A single dose, randomized, double-blind 2-arm parallel-group study to compare the pharmacokinetics, immunogenicity, and safety for PB016 versus US-licensed Entyvio® after subcutaneous administration in healthy participants

开始日期2025-11-14

申办/合作机构

Polpharma Biologics S.A.

NCT07123350

/ Active, not recruitingN/AIIT

Evolving Biologic Administration: Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease

The goal of this retrospective study is to learn about dosing patterns in patients starting subcutaneous vedolizumab administration and patient outcomes after starting subcutaneous administration.
Patients with IBD who are starting subcutaneous vedolizumab administration between September 1, 2023, and March 31, 2025, as part of normal patient care, will be retrospectively reviewed and analyzed.

开始日期2025-10-16

申办/合作机构

Vanderbilt University Medical Center

[+1]

NCT06788340

/ Not yet recruiting临床4期IIT

MOdel-Informed Precision Dosing (MIPD) of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease - An Independent Randomized Controlled Trial

The goal of this clinical trial is to investigate if dosage of Ustekinumab (UST) and Vedolizumab (VDZ) based on Model-Informed Precision Dosing (MIPD) is equally as efficient in keeping adults with Inflammatory Bowel Disease (IBD) in remission as management based on what the treating physician deems best. The main question is:
Is using pharmacokinetic-pharmacodynamic (PK-PD) models to predict the appropriate dose and dosing interval for VDZ and UST at least as effective as current practices in maintaining IBD remission.
As above mentioned the comparison-group is adults with IBD, treated with UST or VDZ, managed as the physician deems best.
Participants will:
Have blood and stool tests done, as well as answer a questionnaire 4th weekly Have their dosage frequency decided on either by the PK-model or as the physician deems best visit the clinic once every 24 weeks for checkups. Have an endoscopy done at completion of the study (if the disease is primarily located in the small intestine, MRI or capsule endoscopy will be used instead)

开始日期2025-09-01

申办/合作机构

Odense University Hospital

100 项与维得利珠单抗相关的临床结果

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100 项与维得利珠单抗相关的转化医学

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100 项与维得利珠单抗相关的专利（医药）

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1,935

项与维得利珠单抗相关的文献（医药）

2026-04-01·DEN open

Vedolizumab Induces Remission in Two Cases of Ulcerative Colitis With Upper Gastrointestinal Involvement

Article

作者: Katagiri, Atsushi ; Otoyama, Yumi ; Yoshida, Hitoshi ; Higuchi, Kensuke ; Suzuki, Norihiro ; Nakatani, Shinya ; Ohara, Jyun ; Fujiwara, Takahisa ; Kikuchi, Kazuo ; Yamazaki, Yuta

ABSTRACT:

Ulcerative colitis (UC) predominantly affects the colon; upper gastrointestinal involvement (UGI) has been reported, but no established treatments exist. We report two cases of UC with concomitant UGI that showed positive responses to vedolizumab therapy. Case 1 involved a 29‐year‐old man who developed continuous inflammation extending from the stomach to the jejunum 1 month after an initial UC diagnosis. Intravenous prednisolone provided clinical remission; however, maintenance therapy with oral azathioprine was unsuccessful. Vedolizumab was initiated. Three months later, esophagogastroduodenoscopy (EGD) and colonoscopy confirmed the resolution of inflammation. Case 2 involved a 19‐year‐old man diagnosed with UGI via endoscopy while being evaluated for nausea and fever during UC treatment. 5‐aminosalicylic acid and prednisolone therapies were ineffective; therefore, vedolizumab was administered. Three months later, EGD confirmed mucosal healing. Both patients have maintained clinical remission for >2 years. To our knowledge, this is the first report of UC with UGI involvement that was successfully treated with vedolizumab. These findings suggest that vedolizumab is effective and safe for UGI treatment.

2026-01-01·ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Frequency and Effectiveness of Dose Escalation and De‐Escalation of Biologic Therapy in Inflammatory Bowel Disease: The RAINBOW ‐ IBD Study of ENEIDA

Article

作者: Sesé, Eva ; Pajares, Ramón ; Robledo Andrés, Pilar ; Muñoz, Fernando ; de Francisco, Ruth ; Barreiro‐de Acosta, Manuel ; Gomollón, Fernando ; Navarro‐Llavat, Mercè ; Fernández, Hipólito ; Jaó, Jordina ; Frago, Santiago ; Suria Bolufer, Carles ; Casanova, María José ; Almela, Pedro ; Navas‐López, Victor Manuel ; Piqueras, Marta ; Vera, Isabel ; Giordano, Antonio ; Márquez, Lucía ; Bujanda, Luis ; Rodríguez‐Gutiérrez, Cristina ; Gilabert, Pau ; Bermejo, Fernando ; Martín‐Arranz, M. Dolores ; Martínez Pérez, Teresa ; Valldosera, Gemma ; Mañosa, Miriam ; Rivero, Montserrat ; Mesonero, Francisco ; Ber, Yolanda ; Esteve, María ; Ramos, Laura ; Ricart, Elena ; Pérez‐Calle, José Lázaro ; Sierra‐Ausín, Mónica ; García‐Sepulcre, Mariana Fe ; de Castro, Luisa ; Van Domselaar, Manuel ; Riera, Joan ; Fernández‐Salazar, Luis Ignacio ; García‐López, Santiago ; Guardiola, Jordi ; Rubín de Célix, Cristina ; García‐Alonso, Francisco Javier ; Alcaín, Guillermo ; Rodríguez‐Lago, Iago ; Ginard, Daniel ; Argüelles‐Arias, Federico ; Muñoz‐Villafranca, Carmen ; Domènech, Eugeni ; Ramírez de la Piscina, Patricia ; Fuentes Coronel, Ana ; Martínez‐Flores, Carlos ; Tardillo, Carlos ; Calvet, Xavier ; Nos, Pilar ; Marín‐Jiménez, Ignacio ; Hernández, Luis ; Huguet, José M. ; Taxonera, Carlos ; Buendía Sánchez, Lidia ; Muñoz, Rosa Ana ; Varela, Pilar ; Lucendo, Alfredo J. ; Carpio, Daniel ; Busquets, David ; Ponferrada‐Díaz, Ángel ; Chaparro, María ; Gutiérrez, Ana ; Iglesias, Eva ; Legido Gil, Jesús ; Arias, Lara ; Gisbert, Javier P. ; Lorente, Rufo ; Camps, Blau ; Vega, Pablo

ABSTRACT:

Background:

Real‐world data on dose escalation/de‐escalation in inflammatory bowel disease (IBD) are scarce.

Aims:

To assess the frequency, effectiveness and durability of escalation/de‐escalation of infliximab, adalimumab, golimumab, vedolizumab and ustekinumab in IBD, and to identify factors influencing relapse and drug discontinuation and re‐escalation efficacy.

Methods:

We included patients from the ENEIDA registry of GETECCU who were exposed to biologics and analysed escalations/de‐escalations. We assessed the impact of variables on durability, drug discontinuation and relapse after escalation/de‐escalation.

Results:

Of 19,720 patients on biologics, 5096 (26%) underwent dose escalation. Frequency of escalation per patient‐year was 5% (infliximab), 7% (adalimumab), 7% (golimumab), 10% (vedolizumab) and 12% (ustekinumab). Clinical remission was recaptured in 32%–49% of patients. Durability of escalation (24 months) ranged from 66% to 88%. Drug discontinuation was associated with previous biologic exposure and disease duration (infliximab), monotherapy (adalimumab) and ulcerative colitis (ustekinumab). There were 669 de‐escalations. The frequency per patient‐year was 6%, 9%, 5%, 6% and 3% for infliximab, adalimumab, golimumab, vedolizumab and ustekinumab. Maintenance of remission after de‐escalation was observed in 75%–100%. Durability of de‐escalation (12 months) was 82%–90%. Factors associated with relapse were biologic exposure (infliximab) and age at de‐escalation (adalimumab). Re‐escalation benefited most patients.

Conclusions:

In the long term, some patients with IBD need biologic escalation, which frequently recaptures durable clinical remission. De‐escalation is feasible in some patients. Re‐escalation is generally effective after relapse.

2026-01-01·Clinics and Research in Hepatology and Gastroenterology

Five-year effectiveness of either ustekinumab or vedolizumab in 239 patients with Crohn's disease refractory to anti-tumour necrosis factor

Article

作者: Allez, Matthieu ; Tréton, Xavier ; Kirchgesner, Julien ; Alric, Hadrien ; Bouhnik, Yoram ; Uzzan, Mathieu ; Bresteau, Clément ; Hammoudi, Nassim ; Carbonnel, Franck ; Seksik, Philippe ; Amiot, Aurélien ; Meyer, Antoine

BACKGROUND:

There are still conflicting data about superiority of ustekinumab over vedolizumab in patients with Crohn's disease (CD) who failed anti-tumour necrosis factor (anti-TNF).

AIM:

To compare the 5-year effectiveness and safety of ustekinumab and vedolizumab in patients with CD who failed anti-TNF in a multicentre retrospective observational cohort.

METHODS:

This is a retrospective cohort study including all consecutive patients with CD refractory or intolerant to anti-TNF who initiated either vedolizumab or ustekinumab between May 2014 and August 2018. Steroid-free clinical remission, clinical remission and treatment persistence were assessed at year 2, 3 and 5 with intention-to-treat analysis and propensity scores weighted logistic models.

RESULTS:

A total of 239 patients were included, 107 received ustekinumab and 132 vedolizumab. At year 5, ustekinumab was associated with a higher rate of steroid-free clinical remission (41.2% vs 20.5%; odds ratio 2.72 [1.43-5.18]) and treatment persistence (46.8% vs 22.5%; OR 3.03 [1.63-5.63]) than vedolizumab but not the rate of CD-related intestinal surgery. Superiority of ustekinumab was more pronounced in patients with ileal CD, stricturing or penetrating behaviour, and history of intestinal CD-related surgery. Patients treated with ustekinumab, were associated with higher treatment persistence compared to patients treated with vedolizumab with low (p < 0.001) or intermediate (p < 0.001) but not with those with high vedolizumab CDST (p = 0.95).

CONCLUSION:

In this study, ustekinumab was associated with higher rate of steroid-free clinical remission and treatment persistence than vedolizumab after 5 years of follow-up, particularly in patients with ileal CD, stricturing or penetrating behaviour and history of CD-related intestinal surgery.

454

项与维得利珠单抗相关的新闻（医药）

2026-01-15

·IBD肠友圈

建议收藏！一文全景看懂8大生物制剂，选择不迷茫

目前国内溃疡性结肠炎（UC）患者可用的生物制剂已经增加到了8种，这些生物制剂有些被写进指南，有些刚获批，有些已被纳入医保目录，今天把这8种生物制剂分别给大家讲讲。生物制剂治疗IBD的底层逻辑 IBD就像一场发生在肠道里的战争，免疫系统错误地把肠道黏膜当成敌人，不断发出“攻击命令”（炎症信号），导致肠道反复受损。生物制剂的作用，就是切断这些“攻击命令”的传递渠道，免疫系统的命令发不出去，就会冷静下来，给肠道黏膜一个自我修复的机会。与传统的激素和免疫抑制剂“不分敌我”地全面压制免疫系统不同，生物制剂能够精准识别并阻断导致肠道炎症的特定信号分子，比如肿瘤坏死因子（TNF）、白介素-23（IL-23）等。因为作用靶点明确，相比于传统药物，生物制剂在控制炎症的同时，对全身免疫系统的影响相对较小。 8种生物制剂，各有特色 1 抗TNF-α家族这一家族包括英夫利西单抗、阿达木单抗和戈利木单抗，这类药物通过与TNF-α结合，阻止其引发炎症反应。英夫利西单抗是全球第一个获批用于UC的生物制剂，在国内已获批UC适应症并纳入医保。它通过静脉输注给药，起效相对较快，特别适合病情较重、需要快速控制症状的患者，经济负担相对较轻。阿达木单抗在全球曾是销售额最高的“药王”，可以通过皮下注射在家使用，方便性更好。目前在国内已获批克罗恩病、类风湿关节炎、银屑病等8个适应症，但UC适应症尚未获批。不过，国内已有10余种阿达木单抗生物类似药上市。生物类似药就是生物制剂的“仿制药”，当一个创新生物制剂（原研药）的专利到期后，其他制药公司就可以按照原研药的结构和工艺，生产出高度相似的产品，疗效相当，但价格更便宜。戈利木单抗在国内目前仅获批类风湿关节炎和强直性脊柱炎，UC和CD适应症均未获批，但在全球范围内已广泛用于UC治疗，其特点是每月只需注射一次，给药频率低。这个家族的共同特点是临床经验丰富、证据充分，但需要注意感染风险，用药前需要筛查结核和乙肝。 2 抗整合素维得利珠单抗是这一类别的代表，也是IBD治疗领域的重要创新。它的独特之处在于“肠道特异性”，只在肠道局部发挥作用，不影响全身免疫系统。维得利珠单抗通过阻断α4β7整合素与MAdCAM-1的结合，阻止炎症细胞进入肠道黏膜，从而减轻炎症。目前，维得利珠单抗已在国内获批UC和CD适应症，并纳入医保。它有静脉输注和皮下注射两种剂型，患者可以根据自己的情况选择。它最大的优势是安全性高，特别适合老年患者、有感染病史的患者，以及计划怀孕或已经怀孕的女性患者。对于曾经使用抗TNF药物但效果不佳的患者，换用维得利珠单抗往往能取得不错的疗效，因为它的作用机制完全不同。 3 抗IL-12/23 乌司奴单抗是这一类别的代表药物，它能同时阻断IL-12和IL-23两条炎症信号通路。这两种白介素在UC和CD的发病中都起着重要作用，乌司奴单抗通过结合它们共有的p40亚基，一石二鸟地阻断两条通路。在国内，乌司奴单抗目前已获批银屑病和克罗恩病适应症，并纳入医保。虽然UC适应症尚未获批，但生物类似药已递交UC适应症的上市申请，预计2026年有望获批。乌司奴单抗的给药方案是首次静脉输注（根据体重调整剂量），之后每12周皮下注射一次维持治疗，相比于戈利木单抗的一月一次，给药间隔更长，频率更低。它特别适合对抗TNF药物应答不佳或失效的患者，即使抗TNF-α家族药物治疗后复发，使用乌司奴单抗还有50~70%的患者能获益。 4 抗IL-23 抗IL-23抑制剂是最新一代的生物制剂，包括古塞奇尤单抗、利生奇珠单抗和米吉珠单抗。与乌司奴单抗不同，它们只阻断IL-23而不阻断IL-12，选择性更高，理论上副作用更小。古塞奇尤单抗是国内首个也是唯一同时获批UC和CD的IL-23抑制剂。这个药物获得了国家药监局“突破性疗法”和“优先审评”双认定，并在2025年12月纳入医保目录，将于2026年1月起正式实施。利生奇珠单抗是国内首个配备随身给药器（自动注射笔）的IL-23抑制剂，操作非常方便。目前明确获批的适应症是克罗恩病，溃疡性结肠炎适应症的审批状态尚待确认。同样在2025年12月纳入医保。米吉珠单抗2023年已在美国获批UC适应症，但目前尚未在国内开展临床试验，预计2026~2027年可能进入国内市场。这个新家族的共同特点是疗效数据优秀、刚纳入医保、代表了未来治疗方向，特别适合初次使用生物制剂或对其他药物失效的患者。详情可回顾往期内容👉喜提医保的IL-23抑制剂有哪些成员？它们治疗IBD有什么不一样？什么时候需要使用生物制剂？如何选择？并非所有UC患者都需要立即使用生物制剂，一般来说，轻度UC患者通常先尝试5-氨基水杨酸类药物（如美沙拉秦），如果症状控制良好，就不必急于使用生物制剂。如果属于以下情况，医生可能会建议使用生物制剂中重度活动性UC，表现为频繁腹泻（每天6次以上）、持续便血、体重下降；激素依赖或激素无效，即使用激素后病情反复，或者无法减停激素； ASA治疗失败，使用足量美沙拉嗪8~12周仍无效；存在高危因素，如年轻发病、广泛性结肠炎、深大溃疡、既往住院史等。至于选择哪种生物制剂，要综合考虑多个因素如果病情严重、需要快速控制，英夫利西单抗通常是首选，它起效快、证据充分，特别适合急重症患者。如果年龄偏大、有感染病史（如结核、乙肝）或计划怀孕，维得利珠单抗是更安全的选择，因为它只在肠道起作用，全身副作用小。如果曾经用过抗TNF药物但效果不佳或失效，可换用不同机制的药物，如维得利珠单抗、古塞奇尤单抗或乌司奴单抗（如获批UC）。如果是初次使用生物制剂，追求长期稳定缓解，可以优先考虑新一代的古塞奇尤单抗、利生奇珠单抗，它的临床数据优秀且刚纳入医保。如果希望在家治疗、不想频繁去医院，可以选择皮下注射剂型，如维得利珠单抗（皮下）、利生奇珠单抗（配有自动注射笔，最方便）。如果经济因素是重要考虑，可以选择已有生物类似药的品种（如英夫利西单抗、阿达木单抗），或者等待新纳入医保的药物价格公布。每位肠友的病情、体质、生活习惯、经济条件都不同，需要与医生充分沟通，根据内镜检查结果、炎症指标、既往治疗史等综合判断，选择最适合您当前情况的药物。用药常见问题和注意事项使用生物制剂前，医生会做一系列检查，包括结核筛查（胸片或结核菌素试验）、乙肝病毒检测、血常规、肝肾功能等，确保用药安全。关于疗效不同药物起效时间不同，英夫利西单抗通常1~2周见效，维得利珠单抗可能需要4~12周，通常在用药12~14周时评估是否有效。如果有效，需要长期维持治疗，不能随意停药，否则病情会复发，甚至产生抗药性。关于副作用最常见的是感染风险增加，尤其是上呼吸道感染和泌尿系感染，发生率约5~15%，多数轻微可控。严重感染较少见，但需警惕。用药期间应避免接触传染病患者，如有发热、咳嗽、尿频尿痛等感染症状，及时就医。注射部位反应（皮下制剂）如红肿、疼痛通常较轻，一般无需停药。关于怀孕多数生物制剂在孕期使用是相对安全的，特别是英夫利西单抗和维得利珠单抗已有较多妊娠期使用数据。如果计划怀孕或已怀孕，一定要告知医生，控制好病情对母婴健康更重要，活动期UC对妊娠的危害远大于药物。关于费用 2025年之前，生物制剂年费用通常在3~5万元，许多患者难以负担。但随着多数药物纳入医保和生物类似药上市，负担已大幅减轻。职工医保通常可报销70～80%，居民医保可报销50～60%，患者年自付费用可降至1万元左右。重要提醒不要自行停药或调整剂量，即使症状完全消失也要继续维持治疗；需要定期复查（血常规、肝功能、炎症指标、必要时复查肠镜）；用药前应接种流感疫苗、肺炎疫苗等，降低感染风险；用药期间如需手术或接种疫苗，务必告知医生您在使用生物制剂；如果一种药物无效，还有其他选择，不要轻易放弃治疗。结语目前国内溃疡性结肠炎患者的治疗选择正在快速增加，除了生物制剂还有小分子药物，随着指南更新和临床研究成熟，中重度UC患者在初次诊断后就可以直接使用生物制剂或小分子药物。当然，最重要的是找到适合自己的治疗方案，与医生建立长期合作关系，规范治疗、定期随访。2026年，让我们期待更多药物获批、治疗费用再降一点~ 参考文献 [1]中华医学会消化病学分会炎症性肠病学组. 中国溃疡性结肠炎诊治指南（2023年·西安）[J]. 中华炎性肠病杂志（中英文），2024，8(1)：1-26. [2]Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease [J]. Gastroenterology, 2024, 166(5):819-843. [3]Rubin DT, Ananthakrishnan AN, Siegel CA, Barnes EL, Long MD. ACG Clinical Guideline Update: Ulcerative Colitis in Adults [J]. Am J Gastroenterol, 2025, 120(6):1187-1224.

专利到期生物类似药

2026-01-15

·BioSpace

Samsung Epis Holdings Delivers Business Updates at the 44th J.P. Morgan Healthcare Conference

Samsung Bioepis plans to secure 20 biosimilars in its products and pipeline by 2030 The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab, in addition to pembrolizumab currently in Phase 1 and 3 clinical studies Having secured investigational new drug application (IND) clearance from the U.S. Food and Drug Administration (FDA), SBE303, Samsung Bioepis’ novel antibody-drug conjugate (ADC) engineered to target Nectin-4, will enter into the Phase 1 first-in-human clinical trial this year Samsung Bioepis plans to add one novel therapeutic candidate in clinical study every year INCHEON, Korea--(BUSINESS WIRE)-- #ADC --Samsung Epis Holdings (KRX: 0126Z0) today shared corporate progress and updates at the 44th J.P. Morgan Healthcare Conference. "2026 is a monumental year for us, as we enter into a new chapter for our company. Today, we are announcing six additional candidates in our biosimilar pipeline, including vedolizumab and dupilumab. We are making great progress to secure 20 biosimilars in our portfolio by 2030," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We also received the investigational new drug application (IND) clearance for the first novel therapeutic candidate developed by Samsung Bioepis, and plan to advance our clinical program this year. As we broaden our portfolio beyond biosimilars, we will continue our development efforts in antibody-drug conjugates (ADCs), leveraging our innovative research and development platform to expand viable treatment options for patients with unmet needs.” Samsung Bioepis Biosimilar Updates Samsung Bioepis currently has 11 biosimilars for 10 unique biological molecules approved and launched in more than 40 countries. 1 The company has pembrolizumab biosimilar undergoing Phase 1 and 3 clinical studies, and plans to secure 20 biosimilars in its portfolio by 2030. The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab. Novel Therapeutics Updates In December 2025, the FDA has cleared the IND Application for SBE303. SBE303 is Samsung Bioepis’ first novel ADC engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer. 2 The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year. Samsung Bioepis plans to have one novel therapeutic candidate enter into clinical study every year. Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform. Samsung Bioepis Biosimilars Portfolio Code Name (Brand Name 3 ) Non-proprietary Name Reference Product Status 4 SB5 (IMRALDI™, HADLIMA™, ADALLOCE™) Adalimumab Humira Launch SB4 (BENEPALI™, BRENZYS™, ETOLOCE™) Etanercept Enbrel Launch SB2 (FLIXABI™, RENFLEXIS™, REMALOCE™) Infliximab Remicade Launch SB3 (ONTRUZANT™, SAMFENET™) Trastuzumab Herceptin Launch SB8 (AYBINTIO™) Bevacizumab Avastin Launch SB11 (BYOOVIZ™, AMELIVU™) Ranibizumab Lucentis Launch SB12 (EPYSQLI™) Eculizumab Soliris Launch SB15 (OPUVIZ™, AFILIVU™) Aflibercept Eylea Launch SB16 (OBODENCE™, OSPOMYV™) Denosumab Prolia Launch SB16 (XBRYK™) Denosumab Xgeva Launch SB17 (PYZCHIVA™, EPYZTEK™) Ustekinumab Stelara Launch SB27 Pembrolizumab Keytruda Phase 1 and 3 Samsung Bioepis Biosimilar Candidates in Early Stage Development Non-proprietary Name Reference Product Dupilumab Dupixent Guselkumab Tremfya Ixekizumab Taltz Vedolizumab Entyvio Ocrelizumab Ocrevus Fam-trastuzumab deruxtecan-nxki Enhertu About Samsung Epis Holdings Co., Ltd. As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . About Epis NexLab Co., Ltd. Established in 2025 as a 100% owned subsidiary of Samsung Epis Holdings, Epis NexLab is committed to driving innovation through the development of next-generation biotechnology platforms. By transforming highly scalable peptide-related technologies into development platforms, Epis NexLab is focused on the discovery of innovative treatment modalities for the development of multiple therapeutic candidates targeting a wide range of diseases. For more information about Epis NexLab, please visit: . 1 “more than 40 countries” signifies countries where Samsung Bioepis has commercial presence, with one or more products. 2 Li K, Zhou Y, Zang M, Jin X, Li X. Therapeutic prospects of nectin-4 in cancer: applications and value. Front Oncol. 2024 Mar 28;14:1354543. doi: 10.3389/fonc.2024.1354543. PMID: 38606099; PMCID: PMC11007101. 3 Different brand names for different regions and countries. 4 “Launch” signifies launch in one or more markets and does not necessarily indicate launch in all markets worldwide Contacts Media Contact Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com

临床1期临床申请抗体药物偶联物

2026-01-14

·拓麦精要

克罗恩病的达标治疗与治疗顺序

点击关注关键信息 ◆ 克罗恩病（CD）是炎症性肠病（IBD）的一种，也是一种免疫介导的慢性炎症性疾病，可造成肠梗阻、瘘管等并发症，并增加结直肠癌的患病风险，严重影响患者生活质量 ◆ CD的治疗策略从传统的症状控制转为达标治疗（包括确定个性化的目标），根据包含疾病严重程度和风险在内的个人因素选择治疗方法，定期密切监测疾病活动，并根据需要优化治疗方法 ◆ CD的治疗选择不断增加，在选择治疗方法时应考虑多种因素（如：疾病活动度及严重程度、并发症、治疗的可及性和可负担性等），提供合理的治疗顺序，这或可改善疾病结果；同时使用达标治疗策略，在早期控制疾病活动并为患者提供全面的治疗背景与主要方法 ◆ 传统治疗策略侧重于症状控制，但无法阻止肠道损伤或改变疾病进展；因此，新治疗策略已转向患者症状及炎症反应的同时改善 ◆ 本综述讨论了CD管理的达标治疗策略及影响CD患者治疗顺序的多种因素主要发现 CD的达标治疗 ◆ 多项研究表明，与常规临床管理相比，达标治疗策略能取得更好的临床和内镜结果，不良反应的发生率更低，但也存在重复监测、时间成本高等局限性，可能不适用于所有患者 ◆ STRIDE共识将达标治疗目标分为短期、中期和长期目标：短期目标——症状应答和缓解；中期目标——炎症标志物正常，儿童生长发育正常；长期目标——内镜愈合，生活质量正常，无残疾 CD的治疗顺序 ◆ 临床试验一再表明，无论选择何种生物制剂，早期启动生物制剂治疗（单独或联合免疫抑制剂）优于单独使用免疫抑制剂；但仍存在中重度CD患者生物制剂治疗的顺序问题 ◆ 在选择初始治疗时，除了考虑疾病的临床严重程度外，其他因素也有助于指导治疗选择，包括疾病亚型和病变部位、肠外表现和其他免疫系统共病等；CD生物制剂治疗顺序的选择见下图：克罗恩病药物治疗顺序（图片来自原文） ◆ 预测药物疗效是研究治疗顺序的未来方向：研究表明，某些肠道微生物或可预测维得利珠单抗（vedolizumab），英夫利西单抗（infliximab）和乌司奴单抗（ustekinumab）的疗效；某些基因组和蛋白质组标志物可预测CD患者对抗肿瘤坏死因子（TNFs）的治疗应答临床意义 ◆ 达标治疗策略促进了医患共同决策，以确定个性化的治疗目标，并选择初始治疗方法，同时持续监测目标并优化疗法 1 END 1 供稿：Lisa，校对：Jeanne＆Echo 如需转载、投稿，请邮件联系：med@edoctor.work 声明：编辑部对刊载内容进行仔细审阅以尽力保持其准确性，但对稿件的使用或其中的任何错误、遗漏或不准确之处等均不承担任何责任。文中所表达的任何观点不代表编辑部的观点，文中提及或排除任何方法或药物并不构成对其使用的提倡、建议或拒绝，因此在为本文中提及的任何产品开处方前，请查阅生产商的最新处方信息。内容仅限医疗卫生专业人士学习交流使用，非医疗卫生专业人士请主动退出浏览与阅读，否则由此产生的相关风险与后果应自行承担。本条内容封面图来自摄图网 ID 500534195 在未获得正式授权前，所有转载及使用文中内容均为侵权。原文来自：Garcia NM, Cohen NA, Rubin DT. Treat-to-target and sequencing therapies in Crohn's disease. United European Gastroenterol J. 2022;10(10):1121-1128. doi:10.1002/ueg2.12336 (© Author(s) (or their employer(s)) 2022. This is an open-access article distributed under the terms of the CC BY-NC-ND.), 作者未参与本精要的编写。 #IBD：Inflammatory Bowel Disease，炎症性肠病 #CD：Crohn's Disease，克罗恩病 #Treat-to-Target：达标治疗 #Sequencing：顺序点击查看原文链接 ↓↓↓

免疫疗法临床研究

100 项与维得利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08083	维得利珠单抗	L04AA33	DB09033

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
回肠疾病	韩国	Takeda Pharmaceuticals Korea Co., Ltd.	2015-06-19
活动性中度克罗恩病	欧盟	Takeda Pharma A/S	2014-05-22
活动性中度克罗恩病	冰岛	Takeda Pharma A/S	2014-05-22
活动性中度克罗恩病	列支敦士登	Takeda Pharma A/S	2014-05-22
活动性中度克罗恩病	挪威	Takeda Pharma A/S	2014-05-22
活动性重度克罗恩病	欧盟	Takeda Pharma A/S	2014-05-22
活动性重度克罗恩病	冰岛	Takeda Pharma A/S	2014-05-22
活动性重度克罗恩病	列支敦士登	Takeda Pharma A/S	2014-05-22
活动性重度克罗恩病	挪威	Takeda Pharma A/S	2014-05-22
隐窝炎	欧盟	Takeda Pharma A/S	2014-05-22
隐窝炎	冰岛	Takeda Pharma A/S	2014-05-22
隐窝炎	列支敦士登	Takeda Pharma A/S	2014-05-22
隐窝炎	挪威	Takeda Pharma A/S	2014-05-22
活动性中度溃疡性结肠炎	欧盟	Takeda Pharma A/S	2014-05-22
活动性中度溃疡性结肠炎	冰岛	Takeda Pharma A/S	2014-05-22
活动性中度溃疡性结肠炎	列支敦士登	Takeda Pharma A/S	2014-05-22
活动性中度溃疡性结肠炎	挪威	Takeda Pharma A/S	2014-05-22
活动性重度溃疡性结肠炎	欧盟	Takeda Pharma A/S	2014-05-22
活动性重度溃疡性结肠炎	冰岛	Takeda Pharma A/S	2014-05-22
活动性重度溃疡性结肠炎	列支敦士登	Takeda Pharma A/S	2014-05-22

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
小儿克罗恩病	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	中国	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	日本	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	澳大利亚	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	比利时	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	加拿大	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	克罗地亚	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	捷克	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	希腊	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	匈牙利	Takeda Pharmaceutical Co., Ltd.	2022-02-10

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临床结果

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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


ASH2025	N/A	类固醇难治性移植物抗宿主病	69	Vedolizumab + basiliximab	簾繭膚窪襯憲築獵製觸(願觸衊夢簾艱遞鑰積壓) = 衊繭襯餘壓願鑰鬱範範觸淵鏇鬱顧蓋衊窪構範 (遞餘鏇壓積網廠積範顧 ) 更多	积极	2025-12-06
NCT06227910 (VICTRIVA, Pubmed \| Contemp Clin Trials Commun)	临床3期	克罗恩病	396	Vedolizumab + Upadacitinib	糧簾齋衊憲鏇選鏇蓋蓋(蓋壓繭積糧齋襯願鏇糧) = 齋壓繭夢鬱憲遞鏇願簾築製糧觸選鹹鏇壓鹹襯 (鏇廠顧積積願壓鏇餘蓋 ) 更多	积极	2025-12-01
				Vedolizumab	觸衊壓獵鹹壓壓遞鹽築(淵鹹醖製襯鬱鹹鑰膚憲) = 廠願網獵廠艱觸積構遞構淵艱積選顧築淵築鹽 (鏇鬱鏇製遞觸憲願廠範 ) 更多
NCT03142321 (CTgov)	临床4期	肠炎 \| 克罗恩病	48	Vedolizumab 300 MG Injection [Entyvio]	憲齋膚淵鹽夢簾淵願夢 = 憲構網願鹽積餘餘糧衊壓觸醖鑰鹽壓鏇餘遞積 (觸窪窪憲獵膚鹽蓋鏇餘, 鏇積艱襯齋繭餘製窪鏇 ~ 衊選廠顧壓糧製積憲糧) 更多	-	2025-09-17
NCT02620046 (CTgov)	临床3期	克罗恩病 \| 溃疡性结肠炎	746	Vedolizumab SC (Ulcerative Colitis: Vedolizumab 108 mg)	鬱獵糧夢窪膚醖鹽艱鏇 = 窪構繭製積鏇遞艱範積積鑰窪鹽範膚築壓選膚 (襯衊範餘積顧膚獵顧糧, 餘齋壓蓋獵艱鹹夢範壓 ~ 齋鏇壓憲遞積窪壓觸鹽) 更多	-	2025-04-03
				Vedolizumab SC (Crohn's Disease: Vedolizumab 108 mg)	鬱獵糧夢窪膚醖鹽艱鏇 = 蓋廠簾膚夢淵憲遞構鹹積鑰窪鹽範膚築壓選膚 (襯衊範餘積顧膚獵顧糧, 糧遞遞壓鹽鑰觸壓構醖 ~ 鹽窪鹽築繭艱簾餘餘鏇) 更多
NCT02862132 (VEDOKIDS, Pubmed \| Lancet Gastroenterol Hepatol)	N/A	炎症性肠病维持	137	Vedolizumab	製願築齋築夢淵鏇鑰壓(夢鏇鏇願簾積襯簾廠鏇) = 夢襯鏇築構壓糧觸鏇廠齋選獵繭製繭廠憲簾衊 (齋夢構窪襯鏇鬱夢齋遞 ) 更多	积极	2025-03-01
ChiCTR2200063233 (Early CD, PRNewswire) 人工标引	临床4期	克罗恩病	172	维得利珠单抗	鑰襯淵鏇餘齋範糧淵窪(獵遞齋糧鹹蓋蓋積網衊) = 繭蓋製膚積壓網網遞壓遞鹹廠鹹鏇壓醖憲淵鏇 (餘襯餘窪鹹鬱鑰顧選範 ) 更多	积极	2025-02-21
NCT04804540 (CTgov)	临床4期	克罗恩病 \| 溃疡性结肠炎	150	Vedolizumab (UC Participants: Vedolizumab 300 mg)	簾遞襯鑰糧築憲壓製憲 = 構鏇壓餘簾繭網繭鹹壓夢襯廠簾構襯窪製淵淵 (鬱範膚簾衊鹽鬱糧獵製, 獵繭築鏇鑰夢願願膚簾 ~ 簾襯廠遞壓遞築衊簾遞) 更多	-	2025-02-12
				Vedolizumab (CD Participants: Vedolizumab 300 mg)	簾遞襯鑰糧築憲壓製憲 = 觸願艱簾鹹獵窪衊衊齋夢襯廠簾構襯窪製淵淵 (鬱範膚簾衊鹽鬱糧獵製, 顧壓繭艱製艱積觸鑰繭 ~ 艱願鏇築蓋齋製膚蓋鏇) 更多
ACR2024	N/A	克罗恩病引起的肛周瘘 \| 溃疡性结肠炎	137	Ustekinumab	壓鹹艱衊築齋獵窪網餘(獵獵簾繭廠積淵糧鬱鹹) = 鑰廠願積簾壓鹹夢憲襯鬱醖鏇膚鬱蓋構鏇餘選 (餘壓鏇鹹壓衊鹹願夢廠 ) 更多	积极	2024-11-10
UEGW2024	N/A	溃疡性结肠炎	-	Anti-TNFs	蓋鑰繭築艱築糧鹹鏇築(簾遞網選獵餘鬱餘積憲) = 1/16 (6.3%) with no cases of herpes zoster or thrombo-embolic events 衊衊顧鏇積鏇繭蓋窪廠 (蓋鏇艱鑰艱構觸鬱餘顧 ) 更多	-	2024-10-13
				Ustekinumab
UEGW2024	N/A	克罗恩病	-	Vedolizumab (Low probability group)	壓廠繭觸鑰選壓艱鹹觸(遞網淵網構遞繭鹹鹹繭) = 鑰積鬱鑰襯獵鑰艱廠網窪夢衊鹹選襯夢顧顧膚 (選艱憲襯觸壓艱鑰衊構 ) 更多	-	2024-10-13
				Vedolizumab (Intermediate probability group)	壓廠繭觸鑰選壓艱鹹觸(遞網淵網構遞繭鹹鹹繭) = 顧鹹衊蓋鹽鏇選壓築夢窪夢衊鹹選襯夢顧顧膚 (選艱憲襯觸壓艱鑰衊構 ) 更多