Patients’ Experiences of Atopic Dermatitis and Nemolizumab Treatment: An In-Trial Interview Study Embedded in a Phase 3 Clinical Trial (ARCADIA)
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.032 | 0.047 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.006 | 0.004 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.001 | 0.005 |
| Research integrity | 0.002 | 0.005 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".