News
Article
Author(s):
The phase 3 clinical trial investigating delgocitinib cream for adolescents with moderate to severe CHE met its primary and key secondary endpoints.
Earlier this month, LEO Pharma announced positive results from its phase 3 DELTA TEEN clinical trial assessing the efficacy and safety of delgocitinib (Anzupgo) in adolescent patients with moderate to severe chronic hand eczema (CHE).1
The study met its primary and secondary endpoints in patients aged 12 to 17 years in whom therapy with topical corticosteroids was ineffective.
Read more from Dermatology Times.
Dermatology Times recently spoke with Alexander Egeberg, MD, PhD, a professor of dermatology and the global head of medical affairs at LEO Pharma, to discuss the result and their significance for this underserved patient population, for which there are currently no approved therapies.2
The DELTA TEEN study was a double-blind, placebo-controlled trial that involved a treatment regimen involved of twice daily application of delgocitinib.
"Currently, there are no approved therapies, neither EMA nor FDA, for adolescents with chronic hand eczema," Egeberg said. "As a clinician, I can tell you that this population does have a high unmet need. If approved, this will really be a promising option."
The primary endpoint focused on the Investigator Global Assessment for Chronic Hand Eczema, with treatment success defined as clear or almost clear skin at week 16, accompanied by at least a 2-point reduction from baseline.
The secondary endpoints included the Hand Eczema Severity Index, with a 90% or greater reduction in symptoms, as well as patient-reported outcomes such as the Hand Eczema Symptom Diary. Significant improvements were also observed in the Children's Dermatology Life Quality Index.
Historically, chronic hand eczema in adolescents has not received the attention it deserves, Egeberg noted. One explanation for the delay in treatment options, he added, is the outdated view that CHE is simply a localized form of atopic dermatitis:.
"If you have eczema on the hands, then that's it. We now know that’s an obsolete way of looking at it. It’s a multifactorial disease," he said.
This misconception, coupled with the complex nature of CHE, which involves various inflammatory mechanisms, has contributed to its understudied status. Egeberg stressed the importance of recognizing CHE as distinct from atopic dermatitis, with many subtypes that require targeted therapy.
The effects of CHE on adolescents go far beyond the physical symptoms. Adolescence is a pivotal time for social development, with many young people building their identity and preparing for future academic or career paths. CHE can affect self-esteem, school performance, and even future career aspirations, with some patients needing to reconsider career dreams due to their condition.
"If you have to hide your hands all of a sudden and live with that insecurity and that anxiety that we can see many adolescents with chronic hand eczema actually have, then obviously that will impact your life course," Egeberg said.
Clinicians must consider several factors, especially in the adolescent population. Communication is key, as parents and guardians are often involved in the treatment process.
Egeberg highlighted that "when patients come from a family where the parents are divorced, you may need to do 2 prescriptions—1 at mom’s and 1 at dad’s place—because adherence can be a challenge."
For clinicians, educating both the patient and their caregivers about proper use and potential adverse effects is essential for treatment success.
While delgocitinib is already approved for adults in several European countries,3 approval for adolescents remains pending. "We are really looking into how we can bring this to the market to serve these patients who are really underserved at this point," Egeberg added.
The availability of delgocitinib could offer a valuable addition to the treatment options for CHE, which currently relies heavily on topical corticosteroids, he added.
"Having any option, in addition to the current standards, will definitely improve the treatment armamentarium," Egeberg concluded. "It gives dermatologists a better chance to consider what’s best for their patients."
References