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关于<\/i><\/b>Anzupgo®<\/i><\/b>(德戈替尼,<\/i><\/b>Delgocitinib<\/i><\/b>)<\/i><\/b><\/p> \n

德戈替尼乳膏(<\/i>Anzupgo®<\/sup><\/i>)是一款在研、外用泛<\/i>Janus<\/i>激酶(<\/i>JAK<\/i>)抑制剂,用于治疗对皮质类固醇治疗应答不充分或不适合接受皮质类固醇治疗的中度至重度慢性手部湿疹的成人患者。其可抑制<\/i>JAK-STAT<\/i>信号的激活,而<\/i>JAK-STAT<\/i>信号在<\/i>CHE<\/i>的发病机制中起着关键作用[<\/sup><\/i>11]<\/sup><\/i>。<\/i>CHE<\/i>的病理生理学的特点是皮肤屏障功能障碍、皮肤炎症和皮肤微生物组的改变[<\/sup><\/i>12]<\/sup><\/i>。<\/i>Anzupgo®<\/sup><\/i>目前已获得欧盟、英国、瑞士、阿联酋、中国澳门等多地批准,用于治疗对皮质类固醇治疗应答不充分或不适合接受皮质类固醇治疗的中度至重度慢性手部湿疹(<\/i>CHE<\/i>)的成人患者。<\/i>2014<\/i>年,利奥制药和日本烟草公司(<\/i>Japan Tobacco Inc.<\/i>,<\/i>JT<\/i>)达成许可协议,利奥制药获得了除日本外在全球范围内开发和商业化德戈替尼乳膏(外用)治疗皮肤病学适应症的独家权利,<\/i>JT<\/i>保留在日本的权利。<\/i><\/p> \n

关于<\/i><\/b>DELTA 1<\/i><\/b>、<\/i><\/b>2<\/i><\/b>和<\/i><\/b>3<\/i><\/b>试验<\/i><\/b><\/p> \n

DELTA 1<\/i>和<\/i>DELTA 2<\/i>是随机、双盲、赋形剂对照、多中心的<\/i>III<\/i>期临床试验,其主要目的是评估每日两次使用<\/i>Anzupgo<\/i>与乳膏赋形剂相比在治疗成人中度至重度<\/i>CHE<\/i>方面的有效性。[<\/sup><\/i>4]-[6]<\/sup><\/i><\/p> \n

试验的主要终点是第<\/i>16<\/i>周时患者达成研究者慢性手部湿疹总体评估的治疗成功(<\/i>IGA-CHE TS<\/i>)。治疗成功被定义为<\/i>IGA-CHE<\/i>分数为<\/i>0<\/i>(清除)或<\/i>1<\/i>(几乎清除),且相较于基线至少有<\/i>2<\/i>个级别的改善。<\/i>IGA-CHE<\/i>的其他评分为<\/i>2<\/i>(轻度)、<\/i>3<\/i>(中度)、<\/i>4<\/i>(重度)。[<\/sup><\/i>4]-[6]<\/sup><\/i><\/p> \n

第<\/i>16<\/i>周时的关键次要终点包括:从基线至第<\/i>16<\/i>周根据手部湿疹症状日记<\/i>(HESD)<\/i>评估的瘙痒和疼痛评分降低<\/i>≥4<\/i>分,以及在第<\/i>16<\/i>周手部湿疹严重指数(<\/i>HECSI<\/i>)相较于基线至少改善<\/i>75%<\/i>和至少改善<\/i>90%<\/i>。该研究的关键安全性终点定义为从基线至第<\/i>16<\/i>周治疗中发生的不良事件数量。[<\/sup><\/i>4]-[6]<\/sup><\/i><\/p> \n

在<\/i>DELTA 1<\/i>或<\/i>DELTA 2<\/i>试验中,完成<\/i>16<\/i>周每日两次使用<\/i>Anzupgo<\/i>或乳膏赋形剂治疗的受试者可继续进入<\/i>DELTA 3<\/i>开放性、多中心的扩展试验。该扩展试验旨在评估<\/i>Anzupgo<\/i>治疗的长期安全性。[<\/sup><\/i>7]<\/sup><\/i><\/p> \n

关于慢性手部湿疹<\/i><\/b> <\/p> \n

慢性手部湿疹(<\/i>CHE<\/i>)是指持续<\/i>3<\/i>个月以上或<\/i>1<\/i>年内复发<\/i>2<\/i>次或<\/i>2<\/i>次以上的的手部湿疹(<\/i>HE<\/i>[<\/sup><\/i>13],[14]<\/sup><\/i>。<\/i> HE<\/i>是手部最常见的皮肤疾病[<\/sup><\/i>15]<\/sup><\/i>,患病率约为<\/i>4.7%[16]<\/sup> <\/i>。在大多数患者中,<\/i>HE<\/i>会发展为慢性疾病[<\/sup><\/i>15]<\/sup><\/i>。<\/i>CHE<\/i>是一种具有瘙痒和疼痛特征的波动性疾病,患者手部和腕部可能出现红斑、鳞屑、苔藓样变、角化过度、水疱、水肿和皲裂等症状。[<\/sup><\/i>17]  <\/sup><\/i><\/p> \n

已证明<\/i>CHE<\/i>会造成心理和功能负担,影响患者的生活质量[<\/sup><\/i>18]<\/sup><\/i>,约<\/i>70%<\/i>的严重<\/i>CHE<\/i>患者认为该疾病对日常活动造成了影响[<\/sup><\/i>19]<\/sup><\/i>。此外,也有证据表明<\/i>CHE<\/i>所带来的生活负担也会影响患者的工作和收入。[<\/sup><\/i>20]<\/sup><\/i><\/p> \n

关于利奥制药<\/i><\/b><\/p> \n

利奥制药是医学皮肤领域的全球领导者。我们基于一个多世纪在医疗健康领域的突破性药物的经验,提供创新的皮肤健康解决方案。我们致力于为人们的生活带来根本性改变,我们广泛的产品组合每年为<\/i>70<\/i>多个国家的近<\/i>1<\/i>亿患者提供服务。利奥制药总部位于丹麦,拥有全球员工<\/i>4000<\/i>多人。利奥制药由主要股东利奥基金会和<\/i>Nordic Capital<\/i>(自<\/i>2021<\/i>年起)共同拥有。更多信息,请访问<\/i>www.leo-pharma.com<\/a><\/i>。<\/i><\/p> \n

在中国,利奥制药专注于银屑病、特应性皮炎、慢性手部湿疹和皮肤感染等疾病领域,是相关领域的市场领导者,通过有竞争力的产品和服务来提高人们的生活质量。<\/i><\/p> \n

声明<\/b><\/p> \n

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  1. 本资料中涉及的信息仅供参考,非推广目的,请遵从医生或其他医疗卫生专业人士的意见或指导。<\/i><\/li> \n
  2. 本文旨在传递医药前沿信息和研究进展,不构成对任何药物的商业推广或对诊疗方案的推荐。<\/li> \n
  3. 本文提及的部分药物和<\/i>\/<\/i>或适应症尚未在中国内地获批。<\/i><\/li> \n<\/ol> \n

    参考资料:<\/b><\/p> \n

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    [3] <\/sup>Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233.<\/span><\/p> <\/td> \n <\/tr> \n

    [4]<\/sup> ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 1). Identifier: NCT04871711. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04872101.<\/span><\/p> <\/td> \n <\/tr> \n

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    [6]<\/sup> Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet 2024; published online July 18. https:\/\/doi.org\/10.1016\/S0140-6736(24)01027-<\/span><\/p> <\/td> \n <\/tr> \n

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    [8] <\/sup>Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet 2024; published online July 18. https:\/\/doi.org\/10.1016\/S0140-6736(24)01027-4..<\/span><\/p> <\/td> \n <\/tr> \n

    [9]<\/sup> Schliemann S, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: results of the Phase 3 DELTA 2 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0395.<\/span><\/p> <\/td> \n <\/tr> \n

    [10]<\/sup> Bissonnette R, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: results of the Phase 3 DELTA 1 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0369.<\/span><\/p> <\/td> \n <\/tr> \n

    [11] <\/sup>Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233.<\/span><\/p> <\/td> \n <\/tr> \n

    [12] <\/sup>Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840.<\/span><\/p> <\/td> \n <\/tr> \n

    [13]<\/sup> Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011 Nov-Dec;15(6):360<\/span><\/p> <\/td> \n <\/tr> \n

    [14]<\/sup> Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22.<\/span><\/p> <\/td> \n <\/tr> \n

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    [16]<\/sup> Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of 60,000 respondents in the general population. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3<\/span><\/p> <\/td> \n <\/tr> \n

    [17] <\/sup>Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.<\/span><\/p> <\/td> \n <\/tr> \n

    [18] <\/sup>Grant L, Seiding Larsen L, Burrows K, et al. Development of a Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative Interviews with Patients and Expert Dermatologists. Adv Ther. 2020;37(2):692-706.<\/span><\/p> <\/td> \n <\/tr> \n

    [19]<\/sup> Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014;70(3):158-168.<\/span><\/p> <\/td> \n <\/tr> \n

    [20]<\/sup> Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity of Hand Eczema in the Dutch General Population: A Cross-sectional, Questionnaire Study within the Lifelines Cohort Study. Acta Derm Venereol. 2022;102:adv00626.<\/span><\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div> \n

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