作者: Stankevich, Katherine ; Anand, Anjela ; Eid, Hala M ; Penckofer, Mary ; Constantinescu, Cris S ; Garfinkel, Lucas P ; Barone, Donald ; Thon, Jesse M ; Thon, Olga R ; Diep, Judy ; Koneru, Manisha ; Lai, Emily ; Sajeendran, Aswathi ; de Sousa, Marina Santos ; Riggs, Alison

BACKGROUND:

Multiple Sclerosis (MS) is a chronic immune-mediated disease affecting >2 million people worldwide. Coexistence with other autoimmune disorders, such as systemic lupus erythematosus (SLE), has been reported. However, reports of MS patients concurrently diagnosed with ankylosing spondylitis (AS) are rare, likely due to their differing immunogenic pathways. Management of patients with both MS and AS presents a clinical challenge, particularly due to the contraindication of TNF-α inhibitors (TNFi) in MS.

METHODS:

We present three patients with coexisting MS and AS. We characterize this population as well as provide an updated review of the literature detailing case reports with clinical information about patients diagnosed with both diseases, focusing on therapeutic challenges.

RESULTS:

Among the 18 total cases from case reports of MS patients with AS (15 published and 3 from this study), where clinical details are available, relapsing remitting MS was the most common MS subtype, and typical presentations included sensory deficits, spastic paraparesis, and optic neuritis. CSF oligoclonal bands were positive in 11 of the 13 cases where lumbar puncture results were reported. TNFi were used in eight patients for AS and were discontinued in all eight due to concern for demyelination. Diagnosis of MS in these patients happened after the TNFi treatment. In contrast, secukinumab, an IL-17A inhibitor, was well tolerated and effective in controlling AS symptoms without worsening MS in the five reported patients who received it. One of our cases illustrates the potential for secukinumab to be used alongside modern MS therapies such as dimethyl fumarate and ocrelizumab. Another case also highlights the complexity of treatment planning in the context of pregnancy.

CONCLUSIONS:

Patients with concurrent MS and AS may have a specific clinical and laboratory profile. In instances where one disease process is more active than the other, a single immunotherapy agent targeting that condition may be favored, whereas using dual immunosuppression can be reserved for those with both highly active MS and AS.

2026-01-01·Lancet Rheumatology

Intensive biological DMARD-first strategy versus standard step-up care in psoriatic arthritis (STAMP): 1-year results from a multicentre, open-label, randomised controlled trial comparing two treat-to-target strategies

Article

作者: Kok, Petra ; Kasiem, Fazira R ; Vis, Marijn ; Koc, Gonul Hazal ; Kok, Marc R ; Denissen, Natasja H A M ; Korswagen, Lindy A ; Tchetverikov, Ilja ; Bos, Reinhard ; Dolhain, Radboud J E M ; Goekoop-Ruiterman, Yvonne P M ; Wilhelm-de Jong, Kim ; Luime, Jolanda J ; Baudoin, Paul

BACKGROUND:

Treat-to-target strategies have previously been shown to improve outcomes in psoriatic arthritis. We aimed to evaluate whether a treat-to-target strategy using early intensive treatment with the IL-17A inhibitor secukinumab improves outcomes compared with a standard step-up treat-to-target approach in patients with psoriatic arthritis.

METHODS:

This multicentre, open-label, randomised controlled trial was done in 11 general hospitals and one academic hospital in the Netherlands. Eligible patients were aged 18 years or older with newly diagnosed psoriatic arthritis, fulfilled the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria, had a minimum of two swollen joints at initial visit and were naive to any disease-modifying antirheumatic drugs. Participants were randomly assigned (1:1) to receive either early secukinumab treatment or standard of care. The early secukinumab group received subcutaneous secukinumab 300 mg at baseline and then every 4 weeks, plus weekly oral methotrexate 15 mg for a maximum of 12 months. If minimal disease activity (assessed at 3 month intervals) was not reached, secukinumab treatment was switched to a TNF inhibitor, followed by a second TNF inhibitor if necessary, and finally the second TNF inhibitor was stopped and treatment switched to apremilast. The standard of care group received weekly oral methotrexate 15 mg, escalating to 25mg at 6 weeks, for a maximum of 12 months. If minimal disease activity was not reached treatment was escalated according to standard of care. Patients in both groups also received a single intramuscular injection of methylprednisolone 80 mg at baseline. The primary outcome was the proportion of patients with an ACR50 response at 6 months in the intention-to-treat population. The safety set included all patients who received at least one dose of study treatment. People with lived experience of psoriatic arthritis were involved in the study design. This trial was registered with ISRCTN (ISRCTN76054545).

FINDINGS:

Between Dec 19, 2019, and Oct 19, 2023, 130 patients were screened for eligibilty and 120 patients were enrolled and randomly assigned to receive either early secukinumab treatment (n=60) or standard of care (n=60). Across the two groups, 49 (41%) of 120 patients were female, 71 (59%) were male, and the mean age was 49 years (SD 15). Of the 110 patients for whom ethnicity data were available, 108 (98%) were of Dutch origin. At month 6, ACR50 was reported in 25 (42%) of 60 patients in the early secukinumab group and 21 (35%) of 60 patients in the standard of care group (relative risk 1·19, 95% CI 0·75-1·88; p=0·45); thus, the primary outcome was not met. Adverse events occurred in 30 (50%) of 60 patients in the early secukinumab group and 32 (53%) of 60 patients in the standard of care group. Serious adverse events were reported in six (10%) patients in the early secukinumab group and five (8%) in the standard of care group. No deaths occurred in either group.

INTERPRETATION:

Early use of intensive treatment with secukinumab in a treat-to-target strategy did not result in statistically superior outcomes compared with a conventional step-up treat-to-target approach. By month 12, both strategies led to similar clinical improvements, with half of patients attaining ACR50, suggesting that treatment targets can be met regardless of initial therapy.

FUNDING:

Novartis.

2025-12-19·BRITISH JOURNAL OF DERMATOLOGY

P08 A case of a 7-year-old female with SAPHO and CRMO treated successfully with IL-17A inhibitor after failure with Anti-TNF α biologic

Article

作者: Sofela, Jasmine ; Cookson, Hannah

Abstract:

7-year old female develops inflamed well demarcated annular patches with golden crust on the plantar surface of both feet. Treated initially for infected discoid eczema in the community. Unresponsive to topical corticosteroids and oral antibiotics. Patient then developed acute left sided lower limb (LLL) bone pain with no pyrexia and a c-reactive protein of 9. MRI imaging showed multiple sites of osteomyelitis in the LLL. Histology from bone aspirate was normal and gram stain/culture was negative. Case was reviewed by rheumatology/paediatric team at tertiary centre, and a diagnosis of SAPHO (synovitis, acne, pustulosis, hyperostosis, osteitis) and CRMO (chronic recurrent multifocal osteomyelitis) was established. She commenced NSAIDs and Anti-TNFa biologic. 12 weeks into treatment the bone pain improved however, the patient developed paradoxical psoriasis on head, neck and limbs. Therapy was switched to IL-17A inhibitor with amelioration of paradoxical psoriasis and improvement seen in inflammatory patches on the plantar aspect of feet after 4 weeks. The prevalence of CRMO in the paediatric population is approximately 0.4/100 000 with a female preponderance. There are case reports in adult patients with SAPHO syndrome developing paradoxical psoriasis after adalimumab, with case series demonstrating improvement in palmoplantar pustulosis after secukinumab. More evidence is required to establish the efficacy of IL-17A inhibitors in the treatment of SAPHO in the paediatric age group.We present a patient with a rare case of SAPHO and CRMO with worsening cutaneous symptoms after commencing anti-TNFa. This paradoxical reaction cleared rapidly on switching to secukinumab (IL-17A inhibitor).

445

项与 IL-17A抑制剂 (C4XD) 相关的新闻（医药）

2026-02-28

·氨基观察

劝君要做“优时比”

氨基观察-创新药组原创出品作者 | 郑晓在创新药的历史坐标系中，唯有两类药物能青史留名：一类是开创全新机制的全球首创（FIC），另一类则是在红海中重塑规则的同类最佳（BIC）。优时比的IL-17A/F双特异性抗体Bimzelx，游走于两者之间——既是全球首个精准靶向IL-17A与IL-17F的双抗，又在多个关键适应症中以颠覆性疗效改写临床格局。 2025年，这份独特的“双优”基因，转化为震撼市场的业绩：全球销售额达到22.27亿欧元，同比增幅超过200%。虽然距离IL-17抑制剂领域的王牌司库奇尤单抗还有较大的绝对差距（66.68亿美元），但在Bimzelx获批的细分领域，早已吹响了颠覆的号角，患者采用率超过同类产品，尤其是在化脓性汗腺炎适应症领域，已经跃居全球第二。 Bimzelx的优异表现，也触动着国内药企的神经。毕竟，该靶点也是国内药企押注最重的领域之一。但无论是先行者智翔金泰，还是恒瑞医药等，多以跟随为主，并未做出差异化创新。这也导致，同样是后来者，优时比大放异彩，而大部分国产IL-17抑制剂，或许只能设法在国内市场抢下一小块蛋糕。对于中国创新药企来说，Bimzelx的成功既是警示，也是启示：我们需要的是更多的“优时比”。 / 01 / 后来者的逆袭相比IL-17抑制剂先驱司库奇尤单抗，Bimzelx是妥妥的后来者。作为全球首个上市的IL-17A抑制剂，自2014年获批上市以来，司库奇尤单抗已占据全球多个国家和地区的银屑病市场，并且适应症不断外扩，最终缔造了年销售额66.68亿美元的神话。 Bimzelx则是在2023年才获得FDA批准。不过，作为后来者，其在细分领域的表现其实相当不错。如下图所示，在目前获批的几个适应症中，各适应症增长均衡：银屑病占销售额30%以上，风湿病学占20%以上，化脓性汗腺炎（HS）约占45%。在美国市场，年内新增3600万人群覆盖。在化脓性汗腺炎适应症领域，它可以说是展现出了统治力：该适应症于2024年11月在美国获批，当年12月实现商业化，到了2025年10月，其市场份额已经逼近32%，并且从趋势来看即将登顶。在其他国家的IL-17类药物中，Bimzelx的HS适应症动态市场份额也遥遥领先。比如，西班牙动态市场份额达到70%，日本达到50%，德国略低，为40%。显而易见，Bimzelx后来居上的势头十足，也因此使得优时比的销售额持续超预期。 / 02 / 更好的生物制剂将赢得市场 Bimzelx的逆袭或许并不让人意外：它的竞争力更强。不同于司库奇尤单抗只阻断IL‑17A，Bimzelx实现了机制升级：同时实现IL‑17A与IL‑17F双靶点抑制。由于IL‑17A与IL‑17F在银屑病、脊柱关节炎、HS等疾病中共同驱动炎症、组织损伤与骨破坏，因此双重抑制有望更全面阻断炎症通路，实现更深层、更广泛的疾病控制。潜在的机制优势，在临床实践中得到了验证，典型如表现强势的HS领域。该领域的研究终点是HiSCR75达标率，这一指标指的是治疗后满足以下全部3个条件的患者比例：脓肿和炎性结节的总数较基线减少≥75%；脓肿和瘘管的数量较基线没有增加；没有出现新的脓肿或瘘管。在非头对头对比下，Bimzelx的HiSCR75达标率不仅超过司库奇尤单抗，也优于其他不同机制的药物。不只在HS领域，在治疗中重度斑块型银屑病的III期临床研究中，Bimzelx也展现出更快速、更彻底的皮损改善。基于此，Bimzelx用爆发式增长的销售额，证明了市场愿意为具有显著临床优势的新疗法支付溢价，中小型非头部企业也能够在该领域，成功实现商业化，并与大药企一较高下。这也吸引了一些跟随者。例如Oruka Therapeutics便认为，基于Bimzelx的表现，银屑病市场远未饱和，更优的生物制剂将赢得市场。 / 03 / 战略的利弊权衡 Bimzelx的逆袭，想必国内的跟随者会深有感触。因为司库奇尤单抗的成功，国内涌入了大量跟随者。2024年8月27日，智翔金泰、恒瑞医药的IL-17A单抗同时获批，开启了国产药物的叙事。而在它们身后，还有一大批国产IL-17A单抗的跟进者，数量超过10家。但如今，这些企业本质上面临上下两难的境地。出海，因为缺乏差异化，并不现实；国内，又不容易赚到钱。毕竟，诺华在积极降价拥抱国内市场，价格受到压制，国内同类产品又极度内卷。而同样是IL-17类药物，Bimzelx不仅在欧美市场逆流而上，甚至在抢夺司库奇尤单抗等先驱的市场份额。截然不同的境遇，也带来了巨大差别：Bimzelx销售额持续向上，也为优时比带来了可观的股价涨幅。这种差异的背后，核心还是战略的利弊权衡。正如《被浪费的10年，日本药企的全球化警示录》所提到的那样：到底是把研发资源聚焦在做困难的全球化创新产品，还是做容易且短期内能赚钱的本土微创新产品？事实证明，后者虽然简单，实则并不可持续。当年日本药企的研发投入看似巨大（占全球17%），但全球化产品的产出效率极低。如今中国药企也在面临同样的困境。这也在进一步提醒中国创新药行业：难，才是有价值的。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

上市批准抗体药物偶联物临床结果

2026-02-27

·科学战银

银屑病怕耐药、复发、打针频繁？这款刚上市的自研创新药凭实力出圈！

点击上面文字添加关注!推荐指数★★★★★ 【伊顿健康导读】对于很多中重度斑块状银屑病病友来说，治疗就像一场漫长的拉锯战。大家最怕遇到的几个“拦路虎”无非是：生物制剂用着用着效果就差了（耐药/疗效衰减）；皮损好了又发（复发）；打针频率太高难以坚持；以及面对众多药物不知如何选择。这些痛点，确实让身心俱疲。有没有一种新选择，能同时回应这些核心困扰？今天要分享的一个刚刚获批的国产创新药资讯，或许能给你带来一些新的希望和思路。直击痛点一：怕“打着打着没效果”？看“完全清除率”和“低免疫原性” 很多病友关心，什么决定了药物的长期效果？其中一个关键因素是 “免疫原性” ，也就是身体会不会产生“抗药抗体”（ADA）去攻击药物，导致药物失效。新获批的这款国产创新药IL-17A抑制剂——安沐奇塔单抗（商品名：益赛拓®），在这一点上交出了一份亮眼的数据。根据其关键临床研究对1292例患者的分析，仅0.7%（9例）的患者产生了抗药抗体，且没有检测到中和抗体。这意味着什么？通俗说，就是它的“分子结构”从源头设计上就更“低调”，不容易被免疫系统当作“敌人”攻击，这为长期稳定治疗、降低疗效衰减风险打下了坚实基础。既然要长久有效，那短期效果如何？数据同样硬核。在代表皮损100%清除的PASI 100指标上，用药第4周就有15%的患者实现完全清除，到第12周达到42.9%，治疗满一年（第52周）更是进一步提升至63.6%。这种快速起效（首次给药后第2周即明显改善）+深度清除的能力，正是回应“反复发作、效果不佳”的有力武器。直击痛点二：怕“打针太频繁、难坚持”？维持期给药延长至8周一次 “坚持就是胜利”，但对于需要常年用药的病友来说，频繁跑医院或自己打针，时间成本和精神压力都不小。目前市面上同靶点药物，很多维持期仍需每4周注射一次。而安沐奇塔单抗提供了更灵活的方案：在治疗初期（前3个月）每4周给药一次快速建立疗效后，进入维持期可选择每8周给药一次。别小看这多出来的4周。换算下来，一年仅需注射约6-7次，大大降低了年度用药频率。这不仅意味着更少的打扰，也有助于提升长期治疗的依从性，让“坚持”这件事变得更容易、更可持续。在不影响疗效和安全性的前提下，这种“减负”对需要终身管理的银屑病来说，意义重大。直击痛点三：面对选择困难症？国产新药提供“疗效+安心+便捷”新选项面对市面上多种生物制剂，病友们常常陷入选择困难。其实，任何选择都离不开三个维度：疗效、安全、便捷。这款国产新药（安沐奇塔单抗）的数据，恰好在这三点上都提供了正面参考：疗效上：如前所述，PASI 100的高应答率和快速起效，处于同靶点药物的领先水平。安心上：除了极低的免疫原性，其临床研究中注射部位反应发生率仅1.6%，严重感染发生率表现优异，为长期用药的安全性增加了保障。便捷上：维持期每8周一次的给药间隔，是目前同靶点抑制剂中给药间隔更长的方案之一。复旦大学附属华山医院的徐金华教授作为该药关键临床研究的牵头研究者就表示：“这款产品具有起效快、皮损清除能力强、免疫原性低、安全性和给药便捷性等核心优势。” 当然，任何药物都需要在医生指导下使用。但如果你正因现有方案的疗效衰减、打针频率过高而困扰，或是在启动治疗前权衡各种选择，那么这款2026年2月13日刚获批的国产新药，无疑提供了一个值得与主治医生深入探讨的 “疗效优、体验佳、可负担”的国产靶向治疗新选项。毕竟，能“强效、安心、易坚持”地管理疾病，才是我们共同追求的目标。【结语】如果您还有困惑，请与我们联系！【银友家族】真实用药经验分享【新药速报】最新审批动态、医保政策、生物制剂使用指南【临床试验招募】省钱治疗【每日愈肤】护肤/饮食/心理调节攻略参考来源： 1.三生国健官网 2.益赛拓3期临床研究 3.中国银屑病生物制剂及小分子药物治疗指南（2024版）点击下方名片关注我们

临床结果

2026-02-26

·百度百家

银屑病1类新药「安沐奇塔单抗」获批上市

近日，中国国家药品监督管理局（NMPA）正式批准三生国健1类生物创新药安沐奇塔单抗在国内上市，用于治疗适合系统治疗或光疗的中度至重度斑块状银屑病成人患者。 IL-17A是银屑病发病的关键效应细胞因子，可直接刺激角质形成细胞过度增殖，并释放多种炎症介质，形成炎症循环。IL-17A抑制剂可阻断炎症级联反应，治疗银屑病起效迅速，能更高比例实现皮损完全清除（PASI 100），并维持长期疗效。随着生物制剂的临床普及，“临床治愈”这已成为中重度银屑病治疗的理想目标。本次获批基于该药的III期临床研究数据。研究显示，第2周首次疗效评价时，安沐奇塔单抗组较安慰剂组出现疾病改善（p<0.05）；第4周，PASI 100应答率为15%。第12周达到主要疗效终点，PASI和sPGA应答显著优于安慰剂组（p<0.0001），疗效持续改善至第52周，PASI较基线变化率稳定在95%以上。第12周时，安沐奇塔单抗组PASI 100应答率为42.9%；第52周时，该比例为63.6%。#前沿研究#

上市批准临床3期

100 项与 IL-17A抑制剂 (C4XD) 相关的药物交易

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