Melinda Gooderham, MD, MSc, FRCPC: Minimal Systemic Exposure of Delgocitinib Cream in Chronic Hand Eczema

At the 2025 American Academy of Dermatology Annual Meeting in Orlando, Florida, Melinda Gooderham, MD, MSc, FRCPC, a dermatologist and clinical researcher from Peterborough, Ontario, Canada, presented findings on the systemic exposure of delgocitinib cream (LEO Pharma) under maximal use conditions in chronic hand eczema (CHE).¹

The study, presented in a poster titled, "Delgocitinib cream has negligible systemic exposure in patients with maximal use of delgocitinib cream for the treatment of chronic hand eczema," was aimed at evaluating the systemic exposure of twice-daily delgocitinib cream in patients with CHE using it at the upper quartile of usage during the phase 3 DELTA 2 trial.²

In addition, the study compared the systemic exposure of delgocitinib cream with data from phase 1 trials, which investigated the use of delgocitinib in moderate to severe atopic dermatitis. The goal was to analyze systemic absorption differences between topical application on a larger body surface area and oral administration.

Dermatology Times spoke with Gooderham to discuss highlights and takeaways from the research.

"We have previously presented on the systemic exposure, but the purpose of this poster at the AAD was to look at the systemic exposure of twice daily delgocitinib cream under maximal use conditions," Gooderham said. "And then we wanted to compare that systemic exposure with data from the phase 1 trials which looked at delgocitinib cream used for moderate to severe atopic dermatitis, so on a wider body surface area, as well as looking at an oral dose that was given in a phase 1 trial, just to compare the systemic absorption of topical use on a larger body surface area, also one that was provided orally."

The study demonstrated minimal systemic absorption of delgocitinib cream, with the highest observed peak systemic exposure recorded at 7.2 ng/mL. In comparison, an oral dose of delgocitinib (1.5 mg) administered in a phase 1 trial resulted in a much higher mean exposure of 99.3 ng/mL.

Gooderham highlighted the clinical significance of these findings: "I think the most important clinical implication is the lack of side effects. We know that JAK inhibitors have been given a black box warning, which makes both prescribers concerned; it makes patients concerned. It showed that there's negligible systemic exposure, which provides a lower risk of systemic side effects. It gives it a more favorable safety profile, and patients will be more comfortable using this on a longer term basis."

The safety profile of delgocitinib cream was favorable, with adverse events reported in 45.7% of patients in the delgocitinib group, and 44.7% in the vehicle group. The most common adverse event was COVID-19 infection, with only one serious adverse event (1.1%) in the delgocitinib group, which was unrelated to the treatment. Importantly, there were no reports of malignancy, major cardiovascular events, or venous thromboembolic events.

Gooderham noted, "We don't have a lot of maximum exposure done with topical steroids that we're commonly using on large body surface areas for our patients. It's nice to be able to reassure patients that these studies have been done when they're putting these creams on for chronic hand eczema."

Gooderham also placed delgocitinib in the broader context of topical treatments, comparing it to other options such as topical corticosteroids and topical calcineurin inhibitors. She added, "We know there's other systemic side effects or local side effects with the use of topical corticosteroids. There are issues with using topical calcineurin inhibitors, but recent data looking at topical JAK inhibitors, we have another with topical ruxolitinib, which also showed limited systemic absorption with topical use. So I think this is adding to that safety profile with these medications so that they can be used with comfort and prescribed by prescribers with comfort."

References

1. LEO Pharma presents new late-breaking delgocitinib cream data for the third consecutive year at AAD 2025. News release. Business wire. March 8, 2025. Accessed March 31, 2025. https://www.businesswire.com/news/home/20250308530521/en/LEO-Pharma-Presents-New-Late-Breaking-Delgocitinib-Cream-Data-For-the-Third-Consecutive-Year-at-AAD-2025
2. Gooderham M. Delgocitinib cream has negligible systemic exposure in patients with maximal use of delgocitinib cream for the treatment of chronic hand eczema. Presented at: American Academy of Dermatology (AAD) Annual Meeting; March 2025; Orlando, FL.