Recurrent implantation failure (RIF), defined as the absence of clinical pregnancy after the transfer of three good-quality embryos, concerns up to 40% of IVF couples and is associated with a low success rate. The causes remain unexplained in over 50% of cases.
Various dysimmune changes (related to immune T cells profiles, pro-inflammatory cytokines levels) have been described in unexplained RIF as compared to fertile controls, and it has been estimated that such dysimmunity may occur in 50% of unexplained RIFs. Previous data on a benefit of general immune modulation by steroids or immunoglobulins are heterogenous and failed to demonstrate clinically significant benefit. The proinflammatory cytokine Tumor Necrosis Factor (TNF) α participates in the regulation of the immune balance of the endometrium, its peripheral blood and endometrial concentrations are increased in RIF patients as compared to fertile controls. In 2009, a pilot placebo controlled study showed that TNF-α antagonist treatment allowed a 56% live birth rate (versus 13% in controls) in 13 women with unexplained RIF. Due to the lack of maternal and fetal tolerance data, TNF-α antagonists were not further evaluated. Today, safety data issued from 1200 pregnancies are reassuring allowing the use of TNF-α antagonists during pregnancy (www.lecrat.org). In addition the TNF-α antagonist certolizumab does not cross the placental barrier.
We hypothesize that certolizumab may improve clinical pregnancy rates in women with unexplained RIF with a good safety profile.

开始日期2023-11-30

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

NCT06028438

/ Completed临床2期

A Phase 2a Multicenter, Randomized, Double Blind, Parallel, Proof of Concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis Despite Prior Treatment With Advanced Therapies (bDMARD or tsDMARD)

The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.

开始日期2023-08-15

申办/合作机构

Janssen Research & Development LLC

NCT05115903

/ Active, not recruiting临床4期IIT

A Prospective, Randomized Biologic Tapering Study of TNF Inhibitors in Axial Spondyloarthritis

Current evidence on tapering of tumor necrosis factor inhibitors (TNFi) in axial spondyloarthritis (axSpA) is still hampered by heterogeneity in tapering regimens, selection and performance biases, and lack of data on optimized treatment dosing strategies especially in real-world clinical settings. This study aims to contribute to the ongoing investigation of disease-activity-guided tapering of TNFi in axSpA in the form of a prospective, randomized controlled trial.

开始日期2021-12-01

申办/合作机构

University Health Network

100 项与培塞利珠单抗相关的临床结果

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100 项与培塞利珠单抗相关的转化医学

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100 项与培塞利珠单抗相关的专利（医药）

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项与培塞利珠单抗相关的文献（医药）

2025-05-01·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

The use of aptamers as therapeutic inhibitors and biosensors of TNF-alpha

Review

作者: Sahebkar, Amirhossein ; Kesharwani, Prashant ; Abianeh, Hossein Samiei

Tumor necrosis factor-alpha (TNF-α) is a pivotal cytokine in the pathogenesis of numerous inflammatory and autoimmune diseases. Precise and sensitive detection of TNF-α is essential for both clinical applications and research endeavors. In the realm of cytokine detection, particularly TNF-α, the development of highly sensitive and specific biosensors has become a focal point. The biosensing landscape encompasses a variety of biorecognition elements, each with its unique set of characteristics. TNF inhibitors come with a significant price tag and, notably, do not yield positive responses in all patients. Despite the availability of numerous FDA-approved biologic agents (e.g., infliximab, adalimumab, certolizumab pegol, etc.) and monoclonal antibodies (e.g., adalimumab) targeting TNF-α, aptamers tailored for blocking TNF-α activities have yet to receive approval. Aptamers have rapidly gained recognition as readily available, versatile, and highly effective molecular tools for both therapeutic and diagnostic purposes in the context of TNF-alpha. In this manuscript, we explore the potential of short single-stranded DNA or RNA sequences known as aptamers as biorecognition elements in biosensors designed for the detection of TNF-α. We delve into the progress made in the development of aptamer-based TNF-α inhibitors and shed light on successful studies in this burgeoning field.

2025-04-01·Drug Delivery and Translational Research

Quality by design driven development of lipid nanoparticles for cutaneous targeting: a preliminary approach

Article

作者: Shah, Jigna ; Patel, Viral ; Soni, Kinal ; Mehta, Tejal

Fungal infections are the fourth common cause of infection affecting around 50 million populations across the globe. Dermatophytes contribute to the majority of superficial fungal infections. Clotrimazole (CTZ), an imidazole derivative is widely preferred for the treatment of topical fungal infections. Conventional topical formulations enable effective penetration of CTZ into the stratum corneum, however, its low solubility results in poor dermal bioavailability, and variable drug levels limit the efficacy. The aim was to increase dermal bioavailability and sustain drug release, thereby potentially enhancing drug retention and reducing its side effects. This work evaluated the CTZ loaded solid lipid nanoparticles (SLN) consisting of precirol and polysorbate-80 developed using high pressure homogenization and optimized with QbD approach. Prior to release studies, CTZ-SLNs were characterized by different analytical techniques. The laser diffractometry and field emission scanning electron microscopy indicated that SLNs were spherical in shape with mean diameter of 450 ± 3.45 nm. DSC and XRD results revealed that the drug remained molecularly dispersed in the lipid matrix. The CTZ-SLNs showed no physicochemical instability during 6 months of storage at different temperatures. Further, the Carbopol with its pseudoplastic behavior showed a crucial role in forming homogenous and stable network for imbibing the CTZ-SLN dispersion for effective retention in skin. As examined, in-vitro drug release was sustained up to 24 h while ex-vivo skin retention and drug permeation studies showed the highest accumulation and lowest permeation with nanogel in comparison to pure drug and Candid^® cream. Further, the in-vivo antifungal efficacy of nanogel suggested once-a-day application for 10 days, supported by histopathological analysis for complete eradication infection. In summary, the findings suggest, that nanogel-loaded with CTZ-SLNs has great potential for the management of fungal infections caused by Candida albicans.

2025-04-01·RHEUMATOLOGY

Ex vivo cell-based assay for assessment of response to TNF inhibitors in patients with rheumatic diseases

Article

作者: Rokach, May ; Wollman, Jonathan ; Gertel, Smadar ; Dovrat, Tali Ofir ; Broyde, Adi ; Neufeld, Yoram ; Polachek, Ari ; Elkayam, Ori ; Levartovsky, David ; Furer, Victoria ; Pel, Sara

Abstract:

Objective:

There are five TNF inhibitors (TNFis), whose structure and signalling differ. An individual patient with a rheumatic disease may respond to one TNFi but not to another. In addition, 30–40% of patients with rheumatic diseases may respond inadequately to TNFis. The downstream signalling of the various TNFis may determine their clinical efficacy. Several reports have shown that the different TNFis exhibited differential effects on Th17 cells. We analysed the effects of the various TNFis on IL-17A expression in peripheral blood mononuclear cells (PBMCs) of patients with rheumatic diseases, in order to evaluate the possibility of predicting responses in an ex vivo setting.

Methods:

PBMCs were co-cultured with the various TNFis or medium (control), and IL-17A mRNA levels were analysed by quantitative PCR. IL-17A expression levels in response to four TNFis (not including certolizumab pegol) were compared with that of the control. The IL-17A expression level as determined by the assay was correlated with the clinical response. The assay sensitivity and specificity for distinguishing responders from non-responders was calculated by receiver-operating characteristic (ROC) analysis.

Results:

The results of the assay for a retrospective cohort of patients with rheumatic diseases (n = 82) correlated with their therapeutic responses to the various TNFis with 89.5% accuracy. Our results indicated that the assay predicted the responses of a prospective cohort (n = 54) to specific TNFis with 79% accuracy.

Conclusion:

This functional assay could assist in predicting the odds for response to TNFi therapy, indicating whether a given patient is likely to respond to a specific TNFi.

项与培塞利珠单抗相关的新闻（医药）

2025-04-16

·梅斯医学

长期使用甲氨蝶呤的风险评估：肾损伤比肝损伤更具致命性

甲氨蝶呤（MTX）是治疗类风湿关节炎（RA）的基石药物，但其潜在的肾毒性与肝毒性可能威胁患者长期安全。尽管现有指南推荐MTX联合生物制剂（如Certolizumab Pegol, CZP）作为标准疗法，但关于联用镇痛药（如非甾体抗炎药NSAIDs、对乙酰氨基酚）是否会加剧器官损伤的争议持续存在。本研究旨在通过分析欧洲药物管理局（EMA）EudraVigilance数据库中的自发不良药物反应（ADR）报告，比较MTX相关肾损伤与肝损伤的发生率、临床特征及致死风险，为优化RA患者的个体化治疗提供循证依据。本研究为基于EudraVigilance数据库（覆盖1950至2022年数据）的回顾性分析，纳入所有与MTX相关的RA患者ADR报告。通过标准化医学词典（MedDRA）筛选出肾脏或肝脏为靶器官的病例，并根据结局（致死/非致死）分层分析。研究采用描述性统计方法，比较两组的人口学特征（年龄、性别）、合并用药（NSAIDs、糖皮质激素等）、MTX使用模式（剂量、疗程）及结局差异。亚组分析进一步探讨同时累及肾脏和肝脏的病例特征。统计软件使用IBM SPSS 29与SAS 9.4，显著性水平设定为p<0.05。研究结果共纳入10,319例MTX相关ADR报告（女性占72.6%，平均年龄62.3岁）。其中，肾脏相关ADR 365例（3.5%），肝脏相关ADR 1,082例（10.5%）。关键发现如下：1. 人群特征差异：肾脏相关ADR患者年龄更大（65.8 vs. 59.6岁），合并用药比例更高（82.7% vs. 64.1%），尤其NSAIDs（23.6% vs. 15.8%）、糖皮质激素（38.1% vs. 24.6%）及甲氨蝶呤长期使用（中位疗程16.2 vs. 9.9个月）。2. 致死风险对比：肾脏相关ADR的致死率为21.1%，显著高于肝脏相关ADR的5.8%。在致死病例中，肾脏组更多合并感染（21.0%）、多器官衰竭（17.7%）及肾衰竭（17.7%），而肝脏组则以多器官衰竭（21.4%）为主。3. 合并用药影响：致死性ADR患者中，联用糖皮质激素（42.9% vs. 36.8%）、对乙酰氨基酚（18.2% vs. 12.5%）及生物制剂（36.4% vs. 24.3%）的比例显著更高。4. 时间趋势：肝脏相关ADR多发生于治疗早期（平均9.7个月），而肾脏相关ADR致死病例多见于治疗1年后（平均16.5个月）。按年份及受累器官分类的甲氨蝶呤相关不良药物反应自发报告数量本研究首次系统揭示了MTX相关肾损伤的临床风险显著高于肝损伤，其致死率约为后者的3.6倍。尽管肝脏毒性报告更常见，但肾损伤的致命性更强，可能与长期用药、合并NSAIDs及糖皮质激素使用有关。临床需加强MTX治疗期间的肾功能监测，尤其关注老年及合并症患者。未来应制定标准化的肾功能评估方案，并探索个体化用药策略以平衡疗效与安全性。原始出处：Khoroshun K, Bantel C, Hoffmann F, Jobski K. Methotrexate-related drug reactions on kidneys and liver in rheumatoid arthritis: an analysis of spontaneous reports in EudraVigilance. Arthritis Res Ther. 2025 Apr 5;27(1):80. doi: 10.1186/s13075-025-03551-6. PMID: 40188149; PMCID: PMC11972469. 撰文 | 阿拉斯加宝编辑 | 阿拉斯加宝● 饿肚子，寿命更长？Science和子刊发文：“饥饿感”本身不仅延长寿命，还能重塑免疫！不用节食，和吃多少无关●“花90元挂号，做完检查专家下班了”“每次拿药都得挂号！”多起医疗投诉引发轰动！卫健委：一次挂号管8天，首诊未完成无需再挂号● 热议！医院新规：正高每周一个大夜班！副主任医师吐槽：小医生累跑了，却让43岁的我去一线值班！人手不够也不招，高年资医生也值夜班了版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。点击下方「阅读原文」立刻下载梅斯医学APP！

临床结果

2025-03-20

·PipelineReview

Alvotech Acquires Xbrane’s R&D Operations in Sweden and Further Affirms its Global Leadership Position in Biosimilars Development and Production

REYKJAVIK, Iceland and STOCKHOLM, Sweden I March 20, 2025 I Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the acquisition of Xbrane Biopharma AB’s (“Xbrane”) R&D operations and a biosimilar candidate (the “Acquisition”), further expanding Alvotech’s development capabilities, and establishing a footprint in the Swedish life science sector. The Acquisition includes Xbrane’s R&D operations based in Campus Solna, at the Karolinska Institute outside Stockholm, Sweden, as well as the biosimilar candidate XB003, referencing Cimzia® (certolizumab pegol). Xbrane retains other pre-clinical assets and will focus on the commercialization of this portfolio. Alvotech also announced that it intends to explore the possibility of a listing of Swedish Depository Receipts (SDR), equity share equivalents, on Nasdaq Stockholm, in the future. The acquisition in brief “Alvotech has a best-in-class biosimilars manufacturing site in Iceland, both for drug substance and drug products. At the same time, our strong in-house R&D capabilities have put Alvotech in a leading position among pure play biosimilar companies in terms of the market value of our product pipeline. This acquisition will further expand Alvotech’s development capacity, allowing our commercial network of 19 leading commercial partners worldwide to continue increasing patient access to quality biologics,” said Robert Wessman, founder, Chairman and CEO of Alvotech. “Furthermore, we will establish a strong presence for Alvotech in the Swedish life science sector, which rivals the U.S. in this field. It will allow Alvotech to attract new talent, create opportunities for scientific collaboration, and support our growth. This is yet another milestone for Alvotech in establishing us as a leader in biosimilars development and production globally.” “With this transaction Xbrane is significantly strengthening its financial position and retains over 75% of the competitively adjusted addressable market of the portfolio including Ximluci (Lucentis biosimilar candidate) currently being approved and sold in Europe as well as Xdivane (Opdivo biosimilar candidate), recently partnered with Intas. Xbrane will, with a more lean and flexible organization after the transaction, be better equipped to fully focus on realizing the full value of Ximluci and Xdivane with the ambition to generate meaningful royalties/profit sharing from these programs in the years to come,” said Martin Åmark, CEO of Xbrane. Headquartered in Reykjavik, Iceland, Alvotech’s shares are listed on Nasdaq Iceland and Nasdaq US. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Since 2013, Alvotech has invested about $1.9 billion in a purpose-built biosimilars R&D and manufacturing platform, established commercial partnerships with 19 leading companies in over 90 of the largest global markets and developed one of the most valuable portfolios in the biosimilars industry. Advisors DNB Carnegie is acting as financial advisor to Alvotech in connection with the Acquisition. Cirio and Westerberg are legal advisors to Alvotech in connection with the Acquisition. About Alvotech Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com . None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our investor portal , and our website or follow us on social media on LinkedIn , Facebook , Instagram , and YouTube . SOURCE: Alvotech

并购上市批准生物类似药

2025-02-28

·小药说药

炎症性肠病的药物开发

1 导语：认识炎症性肠病（IBD）炎症性肠病（IBD）是一组累及胃肠道的慢性、复发性炎症性疾病，主要包括克罗恩病（CD）和溃疡性结肠炎（UC）。这些疾病的特点是持续炎症，导致各种并发症，症状包括腹痛、腹泻、便血等，严重者可致肠梗阻、穿孔甚至癌变，严重影响IBD患者的生活质量。全球范围内，IBD发病率近40年持续攀升，我国患者数量亦呈快速上升趋势。目前可用的IBD治疗包括非靶向治疗（如氨基水杨酸、糖皮质激素和免疫调节剂）和靶向治疗（如抗TNF、抗IL-12/IL-23和抗α4β7整合素）。虽然生物靶向疗法对许多患者有效，但依然有高达30%的患者对初始治疗没有反应，高达50%的患者随着时间的推移反应消失。目前，分子生物学领域的最新进展和对IBD免疫途径的理解为创新药物疗法开辟了新的可能性。一些新兴疗法和药物有望打破IBD治疗的瓶颈，为IBD的患者的疾病改善带来福音。 2 核心战场：肠道免疫系统与IBD的发病机制肠道免疫系统是IBD发生的关键枢纽。健康状态下，肠道需 “双重调节”：既要耐受食物抗原与共生菌群，又要抵御病原体侵袭。而IBD患者的免疫调控网络崩解，引发失控的炎症反应。 1. 先天免疫失控巨噬细胞与树突状细胞：正常状态下呈现“免疫耐受”，但IBD患者中被异常激活，通过TLR/NLR受体识别病原体分子（如LPS），过度分泌IL-1β、IL-6等促炎因子。中性粒细胞与NK细胞：炎症部位大量浸润，释放活性氧和蛋白酶，加重组织损伤。 2. 适应性免疫失衡 Th17/Treg细胞比例失调：IL-23驱动Th17细胞扩增，分泌IL-17、IL-22，促进炎症；而抗炎的Treg细胞功能受抑。 B细胞异常：产生自身抗体攻击肠道组织，加速慢性炎症。 3. 细胞因子风暴促炎因子（IL-12、IL-23、TNF-α）与抗炎因子（IL-10、TGF-β）平衡打破，形成恶性循环。例如： IL-23/Th17轴：驱动黏膜免疫持续活化，与难治性IBD密切相关； TNF-α：促进中性粒细胞迁移和血管通透性增加，介导组织破坏。 4. 肠纤维化：被忽视的“终局挑战 ”约30%克罗恩病患者发生肠纤维化，病理特点为细胞外基质（ECM）过度沉积，导致肠道狭窄。纤维化机制涉及TGF-β、IL-13等因子激活成纤维细胞，而现有抗炎药物对其无效。 3 IBD治疗药物图谱：从传统疗法到精准靶向目前IBD治疗药物分为生物制剂与小分子药物两类，关注点从“广谱抗炎”转向精准靶向免疫通路。 1. 经典生物制剂抗TNF-α单抗：抗TNF的抗体已广泛使用约25年。目前，四种TNF-α抑制剂已被批准用于临床，包括infliximab、adalimumab、golimumab和certolizumab pegol。infliximab可诱导粘膜溃疡愈合，这是第一种被批准用于CD肛周瘘的治疗方法，并被证明对CD和UC都有效。抗α4β7整合素：近年来，整合素受体已成为治疗IBD患者新疗法的可行靶点。整合素包括两个亚基，α和β，存在于特定的B和T淋巴细胞上。与细胞迁移到胃肠组织有关的是α2β2、α4β1和α4β7。通过拮抗这些受体，淋巴细胞在炎症过程中迁移到胃肠道粘膜受到抑制。抗α4β7整合素抗体Vedolizumab已于2020年获得欧洲药品管理局（EMA）的批准，用于治疗中重度UC或CD的成年患者。 2. 新世代靶向药 IL-23是IL-12细胞因子家族的一员，由p40和p19亚基组成，其中p19是IL-23所特有的。IL-23在调节和扩增辅助T细胞和激活各种先天免疫细胞方面发挥着至关重要的作用，这些细胞在UC和CD等慢性炎症性疾病的发展中很重要。Risankizumab是FDA批准的第一种用于治疗中重度CD患者的选择性IL-23p19抑制性抗体。 IL-36细胞因子是更广泛的IL-1细胞因子家族的成员。在过去的几年里，许多研究强调了IL-36R信号在慢性炎症条件下的作用，包括CD和UC。Spesolimab是一种新型人源化IgG1单克隆抗体，特异性抑制IL-36R信号传导，其已在涉及中重度UC患者的三项2/2a期临床试验中进行了评估，然而，尽管spesolimab对UC患者具有良好的耐受性，但并未达到疗效终点。目前，其正在进行一项2期临床试验，以测试spesolimab在造瘘CD患者中的应用。 Olamkicept（sgp130Fc）是一种选择性靶向IL-6反式信号传导的FC融合蛋白。在一项为期12周，涉及16名IBD患者的开放标签2a期研究中，结果显示: 19%的患者获得了临床缓解，44%的患者出现临床响应。此外，最常报告的不良事件包括季节性上呼吸道感染、唇疱疹复发以及皮肤和皮下疾病。目前，其正在进行一项更大规模的安慰剂对照临床研究（NCT03235752）。 3. 小分子药物的崛起 JAK抑制剂：近年来，有许多研究聚焦于JAK-STAT途径，为改善IBD的治疗提供了新的治疗策略。JAK是一个细胞内酪氨酸激酶家族，包括JAK1、JAK2、JAK3和酪氨酸激酶2（TYK2），在通过STAT途径传递细胞因子介导的信号中发挥作用。这些激酶被各种细胞因子受体激活，通过T细胞增殖和分化以及B细胞活化导致炎症。 Izencitinib是一种泛JAK抑制剂，其在一项涉及239名UC患者的2b期临床试验中进行了测试。然而与安慰剂相比，临床缓解的主要次要终点均未实现。Ivarmacidinib（SHR0302）是一种选择性JAK1抑制剂，在涉及146名中重度活动性UC患者的一项2期临床研究中，与安慰剂相比，8 mg每日一次和4 mg每日两次给药方案在第8周显示出显著更高的临床响应率和临床缓解率，不良事件没有显著差异。这些有希望的结果导致其启动了一项3期研究，以进一步研究对UC的疗效。 S1P受体调节剂：鞘氨醇-1磷酸（S1P）是一种来源于细胞膜的高度生物活性分子，主要通过激活细胞表面的五个G蛋白偶联受体发挥作用（S1P1-S1P5）。激活后，该过程触发一系列信号事件，控制广泛的生物学过程，如淋巴细胞迁移、内皮细胞通透性、血管生成以及细胞分化、增殖、存活和凋亡。S1P通路与胃肠道炎症相关的疾病有关。 Ozanimod是S1P受体的选择性调节剂，特异性靶向S1P1和S1P5受体，这两种受体分别存在于内皮细胞和少突胶质细胞上。在一项3期针对中重度UC患者的临床研究（TRUE NORTH）中，结果显示：相比与安慰剂组，Ozanimod组获得了更多的临床缓解（18.4% vs 6.0% p=0.001），此外，在诱导治疗的应答者中，37.0%的患者在52周后持续临床缓解，而安慰剂组为18.5%（p＜0.001）。 4. 抗纤维化药物曙光针对TGF-β、TL1A靶点的药物（如PRA023）进入临床，旨在阻断纤维化核心通路，解决现有治疗空白。PF-06480605是一种抗TL1A的IgG1人源单克隆抗体，在一项针对中重度UC患者的2a期临床研究（TUSCANY）中，有一部分（38.2%）患者在第14周获得了内窥镜改善，这一比例具有统计学意义。此外，最常见的AE是UC疾病恶化和关节痛。组织病理学分析支持PF-06480605进一步的研究。 4 未来市场：百亿美元蓝海的争夺战全球IBD药物市场持续扩容，中国市场规模从2019年的80.9亿元增长至2022年的96.7亿元，预计未来五年复合增长率将超10%。驱动因素包括： 1. 患者基数扩大：年轻群体生活压力与饮食结构变化推高发病率。 2. 政策支持：国家加快创新药审评，生物类似药（如阿达木单抗类似药）降低治疗成本。 3. 技术突破：肠道菌群调控（如益生菌、粪菌移植）、多组学技术助力个体化治疗。未来趋势聚焦于：多靶点药物：如双抗或联合疗法，以克服单靶点耐药性。微生物组疗法：基于菌群代谢产物（如短链脂肪酸）的新型调节剂。个性化医疗：通过基因检测与生物标志物（如粪便钙卫蛋白）实现精准用药。 5 结语：跨学科协作开启IBD治疗新纪元尽管IBD仍无法根治，但免疫学与微生物组研究的深入为药物开发开辟了新路径。IBD药物开发已进入“深水区”，未来需融合免疫学、微生物组学与人工智能，构建精准治疗模型以攻克耐药性、肠外并发症等难题。对患者而言，早诊早治与长期管理是关键；IBD治疗的终极目标，是让患者重获无痛、自由的生活，更安全、长效的药物将不再是遥不可及的梦想。参考文献： 1.Immunology of Inflammatory Bowel Disease: Molecular Mechanisms and Therapeutics. J Inflamm Res.2022; 15: 1825–1844. 2. Inflammatory Bowel Disease: Emerging Therapies and Future Treatment Strategies. Biomedicines.2023 Aug; 11(8): 2249. 公众号内回复“ADC”或扫描下方图片中的二维码免费下载《抗体偶联药物：从基础到临床》的PDF格式电子书！公众号已建立“小药说药专业交流群”微信行业交流群以及读者交流群，扫描下方小编二维码加入，入行业群请主动告知姓名、工作单位和职务。

免疫疗法临床研究ASH会议

100 项与培塞利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03441	培塞利珠单抗	L04AB05	DB08904

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
红皮病性银屑病	日本	UCB Japan Co. Ltd.	2019-12-20
寻常性银屑病	日本	UCB Japan Co. Ltd.	2019-12-20
脓疱型银屑病	日本	UCB Japan Co. Ltd.	2019-12-20
非放射性轴性脊柱关节炎	澳大利亚	UCB Australia Pty Ltd.	2010-01-20
斑块状银屑病	澳大利亚	UCB Australia Pty Ltd.	2010-01-20
强直性脊柱炎	欧盟	UCB Pharma GmbH	2009-10-01
强直性脊柱炎	冰岛	UCB Pharma GmbH	2009-10-01
强直性脊柱炎	列支敦士登	UCB Pharma GmbH	2009-10-01
强直性脊柱炎	挪威	UCB Pharma GmbH	2009-10-01
银屑病关节炎	欧盟	UCB Pharma GmbH	2009-10-01
银屑病关节炎	冰岛	UCB Pharma GmbH	2009-10-01
银屑病关节炎	列支敦士登	UCB Pharma GmbH	2009-10-01
银屑病关节炎	挪威	UCB Pharma GmbH	2009-10-01
中轴性脊柱关节炎	欧盟	UCB Pharma GmbH	2009-10-01
中轴性脊柱关节炎	冰岛	UCB Pharma GmbH	2009-10-01
中轴性脊柱关节炎	列支敦士登	UCB Pharma GmbH	2009-10-01
中轴性脊柱关节炎	挪威	UCB Pharma GmbH	2009-10-01
类风湿关节炎	美国	UCB, Inc.	2009-05-13
克罗恩病	美国	UCB, Inc.	2008-04-22

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
银屑病	临床3期	比利时	UCB SA	2022-01-30
慢性大斑块银屑病	临床3期	美国	UCB Biopharma SRL	2020-01-21
慢性大斑块银屑病	临床3期	加拿大	UCB Biopharma SRL	2020-01-21
慢性大斑块银屑病	临床3期	波多黎各	UCB Biopharma SRL	2020-01-21
活动性中度克罗恩病	临床3期	美国	UCB Biopharma SRL	2017-11-03
泛发性脓疱型银屑病	临床3期	日本	UCB Biopharma SRL	2017-02-21
间质性膀胱炎	临床3期	美国	UCB Pharma GmbH	2015-12-15
炎症	临床3期	美国	UCB BioSciences GmbH	2015-09-01
炎症	临床3期	澳大利亚	UCB BioSciences GmbH	2015-09-01
炎症	临床3期	保加利亚	UCB BioSciences GmbH	2015-09-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00844285 (SECURE Registry, Pubmed \| Crohns Colitis 360)	N/A	克罗恩病	3,072	Certolizumab Pegol (CZP)	簾蓋窪構襯襯鑰襯衊廠(衊簾襯衊觸壓製廠襯遞) = concomitant use of thiopurines was associated with higher odds of NMSC (odds ratio: 2.30 [95% CI: 1.09, 4.89]) 壓築鬱顧窪顧艱淵製繭 (糧蓋顧觸窪網遞襯淵衊 ) 更多	积极	2024-12-30
				Corticosteroids
NCT04163016 (CHERISH, CTgov)	临床1期	斑块状银屑病 \| 银屑病关节炎 \| 炎症 ... 更多	22	CZP (CZP 200 mg Q2W)	網壓積淵艱築鏇襯齋願(廠憲網窪簾鬱憲衊繭鑰) = 鬱鏇願鹽鑰鏇鹽淵憲醖廠鏇鏇鹹淵願鹽鹹鏇壓 (蓋選積鏇繭遞襯觸鹹憲, 68.1) 更多	-	2024-09-19
				CZP (CZP 400 mg Q2W)	製衊蓋窪顧壓艱鑰鑰窪(醖積鹹蓋襯憲蓋淵窪餘) = 繭構願壓襯鹹廠醖壓糧襯齋廠顧觸淵獵膚構鹽 (鏇顧鑰鹹範衊膚製願糧, 鏇蓋襯襯艱醖獵醖獵鹹 ~ 製繭積鹽範遞築鏇積鑰) 更多
NCT04053881 (CIMREAL, Pubmed)	N/A	斑块状银屑病 tumor necrosis factor alpha (TNFα)	399	Certolizumab pegol 400 mg	醖鏇艱艱顧艱範鹽鹽鑰(遞淵鬱構積簾鹽鏇襯觸) = 窪艱襯繭蓋鹽積築廠艱淵夢簾製艱鏇餘糧獵膚 (選顧鬱願積蓋窪築夢艱 ) 更多	积极	2024-06-27
				Certolizumab pegol 200 mg	醖鏇艱艱顧艱範鹽鹽鑰(遞淵鬱構積簾鹽鏇襯觸) = 窪獵選艱鹽獵繭選壓繭淵夢簾製艱鏇餘糧獵膚 (選顧鬱願積蓋窪築夢艱 ) 更多
NCT04163016 (CHERISH, EULAR 12024 \| EULAR 22024) 人工标引	临床1期	自身免疫性疾病	21	CERTOLIZUMAB PEGOL	願願獵鹹齋醖艱憲鹹願(鹽糧獵衊窪鑰鑰選膚廠) = 願艱衊範鹹簾鹹糧襯餘鹽廠鏇廠選築繭艱簾築 (淵築鹹鹽鏇繭醖鑰簾遞 )	积极	2024-06-14
EULAR2024	N/A	中轴性脊柱关节炎	-	Certolizumab	築範艱齋餘糧糧餘膚範(製齋鬱網範憲襯餘夢窪) = 蓋淵壓夢窪積範憲艱簾醖選觸壓壓積獵鬱製鹽 (餘蓋網顧願齋襯觸範觸 )	积极	2024-06-05
				Secukinumab	築範艱齋餘糧糧餘膚範(製齋鬱網範憲襯餘夢窪) = 餘願獵積繭窪鏇膚遞網醖選觸壓壓積獵鬱製鹽 (餘蓋網顧願齋襯觸範觸 )
Apulian BIOPURE registry (EULAR2024)	N/A	慢性关节炎	542	Certolizumab (Fertile female patients)	獵鏇衊構積壓鬱觸選觸(鬱淵遞範艱廠鹽壓獵淵) = 獵夢餘鬱襯鹹餘淵壓遞繭餘觸觸鏇遞獵膚製簾 (鏇膚鏇襯構鏇餘餘範齋 ) 更多	积极	2024-06-05
				Certolizumab (Menopausal female patients)	獵鏇衊構積壓鬱觸選觸(鬱淵遞範艱廠鹽壓獵淵) = 鑰襯範壓繭齋壓淵鏇觸繭餘觸觸鏇遞獵膚製簾 (鏇膚鏇襯構鏇餘餘範齋 ) 更多
EULAR2024	N/A	IL-17A	135	Adalimumab (ADA)	憲積鑰網遞淵積襯夢鏇(壓鏇憲簾餘齋選廠鏇構) = 繭衊鏇範鹹餘繭鏇蓋願憲糧蓋願鏇鑰憲廠鬱顧 (壓淵鹹簾觸鏇範鑰餘簾 )	积极	2024-06-05
				Infliximab (IFX)	憲積鑰網遞淵積襯夢鏇(壓鏇憲簾餘齋選廠鏇構) = 構衊繭齋構夢鏇齋範糧憲糧蓋願鏇鑰憲廠鬱顧 (壓淵鹹簾觸鏇範鑰餘簾 )
EULAR2024	N/A	类风湿关节炎	-	Biologic and targeted synthetic DMARDs	憲廠築獵齋襯襯膚廠選(獵築齋鑰鏇膚簾繭鑰簾) = 淵齋齋糧齋壓廠醖憲顧醖遞淵憲艱鹽膚窪積夢 (憲範顧廠夢鏇壓窪製糧 ) 更多	-	2024-06-05
NCT01500278 (EXXELERATE, ACR2023) 人工标引	临床4期	类风湿关节炎	907	Certolizumab Pegol+Methotrexate	膚鏇遞簾築築醖觸醖網(鏇膚衊齋積簾鏇顧糧糧) = 繭膚選選蓋築齋淵蓋積鑰顧鏇餘餘鑰鏇構網鹹 (簾顧築襯廠選積餘壓積 ) 更多	非优	2023-11-14
				Adalimumab+Methotrexate	膚鏇遞簾築築醖觸醖網(鏇膚衊齋積簾鏇顧糧糧) = 獵膚選窪襯淵憲選艱獵鑰顧鏇餘餘鑰鏇構網鹹 (簾顧築襯廠選積餘壓積 ) 更多
ACR2023	N/A	Rheumatoid Factor (RF)	755	Certolizumab Pegol	齋鹹鬱製醖願膚簾鏇顧(網顧鹽築襯壓窪積簾構) = 廠膚醖簾鹽齋遞鹹獵鏇齋齋選艱獵衊簾餘糧鑰 (壓餘襯艱夢廠膚淵繭願, 3.7 ~ NA)	积极	2023-11-13
				Monoclonal Antibodies (mAB)	齋鹹鬱製醖願膚簾鏇顧(網顧鹽築襯壓窪積簾構) = 淵範鏇簾製簾廠膚鑰繭齋齋選艱獵衊簾餘糧鑰 (壓餘襯艱夢廠膚淵繭願, 3.3 ~ 8.7)