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Clinical trial exit interviews reveal detailed perspectives on disease burden for patients with chronic hand eczema.
At the recent European Academy of Dermatology and Venereology Congress in Amsterdam, Netherlands, from September 25 to 28, a poster was presented offering direct patient experiences of the harmful burden of CHE.1 The results come from exit interviews of a phase 3 DELTA 1 clinical trial (NCT04871711) testing the use of delgocitinib cream versus cream vehicle. According to poster authors Mohandas et al, these qualitative post-trial interviews provide a more detailed insight into patient experiences and the burden of the disease.
Background
In this study, delgocitinib cream was well tolerated in patients with moderate to severe CHE after being applied twice daily (20 mg/g) for 16 weeks. The first-in-class topical JK inhibitor showed greater levels of efficacy compared to cream vehicle. In early October, Germany became the first country to launch the treatment by LEO Pharma.2
Methods and Materials
A total of 27 patients from Canada (n = 16) and the UK (n =11) participated in semi-structured telephone and video call interviews within 2 weeks of completing treatment. The mean age of participants was 43.5 years with 66.7% of participants being female and 81.5% being white. Two-thirds of the patients had moderate CHE at baseline. The most frequently reported symptoms were dryness, itch, erythema, and flaking. Cracking was the most commonly reported (92.6%), which often led to pain and/or bleeding.
The questions were open-ended, asking about experienced signs/symptoms and their overall impact before the start of the trial. Responses were categorized into 6 health-related, quality of life areas. Artificial intelligence software analyzed the interview transcripts.
Results
Almost all participants (96.3%) noted the negative impact on their daily activities (ie, handwashing, chores, avoiding soaps and chemicals). Similarly, 88.9% struggled with their emotional well-being with the most frequently reported feelings being frustration, embarrassment, and sadness/depression.
“I always kind of hid my hands quite a lot, especially when they’re [like] flaking,” one patient said.“It’s not really pleasant for people to be looking at it and it made me very paranoid.”
Another participant said in an exit interview, “I think it’s affected my self-esteem…I have these hands that look about 20 years older than the rest of my body.”
The impact is also felt in the workplace with 84% of participants struggling with tasks such as writing, typing, and manual labor. 44%of participants reported that they had missed work due to their symptoms.
A total of 70.4% struggled with physical functioning, specifically with holding, gripping, and touching objects. Sleep was also a common impact with 63% of patients, especially waking up during the night due to the painful symptoms.
Finally, 55.6% noted issues with social functioning, including sexual/intimate connections and family relationships.
In an exit interview, one patient shared, “During the times my hands were really bad…we [had] a new grandchild and my hands were so scratchy and rough that I couldn’t touch her face.”
“We don’t cuddle on the sofa because it makes my skin prickly,” another said. “Handholding is pretty much out. So I know that affects my wife definitely, as well as myself.”
Conclusion
Through this analysis, researchers confirmed that patients with moderate to severe CHE experience high levels of disease burden. Specifically, they noted negative impacts on several aspects of life, including emotional well-being, social functioning, and daily physical activities.
References
1. Mohandas P, Devani AR, Baranowski K, et al. Clinical trial exit interviews in patients with moderate to severe Chronic Hand Eczema: perspectives on disease burden and its impact on quality of life from participants in the phase 3 DELTA 1 trial.Poster presented at the 2024 European Academy of Dermatology and Venereology Congress. Amsterdam, Netherlands, September 25 to 28, 2024.
2. Germany becomes the first country to launch LEO Pharma’s Anzupgo (delgocitinib) cream. News release. BioSpace. October 15, 2024. Accessed October 21, 2024. https://www.biospace.com/press-releases/germany-becomes-the-first-country-to-launch-leo-pharmas-anzupgo-delgocitinib-cream