Leo Pharma recently reported that delgocitinib cream, an investigational topical pan-JAK inhibitor, demonstrated a superior reduction in Hand Eczema Severity Index (HECSI) score from baseline to Week 12 compared to alitretinoin capsules in people with severe chronic hand eczema (CHE) in the DELTA FORCE Trial, which is the first head-to-head phase 3 trial comparing a systemic and topical treatment for CHE.
Brian Hilberdink, Leo Pharma’s EVP of North America, chatted with TDD about the significance of this study and the deleterious effect that chronic hand eczema can have on a person’s quality of life.
“This is the first phase 3 trial comparing a topical pan-JAK inhibitor with an oral systemic treatment in CHE, and if approved by regulatory authorities for use in moderate to severe CHE, this trial will provide dermatologists with data to support evidence-based decisions that can suit the patient’s need.”
–Brian Hilberdink
TDD: Why is chronic hand eczema so vexing?
Brian Hilberdink: “Our hands are important to everything we do. Patients living with chronic hand eczema are impacted in their everyday lives and experience social, psychological, and physical effects. Oftentimes this can limit their ability to work. Some may even have to change their careers and give up on lifelong dreams because their hands prevent them from doing their job.
Fully 70% of individuals who live with severe CHE admit to problems in performing everyday activities and suffering disruption in their daily life due to the condition, according to a study in contact dermatitis.”
TDD: Why is it so significant that the DELTA FORCE Trial was head-to-head?
Mr. Hilberdink: “There is only one treatment option approved specifically for chronic hand eczema (CHE), and it is an oral systemic treatment, and that is only approved in the EU, Canada, and Israel for severe CHE. CHE affects up to approximately 9-11 % of people globally and there are currently no topical treatments specifically approved for moderate to severe CHE.
There are systemic treatments on the market that have data for atopic dermatitis (AD) on the hands, but chronic hand eczema is defined as hand eczema that lasts for more than three months or relapses twice or more within a year – which applies to several other different kinds of hand eczema as well, not just AD. This is the first phase 3 trial comparing a topical pan-JAK inhibitor with an oral systemic treatment in CHE, and if approved by regulatory authorities for use in moderate to severe CHE, this trial will provide dermatologists with data to support evidence-based decisions that can suit the patient’s need.”
TDD: What is the main takeaway from DELTA FORCE?
Mr. Hilberdink: “The DELTA FORCE trial met both the primary and all key secondary outcome measures compared to oral alitretinoin. Specifically, the results of DELTA FORCE met the endpoints in Hand Eczema Severity Index score (HECSI), health-related quality of life (as measured by the Dermatology Life Quality Index (DLQI), and safety.”
TDD: Please share the next steps for Delgocitinib cream?
Mr. Hilberdink: “Delgocitinib cream is not yet approved for use by any regulatory authority. However, it is currently under investigation and review with the European Medicines Authority (EMA), and has been submitted to the authorities in Switzerland and Canada. We are also assessing ways to bring delgocitinib cream to the U.S. In addition to the above-mentioned markets, LEO Pharma continues to assess where and how delgocitinib cream can be beneficial – including in which geographical markets and other potential indications.”
Delgocitinib cream is currently under investigation and is not yet approved for use by any health authority. Detailed results from DELTA FORCE are planned to be submitted for scientific presentation and publication at a later date.
