At the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California, Melinda Gooderham, MS, MD, FRCPC, presented the long-term safety and efficacy of delgocitinib for moderate to severe chronic hand eczema. Presented the latest data on efficacy (Choi).1
Patients who completed 16 weeks of treatment with DELTA 1 and DELTA 2 were then treated in the DELTA 3 open-label extension study with twice-daily delgocitinib cream as needed to control CHE for 36 weeks . The DELTA 3 extension study (n=801) evaluated the long-term safety of delgocitinib administered as needed. The DELTA 3 extension study identified no new safety concerns and demonstrated consistency with the safety profile of DELTA 1 and DELTA 2.2
Key secondary endpoints also included the proportion of patients with an investigator global CHE score of 0 (clear) or 1 (nearly clear) who achieved 75%/90% or higher improvement in hand condition. It was consistent with DELTA 1 and DELTA 2. Eczema Severity Index (HECSI-75/90) for patients treated with delgocitinib cream in DELTA increased from baseline (24.6%, 51.8%, and 31.8%, respectively) to week 36 (30.0%, 58.6%, respectively; 36.6%). For patients treated with cream vehicle at 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%). Each).
Gooderham, medical director of SKiN Dermatology Center in Peterborough, Ontario, Canada, and lead author of the latest DELTA 3 data, said: Dermatology Times At AAD 2024, we highlight key findings from this trial and what dermatologists need to know.
“Patients are really concerned about chronic topical steroid use, and having this non-steroidal effective topical that can be used for long periods of time if needed, is safe and effective, is a great benefit for our patients. “It's a really great addition to the treatment arsenal for people who suffer from chronic hand eczema,” Gooderham said. Dermatology Times.
transcript
Melinda Gooderham, MSc, MD, FRCPC: Hello, my name is Melinda Gooderham. I'm a dermatologist and clinical researcher from Peterborough, Ontario, Canada.
Dermatology Times: Could you discuss the background and methodology of the DELTA 3 latest data on delgocitinib for chronic hand eczema?
gooderham: Delta 3 was a long-term extension of the use of delgocitinib 20 mg/g cream (BID) for chronic hand eczema or CHE. And it was a rollover study from DELTA 1 and DELTA 2, which were vehicle-controlled studies that administered delgocitinib cream and placebo for 16 weeks.
Dermatology Times: What is the most important thing for dermatologists to know about delgocitinib for chronic hand eczema?
gooderham: When delgocitinib cream becomes available, I think this will be a good option. After a 16-week trial, he found that using delgocitinib for 36 weeks as needed, the patient was able to maintain her response for 16 weeks. Her IGA at 36 weeks was clear or nearly clear with a HECI of 75. [Hand Eczema Severity Index] Half of the patients had a response, and one-third of the patients had a HECSI90 response that was maintained through 36 weeks. And I think one of the important things to note is that the patient was using this intermittently, not continuously. We feel this reflects how patients use topical treatments in the real world.
Dermatology clinic hours: What did you learn 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 and is safe and well tolerated by patients over a 16-week trial. And DELTA 3 was used as needed for 36 weeks, during which time no new adverse effects were observed. Also, I think what's really important is that some prescribers are concerned about systemic absorption and the effects of his JAK inhibitors, but we didn't see any systemic absorption. about it. There were no side effects of JAK, such as venous thromboembolism, MACE, malignancy, or herpes zoster infection. This was not an issue in this study. So I think it's very reassuring for prescribers to be able to use this topical agent without worrying about JAK.
One of the things I would like to say is that patients are really concerned about chronic topical use of steroids and are looking for this non-steroidal effective topical that can be used as needed over a long period of time and is safe and effective. That means it's important to get it. This is a really great addition to our treatment regimen and a really great option in the future for patients who suffer from chronic hand eczema and are being given steroid after steroid.
[Transcript lightly edited for space and clarity.]
References
- Gooderham M. Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with chronic hand eczema: results from the phase 3, open-label, extended DELTA 3 study. Presentation location: 2024 American Academy of Dermatology Annual Meeting. From March 8th to 12th, 2024. San Diego, California.
- LEO Pharma presented updated data from the ground-breaking DELTA 3 open-label extension study 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 -2024-AAD Label Expansion at Annual Conference trial