Patients' Experiences of Atopic Dermatitis and Nemolizumab Treatment: An In-Trial Interview Study Embedded in a Phase 3 Clinical Trial (ARCADIA).
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 wit...
| Publicado en: | Patient Vol. 18; no. 5; pp. 511 - 522 |
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| Autores principales: | , , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
Sep2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=187723440&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 187723440 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 11781653 91S4 jtl: Patient issn: 11781653 maglogo: N pubinfo: dt: Sep2025 vid: 18 iid: 5 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 187723440 185119967 187723440 187723440 10.1007/s40271-025-00741-x 187723440 ppf: 511 ppct: 11 formats: tig: atl: Patients' Experiences of Atopic Dermatitis and Nemolizumab Treatment: An In-Trial Interview Study Embedded in a Phase 3 Clinical Trial (ARCADIA). aug: au: Silverberg, Jonathan I. Filipenko, Dina Dias Barbosa, Carla Rodriguez, Danielle Chambenoit, Olivier Jack, Katrin Piketty, Christophe Subramanian, Ram Puelles, Jorge affil: https://ror.org/00y4zzh67 Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA sug: subj: Dermatitis, Atopic Drug Therapy Dermatitis, Atopic Drug Therapy Dermatitis, Atopic Symptoms Antibodies, Monoclonal Therapeutic Use Research Subjects Psychosocial Factors Randomized Controlled Trials Symptom Burden Patient Attitudes Evaluation Human Male Female Severity of Illness Indices Adolescence Adult Middle Age Funding Source Multimethod Studies Open-Ended Questionnaires Semi-Structured Interview Audiorecording Multicenter Studies Quality of Life Activities of Daily Living Descriptive Statistics Severity of Illness Comparative Studies Interview Guides Canada Australia United States Great Britain Sleep Disorders Interpersonal Relations Attitude to Medical Treatment Content Analysis Adolescent: 13-18 years Adult: 19-44 years Middle Aged: 45-64 years Male Female ab: 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 redness (n = 8/43; 19%), painful skin and dry skin (n = 6/43; 14 % each), and burning sensation (n = 5/43; 12%). Itch was reported by 18% (n = 13/73) of participants to have caused other symptoms, and by a further 12% (n = 9/73) to have impacted their sleep. Participants reported 45 AD-related impact concepts across 6 health-related quality of life domains. Sleep disturbance (n = 20/52; 38%), emotions (n = 14/52; 27%), and daily activities (n = 12/52; 23%) were most often reported as being the most burdensome impact domains. More nemolizumab—than placebo-treated participants reported improvement of the 10 most common pre-trial AD symptoms and all 6 impact domains. More nemolizumab—than placebo-treated participants reported that the treatment helped manage their condition (n = 37/46; 80% versus n = 15/27; 56%), met their expectations (n = 32/46; 70% versus n = 15/27; 56%), and that they would recommend it to others (n = 41/46; 89% versus n = 20/27; 74%). Conclusions: This qualitative study captures the heterogeneous symptoms and impacts of AD and highlights the perceived interrelatedness of itch and other AD symptoms and impacts. Our results show that alleviation of itch via targeted treatment may also reduce the complex physical and psychosocial burden of patients with moderate-to-severe AD, underscoring nemolizumab's potential as a valuable addition to existing AD treatments. Trial Registration: Clinicaltrials.gov NCT03985943. Registered 11 June 2019, https://clinicaltrials.gov/study/NCT03985943 pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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