PB0641 - Association Between Physical Activity and Bleeding Events in People with Hemophilia A Receiving Emicizumab Prophylaxis: Interim Analysis of the TSUBASA Study

Monday, June 26, 2023

18:30 – 19:30 ET

Room: Exhibition

Presenting Author(s)

Teruhisa Fujii, MD (he/him/his)

Associate Professor
Division of Transfusion Medicine/Hemophilia Treatment Center, Hiroshima University Hospital, Hiroshima, Japan
Hiroshima, Hiroshima, Japan

Co-Author(s)

KA

Kagehiro Amano

Professor
Department of Laboratory Medicine, Tokyo Medical University
Tokyo, Tokyo, Japan
AS

Akihiro Sawada

MD
Department of Respiratory Medicine and Hematology, Hyogo Medical University, Hyogo, Japan
Hyogo, Hyogo, Japan
Azusa Nagao, MD, MSc

MD
Department of Blood Coagulation, Ogikubo Hospital, Tokyo, Japan
Tokyo, Tokyo, Japan
CN

Chiai Nagae

MD
Department of Pediatrics, St. Marianna University School of Medicine, Kanagawa, Japan
Kanagawa, Kanagawa, Japan
MN

Masanori Nojima

Associate Professor
Center for Translational Research/Division of Advanced Medicine Promotion, Institute of Medical Science, University of Tokyo, Tokyo, Japan
Tokyo, Tokyo, Japan
NS

Nobuaki Suzuki

Service Lecturer
Department of Transfusion Medicine, Nagoya University Hospital, Nagoya, Japan
Nagoya, Aichi, Japan
DN

Daisuke Nosaka

Medical Science
Chugai Pharmaceutical Co., Ltd, Tokyo, Japan
Tokyo, Tokyo, Japan
TS

Tomomi Shimura

Biostatistics
Chugai Pharmaceutical Co., Ltd, Tokyo, Japan
Tokyo, Tokyo, Japan
YS

Yoshimasa Sugao

Medical Science
Chugai Pharmaceutical Co., Ltd, Tokyo, Japan
Tokyo, Tokyo, Japan
KN

Keiji Nogami

Professor
Nara Medical University, Nara, Japan
Nara, Nara, Japan

Background:

Background: Limited data are available on the relationship between bleeding outcomes and physical activity in people with hemophilia A (PwHA) receiving emicizumab prophylaxis. The TSUBASA study (UMIN-CTR-ID: UMIN000037448) evaluates the association between physical activity and bleeding events, safety, and quality of life (QoL) in PwHA initiating emicizumab.

Aims: To present data from an interim analysis of the TSUBASA study.

Methods: PwHA without factor VIII inhibitors scheduled to begin emicizumab were recruited from 50 sites in Japan. Participants received emicizumab at one of three approved maintenance dosages. Physical activity (participants ≥6 years old), bleeding events, and QoL were captured using the ePRO application; a wearable activity tracker was employed. Adverse events (AEs) were documented. Informed consent and ethics approval were obtained. Funded by Chugai Pharmaceutical Co., Ltd.

Results: By data cut-off (31-May-2022), 129 PwHA were enrolled and received emicizumab (safety population). The median (range) age was 32 (0–73) years; 108 (83.7%) participants had severe HA and 21 (16.3%) had moderate HA (Table 1). Of the 129 participants, 100 had data on physical activities, with 71 (71.0%) participants recording ≥1 activity event (Table 2). The most common physical activities were walking (37; 37.0%), cycling (15; 15.0%), and swimming (8; 8.0%). A total of 866 activity events were documented, with a median (interquartile range [IQR]) duration of 30 (15–60) minutes. Three activity events were associated with bleeding: running and weight training in one participant and fishing in another.
Overall, 42 (32.6%) of the 129 PwHA in the safety population experienced a total of 88 AEs (median [range] follow-up: 561 [47–917] days). A total of 10 (7.8%) participants experienced a serious AE and 4 (3.1%) experienced a total of 5 adverse drug reactions (2 injection-site erythema; 3 injection-site reactions).

Conclusion(s): For PwHA receiving emicizumab in the TSUBASA study, there were few bleeding events associated with physical activity.