Design and Rationale of ARMADA-AD Disease Registry: An International, Prospective, Observational Registry to Characterize Unmet Needs and Evaluate Real-World Effectiveness and Safety of Systemic Therapies in Adults and Adolescents with Atopic Dermatitis

Introduction Despite recent advances in the management of atopic dermatitis (AD), patients continue to face significant burden and diminished quality of life1. Real-world studies are essential to understand patient needs and evaluate long-term effectiveness and safety of current therapies. Here, we present the design of ARMADA-AD disease registry that aims to collect real-world data to characterize unmet needs in AD, patient journey, and long-term outcomes of various AD treatment options. Procedure/Study ARMADA-AD, a global, multicenter, longitudinal, prospective, observational, real-world study, plans to recruit atleast 1000 patients aged ≥12 years with confirmed diagnosis of AD and follow them for 5 years. Patients initiating or switching a systemic therapy for AD (including, but not limited to biologics, oral JAKi, and immunosuppressive/immunomodulatory therapies) will be included. Patients concurrently participating in interventional clinical trials will be excluded. Primary objectives are to comprehensively document patients’ unmet needs, describe patient characteristics and treatment patterns, and characterize real-world safety, effectiveness, and patient satisfaction with systemic treatment options for AD. Key secondary objectives include evaluation of longitudinal course of AD and selected atopic and non-atopic comorbidities, long-term safety and effectiveness of systemic AD therapies, impact of AD treatment across relevant sub-groups, general healthcare practices, and comprehensive patient experiences. Results ARMADA-AD is expected to begin enrollment in H1 2025. Conclusion Data collected from the ARMADA-AD registry will address existing gaps and serve as a valuable resource to further our understanding of unmet needs and burden of AD, and real-world safety and effectiveness of systemic therapies, compared to other registries.