McGuigan Aisling, Shirley Matt
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Drugs. 2025 Jul 14. doi: 10.1007/s40265-025-02206-9.
Delgocitinib is a pan-Janus kinase (JAK) inhibitor that targets all four JAK isoforms. Delgocitinib 20 mg/g cream (Anzupgo 20 mg/g), a non-steroidal therapy, is the first topical treatment indicated in the EU for moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. In two 16-week, double-blind, vehicle-controlled, multinational phase III trials, twice-daily delgocitinib 20 mg/g cream improved the signs and symptoms of CHE and improved health-related quality of life in adults with moderate to severe disease; efficacy was maintained with as-needed treatment in a subsequent 36-week open-label extension study. Moreover, an active-controlled trial demonstrated that delgocitinib 20 mg/g cream had superior efficacy and apparent improved tolerability versus oral alitretinoin in adults with severe CHE. Delgocitinib 20 mg/g cream was well tolerated locally in clinical trials, with low systemic exposure with topical application. In summary, current data show that delgocitinib 20 mg/g cream is an efficacious and well tolerated treatment for moderate to severe CHE in adults. As the first topical treatment specifically approved for CHE, it presents a valuable new non-steroidal option in patients for whom topical corticosteroids are inadequate or inappropriate.
地尔古替尼是一种泛Janus激酶(JAK)抑制剂,可作用于所有四种JAK亚型。地尔古替尼20mg/g乳膏(Anzupgo 20mg/g),一种非甾体疗法,是欧盟首个获批用于局部皮质类固醇治疗不足或不适用的成人中度至重度慢性手部湿疹(CHE)的局部治疗药物。在两项为期16周、双盲、赋形剂对照的跨国III期试验中,每日两次使用地尔古替尼20mg/g乳膏可改善CHE的体征和症状,并改善中度至重度疾病成人的健康相关生活质量;在随后一项为期36周的开放标签扩展研究中,按需治疗可维持疗效。此外,一项活性对照试验表明,对于患有严重CHE的成人,地尔古替尼20mg/g乳膏比口服阿利维A酸具有更高的疗效和明显更好的耐受性。在临床试验中,地尔古替尼20mg/g乳膏局部耐受性良好,局部应用时全身暴露量低。总之,目前的数据表明,地尔古替尼20mg/g乳膏是治疗成人中度至重度CHE的一种有效且耐受性良好的疗法。作为首个专门获批用于CHE的局部治疗药物,它为局部皮质类固醇治疗不足或不适用的患者提供了一种有价值的新型非甾体选择。