Clinical trial exit interviews in patients with moderate-to-severe chronic hand eczema: perspectives on disease burden and treatment experiences with delgocitinib cream in the phase III DELTA 1 trial

Background Delgocitinib cream showed superior efficacy vs. cream vehicle in patients with moderate-to-severe chronic hand eczema (CHE) in pivotal phase III studies. Qualitative clinical trial exit interviews can be utilized to explore patient experiences, supplementing trial results by providing insight into patient perspectives on disease burden and treatment experience. Objectives To explore patient insights into CHE and treatment experience with delgocitinib cream. Methods DELTA 1 (NCT04871711) was a phase III trial in which adults with moderate-to-severe CHE received double-blind treatment with delgocitinib cream 20 mg g–1 or cream vehicle twice daily for 16 weeks. Patients enrolled in Canada or the UK were invited to participate in a semistructured exit interview within 2 weeks of completing treatment at 16 weeks. These were conducted using open-ended questions, and data were analysed using thematic analyses to identify key themes related to disease burden and treatment impact. Results A total of 27 patients were interviewed [mean (SD) age 43.5 (14.0) years, 67% (n = 18) women]. The most frequently reported signs and symptoms of CHE before the trial were cracking, pain, dryness, itch and flaking. Participants described significant impacts on activities of daily living, emotional wellbeing, work, physical functioning, sleep and social functioning. Most participants who received delgocitinib cream described improvements in signs and symptoms and noted a positive impact across multiple quality-of-life domains. Conclusions These exit interviews provide additional understanding of the lived experiences of patients with CHE, highlighting the profound impact on daily life and improvements achieved with treatment beyond that measured with clinician and patient-reported efficacy endpoints.