Delgocitinib cream yields ‘super-response’ in subset of patients with chronic hand eczema
Key takeaways:
- Patients treated with delgocitinib were categorized as achieving a deep, consistent or maintained response.
- In total, 48% achieved deep responses, more than 24% reached consistent responses and about 33% maintained responses.
ORLANDO — A subset of patients treated with delgocitinib cream 20 mg/g for moderate to severe chronic hand eczema achieved a “super-response,” by week 16, according to a presenter at the American Academy of Dermatology Annual Meeting.
According to April W. Armstrong, MD, MPH, professor and chief of dermatology at the University of California, delgocitinib has brought a “new innovation” to the treatment of chronic hand eczema (CHE).
“[Delgocitinib] has shown to be about three-times more efficacious than placebo in this very difficult-to-treat patient population,” Armstrong said during her presentation.
The topical, pan-Janus kinase inhibitor has previously demonstrated efficacy in treating moderate to severe CHE in the phase 3 DELTA 1 and DELTA 2 trials, and its long-term use has been evaluated in the DELTA 3 extension trial.
In this presentation, Armstrong discussed the outcomes of a subset of patients within these trials that achieved a “super-response.”
What is a super-response?
“There are three different ways in which a super-response is considered,” she explained. “No. 1 is a deep response, no. 2 is consistent response and no. 3 is a maintenance of response.”
According to Armstrong a deep response is defined as achieving a Hand Eczema Symptom Diary (HESD) itch score of 0 or 1, HESD pain score of 0 or 1 and/or a DLQI score of 0 or 1 within 16 weeks of treatment.
A consistent response is defined as a 4-point or more reduction in HESD itch, HESD pain or an achievement of Hand Eczema Severity Index-75 at weeks 4, 8, 12 and 16.
Lastly, a maintained response is the achievement of an IGA-CHE 0 score at week 16 and an ability to maintain IGA-CHE 0 or 1 while off treatment.
Trial design
A total of 325 patients in DELTA 1 and 314 patients in DELTA 2 received delgocitinib cream 20 mg/g twice daily for 16 weeks for the treatment of moderate to severe CHE, whereas 162 and 159, respectively, received a vehicle cream.
All of these patients had the option of enrolling in the DELTA 3 extension trial, where, depending on their IGA-CHE score, they either went off treatment or were administered delgocitinib cream 20 mg/g.
Results
By week 16, 48% of patients treated with delgocitinib cream from DELTA 1 and 2 achieved at least one of the outcomes required to qualify as a deep responder, whereas 23.8% of vehicle-treated patients achieved the same. Among the delgocitinib groups, 19.2% reached all three requirements vs. 5.4% of the vehicle groups.
More than 24% of patients treated with delgocitinib cream achieved consistent treatment responses. At weeks 4, 8, 12 and 16, 24.1% achieved a 4-point or more reduction in HESD itch, 25% achieved a 4-point or more reduction in HESD pain and 27.3% reached HECSI-75. In contrast, only 6.6%, 9% and 8.1% of the vehicle-treated patients reached the same respective outcomes.
Among patients treated with delgocitinib cream who had an IGA-CHE score of 0 and were enrolled in the DELTA 3 trial, 32.9% and 15.7% maintained that score until week 8 and 16, respectively.