罗氏（Roche）：Actemra，第3期研究：死亡率降低了44％
罗氏：Actemra
2020年9月18日15:22 JST
9月18日，瑞士罗氏公司宣布“ Actemra”（通用名称：Tosirizumab）在3期试验“ EMPACTA”中达到了其主要终点。 </ s> </ s> </ s>
简报：
Actemra被用于住院的COVID 19肺炎患者。
结果，与仅接受标准治疗的患者相比，需要戴呼吸器或死亡的机会减少了44％。 </ s> </ s> </ s>
Actemra尚未在任何国家被批准用于治疗COVID19相关的肺炎。
彭博社
https://www.bloomberg.co.jp/news/articles/2020-09-18/QGUAVXT0G1L001
Roche – Roche’s phase III EMPACTA study showed Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19 associated pneumonia
EMPACTA is the first global phase III trial to show efficacy with Actemra/RoActemra in COVID-19 associated pneumonia and the first with a focus on enrolling largely underserved and minority patients
There was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo
Roche plans to share these results with health authorities, including the US FDA
Basel, 18 September 2020 –
Roche
today announced that the phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra®/RoActemra® (tocilizumab) plus standard of care
were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]).
The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm.
The EMPACTA study did not identify any new safety signals for Actemra/RoActemra.
https://www.roche.com/media/releases/med-cor-2020-09-18.htm
Sep 18,2020 | Roche Announces Results of EMPACTA Study for Chugai’s Actemra for the Treatment of COVID-19 | News | CHUGAI PHARMACEUTICAL CO., LTD.
https://www.chugai-pharm.co.jp/english/news/detail/20200918142400_766.html