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
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.
禮來在週一宣佈了VIVID-1第3期研究數據,評估了mirikizumab與安慰劑和積極對照(強生公司(NYSE: JNJ)的Stelara(ustekinumab))在成年患有中度至嚴重活動性克羅恩病的安全性和療效。
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).
數據顯示,在總體人群中,mirikizumab在第52周達到組織學反應的患者更多(58.2%對48.8%; p=0.0075)。
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諾和諾德、禮來可能面臨下行壓力,儘管在16種新肥胖藥物市場中佔據主導地位:參見這些藥物的名稱。
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).
在基線患有活動性組織學疾病並至少有一次生物製劑失敗的患者中,mirikizumab在第52周也顯示出更高的組織學反應(56.5%對41.3%; p=0.0064)和在第52周的內鏡-組織學反應(39.6%對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在中度至嚴重活動性克羅恩病患者中的整體安全性概要與患有潰瘍性結腸炎(UC)的患者的已知安全性概要一致。
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.
嚴重不良事件的發生頻率在安慰劑組大於mirikizumab組。最常見的不良事件包括COVID-19、貧血、關節痛、頭痛、上呼吸道感染、鼻咽炎和注射部位反應。
"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.
「作爲第一家報告與最近歐洲克羅恩病與潰瘍性結腸炎聯盟(ECCO)立場一致的嚴格組織學和內鏡-組織學結果的公司,禮來正在爲炎症性腸道疾病的長期治療反應評估設定更高的標準。這包括更爲宏偉的黏膜癒合目標,我們將其應用於比較mirikizumab的組織學-內鏡效果與ustekinumab。」禮來免疫學發展高級副總裁Mark Genovese表示。
Mirikizumab is approved for moderately to severely active ulcerative colitis (UC) in adults and is marketed as Omvoh.
Mirikizumab已獲批用於成人中度至嚴重活動性潰瘍性結腸炎(UC),並在市場上銷售爲Omvoh。
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在潰瘍性結腸炎方面有額外的進行中試驗,包括一項針對小兒患者的研究,以及一項評估Mirikizumab在成年患者中的長期療效和安全性的研究。
Price Action: LLY stock is up 0.17% at $933.68 at last check Monday.
股票價格走勢:LLY股票在上週一最新數據中上漲0.17%,報933.68美元。
Photo via Shutterstock
圖片來自shutterstock。
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