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关于佩索利单抗<\/b><\/p> \n

佩索利单抗是一款新型人源化选择性抗体，可阻断白介素 -36 受体 (IL-36R) 的激活。IL-36通路是免疫系统内的一种信号通路，已被证明与GPP等多种自身炎症性疾病的发病机制有关。^{4,6,7<\/sup>佩索利单抗已获得包括美国、日本、中国大陆和欧盟等多国监管机构批准，用于治疗成人GPP发作。<\/p> \n}

佩索利单抗是首个获批专门靶向 IL-36 通路治疗 GPP发作的疗法，已在一项随机、安慰剂对照试验中获得了具有统计学意义的结果。今年晚些时候将公布更多关于佩索利单抗临床试验的结果，包括研究预防GPP发作的EFFISAYIL™ 2临床试验最终结果。目前，佩索利单抗还被开发用于其他IL-36介导的皮肤疾病。^{10<\/sup><\/p> \n}

关于<\/b>EFFISAYIL<\/b>^{TM<\/sup>临床试验项目<\/b><\/p> \n}

EFFISAYIL^{TM<\/sup>临床试验项目包括：<\/p> \n}

\n
EFFISAYIL^{TM<\/sup> 1：使用佩索利单抗治疗GPP发作显示出快速的脓疱和皮损清除，疗效长达12周。^{3<\/sup>基于这一研究结果，佩索利单抗（圣利卓®）在包括美国、日本、中国大陆和欧盟等多个国家成为首个获批专门针对成人GPP发作的疗法。^{8,9<\/sup><\/li> \n}}}
EFFISAYIL^{TM<\/sup> 2：一项多中心、随机、双盲、安慰剂对照的 IIb 期临床研究，评估将皮下 (SC) 注射佩索利单抗作为维持治疗，在青少年和成人中预防 GPP 发作和持续控制 GPP 症状的有效性和安全性。^{1,2<\/sup><\/li> \n}}
EFFISAYIL^{TM<\/sup> ON：评估佩索利单抗在参与过此前佩索利单抗临床试验的GPP患者中的长期安全性和有效性。^{5<\/sup><\/li> \n<\/ul> \nEFFISAYIL^{TM<\/sup> 2和EFFISAYIL^{TM<\/sup> ON临床试验结果将于今年晚些时候公布。<\/p> \n}}
关于泛发性脓疱型银屑病（GPP）<\/b><\/p> \n
GPP 是一种罕见的、异质性的、可危及生命的嗜中性粒细胞性皮肤病，临床上与斑块状银屑病不同。^{4,11<\/sup>GPP 是由中性粒细胞（一种白细胞）在皮肤中积聚引起的，会在全身广泛爆发疼痛性的无菌性脓疱。^{4,11<\/sup>GPP患者的临床病程各不相同，有些患者的疾病复发并伴有反复发作，而另一些患者的疾病持续存在且间歇性发作。^{11<\/sup>虽然 GPP 发作的严重程度各不相同，但若不及时治疗，可能会出现败血症和多系统器官衰竭等并发症，可能会危及生命。^{4<\/sup>这种慢性全身性疾病会对患者的生活质量产生重大影响，并增加医疗负担。^{12<\/sup>GPP 在不同区域的患病率各不相同，女性患者多于男性患者。^{4,12-15<\/sup>对于能够快速解决 GPP 发作症状并能预防复发，且具有可接受的安全性的疗法存在着高度未满足的需求。^{3,16<\/sup><\/p> \n}}}}}}}
GPP 的发作可导致住院并可能发生严重并发症，包括心力衰竭、肾衰竭和败血症，而疾病发作的不可预测性和严重程度极大地影响了患者的生活质量。^{4,16<\/sup><\/p> \n}
关于勃林格殷格翰<\/b><\/p> \n
勃林格殷格翰致力于研究突破性疗法，旨在改善人类和动物的健康。作为一家研发驱动的全球领先生物制药企业，公司在医疗需求高度未得到满足的领域通过创新展现价值。自1885年成立以来，勃林格殷格翰始终是一家独立的家族企业，从长远来看这一点将不会改变。在人用药品、动物保健和生物制药合同生产三大业务领域，全球有约5.2万名员工服务逾130个地区。更多详情，请访问：www.boehringer-ingelheim.com<\/p> \n
References<\/p> \n
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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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