Late-Breaking Data: Long-Term Safety and Efficacy of Delgocitinib Cream for Chronic Hand Eczema

At the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California, Melinda Gooderham, MSc, MD, FRCPC, presented late-breaking data on the long-term safety and efficacy of delgocitinib for moderate to severe chronic hand eczema (CHE).¹

Patients who completed 16 weeks of treatment in DELTA 1 and DELTA 2 were then treated in the DELTA 3 open-label extension trial with twice daily delgocitinib cream as needed to control their CHE for 36 weeks. The DELTA 3 extension trial (n=801) evaluated the long-term safety of as-needed delgocitinib. No new safety concerns were identified in the DELTA 3 extension trial, which showed consistency with the safety profile from DELTA 1 and DELTA 2.²

Key secondary end points were also consistent with DELTA 1 and DELTA 2, including the proportion of patients achieving an Investigator's Global Assessment for CHE score of 0 (clear) or 1 (almost clear) and a ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) improved from baseline (24.6%, 51.8%, and 31.8%, respectively) to week 36 (30.0%, 58.6%, and 36.6%, respectively) among delgocitinib cream-treated patients in DELTA 1 and DELTA 2. Among those treated with cream vehicle in DELTA 1 and DELTA 2, response rates improved from baseline (9.1%, 23.7%, and 12.0%, respectively) to week 36 (29.5%, 51.5%, and 35.7%, respectively).

Gooderham, medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, Canada, and lead author of the DELTA 3 late-breaking data, spoke with Dermatology Times at AAD 2024 to emphasize the key findings of the trial and what dermatologists need to know.

“Patients really are concerned about chronic topical steroid use and having this non-steroidal effective topical that can be used on an as-needed basis in the long term that's both safe and effective is really a nice addition to our armamentarium of treatments for our patients who've been suffering with chronic hand eczema,” Gooderham told Dermatology Times.

Transcript

Melinda Gooderham, MSc, MD, FRCPC: Hi, my name is Melinda Gooderham. I'm a dermatologist and clinical researcher from Peterborough, Ontario, Canada.

Dermatology Times: Can you please discuss the background and methods of the DELTA 3 late-breaking data on delgocitinib for chronic hand eczema?

Gooderham: DELTA 3 was a long-term extension of using delgocitinib 20 milligrams per gram cream, BID, for chronic hand eczema or CHE. And it was a rollover study from DELTA 1 and DELTA 2, which were the vehicle-controlled studies which were 16 weeks of delgocitinib cream versus placebo.

Dermatology Times: What highlights are most important for dermatologists to know about delgocitinib for chronic hand eczema?

Gooderham: Once delgocitinib cream becomes available, I think this will be a good option, where learned that using delgocitinib on an as-needed basis, over a 36-week period, after the 16-week trial, patients were able to maintain the response over the 36 weeks with IGA clear or almost clear, we saw HECI75 [Hand Eczema Severity Index] responses in half of patients we saw HECSI90 responses in a third of patients and that was maintained throughout the 36 weeks. And I think one important thing to note is that patients were using this on and off, this was not continuous use. I really feel this mirrors how patients use topical therapy in the real world.

Dermatology Times: What have we learned about delgocitinib throughout DELTA 1, DELTA 2, and DELTA 3?

Gooderham: What we learned from DELTA 1 and DELTA 2 is that delgocitinib cream is more effective than placebo is safe and tolerated by patients over a 16-week trial. And DELTA 3 kind of confirmed that where we had 36 weeks of as-needed use and there were no new adverse effects developing over that time. What I also think is really important is I know some prescribers are concerned about systemic absorption and JAK inhibitor effects, but we did not see systemic absorption. There were no JAK side effects such as venous thromboembolism, MACE, malignancy, or Zoster infections; this was not a problem in this study. So, I think that's really reassuring for the prescriber that they can use this topical agent without the concerns of a JAK.

I think the one thing I would just like to say is that patients really are concerned about chronic topical steroid use and having this non-steroidal effective topical that can be used on an as-needed basis in the long term that's both safe and effective is really a nice addition to our armamentarium of treatments for our patients who've been suffering with chronic hand eczema, and really just given steroid after steroid and this is really a nice option for them in the future.

[Transcript lightly edited for space and clarity.]

References

1. Gooderham M. Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with chronic hand eczema: results of the phase 3 open-label extension DELTA 3 trial. Presented at: 2024 American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA.
2. LEO Pharma unveils late-breaking data for landmark DELTA 3 open-label extension trial at the 2024 AAD annual meeting. News release. Business Wire. March 9, 2024. Accessed March 10, 2024. https://www.businesswire.com/news/home/20240309157793/en/LEO-Pharma-Unveils-Late-Breaking-Data-for-Landmark-DELTA-3-Open-Label-Extension-Trial-at-the-2024-AAD-Annual-Meeting