INDIANAPOLIS, Oct. 14, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced data demonstrating more patients with moderately to severely active Crohn's disease treated with mirikizumab achieved histologic response at Week 52 compared to ustekinumab, regardless of prior biologic experience.

印第安纳波利斯，2024年10月14日/PRNewswire/--礼来公司（纽约证券交易所：LLY）公布的数据显示，与ustekinumab相比，mirikizumab治疗的中度至重度活动性克罗恩病患者在第52周达到了组织学反应，无论之前的生物学经验如何。

VIVID-1 is the first Phase 3 study for any approved or investigational treatment in Crohn's disease to report histologic and combined histologic-endoscopic outcomes that were evaluated using a systematic assessment of five bowel segments (four colonic and one ileal) and strict definitions consistent with the recently published European Crohn's and Colitis (ECCO) position statement on mucosal histopathology.

VIVID-1是克罗恩病任何批准或研究性治疗的第一个3期研究，报告组织学和组织学内镜联合结果，这些结果是通过对五个肠段（四个结肠和一个回肠）的系统评估和严格定义进行评估的，与最近发表的欧洲克罗恩病和结肠炎（ECCO）关于粘膜组织病理学的立场声明一致。

These results are being presented as an oral presentation at United European Gastroenterology (UEG) Week, held in Vienna, Austria from October 12-15..

这些结果将在10月12日至15日在奥地利维也纳举行的欧洲胃肠病学联合会（UEG）周上以口头形式呈现。。

Mirikizumab is an IL23p19 antagonist that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. Inflammation due to the overactivation of the IL-23 pathway plays a critical role in pathogenesis of Crohn's disease, a chronic, inflammatory bowel disease associated with progressive bowel damage, disability and decreased health-related quality of life..

Mirikizumab是一种IL23p19拮抗剂，可选择性结合IL-23的p19亚基并抑制其与IL-23受体的相互作用。由于IL-23途径过度活化引起的炎症在克罗恩病的发病机制中起着至关重要的作用，克罗恩病是一种慢性炎症性肠病，与进行性肠损伤，残疾和健康相关生活质量下降有关。。

Crohn's disease inflammation occurs at the cellular level—defined as histologic inflammation—and persists even after treatment with standard of care therapies in up to one-quarter of patients with Crohn's disease despite evidence of endoscopic mucosal healing.1

克罗恩病炎症发生在定义为组织学炎症的细胞水平，即使在多达四分之一的克罗恩病患者接受标准治疗后，尽管有内镜粘膜愈合的证据，炎症仍然持续存在

'Treatment strategies for Crohn's disease must evolve beyond traditional measures of clinical remission and endoscopy, to the evaluation of depth of intestinal healing by measuring histologic and transmural resolution,' said Fernando Magro, M.D., Ph.D., head of clinical pharmacology at University Hospital São João.

“克罗恩病的治疗策略必须超越传统的临床缓解和内窥镜检查方法，通过测量组织学和透壁分辨率来评估肠道愈合的深度，”圣若昂大学医院临床药理学负责人费尔南多·马格罗博士说。

'These histologic data build on the growing body of evidence for mirikizumab, which may provide a greater depth of mucosal healing for those living with this chronic, progressive disease.'.

这些组织学数据为米利珠单抗提供了越来越多的证据，可为这种慢性、进展性疾病患者提供更深层次的粘膜愈合。

In VIVID-1, mirikizumab achieved nominally statistically significant improvements across all histologic and histologic-endoscopic endpoints versus placebo at Weeks 12 and 52, and versus ustekinumab on the following endpoints. A greater number of patients that achieved histologic response were observed with mirikizumab at Week 52 in the overall population (58.2% versus 48.8%; p=0.0075).

在VIVID-1中，mirikizumab在第12周和第52周在所有组织学和组织学内镜终点与安慰剂相比，在以下终点与ustekinumab相比，名义上取得了统计学上的显着改善。mirikizumab在第52周在总体人群中观察到更多达到组织学反应的患者（58.2%对48.8%；p=0.0075）。

In patients with active histologic disease at baseline and with at least one prior biologic failure, mirikizumab also showed greater histologic response at Week 52 (56.5% versus 41.3%; p=0.0064) and endoscopic-histologic response at Week 52 (39.6% versus 27.8%; p=0.024)..

在基线时患有活动性组织学疾病且至少有一次先前的生物学失败的患者中，mirikizumab在第52周时也显示出更大的组织学反应（56.5%比41.3%；p=0.0064），在第52周时内镜组织学反应（39.6%比27.8%；p=0.024）。。

The overall safety profile of mirikizumab in patients with moderately to severely active Crohn's disease was consistent with the known safety profile in patients with ulcerative colitis (UC). The frequency of serious adverse events was greater in placebo than mirikizumab. The most common adverse events were COVID-19, anemia, arthralgia, headache, upper respiratory tract infection, nasopharyngitis and injection site reactions. .

mirikizumab在中度至重度活动性克罗恩病患者中的总体安全性与溃疡性结肠炎（UC）患者的已知安全性一致。安慰剂组严重不良事件的发生率高于mirikizumab。。。

'As the first company to report rigorous histologic and endo-histologic outcomes in Crohn's disease that align with a recent ECCO position statement, Lilly is setting a higher bar for the evaluation of long-term treatment response in inflammatory bowel disease. This includes more ambitious targets of mucosal healing, which we applied to compare mirikizumab's histo-endoscopic effect to ustekinumab,' said Mark Genovese, M.D., senior vice president of Lilly Immunology development.

“作为第一家报告克罗恩病严格组织学和组织学结果的公司，礼来公司与ECCO最近的立场声明一致，为评估炎症性肠病的长期治疗反应设定了更高的标准。礼来免疫发展高级副总裁马克·吉诺维斯医学博士说，这包括更雄心勃勃的粘膜愈合目标，我们将其用于比较米利珠单抗与ustekinumab的组织内镜效应。

'These data also broaden our understanding of the underlying inflammation that drives Crohn's disease and may represent a critical step forward in helping health care providers and their patients make more informed choices about treatment.'.

“这些数据也拓宽了我们对克罗恩病潜在炎症的理解，可能是帮助医疗保健提供者及其患者做出更明智的治疗选择的关键一步。”。

Lilly has submitted marketing authorization applications for mirikizumab in Crohn's disease around the globe, including in the U.S., Europe, Japan and China. Additional global regulatory submissions are planned.

礼来公司已在全球范围内（包括美国、欧洲、日本和中国）提交了米利珠单抗治疗克罗恩病的上市许可申请。计划提交更多的全球监管报告。

Lilly is committed to finding solutions to elevate care and improve treatment outcomes for people living with inflammatory bowel disease, which includes studying the long-term efficacy and safety of mirikizumab in pediatric patients (NCT05509777 and NCT04844606) and adults (NCT04232553).

礼来致力于为炎症性肠病患者寻找提升护理水平和改善治疗效果的解决方案，其中包括研究mirikizumab在儿童患者（NCT05509777和NCT04844606）和成人患者（NCT04232553）中的长期疗效和安全性。

Mirikizumab is approved for the treatment of moderately to severely active UC in adults and is marketed as Omvoh™. Mirikizumab has additional ongoing trials in UC, including a study in pediatric patients (NCT05784246) and a study to evaluate the long-term efficacy and safety of mirikizumab in adults (NCT03519945).

Mirikizumab在UC中还有其他正在进行的试验，包括一项针对儿科患者的研究（NCT05784246）和一项评估Mirikizumab在成人中的长期疗效和安全性的研究（NCT03519945）。

Lilly is continuing to advance the science with an open-label UC trial studying two new endpoints in the assessment of bowel urgency with frequency and deferral time, both of which impact the quality of life for patients (NCT05767021)..

礼来公司正在通过一项开放标签的UC试验继续推进这项科学，该试验研究了两个新的终点，用于评估肠道急迫的频率和延迟时间，这两个终点都会影响患者的生活质量（NCT05767021）。。

About the VIVID-1 Clinical Trial Program

关于VIVID-1临床试验计划

VIVID-1 was a Phase 3, randomized, double-blind, treat-through study that evaluated the safety and efficacy of mirikizumab compared with placebo and an active control (ustekinumab) in adults with moderately to severely active Crohn's disease. Patients randomized to mirikizumab were administered 900 mg of mirikizumab intravenously every four weeks from Week 0-12, then 300 mg subcutaneously every four weeks from Weeks 12-52.

VIVID-1是一项3期随机双盲治疗研究，评估了mirikizumab与安慰剂和活性对照（ustekinumab）相比在中度至重度活动性克罗恩病成人中的安全性和有效性。随机接受mirikizumab治疗的患者从第0-12周开始每四周静脉注射900 mg mirikizumab，然后从第12-52周开始每四周皮下注射300 mg。

In this study, 49% of patients taking mirikizumab or placebo had experienced a prior biologic failure..

在这项研究中，49%服用米利珠单抗或安慰剂的患者之前曾经历过生物制剂失败。

Indications and Usage for Omvoh™ (mirikizumab-mrkz) (in the United States)

Omvoh™（mirikizumab mrkz）的适应症和用法（在美国）

Omvoh™ is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Omvoh™适用于治疗成人中度至重度活动性溃疡性结肠炎。

About Omvoh™

关于Omvoh™

Omvoh™ (mirikizumab-mrkz) is an interleukin-23p19 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of ulcerative colitis.

Omvoh™（mirikizumab mrkz）是一种白细胞介素-23p19拮抗剂，用于治疗成人中度至重度活动性溃疡性结肠炎。Omvoh选择性靶向IL-23的p19亚基并抑制IL-23途径。IL-23途径过度激活引起的炎症在溃疡性结肠炎的发病机制中起关键作用。

Treatment of ulcerative colitis with Omvoh starts with 300-mg IV infusions, once every four weeks for a total of three infusions, and transitions to two, 100-mg subcutaneous injections every four weeks during maintenance treatment..

用Omvoh治疗溃疡性结肠炎始于300 mg IV输注，每四周一次，共输注三次，并在维持治疗期间每四周过渡到两次100 mg皮下注射。。

Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company.

Omvoh及其交付设备底座是礼来公司拥有的商标。

About Lilly

关于礼来

Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases.

礼来是一家将科学转化为治疗的医药公司，旨在让世界各地的人们生活得更好。近150年来，我们一直在开创改变生活的发现，今天，我们的药物帮助了全球数以千万计的人。利用生物技术、化学和遗传医学的力量，我们的科学家正在迫切推进新发现，以解决世界上一些最重大的健康挑战：重新定义糖尿病护理；治疗肥胖并减少其最具破坏性的长期影响；推进与阿尔茨海默病的斗争；为一些最致命的免疫系统疾病提供解决方案；。

With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn.

在迈向更健康世界的每一步中，我们都有一个动机：让数百万人的生活变得更好。这包括提供反映我们世界多样性的创新临床试验，并努力确保我们的药物可获得且负担得起。要了解更多信息，请访问Lilly.com和Lilly.com/news，或在Facebook、Instagram和LinkedIn上关注我们。