Spesolimab

Long-term subcutaneous SPEVIGO ® (spesolimab-sbzo) treatment reduced flare frequency in patients with generalized pustular psoriasis (GPP), with nearly 75% experiencing no flares over three years. 1 Rapid flare control was observed, with 50% of patients achieving a GPPGA pustulation subscore of 0 at Week 1 with intravenous SPEVIGO. 2 LEO Pharma A/S, a global leader in medical dermatology, today announced new long-term results from EFFISAYIL® ON, an ongoing five-year open-label extension study of the pivotal EFFISAYIL 1 trial and the EFFISAYIL 2 trial, evaluating the efficacy, safety and tolerability of SPEVIGO® (spesolimab-sbzo) injection in patients with generalized pustular psoriasis (GPP). The findings are being shared at the 2026 American Academy of Dermatology (AAD) Annual Meeting.1,2 GPP is a systemic, neutrophilic inflammatory skin disease with a heterogeneous clinical course characterized by chronic symptoms and recurrent, unpredictable periods of acute flares.3,4 Preliminary results from the EFFISAYIL ON study demonstrated that long-term subcutaneous (SC) SPEVIGO treatment is effective in reducing the cumulative number of flares in patients with GPP. Long-term SPEVIGO SC treatment led to a reduction in the number of flares, from 2.0 flares per year reported before entering the EFFISAYIL program to a cumulative mean of 0.13 flares per year. Of the 118 patients who received three or more years of SPEVIGO SC treatment, 74.6% (n=88) experienced no flares during this period.1 “The long-term data from the EFFISAYIL ON study further strengthen the evidence base for SPEVIGO as an effective treatment for generalized pustular psoriasis, a rare, chronic, and often-overlooked disease,” said Shannon Schneider, Vice President of North America Medical Affairs for LEO Pharma. “LEO Pharma is committed to addressing the serious impact of GPP on people living with this condition, through continued data generation and clinical insights.” For patients who experienced flares during the EFFISAYIL ON study, preliminary results showed that intravenous (IV) SPEVIGO is an effective and well tolerated treatment. Of the 131 patients enrolled in EFFISAYIL ON, 21 (16.0%) received SPEVIGO IV to treat a total of 36 flare events. A GPP Physician Global Assessment (GPPGA) pustulation subscore of 0 (clear) was observed in 50.0% (n=18) of flare treatments at Week 1 and 58.3% (n=21) at Week 2. A GPPGA total score of 0/1 (clear/almost clear) was observed in 41.7% (n=15) of flare treatments at Week 1 and 55.6% (n=20) at Week 2.2 Preliminary safety data remained consistent with the known safety profile of SPEVIGO. The percentage of patients reporting adverse events (AE) leading to treatment discontinuation in the SC arm was 4.2%. In the IV arm, serious AEs were 36.6% and AEs leading to treatment discontinuation was 4.6%.1,2 “Together these findings highlight the complementary roles of IV and SC SPEVIGO in the long-term management of GPP, supporting a treatment approach that helps address the full course of this chronic and unpredictable disease,” said Arash Mostaghimi, MD, MPH, FAAD, assistant professor of dermatology, Brigham & Women’s Hospital. The SPEVIGO study presentations are part of LEO Pharma’s extensive data program at AAD, which includes 17 accepted abstracts across the company’s medical dermatology portfolio and pipeline. The primary objective of this ongoing open-label, multicenter, 5-year long-term extension of the EFFISAYIL 1 and EFFISAYIL 2 trials is to assess the long-term safety and efficacy of SPEVIGO® (spesolimab-sbzo) treatment in patients with GPP. Subjects received SC SPEVIGO (300 mg every 4, 6, or 12 weeks; dose escalation and de-escalation for flare recurrence/resolution allowed per protocol) for up to 252 weeks. In case of a protocol-defined GPP flare, patients received IV SPEVIGO 900 mg (≤2 doses within 1 week). The primary outcome measure of the study was the occurrence of treatment-emergent adverse events (TEAEs) up to Week 252 of maintenance treatment. The secondary outcome measures the reoccurrence of a GPP flare (defined by the GPPGA), the time to first achievement of a GPPGA score of 0 or 1 in patients who received flare rescue treatment, a GPPGA pustulation sub-score of 0 indicating no visible pustules (by visit), and the change from baseline in Psoriasis Symptom Scale (PSS) score (by visit).1,2,5 Generalized pustular psoriasis (GPP) is a chronic, heterogeneous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment.3,4 GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems.6,7 GPP symptoms appear unpredictably and present on a continuum, which greatly impacts a patient’s quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities and finances.7,8 SPEVIGO® (spesolimab-sbzo) is a humanized, selective antibody that specifically blocks the activation of the IL-36R, a signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP.9 It is the first targeted therapy for the treatment of GPP and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP.10-12References Gudjonsson J, Navarini A, Langley R, et al. Long‑term (≥3‑year) efficacy of subcutaneous spesolimab treatment for prevention of flares in patients with generalized pustular psoriasis: results from the EFFISAYIL program. Presented at the 2026 AAD Conference, March 27–31, Denver, CO. Poster Presentation. Gordon K, Navarini A, Choon SE, et al. Intravenous spesolimab for (re)treatment of generalized pustular psoriasis flares in patients receiving subcutaneous spesolimab: results from the 5‑year, open‑label EFFISAYIL ON extension study. Presented at the 2026 AAD Conference, March 27–31, Denver, CO. Poster Presentation. Marrakchi S, Puig L. Pathophysiology of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:13–19. Prinz JC, Choon SE, Griffiths CEM, et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. J Eur Acad Dermatol Venereol . 2023;37:256–273. ClinicalTrials.gov. National Library of Medicine (U.S.). Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study. Identifier: NCT03886246. Accessed March 2026. Choon SE, Navarini AA, Pinter A. Clinical course and characteristics of generalized pustular psoriasis. Am J Clin Dermatol . 2022;23:21–29. Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Rev Clin Immunol. 2019;15:907–919. Reisner DV, Johnsson FD, Kotowsky N, et al. Impact of generalized pustular psoriasis from the perspective of people living with the condition: Results of an online survey. Am J Clin Dermatol. 2022;23:65–71. SPEVIGO ® (spesolimab-sbzo). Prescribing Information. FDA. October 2025. Morita A, Strober B, Burden AD, et al. Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial. Lancet. 2023;402:1541–1551. Choon SE, Lebwohl MG, Marrakchi S, et al. Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open . 2021;11:e043666. Bachelez H, Choon SE, Marrakchi S, et al. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med . 2021;385:2431–2440. MAT-93221 March 2026 The content above comes from the network. if any infringement, please contact us to modify.

伊顿健康导读： 面对琳琅满目的银屑病生物制剂，你是否也有这样的困惑？ 面对TNF-α、IL-12/23、IL-17、IL-23等这么多不同靶点的药物，它们到底有什么区别？我该怎么选？ 价格从几百到上千元一针不等，哪些进医保了？医保能报销多少？ 皮屑瘙痒难耐，我想快速起效；但又担心未来，我想维持长期治疗且不易耐药，该如何权衡？ 理解这些差异，是做出明智选择的第一步。本文将为您梳理2026年银屑病主要生物制剂的核心靶点优势、用法用量，并在文末提供清晰的价格与医保信息对比，助您一目了然。 银屑病生物制剂主要治疗靶点、 代表药物、用法用量与价格参考 目前，银屑病的生物治疗主要针对几个关键的炎症因子，不同靶点的药物各有其临床特点与经济成本： 1. TNF-α抑制剂 以阿达木单抗（商品名：修美乐）为例。作为较早上市的生物制剂，其优势在于适应症广泛，不仅能治疗中重度斑块状银屑病，对银屑病关节炎、强直性脊柱炎等也有明确疗效，适合需要同时治疗关节症状的患者。 用法用量：通常起始阶段需在第0、1、2周密集给药，之后转为每2周一次维持。 价格参考：根据文档内表格，其单价约为1290元/支（40mg），目前已纳入医保。 2. IL-12/23抑制剂 以乌司奴单抗（商品名：喜达诺、普达通）为例。它同时阻断白细胞介素-12和-23。其特点是能实现较长的给药间隔（维持期每12周一次），在当时显著提升了治疗便利性，且不增加结核病风险。 用法用量：起始在第0、4周注射，之后每12周一次维持。 价格参考：以“喜达诺”为例，单价约3614元/支（45mg），已纳入医保。 往期相关阅读：首个国产乌司奴单抗儿童适应症获批！银屑病患儿迎来曙光！ 3. IL-23抑制剂 这是当前重要的治疗方向。以古塞奇尤单抗（商品名：特诺雅）为例，它特异性抑制IL-23的p19亚基，能从炎症通路上游发挥作用，通常能达到较高且持续的皮损清除率。 用法用量：起始在第0、4周注射，之后每8周一次维持。 价格参考：单价约3980元/支（100mg），已纳入医保。  往期相关阅读：古塞奇尤单抗（特诺雅）针对既往打过生物制剂的难治银屑病患者效果如何？ 4. IL-17A抑制剂 以司库奇尤单抗（商品名：可善挺）为例，这类药物能快速强效地抑制IL-17A，临床数据显示其起效速度快，对头皮、指甲等特殊部位的皮损改善效果良好，是临床应用非常广泛的药物。 用法用量：起始阶段（第0、1、2、3、4周）需每周给药，之后转为每月一次维持。 价格参考：单价约778.66元/支（150mg），已纳入医保。 往期相关阅读：一文让你了解银屑病最便宜的生物制剂—可善挺 5. IL-17A/F双靶点抑制剂 代表药物是比奇珠单抗。能同时阻断IL-17A和IL-17F，实现更全面的抗炎。在临床研究中显示出在实现深度皮损清除（如PASI100）方面的优势，可能对难治部位效果更优。 用法用量：通常为每4周一次皮下注射。 价格参考：单价在2500-3200元/支（160mg）区间，目前未纳入医保。 往期相关阅读：比奇珠单抗（倍捷乐）双适应症获批，银屑病与化脓性汗腺炎疗效数据与安全性详解！ 6. IL-36抑制剂 代表药物：佩索利单抗（商品名：圣利卓） 靶点优势：这是专门用于治疗泛发性脓疱型银屑病（GPP） 急性发作的靶向药。GPP是一种罕见但可能危及生命的严重亚型，该药为其提供了关键治疗选择。 用法用量：用于GPP急性期治疗，通常为单次静脉输注，可根据需要重复给药。价格参考：单价较高，约26,436元/套（450mg/1.5mL*2瓶），已纳入医保。 往期相关阅读：从功效和用法用量，看佩索利单抗（圣利卓）精准靶向IL-36革新治疗脓疱型银屑病 2026银屑病新型生物制剂有哪些？ 优势分别是什么？ 最新一代的药物通过更精密的抗体工程技术，在原有靶点基础上进一步优化了药物性能。 1. 匹康奇拜单抗：同等疗效下用药间隔更久 匹康奇拜单抗属于IL-23抑制剂，但其核心优势在于对抗体结构的Fc段进行改造，显著延长了药物在体内的半衰期。因此，进入长期维持期，每12周（即每3个月）皮下注射100mg一次，患者每年仅需注射4次即可维持疗效，极大提升了治疗便利性。 往期相关阅读：2026年黑马再现！新药匹康奇拜：强效、安全、低复发，打赢银屑病持久战 2. 安沐奇塔单抗：长期疗效稳定、不易发生“耐药” 安沐奇塔单抗是一种IL-17A抑制剂，其通过提高与抗原的结合亲和力，并优化结构以极大降低抗药抗体产生的风险，旨在为患者提供长期疗效稳定、不易发生“耐药”的治疗选择。 往期相关阅读：高效难复发的银屑病热门新药【安沐奇塔单抗】怎么打？用法用量、操作步骤与注意事项一文看懂！ 3. 比奇珠单抗：双靶点阻断，疗效更优 比奇珠单抗采用IL-17A/F双靶点抑制技术，能同时、特异性中和两种炎症因子。这种对炎症通路更全面的封锁，在临床中表现为更快起效、实现更高比例的深度皮损清除（PASI100）等潜在优势。 往期相关阅读：比奇珠单抗（倍捷乐）双适应症获批，银屑病与化脓性汗腺炎疗效数据与安全性详解！ 2026年银屑病生物制剂信息汇总 了解不同靶点和技术优势后，药物价格、医保情况等经济因素直接影响治疗选择。下表汇总了文档中提到的主要生物制剂的经济性信息，以供参考： 点击图片可查看大图 总结 选择银屑病生物制剂，本质上是寻找最适合您个人情况的“平衡点”： 若追求快速消除症状：可重点关注起效快的IL-17A抑制剂。 若希望减少打针频率：IL-23抑制剂（如匹康奇拜单抗）和IL-17抑制剂（如安沐奇塔单抗）是优选。 若关注长期疗效稳定性与耐药风险：可咨询医生关于新一代低免疫原性药物（如安沐奇塔单抗）或从上游阻断的IL-23抑制剂。 若合并银屑病关节炎：治疗方案需个体化。对于中轴关节（脊柱、骶髂关节）受累者，推荐使用TNF-α抑制剂或IL-17抑制剂。对于皮损严重的PsA患者，可优先选用IL-17抑制剂、IL-23抑制剂及IL-12/23抑制剂。具体方案应由风湿免疫科和皮肤科医生共同评估后制定。 若为泛发性脓疱型银屑病（GPP）：IL-36抑制剂是专门的治疗武器。 最终，请务必与您的皮肤科医生深入沟通，结合您的疾病严重程度、皮损部位、个人治疗目标、生活节奏、经济状况及医保政策，共同制定出最理想的长期管理方案。 临床招募分享 伊顿健康平台为大家争取优惠用药福利价格和银屑病相关的临床用药（符合临床条件，用药体检由项目组承担，不额外对患者收费费用） 银屑病临床分享： 银屑病关节炎新型IL-23p19靶向药（匹康奇拜单抗）临床研究招募！ 青少年银屑病新希望：长效IL-23靶向匹康奇拜单抗招募中！一年用药 银屑病重磅招募：可用药2年的IL-17新药SCT650C III期临床招募中！ 脓疱型银屑病招募分享（IL-36 生物制剂），有效预防和减少脓疱反复发作 有需要的患者可以通过下列方式报名咨询 参加临床项目 可直接报名 了解更多资讯 可添加工作人员 本文仅做参考，不构成对任何药物或诊疗方案的推荐、推广或宣传，也不可替代专业医疗建议。如有问题，请咨询医疗卫生专业人士。材料图片等源自网络，侵删。 点击下方关注我们