorbidities seen in patients at index. Anxiety (11%), obesity (11%), and sleep disorders (11%) accounted for other comorbidities. Pre-index tx in 1,450 patients were TCS (78%), oral/injectable corticosteroids (OIC; 68%), topical calcineurin inhibitors (17%), phosphodiesterase-4 inhibitors (PDE-4; 12%), systemic immunosuppressants (SI; 28%), phototherapy (PT; 3%), any topical (TCS, TCI, or PDE-4; 85%), any SI, OIC, or PT (77%), and others (7%). Up to two, three, or four different types of pre-dup tx were used by 46%, 27%, 4%, of the 1,450 patients, respectively.

“This real-world study suggests that dupilumab meets a significant unmet medical need for patients with AD, for whom other prior off-label systemic medications have been insufficient,” the study authors concluded.

This research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc.

Meeting Abstract: Armstrong A, Mallya U, et al. Understanding Characteristics of Early Users of Dupilumab for Atopic Dermatitis (AD) in the U.S. Presented at: AMCP Nexus 2019; October 29 – Nov 1; National Harbor, MD.