Patients’ Experiences of Atopic Dermatitis and Nemolizumab Treatment: An In-Trial Interview Study Embedded in a Phase 3 Clinical Trial (ARCADIA)

作者：Jonathan I. Silverberg, Dina Filipenko, Carla Dias Barbosa, Danielle Rodriguez, Olivier Chambenoit, Katrin Jack, Christophe Piketty, Ram Subramanian, Jorge Puelles · 发表于：Patient · 年份：2025 · DOI：10.1007/s40271-025-00741-x · 被引用次数：2 · 研究领域：Dermatology and Skin Diseases、Psoriasis: Treatment and Pathogenesis、Allergic Rhinitis and Sensitization

BACKGROUND: Patients with atopic dermatitis (AD) often experience a multitude of interrelated symptoms and impacts linked to the cardinal symptom of itch. Individual patient-reported outcome measures do not on their own reflect the complex physical and psychosocial burden experienced by patients with AD. This manuscript describes a qualitative in-trial interview substudy embedded in a phase 3 trial of nemolizumab in adults and adolescents with moderate-to-severe AD (ClinicalTrials.gov NCT03985943) and supplements evidence gathered during the core clinical trial. METHODS: Clinical trial participants enrolled at sites in Canada, Australia, Great Britain, and the USA were invited to the substudy. They participated in blinded telephone interviews within 2 weeks of treatment completion. Interviews were conducted in English using a semi-structured interview guide. They explored participants' experiences of AD symptoms and impacts pre-trial and during the trial. Deidentified interview transcripts were coded and analyzed deductively following a content analysis approach. The interview sample was described using sociodemographic and key clinical trial data. RESULTS: A total of 73 participants reported 40 pre-trial symptoms, 10 of which affected more than half of the participants. Itch was simultaneously the most common pre-trial symptom and the symptom most commonly perceived as burdensome. Other common burdensome pre-trial symptoms were peeling/flaky/scaly skin (n = 9/43; 21%), skin ...