Yasaka Masahiro, Yokota Hiroyuki, Suzuki Michiyasu, Asakura Hidesaku, Yamane Teiichi, Ogi Yukako, Ochiai Kaori, Nakayama Daisuke
Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Department of Emergency and Critical Care Medicine, Nippon Medical School, Tokyo, Japan.
Cardiol Ther. 2020 Jun;9(1):167-188. doi: 10.1007/s40119-020-00165-8. Epub 2020 Mar 9.
Idarucizumab, a monoclonal antibody fragment, was developed to reverse the anticoagulant effect of dabigatran, and it was approved in Japan in September 2016. An all-case post-marketing surveillance is ongoing to collect data in Japanese patients treated with idarucizumab who had serious bleeding (Group A) or required an urgent procedure (Group B).
The primary endpoint was the incidence of adverse drug reactions (ADRs). The secondary endpoint was the maximum extent of reversal of the anticoagulant effect of dabigatran based on activated partial thromboplastin time (aPTT) within 4 h after idarucizumab administration.
This interim analysis included 262 patients who received idarucizumab. Eighteen patients (6.9%) experienced ADRs within 4 weeks. The reversal effect of idarucizumab based on aPTT within 4 h after idarucizumab administration was assessed in 30 patients and the median maximum percentage reversal was 100%. In Group A, the median time to bleeding cessation in patients without intracranial bleeding was 3.3 h. In Group B, normal intraoperative hemostasis was reported in 63 patients (72.4%).
The results of this interim analysis suggest that idarucizumab is safe and effective for the reversal of dabigatran in Japanese patients in a real-world setting, and support the continued use of idarucizumab.
ClinicalTrials.gov identifier, NCT02946931.
艾达赛珠单抗是一种单克隆抗体片段，用于逆转达比加群的抗凝作用，并于2016年9月在日本获批。目前正在进行一项全病例上市后监测，以收集接受艾达赛珠单抗治疗的日本严重出血患者（A组）或需要紧急手术的患者（B组）的数据。
主要终点为药物不良反应（ADR）的发生率。次要终点为艾达赛珠单抗给药后4小时内基于活化部分凝血活酶时间（aPTT）的达比加群抗凝作用的最大逆转程度。
这项中期分析纳入了262例接受艾达赛珠单抗治疗的患者。18例患者（6.9%）在4周内出现了药物不良反应。对30例患者评估了艾达赛珠单抗给药后4小时内基于aPTT的逆转效果，最大逆转百分比中位数为100%。在A组中，无颅内出血患者的出血停止中位时间为3.3小时。在B组中，63例患者（72.4%）报告术中止血正常。
这项中期分析结果表明，在真实世界环境中，艾达赛珠单抗在日本患者中逆转达比加群的作用安全有效，并支持继续使用艾达赛珠单抗。
ClinicalTrials.gov标识符，NCT02946931。
