Long-term safety and efficacy of delgocitinib cream for up to 52 weeks in adults with Chronic Hand Eczema: results of the phase 3 open-label extension DELTA 3 trial following the DELTA 1 and 2 trials.
Melinda Gooderham, Sonja Molin, Robert Bissonnette, Margitta Worm, Marie-Noëlle Crépy, Luca Stingeni, Richard B Warren, Sibylle Schliemann, Marie-Louise Schuttelaar, Silvia Ferrucci, Esther Serra-Baldrich, Jonathan I Silverberg, Cherry Lou Balita-Crisostomo, Marie Louise Oesterdal, Ursula Plohberger, Tove Agner
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引用次数: 0
Abstract
Background: There are no topical treatments that have been specifically developed and approved for moderate to severe Chronic Hand Eczema (CHE).
Objective: To evaluate the long-term safety and efficacy of delgocitinib cream 20 mg/g as needed for 36 weeks in adults with CHE.
Methods: In phase 3 open-label DELTA 3 (NCT04949841), patients who completed the 16-week(W) treatment period in DELTA 1 and 2 were treated on an as-needed basis with twice-daily delgocitinib for 36 weeks (n=801). Patients with Investigator's Global Assessment for CHE (IGA-CHE)≥2 received treatment until IGA-CHE≤1 was achieved. Primary endpoint was number of treatment-emergent adverse events (AEs). Key secondary endpoints were IGA-CHE 0/1 and ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) scores.
Results: Delgocitinib was well tolerated (n=801; R=231.1; PYO=535.7), with most frequent AEs being COVID-19 and nasopharyngitis. DELTA 3 baseline IGA-CHE 0/1 (24.6%), HECSI-75/HECSI-90 (51.8%/31.8%) were maintained to W36 (30.0% and 58.6%/36.6%, respectively) among delgocitinib-treated patients in the parent trials. Among those previously treated with cream vehicle, corresponding response rates improved from DELTA 3 baseline (9.1% and 23.7%/12.0%, respectively) to W36 (29.5% and 51.5%/35.7%).
Limitations: Open-label trial.
Conclusion: Delgocitinib cream treatment was well-tolerated and efficacious in maintaining disease control in CHE patients up to 52 weeks.
期刊介绍：
The Journal of the American Academy of Dermatology (JAAD) is the official scientific publication of the American Academy of Dermatology (AAD). Its primary goal is to cater to the educational requirements of the dermatology community. Being the top journal in the field, JAAD publishes original articles that have undergone peer review. These articles primarily focus on clinical, investigative, and population-based studies related to dermatology. Another key area of emphasis is research on healthcare delivery and quality of care. JAAD also highlights high-quality, cost-effective, and innovative treatments within the field. In addition to this, the journal covers new diagnostic techniques and various other topics relevant to the prevention, diagnosis, and treatment of skin, hair, and nail disorders.
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