在患有慢性手部湿疹的成人中，使用delgocitinib乳膏长达52周的长期安全性和有效性：DELTA 1和2试验之后的3期开放标签扩展DELTA 3试验结果。

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.

作者信息

Gooderham Melinda, Molin Sonja, Bissonnette Robert, Worm Margitta, Crépy Marie-Noëlle, Stingeni Luca, Warren Richard B, Schliemann Sibylle, Schuttelaar Marie-Louise, Ferrucci Silvia, Serra-Baldrich Esther, Silverberg Jonathan I, Balita-Crisostomo Cherry Lou, Østerdal Marie Louise, Plohberger Ursula, Agner Tove

机构信息

Department of Medicine, Queens University, Kingston, Ontario, Canada; SKiN Centre for Dermatology and Probity Medical Research, Peterborough, Ontario, Canada.

Division of Dermatology, Queen's University, Kingston, Ontario, Canada; Division of Allergy and Immunology, Department of Dermatology, Venerology and Allergy, Charité Universitätsmedizin Berlin, Berlin, Germany.

出版信息

J Am Acad Dermatol. 2025 Mar 11. doi: 10.1016/j.jaad.2025.03.008.

DOI:10.1016/j.jaad.2025.03.008

PMID:40081663

Abstract

BACKGROUND

Delgocitinib cream is the only topical treatment that has been specifically developed and approved for moderate to severe Chronic Hand Eczema (CHE).

OBJECTIVE

The objective of this trial was 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 treatment period in the DELTA 1 and 2 trials were treated on an as-needed basis with twice-daily delgocitinib cream for 36 weeks (n = 801). Patients with Investigator's Global Assessment for CHE (IGA-CHE) ≥2 received treatment until IGA-CHE ≤1 was achieved. The primary endpoint was the number of treatment-emergent adverse events. 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; patient years of observation = 535.7), with most frequent adverse events being COVID-19 and nasopharyngitis. DELTA 3 baseline IGA-CHE 0/1 (24.6%) and HECSI-75/HECSI-90 (51.8%/31.8%) were maintained to week 36 (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 week 36 (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 patients with CHE for up to 52 weeks.

摘要

背景

地尔他替尼乳膏是唯一专门研发并获批用于治疗中度至重度慢性手部湿疹（CHE）的局部用药。

目的

本试验旨在评估20mg/g地尔他替尼乳膏按需治疗36周对CHE成年患者的长期安全性和疗效。

方法

在3期开放标签DELTA 3试验（NCT04949841）中，在DELTA 1和2试验中完成16周治疗期的患者按需接受每日两次地尔他替尼乳膏治疗36周（n = 801）。研究者对CHE的整体评估（IGA-CHE）≥2的患者接受治疗，直至IGA-CHE≤1。主要终点是治疗中出现的不良事件数量。关键次要终点是IGA-CHE 0/1以及手部湿疹严重程度指数（HECSI-75/90）评分改善≥75%/≥90%。

结果

地尔他替尼耐受性良好（n = 801；R = 231.1；观察患者年数 = 535.7），最常见的不良事件是新型冠状病毒肺炎和鼻咽炎。在原试验中接受地尔他替尼治疗的患者中，DELTA 3基线时的IGA-CHE 0/1（24.6%）和HECSI-75/HECSI-90（51.8%/31.8%）维持到第36周（分别为30.0%和58.6%/36.6%）。在先前接受乳膏基质治疗的患者中，相应的缓解率从DELTA 3基线时的（分别为9.1%和23.7%/12.0%）提高到第36周时的（29.5%和51.5%/35.7%）。