Evidence map›Paper›PMID 40534253›Full record

Observational studyHaemophilia : the official journal of the World Federation of Hemophilia2025

TSUBASA Study: Evaluating Association of Physical Activity and Bleeding Events in People With Haemophilia A Without Factor VIII Inhibitors Receiving Emicizumab.

Kagehiro Amano, Teruhisa Fujii, Akihiro Sawada, Azusa Nagao, Chiai Nagae, Masanori Nojima, Nobuaki Suzuki, Mika Kawano, Tomomi Shimura, Yoshimasa Sugao and 2 more

Abstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Haemophilia : the official journal of the World Federation of Hemophilia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Kagehiro AmanoDepartment of Laboratory Medicine, Tokyo Medical University, Tokyo, Japan.
Teruhisa FujiiDivision of Transfusion Medicine/Hemophilia Treatment Center, Hiroshima University Hospital, Hiroshima, Japan.ORCID https://orcid.org/0000-0002-6959-6346
Akihiro SawadaDepartment of Respiratory Medicine and Hematology, Hyogo Medical University, Hyogo, Japan.
Azusa NagaoDepartment of Blood Coagulation, Ogikubo Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0002-1126-1498
Chiai NagaeDepartment of Pediatrics, St. Marianna University School of Medicine, Kanagawa, Japan.
Masanori NojimaCenter for Translational Research/Division of Advanced Medicine Promotion, Institute of Medical Science, University of Tokyo, Tokyo, Japan.
Nobuaki SuzukiDepartment of Transfusion Medicine, Nagoya University Hospital, Aichi, Japan.
Mika KawanoChugai Pharmaceutical Co., Ltd., Tokyo, Japan.ORCID https://orcid.org/0009-0001-1632-5315
Tomomi ShimuraChugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Yoshimasa SugaoChugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Naoto HattoriChugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Keiji NogamiDepartment of Pediatrics, Nara Medical University, Nara, Japan.ORCID https://orcid.org/0000-0002-2415-2194

Funding

Chugai Pharmaceutical Co., Ltd
6 · The paper itself

Abstract

backgroundEmicizumab is approved for routine prophylaxis, but limited data exist investigating the relationship between bleeds and exercise in people with haemophilia A (PwHA) receiving emicizumab.

aimTo evaluate the relationship between physical activity and bleeding outcomes in Japanese PwHA receiving emicizumab prophylaxis.

methodsThis 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.

resultsOverall, 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).

conclusionThis 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.

Indexed as

Antibodies, BispecificAntibodies, Monoclonal, HumanizedExerciseHemophilia AHemorrhageAdolescentAdultAgedChildChild, PreschoolFactor VIIIFemaleHumansInfantInfant, NewbornMaleAntibodies, BispecificAntibodies, Monoclonal, HumanizedemicizumabFactor VIIIemicizumabexercisehaemophilia AhaemorrhageJapanphysical activityprospective studies

Identifiers

PMID40534253
PMCPMC12311898

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.