Leo scores again in hand eczema with its JAK inhibitor cream

It’s been four years since Japan Tobacco snagged approval in its home country for its topical JAK inhibitor delgocitinib to treat atopic dermatitis.

Slowly but surely, Denmark’s Leo Pharma—which gained the rights to develop and commercialize delgocitinib in the rest of the world a decade ago—is working toward its first green light for the topical cream.

Two identical phase 3 trials against a placebo cream and an open-label extension study have demonstrated delgocitinib’s success in treating patients with moderate-to-severe chronic hand eczema (CHE).

Now, a fourth phase 3 study, comparing delgocitinib to alitretinoin capsules, has provided Leo with more evidence of its value. Alitretinoin is the only treatment approved for CHE patients who do not respond to topical corticosteroids.

In the DELTA FORCE study of 513 patients, delgocitinib was associated with a superior reduction in the Hand Eczema Severity Index (HECSI), a scoring system in which success is defined by a two-point improvement on the following scale: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe).

From baseline to week 12, which was the primary measure in the study, patients who received delgocitinib twice daily had better clearance scores than those who took a once-daily dose of alitretinoin. As a secondary measure, from baseline to week 24, delgocitinib also provided superior results to alitretinoin.

Delgocitinib outperformed alitretinoin in two other secondary measures—the Investigator’s Global Assessment (IGA)-CHE treatment success and the Dermatology Life Quality Index (DLQI).

Additionally, patients receiving delgocitinib experienced fewer adverse events than those receiving alitretinoin. The overall safety profile was consistent with what was observed in the previous three trials—DELTA 1, 2 and 3.

“We are confident that with the DELTA FORCE study, delgocitinib cream may play a crucial role in expanding the options available for patients in this hard-to-treat condition,” Kreesten Meldgaard Madsen, Leo’s chief development officer, said in a release.

Detailed results from DELTA FORCE will be provided for publication later, Leo said.

The only other topical JAK inhibitor on the market is Incyte’s Opzelura, which was approved for mild-to-moderate cases of eczema in 2021. The treatment, which is the cream version of Incyte’s blockbuster Jakafi, and is off to a successful launch, generating sales of $80 million and $92 million in the second and third quarters of last year.

Safety issues with JAK inhibitor creams are being closely monitored because oral treatments from the drug class—such as Pfizer’s Xeljanz, Eli Lilly’s Olumiant and AbbVie’s Rinvoq—now carry warnings about increased risk of heart attack and stroke.