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關于<\/span><\/b>EFFISAYIL?<\/sup>臨床試驗項目<\/span><\/b><\/p> \n 關于圣利卓<\/span><\/b>®<\/span><\/sup><\/b><\/p> \n 圣利卓(佩索利單抗)是一款新型人源化選擇性抗體,可阻斷白介素<\/span>-36受體 (IL-36R)的激活。IL-36通路是免疫系統內的一種信號通路,已被證明與GPP等多種自身炎癥性疾病的發病機制有關[3],[5],[6]<\/sup>。佩索利單抗已獲得包括美國、日本、中國大陸和歐盟等多國監管機構批準,用于治療成人GPP發作。<\/span><\/p> \n 關于泛發性膿皰型銀屑病(<\/span><\/b>GPP)<\/span><\/b><\/p> \n GPP是一種罕見的、異質性的、可危及生命的嗜中性粒細胞性皮膚病,臨床上與斑塊狀銀屑病不同[2],[3]<\/sup>。GPP是由中性粒細胞(一種白細胞)在皮膚中積聚引起的,會在全身廣泛爆發疼痛性的無菌性膿皰[2],[3]<\/sup>。GPP患者的臨床病程各不相同,有些患者可反復發作,而另一些患者則表現為疾病持續存在且間歇性發作[2]<\/sup>。雖然GPP發作的嚴重程度各不相同,但若不及時治療,可能會出現敗血癥和多系統器官衰竭等并發癥,可能會危及生命[3]<\/sup>。這種慢性全身性疾病會對患者的生活質量產生重大影響,并增加醫療負擔[13]<\/sup>。GPP在不同區域的患病率各不相同,女性患者多于男性患者[3],[13],[14]<\/span>,[15]<\/span>,[16]<\/span><\/sup>。對于能夠快速解決GPP發作癥狀并能預防復發,且具有可接受的安全性的療法存在著高度未滿足的需求[4],[17]<\/span><\/sup>。<\/span><\/p> \n GPP的發作可導致住院并可能發生嚴重并發癥,包括心力衰竭、腎衰竭和敗血癥,而疾病發作的不可預測性和嚴重程度極大地影響了患者的生活質量[3],[4]<\/sup>。<\/span><\/p> \n [1] 《我國泛發性膿皰型銀屑病的患病率和疾病負擔調查:一項基于全國2012-2016年城鎮醫療保險數據的估算》,中華醫學會第二十七次全國皮膚性病學學術年會,2021年6月<\/span><\/p> <\/td> \n <\/tr> \n [2] Navarini AA, et al. European consensus statement on phenotypes of pustular psoriasis. JEADV. 2017;31:1792-1799.<\/span><\/p> <\/td> \n <\/tr> \n [3] Crowley JJ, et al. A brief guide to pustular psoriasis for primary care providers, Postgraduate Medicine. 2021;133(3):330-344.<\/span><\/p> <\/td> \n <\/tr> \n [4] Puig L, Choon SE, Gottlieb AB, et al. Generalized pustular psoriasis: a global Delphi consensus on clinical course, diagnosis, treatment goals, and disease management. J Eur Acad Dermatol Venereol. 2023 Jan 6. doi: 10.1111\/jdv.18851.<\/span><\/p> <\/td> \n <\/tr> \n [5] Furue K, et al. Highlighting Interleukin-36 Signalling in plaque psoriasis and pustular psoriasis. Acta Derm Venereol. 2018;98:5–13.<\/span><\/p> <\/td> \n <\/tr> \n [6] Bachelez H, et al. Inhibition of the Interleukin-36 Pathway for the Treatment of Generalized Pustular Psoriasis. N Engl J Med. 2019; 380:981-983.<\/span><\/p> <\/td> \n <\/tr> \n [7] Morita A, Choon SE, Bachelez H et al. Design of EffisayilTM 2: A randomized, double-blind, placebo-controlled study of spesolimab in preventing flares in patients with generalized pustular psoriasis. Dermatol Ther (Heidelb) (2023) 13:347–359.<\/span><\/p> <\/td> \n <\/tr> \n [8] A study to test whether BI 655130 (spesolimab) prevents flare-ups in patients with generalized pustular psoriasis. www.clinicaltrials.gov\/ct2\/show\/study\/NCT04399837?term=Boehringer. Last accessed January 2023.<\/span><\/p> <\/td> \n <\/tr> \n [9] Bachelez H et al. Trial of spesolimab for generalized pustular psoriasis. NEJM. 2021;385:2431-40.<\/span><\/p> <\/td> \n <\/tr> \n [10] Federal Drug Administration. New Drug Approvals for 2022. Available at: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/761244s000lbl.pdf. Accessed January 2023.<\/span><\/p> <\/td> \n <\/tr> \n [11] EC approval statement (data on file).<\/span><\/p> <\/td> \n <\/tr> \n [12] Effisayil ON: An open-label, long term extension study to assess the safety and efficacy of spesolimab treatment in patients with generalized pustular psoriasis (GPP). https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03886246?term=Effisayil&draw=2&rank=1. Last accessed January 2023.<\/span><\/p> <\/td> \n <\/tr> \n [13] Hanna M, et al. Economic burden of generalized pustular psoriasis and palmoplantar pustulosis in the United States. Curr Med Res Opin. 2021. 37(5):735-742.<\/span><\/p> <\/td> \n <\/tr> \n [14] Augey F, et al. Generalized pustular psoriasis (Zumbusch): a French epidemiological survey. Eur J Derm. 2006; 16(6):669-673.<\/span><\/p> <\/td> \n <\/tr> \n [15] Ohkawara A et al. Generalized pustular psoriasis in Japan: two distinct groups formed by differences in symptoms and genetic background. Acta Derm Venereol. 1996 Jan;76(1):68–71.<\/span><\/p> <\/td> \n <\/tr> \n [16] Jin H, et al. Clinical features and course of generalized pustular psoriasis in Korea. J Dermatol. 2015; 42(7):674-678.<\/span><\/p> <\/td> \n <\/tr> \n [17] Bachelez, H. Pustular psoriasis: the dawn of a new era. Acta Derm Venereol. 2020;100(3):adv000343<\/span><\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div> \n <\/p>"];
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