Melinda Gooderham, MD, MSc, FRCPC: Reaffirming Delgocitinib Safety With Minimal Absorption, Maximum Confidence

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, provided further insights into the safety and systemic exposure profile of delgocitinib cream (LEO Pharma) for chronic hand eczema (CHE).^1-2

In part 2 of her interview with Dermatology Times, Gooderham emphasized the importance of safety data, global regulatory approval considerations, and the potential for expanded indications and future comparative studies. Readers can view part 1 of this discussion here.

Gooderham reiterated that delgocitinib’s systemic absorption remained minimal even under maximal use conditions. This conclusion builds upon previous research that assessed systemic exposure in both the CHE patient population and a phase 1 trial evaluating delgocitinib in moderate to severe atopic dermatitis.

"Because we had previously reported on the minimal absorption in the past in the whole cohort, looking at those with the maximal use, there was nothing unexpected," Gooderham explained. "It kind of confirmed what we thought—that even patients using a higher amount of product or covering more body surface area in the phase 1 trial for atopic dermatitis—it wasn't surprising; it was more reassuring."

The findings reinforce the safety profile of topical delgocitinib and provide reassurance to both prescribers and patients. Notably, even in cases where patients use the product on larger areas, there was no indication of concerning systemic absorption.

As delgocitinib has already gained approval in some regions, Gooderham noted that additional regulatory submissions and approvals worldwide will benefit from this safety data.

"Moving forward, delgo[citinib] is already approved in a couple of regions, but there will be regulatory submissions and approvals more globally, and having this safety data will help with those approvals," she said.

Furthermore, these findings could influence product labeling by offering more comprehensive safety information to prescribing physicians.

"Maybe it will also impact the label that is put on these products," Gooderham added, highlighting the potential for expanded indications or more detailed guidance on usage.

While delgocitinib’s safety and efficacy profile is promising, Gooderham underscored the importance of future comparative studies.

"As far as the development, hopefully we could have in the future some head-to-head studies," she said, "so we can look more at how it's working compared to a topical steroid or a topical calcineurin inhibitor or PDE4 inhibitor. Head-to-head studies are always great for informing prescribers and patients when they're making choices."

Additionally, Gooderham emphasized the necessity of real-world data to assess delgocitinib’s long-term effectiveness and safety in clinical practice.

"I think we'll also need to have some real-world studies come out on how delgocitinib is working in the real world as far as efficacy and safety, of course," she noted. "That’s what we're trying to show in this poster—that there's less concern of safety issues when you're using a JAK inhibitor topically."

Despite delgocitinib’s current approvals for CHE, Gooderham acknowledged that clinicians might prescribe it for other types of eczema.

"One thing that I didn’t mention earlier is that although delgocitinib is approved for chronic hand eczema, we know that patients may use it on other areas of eczema, or prescribers might be using this product off-label," she said.

This is particularly relevant given the reassuring findings on systemic absorption. "Having this data, knowing that the absorption is negligible, even under maximal use conditions, I think moving forward, will open up options for patients and potential future indications," she added.

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.