Delgocitinib cream is efficacious and well-tolerated up to 52 weeks among adults with chronic hand eczema (CHE), according to study findings published in the Journal of the American Academy of Dermatology.
Following encouraging results regarding the efficacy and safety of delgocitinib cream for CHE in the DELTA 1 (ClinicalTrials.gov Identifier: NCT04871711) and DELTA 2 (ClinicalTrials.gov Identifier: NCT04872101) trials, researchers in the current study aimed to further assess the long-term efficacy and safety of delgocitinib cream.
The researchers conducted the phase 3, open-label, extension DELTA 3 (ClinicalTrials.gov Identifier: NCT04949841) trial, that included 801 patients from DELTA 1 and DELTA 2 who completed the 16-week treatment period for moderate to severe CHE with delgocitinib cream 20 mg/g or vehicle cream.
Patients in DELTA 3 were treated with twice-daily delgocitinib as needed for 36 weeks. All patients had an Investigator’s Global Assessment for CHE (IGA-CHE) score of at least 2 and were treated until a score of IGA-CHE 0/1 was achieved. DELTA 3 was conducted at 99 trial centers in 10 countries from August 2021 through September 2023. Most patients were White (91.4%) and women (63.9%). The median age at onset of CHE was 34.0 years and the median age overall was 45.0 years. The number of treatment-emergent adverse events (AEs) from baseline to week 38 was the primary endpoint.
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Patients who stopped treatment due to disease remission (IGA-CHE 0/1) were able to regain response upon restart of treatment, thereby helping clinicians to contextualize potential benefits of delgocitinib cream to patients with CHE.
DELTA 3 was completed by 82.9% of patients overall, with 17.1% of patients discontinuing treatment. Discontinuation was primarily due to lack of efficacy and patient withdrawal from the study. Further, 3.6% of patients used rescue treatment.
The researchers noted delgocitinib was well-tolerated across 535.7 total patient-years of observation. Nasopharyngitis (16.0%) and COVID-19 (16.7%) were the most frequent AEs. Compared with DELTA 1 and 2, no increase in AE rates was noted in DELTA 3. Severity in the majority of AEs was mild or moderate.
The rate of patients receiving delgocitinib cream in the parent trials who had IGA-CHE 0/1 at baseline in DELTA 3 was 24.6%, which was maintained until week 36 (30.0%). Similarly, Hand Eczema Severity Index (HECSI) scores of 75 and 90 were achieved at baseline in DELTA 3 in 51.8% and 31.8% of patients who were previously receiving delgocitinib cream, which were also maintained to week 36 (58.6% and 36.6%). Patients who were previously treated with vehicle cream showed improved response rates from DELTA 3 baseline (9.1%, 23.7%, and 12.0%) to week 36 (29.5%, 51.5%, and 35.7%) across all 3 measures, respectively.
Study limitations include the preponderance of White patients limiting generalizability, and the open-label, non-randomized design.
“Delgocitinib cream treatment was well-tolerated and efficacious in maintaining disease control in CHE patients up to 52 weeks,” the researched concluded. They added, “Patients who stopped treatment due to disease remission (IGA-CHE 0/1) were able to regain response upon restart of treatment, thereby helping clinicians to contextualize potential benefits of delgocitinib cream to patients with CHE.”
Disclosure: This research was supported by LEO Pharma A/S. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
