Eli Lilly-Incyte's Baricitinib Study In Hospitalized COVID-19 Patients Fails To Meet Main Goal
Eli Lilly-Incyte's Baricitinib Study In Hospitalized COVID-19 Patients Fails To Meet Main Goal
礼来公司在住院新冠肺炎患者中的巴利替尼研究未能达到主要目标
- Eli Lilly And Co (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) have reported results from the COV-BARRIER Phase 3 study evaluating baricitinib plus standard of care (SoC) versus placebo plus SoC in hospitalized COVID-19 patients.
- The trial did not meet statistical significance on the primary endpoint of the proportion of participants progressing to non-invasive ventilation or death by Day 28.
- Baricitinib-treated patients were 2.7% less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death.
- Treatment with baricitinib in addition to SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) resulted in a significant reduction in death from any cause by 38%.
- A numerical reduction in mortality was observed for all baseline severity subgroups of baricitinib-treated patients. It was most pronounced for patients receiving non-invasive mechanical ventilation at baseline (17.5% versus 29.4% for baricitinib plus SoC versus SoC.
- The frequency of adverse events was generally similar in the baricitinib and placebo groups.
- Severe infections and venous thromboembolism occurred in 8.5% and 2.7% of patients treated with baricitinib, respectively, versus 9.8 % and 2.5% on placebo.
- Lilly intends to publish detailed results of this study in a peer-reviewed journal in the coming months.
- The company will share the data from the study with regulatory authorities in the U.S., European Union, and other geographies to evaluate the next steps for baricitinib in hospitalized COVID-19 patients.
- Yesterday, the FDA extended the review period for baricitinib in atopic dermatitis by three months.
- Price Action: LLY shares are up 0.3% at $182.8 in premarket trading on the last check Thursday, while INCY shares closed 2.2% lower at $81.38 on Wednesday.
- Eli Lilly And Co (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) have reported results from the COV-BARRIER Phase 3 study evaluating baricitinib plus standard of care (SoC) versus placebo plus SoC in hospitalized COVID-19 patients.
- The trial did not meet statistical significance on the primary endpoint of the proportion of participants progressing to non-invasive ventilation or death by Day 28.
- Baricitinib-treated patients were 2.7% less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death.
- Treatment with baricitinib in addition to SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) resulted in a significant reduction in death from any cause by 38%.
- A numerical reduction in mortality was observed for all baseline severity subgroups of baricitinib-treated patients. It was most pronounced for patients receiving non-invasive mechanical ventilation at baseline (17.5% versus 29.4% for baricitinib plus SoC versus SoC.
- The frequency of adverse events was generally similar in the baricitinib and placebo groups.
- Severe infections and venous thromboembolism occurred in 8.5% and 2.7% of patients treated with baricitinib, respectively, versus 9.8 % and 2.5% on placebo.
- Lilly intends to publish detailed results of this study in a peer-reviewed journal in the coming months.
- The company will share the data from the study with regulatory authorities in the U.S., European Union, and other geographies to evaluate the next steps for baricitinib in hospitalized COVID-19 patients.
- Yesterday, the FDA extended the review period for baricitinib in atopic dermatitis by three months.
- Price Action: LLY shares are up 0.3% at $182.8 in premarket trading on the last check Thursday, while INCY shares closed 2.2% lower at $81.38 on Wednesday.
- 礼来公司(纽约证券交易所股票代码：LLY)和Incell公司美国疾病控制与预防中心(纳斯达克股票代码：INCY)已经报告了COV-BALKAR第三阶段研究的结果，该研究评估了住院新冠肺炎患者使用巴利替尼加标准治疗(SOC)与安慰剂加SOC治疗的效果。
- 在参与者进展为无创通气或在第28天死亡的比例这一主要终点上，该试验没有达到统计学意义。
- 接受巴利西尼治疗的患者进展为机械通气(非侵入性或机械性)或死亡的可能性比接受标准护理的患者低2.7%。
- 在SOC的基础上加用巴利西尼治疗(包括79%接受皮质类固醇治疗，19%接受瑞希韦治疗，有些人同时接受这两种治疗)，使各种原因的死亡率显著降低38%。
- 巴利西尼治疗患者的所有基线严重亚组的死亡率均有数字上的降低。在基线水平接受无创机械通气的患者中这一问题最为明显(巴利替尼加SOC组与SOC组分别为17.5%和29.4%。
- 巴利西尼组和安慰剂组的不良事件发生频率大致相似。
- 接受巴利替尼治疗的患者中，严重感染和静脉血栓栓塞的发生率分别为8.5%和2.7%，而服用安慰剂的患者分别为9.8%和2.5%。
- 礼来公司打算在未来几个月内在一份同行评议的期刊上发表这项研究的详细结果。
- 该公司将与美国、欧盟和其他地区的监管机构分享这项研究的数据，以评估住院的新冠肺炎患者使用巴利替尼的下一步措施。
- 昨天，FDA将巴利替尼治疗特应性皮炎的审查期延长了三个月。
- 价格行动：在周四的盘前交易中，Lly股价上涨0.3%，至182.8美元，而INCY股价周三收盘下跌2.2%，至81.38美元。
译文内容由第三方软件翻译。
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