Amano Kagehiro, Fujii Teruhisa, Sawada Akihiro, Nagao Azusa, Nagae Chiai, Nojima Masanori, Suzuki Nobuaki, Kawano Mika, Shimura Tomomi, Sugao Yoshimasa, Hattori Naoto, Nogami Keiji
Department of Laboratory Medicine, Tokyo Medical University, Tokyo, Japan.
Division of Transfusion Medicine/Hemophilia Treatment Center, Hiroshima University Hospital, Hiroshima, Japan.
Haemophilia. 2025 Jul;31(4):703-712. doi: 10.1111/hae.70070. Epub 2025 Jun 18.
Emicizumab is approved for routine prophylaxis, but limited data exist investigating the relationship between bleeds and exercise in people with haemophilia A (PwHA) receiving emicizumab.
To evaluate the relationship between physical activity and bleeding outcomes in Japanese PwHA receiving emicizumab prophylaxis.
This prospective, multicentre, observational study was conducted in Japanese PwHA initiating emicizumab between November 2019 and October 2021. Physical activity and bleeding events were reported using an electronic patient-reported outcomes application, while activity intensity was collected by a wearable activity tracker worn over five 8-day monitoring periods. Data on safety were recorded by investigators using electronic case report forms. Quality of life data were also collected and will be reported in a separate publication.
Overall, 129 participants enrolled. Median age was 32 years (range 0-73), and 83.7% of participants had severe HA. Overall, 73 participants performed 968 exercise events, with 18.8% and 6.0% of events classified as moderate and high risk, respectively. Two (0.2%) exercise events were associated with bleeding: one basketball (moderate risk) and one fishing (low risk). In total, 137 adverse events (AEs) were reported in 62 participants. No serious AEs were emicizumab-related. The mean annualised treated bleed rate was 1.9 and 51 (39.5%) participants experienced zero bleeds during the study period (97 weeks).
This study suggests that PwHA receiving emicizumab prophylaxis can participate in a wide range of physical activities with minimal bleeding risk, which supports their access to the health benefits of exercise. Emicizumab remains well tolerated.
艾美赛珠单抗已获批用于常规预防，但关于接受艾美赛珠单抗治疗的甲型血友病患者（PwHA）出血与运动之间关系的研究数据有限。
评估接受艾美赛珠单抗预防治疗的日本PwHA的身体活动与出血结局之间的关系。
这项前瞻性、多中心、观察性研究在2019年11月至2021年10月期间开始使用艾美赛珠单抗的日本PwHA中进行。使用电子患者报告结局应用程序报告身体活动和出血事件，同时通过在五个8天监测期佩戴的可穿戴活动追踪器收集活动强度。研究人员使用电子病例报告表记录安全性数据。还收集了生活质量数据，并将在另一篇出版物中报告。
总体而言，129名参与者入组。中位年龄为32岁（范围0 - 73岁），83.7%的参与者患有严重血友病A。总体而言，73名参与者进行了968次运动事件，其中18.8%和6.0%的事件分别被归类为中度和高风险。两次（0.2%）运动事件与出血相关：一次篮球运动（中度风险）和一次钓鱼（低风险）。总共62名参与者报告了137例不良事件（AE）。没有严重AE与艾美赛珠单抗相关。平均年化治疗出血率为1.9，51名（39.5%）参与者在研究期间（97周）无出血。
本研究表明，接受艾美赛珠单抗预防治疗的PwHA可以参与广泛的体育活动，出血风险最小，这支持他们获得运动对健康的益处。艾美赛珠单抗耐受性良好。
