COVID-19：アクテムラ、重症に有効性示せず：海外第３相臨床試験（動画）：
COVID-19:Actemra/Roche shows no efficacy in severe cases: Phase3 trial:
COVID-19：罗氏Actemra在严重病例中未显示疗效：海外3期临床试验
COVID-19：
スイス・ロシュ：
7月２９日、中外製薬創製の抗体医薬「アクテムラ」が、「臨床試験で、主要評価項目を達成できなかった」と、発表しました。
重症患者を対象：
欧米で行った試験で、肺炎症状・死亡率改善に関する、有意データが得られていません。
「アクテムラ」は関節リウマチ治療薬として使われています。
新型コロナの重い肺炎「サイトカインストーム」に対する有効性が、期待されていました。
第３相臨床試験：
ロシュが重症入院患者４５０例を対象に行った第３相臨床試験。
主要評価項目に設定した症状改善度：
- プラセボと比較した、統計学的な有意差が認められていません。
- 死亡率もプラセボ群と同等。
- 退院までの期間はプラセボ群より短かったとのこと。
化学工業日報
https://www.chemicaldaily.co.jp/
Roche provides an update on the phase III COVACTA trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 associated pneumonia
COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality
The study is the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting
Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore
Actemra/RoActemra in other treatment settings, including in combination with an antiviral
Basel, 29 July – Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced that the phase III COVACTA study of Actemra®/RoActemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia.
In addition, the key secondary endpoints, which included the difference in patient mortality at week four, were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra.
The COVACTA study did not identify any new safety signals for Actemra/RoActemra.
Further analysis of the trial results is needed to fully understand the data. The results will be submitted for publication in a peer-reviewed journal.
“People around the world
are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four.
We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra in COVID-19 associated pneumonia,” said
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.
“We are grateful for the patients and physicians around the world who helped us to complete this study quickly during a public health crisis, while upholding the highest standards of scientific rigour. We will keep working to help combat the COVID-19 pandemic.”
The COVACTA trial
was conducted in collaboration with
the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.