In LUCENT-2, more than one in four (27.7%) Omvoh-treated patients with ulcerative colitis achieved comprehensive disease control, a novel composite outcome defined by simultaneous symptomatic, endoscopic and histologic remission, biomarker normalization and no corticosteroid use

在LUCENT-2研究中，超过四分之一（27.7%）接受Omvoh治疗的溃疡性结肠炎患者实现了全面疾病控制，这是一种新型的复合结局，定义为同时达到症状缓解、内镜缓解和组织学缓解、生物标志物正常化以及未使用皮质类固醇。

In VIVID-1, one in five (20.4%) Omvoh-treated patients with Crohn's disease achieved corticosteroid-free deep remission, a composite outcome defined by simultaneous clinical remission, endoscopic remission and no corticosteroid use

在VIVID-1研究中，五分之一（20.4%）接受Omvoh治疗的克罗恩病患者实现了无皮质类固醇的深度缓解，这是一个由同时达到临床缓解、内镜缓解且未使用皮质类固醇定义的复合终点。

Across both types of inflammatory bowel disease, including patients with prior biologic failure, achieving comprehensive disease control or corticosteroid-free deep remission was associated with improved patient-reported outcomes

在包括既往生物制剂治疗失败患者在内的两类炎症性肠病中，实现全面疾病控制或无皮质类固醇的深度缓解与患者报告结局的改善相关

INDIANAPOLIS

印第安纳波利斯

,

，

Oct. 15, 2026

2026年10月15日

/PRNewswire/ -- New data analyses from Eli Lilly and Company (NYSE:

/美通社/ -- 礼来公司（纽约证券交易所代码：

LLY

礼来公司

) show patients with moderately to severely active ulcerative colitis (UC) and Crohn's disease treated with Omvoh (mirikizumab-mrkz) achieved multiple treatment goals simultaneously at one year, as measured by comprehensive disease control in UC and corticosteroid-free deep remission in Crohn's disease.

) 显示，接受 Omvoh（mirikizumab-mrkz）治疗的中度至重度活动性溃疡性结肠炎（UC）和克罗恩病患者在一年内同时实现了多项治疗目标，具体表现为溃疡性结肠炎的综合疾病控制以及克罗恩病的无皮质类固醇深度缓解。

These multidimensional outcomes were observed even in patients with prior biologic failure, a population often facing greater treatment challenges. More than one-third of patients in the UC analysis and nearly half of patients in the Crohn's disease analysis had previously experienced biologic treatment failure.

即使在既往生物制剂治疗失败的患者中，也观察到了这些多维度的疗效结果，而这一人群通常面临更大的治疗挑战。在溃疡性结肠炎的分析中，超过三分之一的患者以及在克罗恩病的分析中，近一半的患者此前曾经历过生物制剂治疗失败。

Furthermore, patients who achieved these endpoints were more likely to also achieve remission on the Inflammatory Bowel Disease Questionnaire (IBDQ), a validated patient-reported measure of health-related quality of life. Together, these findings reflect an evolution of treatment goals in inflammatory bowel disease (IBD), looking across symptoms, inflammation and impact of disease on daily life to support a more holistic, patient-centered approach that goes beyond clinical remission.

此外，达到这些终点的患者也更有可能在炎症性肠病问卷（IBDQ）上实现缓解，该问卷是一种经过验证的患者报告的健康相关生活质量评估工具。综上所述，这些发现反映了炎症性肠病（IBD）治疗目标的演变，即综合考量症状、炎症以及疾病对日常生活的影响，以支持一种超越临床缓解的、更全面且以患者为中心的治疗策略。

These post-hoc data from the LUCENT and VIVID programs will be presented at United European Gastroenterology (UEG) Week 2026..

这些来自 LUCENT 和 VIVID 项目的上市后数据分析将在 2026 年欧洲联合胃肠病学周（UEG Week）上展示。

1,2

1,2

'Treatment in inflammatory bowel disease is often measured one endpoint at a time. These new data show that patients treated with Omvoh achieved multiple treatment goals simultaneously at one year, including those with prior biologic failure, and were more likely to report better quality of life,' said Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs.

“炎症性肠病的治疗效果通常一次仅评估一个终点。这些新数据显示，接受Omvoh治疗的患者在一年时同时实现了多项治疗目标，包括既往生物制剂治疗失败的患者，且他们更可能报告生活质量改善，”礼来免疫学医学事务高级副总裁Anabela Cardoso表示。

'These findings reinforce the impact that Omvoh can have for people living with ulcerative colitis and Crohn's disease and show that a higher bar for disease control is achievable.'.

“这些发现强化了Omvoh对溃疡性结肠炎和克罗恩病患者可能产生的影响，并表明实现更高标准的疾病控制是可行的。”

A comprehensive approach to IBD management considers multiple dimensions of disease, including the symptoms patients experience, what clinicians can objectively measure and how disease affects daily life.

炎症性肠病（IBD）的综合管理方法需考虑疾病的多重维度，包括患者经历的症状、临床医生可客观测量的指标，以及疾病对日常生活的影响。

3-4

3-4

In previously published real-world studies, improvements across multiple dimensions of disease have been associated with a lower risk of flares, steroid use, hospitalization and surgery over time.

在先前发表的真实世界研究中，疾病多个维度的改善与随时间推移的发作风险、类固醇使用、住院和手术风险降低相关。

4-7

4-7

'Inflammatory bowel disease is complex, and understanding treatment impact requires a broader view than any single endpoint can provide. These endpoints reflect a meaningful shift in how we define treatment success,' said Stefan Schreiber, M.D., University Hospital Schleswig-Holstein, Christian-Albrecht University of Kiel.

“炎症性肠病具有复杂性，要理解治疗的影响，需要比任何单一终点所能提供的更广阔的视角。这些终点反映了我们在定义治疗成功方面发生了有意义的转变，”石勒苏益格-荷尔斯泰因大学医院、基尔克里斯蒂安-阿尔布雷希特大学的斯特凡·施赖伯博士表示。

'Across the LUCENT and VIVID programs, Omvoh-treated patients achieved multidimensional treatment outcomes, including comprehensive disease control in ulcerative colitis and corticosteroid-free deep remission in Crohn's disease. Importantly, these outcomes were also observed in patients with prior biologic failure.'.

在LUCENT和VIVID研究中，接受Omvoh治疗的患者实现了多维度的治疗结局，包括溃疡性结肠炎的综合疾病控制以及克罗恩病的无皮质类固醇深度缓解。重要的是，在既往生物制剂治疗失败的患者中也观察到了这些结局。

Comprehensive disease control with Omvoh in ulcerative colitis

Omvoh 在溃疡性结肠炎中的全面疾病控制

Comprehensive disease control is a novel composite outcome, informed by an international expert consensus

全面疾病控制是一种新型复合结局，基于国际专家共识制定

3

3

, that combines clinical remission

，结合临床缓解

*

*

, no corticosteroid use for at least 12 weeks before Week 52, histologic remission

在第52周前至少12周内未使用皮质类固醇，组织学缓解

†

†

and fecal calprotectin ≤250 μg/g. Omvoh is the first IL-23p19 inhibitor evaluated for comprehensive disease control in UC, reflecting an evolving approach to treatment goals that goes beyond individual measures of disease activity for people living with UC.

且粪便钙卫蛋白≤250 μg/g。Omvoh是首个在溃疡性结肠炎（UC）中评估全面疾病控制的IL-23p19抑制剂，这反映了治疗目标的演变方法，超越了仅针对溃疡性结肠炎患者疾病活动度的单一指标。

Comprehensive disease control was evaluated in a post hoc analysis at one year in patients with UC who responded to Omvoh at Week 12 in the LUCENT-1 induction study and were re-randomized in LUCENT-2 to continue Omvoh or receive placebo. More than one-third of patients (35.3%) had previously experienced biologic treatment failure..

在LUCENT-1诱导研究中，对第12周对Omvoh有反应的溃疡性结肠炎（UC）患者进行了事后分析，评估其在一年时的全面疾病控制情况。这些患者在LUCENT-2研究中被重新随机分配，继续接受Omvoh治疗或接受安慰剂。超过三分之一（35.3%）的患者此前曾经历生物制剂治疗失败。

At one year:

一年后：

1

1

27.7% of patients treated with Omvoh achieved comprehensive disease control compared with 14% receiving placebo.

27.7%的接受Omvoh治疗的患者实现了全面疾病控制，而接受安慰剂治疗的患者中这一比例为14%。

‡

‡

Among patients with prior biologic failure, 23.4% of those treated with Omvoh achieved comprehensive disease control compared with 9.4% receiving placebo.

在既往生物制剂治疗失败的患者中，接受Omvoh治疗的患者有23.4%实现了全面疾病控制，而接受安慰剂治疗的患者仅为9.4%。

‡

‡

Among Omvoh-treated patients, 91.1% of those who achieved comprehensive disease control also achieved IBDQ remission

在接受Omvoh治疗的患者中，实现全面疾病控制的患者中有91.1%也实现了IBDQ缓解。

§

§

, compared with 65.2% of those who did not achieve comprehensive disease control.

，相比之下，未实现全面疾病控制的患者比例为65.2%。

Omvoh-treated patients who achieved comprehensive disease control were also more likely to report no to minimal bowel urgency (bowel urgency remission) and greater improvements in work productivity than those who did not achieve comprehensive disease control.

与未实现全面疾病控制的患者相比，接受Omvoh治疗并实现全面疾病控制的患者更有可能报告无或仅有轻微肠道急迫感（肠道急迫感缓解），且在工作生产力方面表现出更大的改善。

∥

∥

Corticosteroid-free deep remission with Omvoh in Crohn's disease

奥木伏单抗在克罗恩病中实现无皮质类固醇的深度缓解

Corticosteroid-free deep remission was evaluated in a post hoc analysis at one year in patients with Crohn's disease in VIVID-1. Nearly half of patients (48.6%) had previously experienced biologic treatment failure. Corticosteroid-free deep remission is a composite outcome that combines clinical remission (as measured by the Crohn's Disease Activity Index), endoscopic remission and no corticosteroid use for at least 12 weeks before Week 52..

在VIVID-1研究中，通过事后分析评估了克罗恩病患者在第52周时达到无皮质类固醇深度缓解的情况。近半数患者（48.6%）此前曾经历生物制剂治疗失败。无皮质类固醇深度缓解是一个复合终点，结合临床缓解（以克罗恩病活动指数衡量）、内镜缓解以及在第52周前至少12周内未使用皮质类固醇。

¶

段落

At one year:

一年后：

2

2

20.4% of patients receiving Omvoh achieved corticosteroid-free deep remission compared with 2% receiving placebo.

在接受 Omvoh 治疗的患者中，有 20.4% 实现了无皮质类固醇的深度缓解，而接受安慰剂治疗的患者中这一比例仅为 2%。

#

#

Among patients with prior biologic failure, 15.7% of those treated with Omvoh achieved corticosteroid-free deep remission compared with none of those receiving placebo.

在既往生物制剂治疗失败的患者中，接受Omvoh治疗的患者中有15.7%实现了无皮质类固醇的深度缓解，而接受安慰剂治疗的患者中无人实现这一目标。

#

#

Among Omvoh-treated patients, 88.1% of those who achieved corticosteroid-free deep remission also achieved IBDQ remission

在接受 Omvoh 治疗的患者中，实现无皮质类固醇深度缓解的患者中有 88.1% 也实现了 IBDQ 缓解。

§

§

, compared with 51% of those who did not achieve corticosteroid-free deep remission.

，而在未实现无皮质类固醇深度缓解的患者中，这一比例为51%。

The safety findings observed in the Phase 3 LUCENT and VIVID clinical trial programs have been reported previously. The most common adverse reactions associated with Omvoh treatment in LUCENT-1 and -2 (reported in at least 2% of subjects at a higher frequency than placebo) were upper respiratory tract infections, injection site reactions, arthralgia, rash, headache and herpes viral infection.

此前已报告在III期LUCENT和VIVID临床试验项目中观察到的安全性结果。在LUCENT-1和LUCENT-2研究中，与Omvoh治疗相关的最常见不良反应（报告发生率至少为2%且高于安慰剂组）包括上呼吸道感染、注射部位反应、关节痛、皮疹、头痛和疱疹病毒感染。

In VIVID-1, the most common adverse reactions associated with Omvoh treatment (reported in at least 5% of subjects at a higher frequency than placebo) were upper respiratory tract infections, injection site reactions, headache, arthralgia and elevated liver tests..

在VIVID-1研究中，与Omvoh治疗相关的最常见不良反应（报告频率高于安慰剂组且发生率至少为5%）包括上呼吸道感染、注射部位反应、头痛、关节痛和肝功能检查升高。

8

8

Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn's disease in adults and has been approved in 47 countries. Omvoh is also approved as a single-injection maintenance regimen for adults with UC in several countries around the world, including the U.S., EU, Canada and Japan..

Omvoh 已获得监管机构批准，用于治疗成人中度至重度活动性溃疡性结肠炎（UC）和中度至重度活动性克罗恩病，并已在 47 个国家获批。此外，Omvoh 还在包括美国、欧盟、加拿大和日本在内的全球多个国家被批准作为成人溃疡性结肠炎患者的单注射维持治疗方案。

Lilly continues to advance the standard of care in gastroenterology through the next wave of immunology innovation, including combination approaches, novel mechanisms and the potential of incretins. Lilly is pursuing combination studies of mirikizumab aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety.

礼来公司通过下一波免疫学创新，包括联合疗法、新颖作用机制以及肠促胰岛素的潜力，持续提升胃肠病学的护理标准。礼来正在开展米吉珠单抗的联合研究，旨在实现突破性的诱导疗效，同时维持长期的缓解和安全性。

These include studies in UC with eltrekibart (.

这些研究包括在溃疡性结肠炎（UC）中使用eltrekibart的研究。

NCT06598943

NCT06598943

), a monoclonal antibody that targets neutrophil-driven inflammation, and with zotemtegrast (

），一种靶向中性粒细胞驱动炎症的单克隆抗体，以及佐替美格司特（

NCT07186101)

NCT07186101）

, an oral α4β7 integrin inhibitor. In Crohn's disease, Lilly is studying mirikizumab in combination with an FXR agonist (

，一种口服α4β7整合素抑制剂。在克罗恩病方面，礼来公司正在研究mirikizumab与FXR激动剂联合使用（

NCT07483099

NCT07483099

). The COMMIT-UC (

）。COMMIT-UC（

NCT06937086

NCT06937086

) and COMMIT-CD (

）和 COMMIT-CD（

NCT06937099

NCT06937099

) trials are investigating the concomitant use of mirikizumab and an incretin-based therapy in adults with UC or Crohn's disease and obesity or overweight with at least one additional weight-related comorbid condition. In addition, trials of mirikizumab in pediatric patients are ongoing, including a long-term extension study in UC and Crohn's disease (.

）多项临床试验正在调查米瑞珠单抗（mirikizumab）与基于肠促胰素疗法在患有溃疡性结肠炎或克罗恩病且伴有肥胖或超重、并至少合并一种其他体重相关并发症的成年患者中的联合使用。此外，米瑞珠单抗在儿科患者中的临床试验正在进行中，包括一项针对溃疡性结肠炎和克罗恩病的长期扩展研究。

NCT04844606

NCT04844606

) and an ongoing Phase 3 study in pediatric Crohn's disease (

）以及一项正在进行的针对儿童克罗恩病的3期临床试验（

NCT05509777

NCT05509777

).

）。

About the LUCENT Clinical Trial Program

关于 LUCENT 临床试验项目

Omvoh was studied in two Phase 3 clinical trials which evaluated the efficacy and safety of Omvoh in adults with moderately to severely active UC, in both biologic-naïve patients and those who had previously failed a biologic or Janus kinase inhibitor (JAKi).

Omvoh 在两项 III 期临床试验中进行了研究，这些试验评估了 Omvoh 在中重度活动性溃疡性结肠炎（UC）成人患者中的疗效和安全性，包括生物制剂初治患者以及此前生物制剂或 Janus 激酶抑制剂（JAKi）治疗失败的患者。

The randomized, double-blind, placebo-controlled LUCENT-1 (induction) study included patients with an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, biologic therapy, or JAKi, and LUCENT-2 (maintenance) evaluated continued treatment versus placebo in patients who achieved a clinical response to Omvoh in LUCENT-1..

随机、双盲、安慰剂对照的 LUCENT-1（诱导期）研究纳入了对皮质类固醇、免疫调节剂、生物制剂或 JAK 抑制剂反应不足、失应答或不耐受的患者；LUCENT-2（维持期）研究则在 LUCENT-1 中对 Omvoh 达到临床应答的患者中评估了继续治疗与安慰剂的疗效。

About the VIVID Clinical Trial Program

关于VIVID临床试验项目

VIVID-1 was a Phase 3 randomized, double-blind, placebo-controlled 52-week study in adults with moderately to severely active Crohn's disease. Patients randomized to Omvoh received Omvoh 900 mg by intravenous (IV) infusion at Week 0, Week 4 and Week 8, followed by a maintenance dose of 300 mg by subcutaneous injection (SC) at Week 12 and then every four weeks (Q4W) for 40 weeks..

VIVID-1 是一项在患有中度至重度活动性克罗恩病的成人中开展的3期、随机、双盲、安慰剂对照的52周研究。随机分配至 Omvoh 组的患者在第0周、第4周和第8周接受900 mg Omvoh静脉输注（IV），随后在第12周接受300 mg皮下注射（SC）作为维持剂量，之后每四周（Q4W）给药一次，持续40周。

About Omvoh

关于 Omvoh

Omvoh (mirikizumab-mrkz) is an interleukin-23p19 (IL-23p19) antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn's disease 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 inflammatory bowel disease..

Omvoh（mirikizumab-mrkz）是一种白细胞介素-23p19（IL-23p19）拮抗剂，适用于治疗成人中度至重度活动性溃疡性结肠炎和克罗恩病。Omvoh 选择性靶向 IL-23 的 p19 亚基并抑制 IL-23 通路。IL-23 通路过度激活引发的炎症在炎症性肠病的发病机制中起着关键作用。

8

8

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

Omvoh 及其给药装置底座是礼来公司拥有的商标。

Endnotes and References

尾注与参考文献

*Clinical remission (based on the modified Mayo score [mMS]): stool frequency subscore=0 or 1 with a ≥1-point decrease from baseline, and rectal bleeding subscore=0, and endoscopic subscore (ES)=0 or 1 (excluding friability).

*临床缓解（基于改良Mayo评分[mMS]）：排便频率子评分=0或1，且较基线下降≥1分；直肠出血子评分=0；内镜子评分（ES）=0或1（不包括黏膜脆性）。

†

†

Histologic remission: Geboes subscores of 0 for grades 2b (neutrophils in lamina propria), 3 (neutrophils in epithelium), 4 (crypt destruction) and 5 (erosion or ulceration).

组织学缓解：Geboes 分级中 2b 级（固有层中性粒细胞）、3 级（上皮内中性粒细胞）、4 级（隐窝破坏）和 5 级（糜烂或溃疡）的亚评分均为 0。

‡

双剑号

In LUCENT-2, patients randomized to placebo had achieved clinical response with Omvoh during LUCENT-1 induction and were then re-randomized to discontinue from Omvoh and receive placebo through the maintenance period. Patients randomized to Omvoh continued treatment, for a total of 52 weeks from induction baseline..

在LUCENT-2研究中，在LUCENT-1诱导期使用Omvoh达到临床应答并随机分配至安慰剂组的患者，随后被重新随机分配以停用Omvoh并在维持期接受安慰剂治疗。随机分配至Omvoh组的患者则继续接受治疗，自诱导期基线起总疗程为52周。

§

§

Inflammatory Bowel Disease Questionnaire (IBDQ) remission: total score ≥170.

炎症性肠病问卷（IBDQ）缓解：总分≥170。

∥

平行

No to minimal bowel urgency (bowel urgency remission) was defined as an Urgency NRS score of 0 or 1; work productivity assessed using the Work Productivity and Activity Impairment Questionnaire for UC (WPAI).

无或轻微排便急迫感（排便急迫感缓解）定义为急迫感数字评定量表（Urgency NRS）评分为0或1；工作生产力采用溃疡性结肠炎工作生产力与活动损害问卷（WPAI-UC）进行评估。

¶

段落

Corticosteroid-free Crohn's Disease Activity Index (CDAI)-based deep remission: CDAI <150, endoscopic remission (SES-CD ≤4 and ≥2-point reduction from baseline with no subscore >1) and no corticosteroid use during the 12 weeks before Week 52.

基于克罗恩病活动指数（CDAI）的无皮质类固醇深度缓解：CDAI <150，内镜缓解（SES-CD ≤4 且较基线降低 ≥2 分，各分项评分均 ≤1），以及在第52周前的12周内未使用皮质类固醇。

#

#

Patients receiving placebo in VIVID-1 were randomized to placebo at baseline. Those who did not respond by Week 12 switched to Omvoh and were counted as non-responders in this analysis.

在VIVID-1研究中接受安慰剂的患者在基线时被随机分配至安慰剂组。那些在第12周时未产生应答的患者切换至Omvoh治疗，并在本分析中被计为无应答者。

1

1

Schreiber S, et al. Mirikizumab therapy enables comprehensive disease control with improved quality of life in patients with moderately-to-severely active ulcerative colitis: a post-hoc analysis of Phase 3 LUCENT-1 and LUCENT-2 trials. American College of Gastroenterology (ACG) Annual Scientific Meeting; October 11, 2026; Nashville, TN.

Schreiber S 等。米瑞珠单抗治疗可实现中度至重度活动性溃疡性结肠炎患者的全面疾病控制并改善生活质量：III期LUCENT-1和LUCENT-2试验的事后分析。美国胃肠病学会（ACG）年度科学会议；2026年10月11日；田纳西州纳什维尔。

P-1182..

P-1182..

2

2

Schreiber S, et al. Mirikizumab effect on deep remission with improved quality of life in moderately to severely active Crohn's disease: a post hoc analysis from VIVID-1. United European Gastroenterology Week 2026;. October 18, 2026; Barcelona, Spain. MP0290.

Schreiber S 等. Mirikizumab 对中重度活动性克罗恩病患者深度缓解及生活质量改善的影响：来自 VIVID-1 研究的事后分析。2026 年联合欧洲胃肠病学周；2026 年 10 月 18 日；西班牙巴塞罗那。MP0290。

3

3

Schreiber, S, Danese, S, Dignass, A, et al. Defining comprehensive disease

Schreiber, S，Danese, S，Dignass, A，等. 定义全面疾病

control for use as a treatment target for ulcerative colitis in clinical practice: International Delphi consensus recommendations.

作为溃疡性结肠炎临床实践治疗目标的控制：国际德尔菲共识建议。

J Crohns Colitis.

《克罗恩病与结肠炎杂志》

2024;18(1):91–105.

2024；18(1):91–105。

https://doi.org/10.1093/ecco-jcc/jjad130

https://doi.org/10.1093/ecco-jcc/jjad130

4

4

Fanizzi, F, D'Amico, F, Peyrin-Biroulet, L, Danese, S, & Dignass, A.

法尼齐，F，达米科，F，佩林-比鲁莱，L，达内塞，S，和迪格纳斯，A。

Treatment targets in IBD: Is it time for new strategies?

炎症性肠病的治疗目标：是时候采取新策略了吗？

Best Pract Res Clin Gastroenterol.

《最佳实践与研究：临床胃肠病学》

2025;77:101990.

2025;77:101990.

https://doi.org/10.1016/j.bpg.2025.101990

https://doi.org/10.1016/j.bpg.2025.101990

5

5

Shehab M, et al. Histological disease activity as predictor of clinical relapse, hospitalization, and surgery in inflammatory bowel disease: systematic review and meta-analysis.

Shehab M 等. 组织学疾病活动度作为炎症性肠病临床复发、住院和手术的预测因子：系统综述与荟萃分析。

Inflamm Bowel Dis.

炎症性肠病

2024;30(4):563-572. doi:10.1093/ibd/izad119

2024;30(4):563-572. doi:10.1093/ibd/izad119

6

6

Andronic AM, Toader E. P398 Disease clearance: a potential target for management of patients with ulcerative colitis.

Andronic AM, Toader E. P398 疾病清除：溃疡性结肠炎患者管理的一个潜在目标。

J Crohns Colitis.

《克罗恩病与结肠炎杂志》

2023;17(Suppl 1):i529. doi:10.1093/ecco-jcc/jjac190.0528

2023;17(增刊1):i529. doi:10.1093/ecco-jcc/jjac190.0528

7

7

Pai RK, D'Haens G, Kobayashi T, et al. Histologic assessments in ulcerative colitis: the evidence behind a new endpoint in clinical trials.

Pai RK，D'Haens G，Kobayashi T，等。溃疡性结肠炎的组织学评估：临床试验中新终点的证据基础。

Expert Rev Gastroenterol Hepatol.

《专家评论：胃肠病学与肝病学》

2024;18(1-3):73-87. doi:10.1080/17474124.2024.2326838

2024;18(1-3):73-87. doi:10.1080/17474124.2024.2326838

8

8

Omvoh. Prescribing Information. Lilly USA, LLC.

Omvoh. 处方信息。礼来美国有限责任公司。

Indications and Usage for Omvoh

Omvoh 的适应症和用法

®

®

(mirikizumab-mrkz) (in the United States)

（米瑞奇珠单抗-mrkz）（在美国）

Omvoh is an interleukin-23 antagonist indicated for adults with:

Omvoh 是一种白细胞介素-23 拮抗剂，适用于以下成人患者：

Moderately to severely active ulcerative colitis

中度至重度活动性溃疡性结肠炎

Moderately to severely active Crohn's disease

中度至重度活动性克罗恩病

Important Safety Information for Omvoh (mirikizumab-mrkz)

Omvoh（mirikizumab-mrkz）的重要安全信息

CONTRAINDICATIONS

禁忌症

Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.

对于有对mirikizumab-mrkz或任何辅料严重过敏反应史的患者，禁用Omvoh。

WARNINGS AND PRECAUTIONS

警告与注意事项

Hypersensitivity Reactions

超敏反应

Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with Omvoh administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction. If a severe hypersensitivity reaction occurs, discontinue Omvoh immediately and initiate appropriate treatment..

已有报告指出，在使用Omvoh期间发生严重的过敏反应，包括静脉输注过程中的过敏性休克。在诱导治疗期间，也报告了与输注相关的过敏反应，包括皮肤黏膜红斑和瘙痒。如果发生严重过敏反应，应立即停用Omvoh并开始适当的治疗。

Infections

感染

Omvoh may increase the risk of infection. Do not initiate treatment with Omvoh in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing Omvoh.

Omvoh 可能会增加感染风险。在患者存在具有临床重要意义的活动性感染时，不应启动 Omvoh 治疗，直至感染消退或得到充分治疗。对于患有慢性感染或有复发性感染病史的患者，在处方 Omvoh 前应权衡其风险与获益。

Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer Omvoh until the infection resolves..

指导患者在出现具有临床意义的急性或慢性感染的体征或症状时寻求医疗建议。如果发生严重感染或感染对标准治疗无反应，应密切监测患者，并在感染消退前暂停给予Omvoh。

Tuberculosis

结核病

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Omvoh. Do not administer Omvoh to patients with active TB infection. Initiate treatment of latent TB prior to administering Omvoh. Consider anti-TB therapy prior to initiation of Omvoh in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

在开始使用Omvoh治疗前，应对患者进行结核病（TB）感染评估。活动性结核病患者不得使用Omvoh。在使用Omvoh之前，应先对潜伏性结核病进行治疗。对于有潜伏性或活动性结核病史且无法确认已完成充分疗程的患者，在开始使用Omvoh前应考虑抗结核治疗。

Monitor patients for signs and symptoms of active TB during and after Omvoh treatment. In clinical trials, subjects were excluded if they had evidence of active TB, a history of active TB, or were diagnosed with latent TB at screening..

在Omvoh治疗期间及治疗后，监测患者是否出现活动性结核病的体征和症状。在临床试验中，若受试者有活动性结核病的证据、活动性结核病史，或在筛查时被诊断为潜伏性结核病，则被排除在外。

Hepatotoxicity

肝毒性

Drug-induced liver injury in conjunction with pruritus was reported in a clinical trial subject following a longer than recommended induction regimen. Omvoh was discontinued. Liver test abnormalities eventually returned to baseline. Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment.

在一项临床试验中，一名受试者在接受超过推荐时长的诱导治疗方案后，报告了伴有瘙痒的药物性肝损伤。随后停用了Omvoh。肝功能检查异常最终恢复至基线水平。应在基线时以及治疗的前24周内评估肝酶和胆红素水平。

Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded.

此后按照常规患者管理进行监测。对于有肝硬化证据的患者，应考虑其他治疗选择。建议对肝酶升高的原因进行及时调查，以识别潜在的药物性肝损伤病例。如果怀疑为药物性肝损伤，应中断治疗，直至排除该诊断。

Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction..

指导患者若出现提示肝功能异常的症状，应立即就医。

Immunizations

免疫接种

Avoid use of live vaccines in patients treated with Omvoh. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines.

避免在接受 Omvoh 治疗的患者中使用活疫苗。与免疫系统相互作用的药物可能会增加接种活疫苗后感染的风险。在开始治疗前，应根据当前的免疫接种指南完成所有适合年龄的疫苗接种。

No data are available on the response to live or non-live vaccines in patients treated with Omvoh..

目前尚无关于接受 Omvoh 治疗的患者对减毒活疫苗或非减毒活疫苗反应的数据。

ADVERSE REACTIONS

不良反应

Most common adverse reactions associated with Omvoh (≥2% of subjects and at a higher frequency than placebo) in ulcerative colitis treatment are upper respiratory tract infections and arthralgia during the induction study (UC-1), and upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection during the maintenance study (UC-2).

在溃疡性结肠炎治疗中，与Omvoh相关的最常见不良反应（发生率≥2%且高于安慰剂）包括：在诱导期研究（UC-1）中为上呼吸道感染和关节痛；在维持期研究（UC-2）中为上呼吸道感染、注射部位反应、关节痛、皮疹、头痛和疱疹病毒感染。

Most common adverse reactions associated with Omvoh in the Crohn's disease study (CD-1) (≥5% of subjects and at a higher frequency than placebo) are upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests..

在克罗恩病研究（CD-1）中，与Omvoh相关的最常见不良反应（发生率≥5%且高于安慰剂组）包括上呼吸道感染、注射部位反应、头痛、关节痛和肝酶升高。

Omvoh injection is available as a 300 mg/15 mL solution in a single-dose vial for intravenous infusion, and as a 100 mg/mL solution or a 200 mg/2 mL solution in a single dose prefilled pen or prefilled syringe for subcutaneous injection. Refer to the Prescribing Information for dosing information.

Omvoh 注射液有以下几种剂型：用于静脉输注的 300 mg/15 mL 溶液，装于单剂量小瓶中；以及用于皮下注射的 100 mg/mL 溶液或 200 mg/2 mL 溶液，装于单剂量预充式注射笔或预充式注射器中。剂量信息请参阅处方资料。

MR HCP ISI CD APP

医疗代表 医疗保健专业人士 独立销售机构 临床决策 应用程序

Click to access provided

点击以访问提供的

Prescribing Information

处方信息

and

和

Medication Guide

用药指南

. See Instructions for Use provided with the device.

. 请参阅随设备提供的使用说明书。

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 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疗愈、致力于改善全球人民生活的制药公司。150年来，我们一直引领着改变生命的发现，如今我们的药物帮助了全球数千万人。借助生物技术、化学和基因医学的力量，我们的科学家正迫切推动新发现，以应对一些世界上最重大的健康挑战：重新定义糖尿病护理；治疗肥胖并减轻其最具破坏性的长期影响；推进对抗阿尔茨海默病的斗争；为一些最使人衰弱的免疫系统疾病提供解决方案；并将最难治疗的癌症转变为可管理的疾病。

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 .

在迈向更健康世界的每一步中，我们始终受一个目标驱动：为更多数百万人改善生活。这包括开展反映世界多样性的创新临床试验，并致力于确保我们的药物可及且负担得起。欲了解更多信息，请访问 。

Lilly.com

礼来官网

and

和

Lilly.com/news

Lilly.com/新闻

, or follow us on

，或在以下平台关注我们

Facebook

脸书

,

，

Instagram

Instagram

, and

，和

LinkedIn

领英

. P-LLY

. P-LLY

Trademarks and Trade Names

商标与商号

All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto.

本新闻稿中提及的所有商标或商号均为本公司财产，或在涉及其他公司商标或商号的范围内，归其各自所有者所有。仅为方便起见，本新闻稿中的商标和商号未附带®和™符号，但此类表述不应被解释为本公司或在适用情况下其各自所有者不会根据适用法律最大限度地主张其相关权利的任何暗示。

We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies..

我们无意通过使用或展示其他公司的商标和商号来暗示与任何其它公司存在关联，或获得其认可或赞助。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性陈述的警示性声明

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Omvoh (mirikizumab-mrkz) as a treatment for people with moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease and reflects Lilly's current beliefs and expectations.

本新闻稿包含有关Omvoh（mirikizumab-mrkz）作为中度至重度活动性溃疡性结肠炎和中度至重度活动性克罗恩病治疗药物的前瞻性陈述（该术语定义见1995年《私人证券诉讼改革法案》），并反映了礼来公司当前的信念和预期。

However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other things, there is no guarantee that future study results will be consistent with the results to date, or that Lilly will execute its strategies as planned.

然而，与任何医药产品一样，在药物的研发和商业化过程中存在重大风险和不确定性。除其他因素外，无法保证未来的研究结果将与迄今为止的结果一致，也无法保证礼来公司将按计划执行其战略。

For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release..

有关可能导致实际结果与礼来公司预期存在差异的上述及其他风险和不确定性的进一步讨论，请参阅礼来公司向美国证券交易委员会提交的10-K表和10-Q表文件。除法律要求外，礼来公司不承担更新前瞻性声明以反映本新闻稿发布日后发生的事件的义务。

Refer to:

请参考：

Kelly Hoffman;

凯莉·霍夫曼；

[email protected]

[email protected]

(Media)

（媒体）

Michael Czapar;

迈克尔·查帕尔；

[email protected]

[email protected]

(Investors)

（投资者）

SOURCE Eli Lilly and Company

来源：礼来公司

21

二十一

%

%

more press release views with

更多新闻稿浏览量，通过

Request a Demo

申请演示