關于佩索利單抗<\/b><\/p> \n
佩索利單抗是一款新型人源化選擇性抗體，可阻斷白介素 -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。4,6,7<\/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。<\/p> \n 佩索利單抗是首個獲批專門靶向 IL-36 通路治療 GPP發作的療法，已在一項隨機、安慰劑對照試驗中獲得了具有統計學意義的結果。今年晚些時候將公布更多關于佩索利單抗臨床試驗的結果，包括研究預防GPP發作的EFFISAYIL? 2臨床試驗最終結果。目前，佩索利單抗還被開發用于其他IL-36介導的皮膚疾病。10<\/sup><\/p> \n 關于<\/b>EFFISAYIL<\/b>TM<\/sup>臨床試驗項目<\/b><\/p> \n EFFISAYILTM<\/sup>臨床試驗項目包括：<\/p> \n EFFISAYILTM<\/sup> 2和EFFISAYILTM<\/sup> ON臨床試驗結果將于今年晚些時候公布。<\/p> \n 關于泛發性膿皰型銀屑病（GPP）<\/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。4,11<\/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。4,11<\/sup>GPP患者的臨床病程各不相同，有些患者的疾病復發并伴有反復發作，而另一些患者的疾病持續存在且間歇性發作。11<\/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。4<\/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。12<\/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。4,12-15<\/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。3,16<\/sup><\/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。4,16<\/sup><\/p> \n 關于勃林格殷格翰<\/b><\/p> \n 勃林格殷格翰致力于研究突破性療法，旨在改善人類和動物的健康。作為一家研發驅動的全球領先生物制藥企業，公司在醫療需求高度未得到滿足的領域通過創新展現價值。自1885年成立以來，勃林格殷格翰始終是一家獨立的家族企業，從長遠來看這一點將不會改變。在人用藥品、動物保健和生物制藥合同生產三大業務領域，全球有約5.2萬名員工服務逾130個地區。更多詳情，請訪問：www.boehringer-ingelheim.com<\/p> \n References<\/p> \n 1. Morita A, Choon SE, Bachelez H et al<\/i>. Design of EffisayilTM<\/sup> 2: A randomized, double-blind, placebo-controlled study of spesolimab in preventing flares in patients with generalized pustular psoriasis. Dermatol Ther<\/i> (Heidelb) (2023) 13:347–359.<\/p> \n 2. 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<\/a>. Last accessed January 2023<\/span>.<\/p> \n 3. Bachelez H et al<\/i>. Trial of spesolimab for generalized pustular psoriasis. NEJM<\/i>. 2021;385:2431-40.<\/p> \n 4. Crowley JJ, et al<\/i>. A brief guide to pustular psoriasis for primary care providers, Postgraduate Medicine<\/i>. 2021;133(3):330-344.<\/p> \n 5. 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<\/a>. Last accessed January 2023<\/span>.<\/p> \n 6. Furue K, et al<\/i>. Highlighting Interleukin-36 Signalling in plaque psoriasis and pustular psoriasis. Acta Derm Venereol<\/i>. 2018;98:5–13.<\/p> \n 7. Bachelez H, et al<\/i>. Inhibition of the Interleukin-36 Pathway for the Treatment of Generalized Pustular Psoriasis. N Engl J Med<\/i>. 2019; 380:981-983.<\/p> \n 8. 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><\/a>.<\/p> \n 9. EC approval statement (data on file).<\/p> \n 10. A study to test whether spesolimab helps people with a skin disease called hidradenitis suppurativa. Available at: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04762277.January 2023<\/a>.<\/p> \n 11. Navarini AA, et al<\/i>. European consensus statement on phenotypes of pustular psoriasis. JEADV<\/i>. 2017;31:1792-1799.<\/p> \n 12. Hanna M, et al<\/i>. Economic burden of generalized pustular psoriasis and palmoplantar pustulosis in the United States<\/span>. Curr Med Res Opin<\/i>. 2021. 37(5):735-742.<\/p> \n 13. Augey F, et al<\/i>. Generalized pustular psoriasis (Zumbusch): a French epidemiological survey. Eur J Derm<\/i>. 2006; 16(6):669-673.<\/p> \n 14. Ohkawara A et al<\/i>. Generalized pustular psoriasis in Japan<\/span>: two distinct groups formed by differences in symptoms and genetic background. Acta Derm Venereol<\/i>. 1996 Jan;76(1):68–71.<\/p> \n 15. Jin H, et al<\/i>. Clinical features and course of generalized pustular psoriasis in Korea. J Dermatol<\/i>. 2015; 42(7):674-678.<\/p> \n 16. Puig L, Choon SE, Gottlieb AB, et al<\/i>. Generalized pustular psoriasis: a global Delphi consensus on clinical course, diagnosis, treatment goals, and disease management. J Eur Acad Dermatol Venereol<\/i>. 2023 Jan 6<\/span>. doi: 10.1111\/jdv.18851.<\/p>"];
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