Chronic hand eczema (CHE) is a common and troublesome inflammatory skin condition that affects a subset of moderate to severe atopic dermatitis (AD) patients and presents itself on both the hands and feet, but more commonly on the hands. It is diagnosed in individuals with persistent AD of the hands and/or feet for more than six months and is associated with scaling, hyperkeratosis and symptoms of itch and pain. CHE has an overwhelming impact on quality of life due to continued discomfort and pain from itching, as well as visible scarring on the hands. This has a significant psychological impact on patients, resulting in personal and work-related hardships.

The lack of approved treatments for this condition demonstrates that there is a clear need for more targeted therapies that limit and control this burdensome disease. Based on the recent boost of interest by drug developers in targeting CHE, GlobalData believes that great strides will be made over the next decade toward better management of the disease.

Poor quality of therapies available for chronic hand eczema

The standard of care for CHE generally encompasses topical therapeutics such as emollients, calcineurin inhibitors and high potency steroids. Few cases, however, are resolved after these treatments. In addition, moderate-to-severe cases are often resistant to topical therapeutics and require systemic options. Alitretinoin is the only marketed systemic therapy for treating CHE but is only approved in the five major European markets (5EU), namely France, Germany, Italy, Spain and the UK.

Alitretinoin is used for the treatment of moderate to severe CHE and is often prescribed once it is clear that a patient is resistant to the very potent topical corticosteroids. Although it is an established drug for this indication, KOLs interviewed by GlobalData mentioned it does not work well on both hands and feet and its effectiveness is limited to treating the hands only. In addition, although alitretinoin has a tolerable side-effect profile, the drug is teratogenic, so female patients need to be on a pregnancy prevention program while on this medication. As such, there is great unmet need for therapies that can provide relief to patients with CHE.

New options for CHE are in development

There have recently been some notable developments toward improving the care of CHE patients. These include the ongoing clinical development of Sanofi/Regeneron’s Dupixent (dupilumab), Leo Pharma’s delgocitinib and Asana Biosciences’ gusacitinib. Dupixent is an IL-4α receptor antagonist indicated for moderate-to-severe AD currently being investigated in CHE. There are currently three ongoing trials investigating Dupixent for the treatment of CHE: one industry-sponsored Phase III (NCT04417894) and two-Phase II trials (NCT03861455, NCT04512339) sponsored by academic institutions.

Although these trials are not expected to read out until next year and beyond, data from a previous observational study has suggested that Dupixent may be efficacious in patients with moderate-to-severe hand eczema. The observational trial was conducted in 55 patients at the University Medical Centre Groningen in the Netherlands between October 2017 and September 2018. Although the primary endpoint, a minimum improvement of 75% in Hand Eczema Severity Index (HECSI), was not met, 60% of patients did achieve HECSI-75 and HECSI improved in almost all patients (96%). GlobalData believes that Dupixent may hold promise for patients with chronic hand eczema but requires evaluation in a larger study.

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Delgocitinib is a topical pan-JAK inhibitor currently marketed in Japan under the brand name Corectim by Japan Tobacco for all severities of AD. LEO Pharma has, however, recently begun pursuing the drug’s development specifically for CHE in the US and 5EU. This year, LEO Pharma initiated three Phase III trials, namely DELTA 1 (NCT04871711), DELTA 2 (NCT04872101) and DELTA 3 (NCT04949841), evaluating the clinical profile of delgocitinib in adults with moderate to severe CHE. KOLs interviewed by GlobalData expressed that although earlier data from Japan Tobacco is based on mild to moderate patients in Japan only, they were hopeful this new JAK inhibitor would offer a safe topical option for patients with more severe CHE.

Another notable Phase III-ready agent is gusacitinib, an oral JAK/SYK inhibitor targeting moderate-to-severe CHE. RADIANT (NCT03531957), a Phase IIb trial of gusacitinib in CHE, has reported promising results, with dose-dependent and clinically meaningful improvements in hand eczema compared to placebo. This year, the US Food and Drug Administration (FDA) issued gusacitinib a fast-track designation, thus consolidating the idea that the therapy may offer a unique solution to CHE. Phase III development is expected to begin in the second half of this year. KOLs interviewed by GlobalData expressed optimism for gusacitinib’s potential to change the treatment paradigm for CHE sufferers.

Considering the growing profile of CHE in the AD community and the strong pipeline activity, GlobalData believes novel and existing therapies such as gusacitinib, delgocitinib and Dupixent will greatly improve the management of this burdensome disease.