More Patients On Eli Lilly's Mirikizumab Achieved Histologic Response At One Year Compared To Johnson & Johnson's Drug
More Patients On Eli Lilly's Mirikizumab Achieved Histologic Response At One Year Compared To Johnson & Johnson's Drug
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).On Monday, Eli Lilly And Co (NYSE:LLY) announced data from a VIVID-1 Phase 3 study that evaluated the safety and efficacy of mirikizumab compared with a placebo and active control (Johnson & Johnson's (NYSE: JNJ) Stelara (ustekinumab)) in adults with moderately to severely active Crohn's disease.
周一，礼来公司（纽约证券交易所代码：LLY）公布了一项 VIVID-1 3期研究的数据，该研究评估了米利珠单抗与安慰剂和主动对照（强生（纽约证券交易所代码：JNJ）Stelara（ustekinumab））对中度至重度活跃性克罗恩病成人的安全性和有效性。
The data showed that more patients achieved histologic response were observed with mirikizumab at Week 52 in the overall population (58.2% versus 48.8%; p=0.0075).
数据显示，在第52周观察到使用米利珠单抗获得组织学反应的患者在总人群中（58.2％对48.8％；p=0.0075）。
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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先前至少有一次生物学衰竭的患者中，米利珠单抗在第52周也表现出更大的组织学反应（56.5％对41.3％；p=0.0064），在第52周表现出内窥镜组织学反应（39.6％对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).
mirikizumab在中度至重度活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。
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.
安慰剂中严重不良事件的发生频率高于米利珠单抗。最常见的不良事件是 COVID-19、贫血、关节痛、头痛、上呼吸道感染、鼻咽炎和注射部位反应。
"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, senior vice president of Lilly Immunology development.
“作为第一家报告克罗恩病的严格组织学和内组织学结果的公司，礼来公司正在为炎症性肠病的长期治疗反应的评估设定更高的标准，这些结果与ECCO最近的立场声明一致。这包括更雄心勃勃的粘膜愈合目标，我们应用这些目标来比较mirikizumab的组织内窥镜作用与ustekinumab的作用。” 礼来免疫学开发高级副总裁马克·热诺维斯说。
Mirikizumab is approved for moderately to severely active ulcerative colitis (UC) in adults and is marketed as Omvoh.
Mirikizumab获准用于成人中度至重度活动性溃疡性结肠炎（UC），并以Omvoh的名义上市。
Mirikizumab has additional ongoing trials in UC, including a study in pediatric patients and a study to evaluate the long-term efficacy and safety of mirikizumab in adults.
Mirikizumab在加州大学还有其他正在进行的试验，包括一项针对儿科患者的研究和一项评估mirikizumab对成人的长期疗效和安全性的研究。
Price Action: LLY stock is up 0.17% at $933.68 at last check Monday.
价格走势：周一最后一次检查时，LLY股价上涨0.17％，至933.68美元。
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