A new analysis of real-world data presented at AMCP Nexus 2019 suggests there exist significant unmet medical needs in patients with atopic dermatitis (AD) prior to their use of dupilumab.
The study researchers reported that most patients treated with dupilumab have moderate-to-severe AD, type 2 and other comorbidities, and significant prior usage of off-label systemic medications. Patients with moderate-to-severe AD experience significant burden from symptoms such as itchiness, poor quality of sleep, depression and anxiety, and type 2 inflammatory comorbidities (T2-IC). Dupilumab, a human monoclonal antibody treatment that targets the interleukin-4 receptor α, is approved for use in moderate-to-severe AD patients aged 12 and older in the U.S. The drug is approved in adults in the European Union and other countries.
Dupilumab has demonstrated efficacy and safety in improving AD signs and symptoms in multiple clinical trials, used both on its own and in concert with topical corticosteroids (TCS). In this new study, the researchers aimed to identify real-world patient characteristics and AD treatments before dupilumab treatment (pre-dup tx). The data used in this research were collected at point-of-care between March 2016 and November 2017 from Modernizing Medicine’s dermatology-specific (MMDS) EMR, which covers roughly 5,000 dermatologists in the U.S. To be included in this study, patients had to be at least 18 years of age, have one or more dupilumab prescription between the drug’s approval date (March 28, 2017) and November 20, 2017, (index date for all pts=1st dupilumab Rx after U.S. approval), and at least one year of pre-index observation. Descriptive analyses were carried out for index AD symptoms and signs: (0-5-point Investigator Global Assessment [IGA] scale, percent body surface area [BSA] affected, 0-10-point Peak Pruritus Numerical Rating Scale [PNRS]), comorbidities, and pre-index tx.
A total of 4,253 patients were involved in this trial, with an average age of 46 years (±17.8) and 51% being female. The IGA levels in 1,488 patients were: 0/1 (clear): 4.8%; 2 (mild): 6.6%; 3 (moderate): 32.4%; 4 (marked): 46.3%; 5 (severe): 9.9%. The average BSA in 157 patients was found to be 39.3 (±27.4) with an average PNRS in 836 patients being 5.5 (±3.2).
The most common T2-IC were asthma (32.1%), allergic rhinitis (25.6%), and allergic urticaria (4.0%). Other prevalent comorbidities were anxiety (15.9%), depression (12.6%), and skin infections (16.8%). Pre-dup tx in 3,813 of the patients were TCS (78.2%), oral/injectable corticosteroids (44.9%), topical calcineurin inhibitors (23.5%), phosphodiesterase-4 inhibitors (22.4%), systemic immunosuppressants (18.8%) or phototherapy (6.7%). Two, three, or four different pre-dup tx forms were used by 37.5%, 10.1%, 0.5%, of 3,813 patients, respectively.
“These data indicate that most pts treated with dupilumab in the real world have moderate-to-severe AD, type 2 and other comorbidities, and significant prior off-label systemic medications use, suggesting a significant unmet medical need prior to the introduction of dupilumab,” the authors concluded.
This research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc.
Meeting Abstract: Armstrong A, Eichenfield L, et al. Characteristics and Treatment History of Early Users of Dupilumab for Atopic Dermatitis (AD) in the U.S.: Analysis of an Electronic Medical Records Dataset. Presented at: AMCP Nexus 2019; October 29 – Nov 1; National Harbor, MD.