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關于<\/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>)抑制劑,用于治療對皮質類固醇治療應答不充分或不適合接受皮質類固醇治療的中度至重度慢性手部濕疹的成人患者。其可抑制<\/i>JAK-STAT<\/i>信號的激活,而<\/i>JAK-STAT<\/i>信號在<\/i>CHE<\/i>的發病機制中起著關鍵作用[<\/sup><\/i>11]<\/sup><\/i>。<\/i>CHE<\/i>的病理生理學的特點是皮膚屏障功能障礙、皮膚炎癥和皮膚微生物組的改變[<\/sup><\/i>12]<\/sup><\/i>。<\/i>Anzupgo®<\/sup><\/i>目前已獲得歐盟、英國、瑞士、阿聯酋、中國澳門等多地批準,用于治療對皮質類固醇治療應答不充分或不適合接受皮質類固醇治療的中度至重度慢性手部濕疹(<\/i>CHE<\/i>)的成人患者。<\/i>2014<\/i>年,利奧制藥和日本煙草公司(<\/i>Japan Tobacco Inc.<\/i>,<\/i>JT<\/i>)達成許可協議,利奧制藥獲得了除日本外在全球范圍內開發和商業化德戈替尼乳膏(外用)治療皮膚病學適應癥的獨家權利,<\/i>JT<\/i>保留在日本的權利。<\/i><\/p> \n

關于<\/i><\/b>DELTA 1<\/i><\/b>、<\/i><\/b>2<\/i><\/b>和<\/i><\/b>3<\/i><\/b>試驗<\/i><\/b><\/p> \n

DELTA 1<\/i>和<\/i>DELTA 2<\/i>是隨機、雙盲、賦形劑對照、多中心的<\/i>III<\/i>期臨床試驗,其主要目的是評估每日兩次使用<\/i>Anzupgo<\/i>與乳膏賦形劑相比在治療成人中度至重度<\/i>CHE<\/i>方面的有效性。[<\/sup><\/i>4]-[6]<\/sup><\/i><\/p> \n

試驗的主要終點是第<\/i>16<\/i>周時患者達成研究者慢性手部濕疹總體評估的治療成功(<\/i>IGA-CHE TS<\/i>)。治療成功被定義為<\/i>IGA-CHE<\/i>分數為<\/i>0<\/i>(清除)或<\/i>1<\/i>(幾乎清除),且相較于基線至少有<\/i>2<\/i>個級別的改善。<\/i>IGA-CHE<\/i>的其他評分為<\/i>2<\/i>(輕度)、<\/i>3<\/i>(中度)、<\/i>4<\/i>(重度)。[<\/sup><\/i>4]-[6]<\/sup><\/i><\/p> \n

第<\/i>16<\/i>周時的關鍵次要終點包括:從基線至第<\/i>16<\/i>周根據手部濕疹癥狀日記<\/i>(HESD)<\/i>評估的瘙癢和疼痛評分降低<\/i>≥4<\/i>分,以及在第<\/i>16<\/i>周手部濕疹嚴重指數(<\/i>HECSI<\/i>)相較于基線至少改善<\/i>75%<\/i>和至少改善<\/i>90%<\/i>。該研究的關鍵安全性終點定義為從基線至第<\/i>16<\/i>周治療中發生的不良事件數量。[<\/sup><\/i>4]-[6]<\/sup><\/i><\/p> \n

在<\/i>DELTA 1<\/i>或<\/i>DELTA 2<\/i>試驗中,完成<\/i>16<\/i>周每日兩次使用<\/i>Anzupgo<\/i>或乳膏賦形劑治療的受試者可繼續進入<\/i>DELTA 3<\/i>開放性、多中心的擴展試驗。該擴展試驗旨在評估<\/i>Anzupgo<\/i>治療的長期安全性。[<\/sup><\/i>7]<\/sup><\/i><\/p> \n

關于慢性手部濕疹<\/i><\/b> <\/p> \n

慢性手部濕疹(<\/i>CHE<\/i>)是指持續<\/i>3<\/i>個月以上或<\/i>1<\/i>年內復發<\/i>2<\/i>次或<\/i>2<\/i>次以上的的手部濕疹(<\/i>HE<\/i>[<\/sup><\/i>13],[14]<\/sup><\/i>。<\/i> HE<\/i>是手部最常見的皮膚疾病[<\/sup><\/i>15]<\/sup><\/i>,患病率約為<\/i>4.7%[16]<\/sup> <\/i>。在大多數患者中,<\/i>HE<\/i>會發展為慢性疾病[<\/sup><\/i>15]<\/sup><\/i>。<\/i>CHE<\/i>是一種具有瘙癢和疼痛特征的波動性疾病,患者手部和腕部可能出現紅斑、鱗屑、苔蘚樣變、角化過度、水皰、水腫和皸裂等癥狀。[<\/sup><\/i>17]  <\/sup><\/i><\/p> \n

已證明<\/i>CHE<\/i>會造成心理和功能負擔,影響患者的生活質量[<\/sup><\/i>18]<\/sup><\/i>,約<\/i>70%<\/i>的嚴重<\/i>CHE<\/i>患者認為該疾病對日常活動造成了影響[<\/sup><\/i>19]<\/sup><\/i>。此外,也有證據表明<\/i>CHE<\/i>所帶來的生活負擔也會影響患者的工作和收入。[<\/sup><\/i>20]<\/sup><\/i><\/p> \n

關于利奧制藥<\/i><\/b><\/p> \n

利奧制藥是醫學皮膚領域的全球領導者。我們基于一個多世紀在醫療健康領域的突破性藥物的經驗,提供創新的皮膚健康解決方案。我們致力于為人們的生活帶來根本性改變,我們廣泛的產品組合每年為<\/i>70<\/i>多個國家的近<\/i>1<\/i>億患者提供服務。利奧制藥總部位于丹麥,擁有全球員工<\/i>4000<\/i>多人。利奧制藥由主要股東利奧基金會和<\/i>Nordic Capital<\/i>(自<\/i>2021<\/i>年起)共同擁有。更多信息,請訪問<\/i>www.leo-pharma.com<\/a><\/i>。<\/i><\/p> \n

在中國,利奧制藥專注于銀屑病、特應性皮炎、慢性手部濕疹和皮膚感染等疾病領域,是相關領域的市場領導者,通過有競爭力的產品和服務來提高人們的生活質量。<\/i><\/p> \n

聲明<\/b><\/p> \n

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  1. 本資料中涉及的信息僅供參考,非推廣目的,請遵從醫生或其他醫療衛生專業人士的意見或指導。<\/i><\/li> \n
  2. 本文旨在傳遞醫藥前沿信息和研究進展,不構成對任何藥物的商業推廣或對診療方案的推薦。<\/li> \n
  3. 本文提及的部分藥物和<\/i>\/<\/i>或適應癥尚未在中國內地獲批。<\/i><\/li> \n<\/ol> \n

    參考資料:<\/b><\/p> \n

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    [1] <\/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

    [2] <\/sup>Ther Clin Risk Manag. 2020 Dec 31;16:1319-1332.<\/span><\/p> <\/td> \n <\/tr> \n

    [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

    [5]<\/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 2). Identifier: NCT04872101. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04872101.<\/span><\/p> <\/td> \n <\/tr> \n

    [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

    [7] <\/sup>ClinicalTrials.gov. National Library of Medicine (U.S.). Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials (DELTA3). Identifier: NCT04949841 https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04949841<\/span><\/p> <\/td> \n <\/tr> \n

    [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

    [15] <\/sup>Bissonnette R, Diepgen TL, Elsner P, et al. Redefining treatment options in chronic hand eczema (CHE). J Eur Acad Dermatol Venereol. 2010;24 Suppl 3:1-20.<\/span><\/p> <\/td> \n <\/tr> \n

    [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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