Association of physical activity with bleeding events and safety in patients with haemophilia A starting emicizumab prophylaxis: an interim analysis of the TSUBASA study
Introduction Little information exists on the relationship between bleeding outcomes and physical activity in patients with haemophilia A (PwHA). Aim This interim analysis of the TSUBASA study (UMIN-CTR ID: UMIN000037448) evaluated the association of physical activity with bleeding and safety in PwH...
Gespeichert in:
| Veröffentlicht in: | International journal of hematology 2024-01, Vol.119 (1), p.14-23 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 23 |
|---|---|
| container_issue | 1 |
| container_start_page | 14 |
| container_title | International journal of hematology |
| container_volume | 119 |
| creator | Nogami, Keiji Fujii, Teruhisa Sawada, Akihiro Nagao, Azusa Nagae, Chiai Nojima, Masanori Suzuki, Nobuaki Nosaka, Daisuke Shimura, Tomomi Sugao, Yoshimasa Amano, Kagehiro |
| description | Introduction
Little information exists on the relationship between bleeding outcomes and physical activity in patients with haemophilia A (PwHA).
Aim
This interim analysis of the TSUBASA study (UMIN-CTR ID: UMIN000037448) evaluated the association of physical activity with bleeding and safety in PwHA starting emicizumab.
Methods
PwHA without factor VIII inhibitors were recruited. Physical activity and bleed data were obtained using an electronic patient-reported outcome application and wearable activity tracker. Adverse events (AEs) were documented.
Results
At data cut-off (31-May-2021), 107 PwHA were enrolled, with a median (range) age of 35 (0–73) years. Physical activity data were obtained for 74 participants. Of these, 47 (63.5%) recorded a total of 396 exercise events. The most common exercise events were walking (32.4%), cycling (14.9%), and football (5.4%). Two (0.5%) exercise events in the same individual were associated with bleeding (running, weight training).
The safety analysis population consisted of 106 participants treated with emicizumab (median observation period: 241.5 days). Twenty-one (19.8%) participants experienced a total of 39 AEs. Five (4.7%) experienced a serious AE, none of which was emicizumab-related, and three (2.8%) experienced an adverse drug reaction.
Conclusions
PwHA receiving emicizumab in the TSUBASA study experienced minimal bleeding associated with physical activity.
Trial registration
Trial registration: UMIN-CTR ID: UMIN000037448. |
| doi_str_mv | 10.1007/s12185-023-03679-8 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10769904</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2902971749</sourcerecordid><originalsourceid>FETCH-LOGICAL-c475t-b6884a0706cb98622bbcb4099bb55d632f7debdf0a02265bcc78be357c0001cc3</originalsourceid><addsrcrecordid>eNp9kstu1DAUhi0EotPCC7BAltiwCRzbSRyzQUNVLlIlFm3Xlu04E1dJHGJnILwRb4kzU8plwcqW__985-KD0DMCrwgAfx0IJVWRAWUZsJKLrHqANqQqi4xxnj9EGxC0yApO4ASdhnALQDjk_DE6YVUCAC036Mc2BG-cis4P2Dd4bJfgjOqwMtHtXVzwVxdbrDtrazfssN3bIQashhoH1dikuwGPKfzwfPC2yvZ-bF3nFN7iENUUD5G9M-773CuNxynpS6e-ufAmoRIi2sn16aq6lD6shcTW4uurm3fbq5Ux18sT9KhRXbBP784zdPP-4vr8Y3b5-cOn8-1lZnJexEyXVZUr4FAaLaqSUq2NzkEIrYuiLhlteG113YACSstCG8MrbVnBTZoIMYadobdH7jjr3tYmNTapTo6pQDUt0isn_1YG18qd30sCvBQC8kR4eUeY_JfZhih7F4ztOjVYPwdJBVDBCc9Fsr74x3rr5ymNYXUlIAMGVXLRo8tMPoTJNvfVEJDrKsjjKsi0CvKwCnINev5nH_chv_4-GdjREJI07Oz0O_d_sD8B9ZzDgw</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2910730308</pqid></control><display><type>article</type><title>Association of physical activity with bleeding events and safety in patients with haemophilia A starting emicizumab prophylaxis: an interim analysis of the TSUBASA study</title><source>SpringerLink Journals - AutoHoldings</source><creator>Nogami, Keiji ; Fujii, Teruhisa ; Sawada, Akihiro ; Nagao, Azusa ; Nagae, Chiai ; Nojima, Masanori ; Suzuki, Nobuaki ; Nosaka, Daisuke ; Shimura, Tomomi ; Sugao, Yoshimasa ; Amano, Kagehiro</creator><creatorcontrib>Nogami, Keiji ; Fujii, Teruhisa ; Sawada, Akihiro ; Nagao, Azusa ; Nagae, Chiai ; Nojima, Masanori ; Suzuki, Nobuaki ; Nosaka, Daisuke ; Shimura, Tomomi ; Sugao, Yoshimasa ; Amano, Kagehiro</creatorcontrib><description>Introduction
Little information exists on the relationship between bleeding outcomes and physical activity in patients with haemophilia A (PwHA).
Aim
This interim analysis of the TSUBASA study (UMIN-CTR ID: UMIN000037448) evaluated the association of physical activity with bleeding and safety in PwHA starting emicizumab.
Methods
PwHA without factor VIII inhibitors were recruited. Physical activity and bleed data were obtained using an electronic patient-reported outcome application and wearable activity tracker. Adverse events (AEs) were documented.
Results
At data cut-off (31-May-2021), 107 PwHA were enrolled, with a median (range) age of 35 (0–73) years. Physical activity data were obtained for 74 participants. Of these, 47 (63.5%) recorded a total of 396 exercise events. The most common exercise events were walking (32.4%), cycling (14.9%), and football (5.4%). Two (0.5%) exercise events in the same individual were associated with bleeding (running, weight training).
The safety analysis population consisted of 106 participants treated with emicizumab (median observation period: 241.5 days). Twenty-one (19.8%) participants experienced a total of 39 AEs. Five (4.7%) experienced a serious AE, none of which was emicizumab-related, and three (2.8%) experienced an adverse drug reaction.
Conclusions
PwHA receiving emicizumab in the TSUBASA study experienced minimal bleeding associated with physical activity.
Trial registration
Trial registration: UMIN-CTR ID: UMIN000037448.</description><identifier>ISSN: 0925-5710</identifier><identifier>EISSN: 1865-3774</identifier><identifier>DOI: 10.1007/s12185-023-03679-8</identifier><identifier>PMID: 38100026</identifier><language>eng</language><publisher>Singapore: Springer Nature Singapore</publisher><subject>Bleeding ; Coagulation factors ; Exercise ; Hematology ; Hemophilia ; Medicine ; Medicine & Public Health ; Monoclonal antibodies ; Oncology ; Original ; Original Article ; Physical activity ; Physical fitness ; Physical training ; Prophylaxis ; Safety ; Tracking devices ; Weightlifting</subject><ispartof>International journal of hematology, 2024-01, Vol.119 (1), p.14-23</ispartof><rights>The Author(s) 2023</rights><rights>2023. The Author(s).</rights><rights>The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c475t-b6884a0706cb98622bbcb4099bb55d632f7debdf0a02265bcc78be357c0001cc3</citedby><cites>FETCH-LOGICAL-c475t-b6884a0706cb98622bbcb4099bb55d632f7debdf0a02265bcc78be357c0001cc3</cites><orcidid>0000-0002-2415-2194</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12185-023-03679-8$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12185-023-03679-8$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38100026$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nogami, Keiji</creatorcontrib><creatorcontrib>Fujii, Teruhisa</creatorcontrib><creatorcontrib>Sawada, Akihiro</creatorcontrib><creatorcontrib>Nagao, Azusa</creatorcontrib><creatorcontrib>Nagae, Chiai</creatorcontrib><creatorcontrib>Nojima, Masanori</creatorcontrib><creatorcontrib>Suzuki, Nobuaki</creatorcontrib><creatorcontrib>Nosaka, Daisuke</creatorcontrib><creatorcontrib>Shimura, Tomomi</creatorcontrib><creatorcontrib>Sugao, Yoshimasa</creatorcontrib><creatorcontrib>Amano, Kagehiro</creatorcontrib><title>Association of physical activity with bleeding events and safety in patients with haemophilia A starting emicizumab prophylaxis: an interim analysis of the TSUBASA study</title><title>International journal of hematology</title><addtitle>Int J Hematol</addtitle><addtitle>Int J Hematol</addtitle><description>Introduction
Little information exists on the relationship between bleeding outcomes and physical activity in patients with haemophilia A (PwHA).
Aim
This interim analysis of the TSUBASA study (UMIN-CTR ID: UMIN000037448) evaluated the association of physical activity with bleeding and safety in PwHA starting emicizumab.
Methods
PwHA without factor VIII inhibitors were recruited. Physical activity and bleed data were obtained using an electronic patient-reported outcome application and wearable activity tracker. Adverse events (AEs) were documented.
Results
At data cut-off (31-May-2021), 107 PwHA were enrolled, with a median (range) age of 35 (0–73) years. Physical activity data were obtained for 74 participants. Of these, 47 (63.5%) recorded a total of 396 exercise events. The most common exercise events were walking (32.4%), cycling (14.9%), and football (5.4%). Two (0.5%) exercise events in the same individual were associated with bleeding (running, weight training).
The safety analysis population consisted of 106 participants treated with emicizumab (median observation period: 241.5 days). Twenty-one (19.8%) participants experienced a total of 39 AEs. Five (4.7%) experienced a serious AE, none of which was emicizumab-related, and three (2.8%) experienced an adverse drug reaction.
Conclusions
PwHA receiving emicizumab in the TSUBASA study experienced minimal bleeding associated with physical activity.
Trial registration
Trial registration: UMIN-CTR ID: UMIN000037448.</description><subject>Bleeding</subject><subject>Coagulation factors</subject><subject>Exercise</subject><subject>Hematology</subject><subject>Hemophilia</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Monoclonal antibodies</subject><subject>Oncology</subject><subject>Original</subject><subject>Original Article</subject><subject>Physical activity</subject><subject>Physical fitness</subject><subject>Physical training</subject><subject>Prophylaxis</subject><subject>Safety</subject><subject>Tracking devices</subject><subject>Weightlifting</subject><issn>0925-5710</issn><issn>1865-3774</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kstu1DAUhi0EotPCC7BAltiwCRzbSRyzQUNVLlIlFm3Xlu04E1dJHGJnILwRb4kzU8plwcqW__985-KD0DMCrwgAfx0IJVWRAWUZsJKLrHqANqQqi4xxnj9EGxC0yApO4ASdhnALQDjk_DE6YVUCAC036Mc2BG-cis4P2Dd4bJfgjOqwMtHtXVzwVxdbrDtrazfssN3bIQashhoH1dikuwGPKfzwfPC2yvZ-bF3nFN7iENUUD5G9M-773CuNxynpS6e-ufAmoRIi2sn16aq6lD6shcTW4uurm3fbq5Ux18sT9KhRXbBP784zdPP-4vr8Y3b5-cOn8-1lZnJexEyXVZUr4FAaLaqSUq2NzkEIrYuiLhlteG113YACSstCG8MrbVnBTZoIMYadobdH7jjr3tYmNTapTo6pQDUt0isn_1YG18qd30sCvBQC8kR4eUeY_JfZhih7F4ztOjVYPwdJBVDBCc9Fsr74x3rr5ymNYXUlIAMGVXLRo8tMPoTJNvfVEJDrKsjjKsi0CvKwCnINev5nH_chv_4-GdjREJI07Oz0O_d_sD8B9ZzDgw</recordid><startdate>20240101</startdate><enddate>20240101</enddate><creator>Nogami, Keiji</creator><creator>Fujii, Teruhisa</creator><creator>Sawada, Akihiro</creator><creator>Nagao, Azusa</creator><creator>Nagae, Chiai</creator><creator>Nojima, Masanori</creator><creator>Suzuki, Nobuaki</creator><creator>Nosaka, Daisuke</creator><creator>Shimura, Tomomi</creator><creator>Sugao, Yoshimasa</creator><creator>Amano, Kagehiro</creator><general>Springer Nature Singapore</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7T5</scope><scope>7T7</scope><scope>7TM</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-2415-2194</orcidid></search><sort><creationdate>20240101</creationdate><title>Association of physical activity with bleeding events and safety in patients with haemophilia A starting emicizumab prophylaxis: an interim analysis of the TSUBASA study</title><author>Nogami, Keiji ; Fujii, Teruhisa ; Sawada, Akihiro ; Nagao, Azusa ; Nagae, Chiai ; Nojima, Masanori ; Suzuki, Nobuaki ; Nosaka, Daisuke ; Shimura, Tomomi ; Sugao, Yoshimasa ; Amano, Kagehiro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c475t-b6884a0706cb98622bbcb4099bb55d632f7debdf0a02265bcc78be357c0001cc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Bleeding</topic><topic>Coagulation factors</topic><topic>Exercise</topic><topic>Hematology</topic><topic>Hemophilia</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Monoclonal antibodies</topic><topic>Oncology</topic><topic>Original</topic><topic>Original Article</topic><topic>Physical activity</topic><topic>Physical fitness</topic><topic>Physical training</topic><topic>Prophylaxis</topic><topic>Safety</topic><topic>Tracking devices</topic><topic>Weightlifting</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nogami, Keiji</creatorcontrib><creatorcontrib>Fujii, Teruhisa</creatorcontrib><creatorcontrib>Sawada, Akihiro</creatorcontrib><creatorcontrib>Nagao, Azusa</creatorcontrib><creatorcontrib>Nagae, Chiai</creatorcontrib><creatorcontrib>Nojima, Masanori</creatorcontrib><creatorcontrib>Suzuki, Nobuaki</creatorcontrib><creatorcontrib>Nosaka, Daisuke</creatorcontrib><creatorcontrib>Shimura, Tomomi</creatorcontrib><creatorcontrib>Sugao, Yoshimasa</creatorcontrib><creatorcontrib>Amano, Kagehiro</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Nucleic Acids Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>International journal of hematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nogami, Keiji</au><au>Fujii, Teruhisa</au><au>Sawada, Akihiro</au><au>Nagao, Azusa</au><au>Nagae, Chiai</au><au>Nojima, Masanori</au><au>Suzuki, Nobuaki</au><au>Nosaka, Daisuke</au><au>Shimura, Tomomi</au><au>Sugao, Yoshimasa</au><au>Amano, Kagehiro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Association of physical activity with bleeding events and safety in patients with haemophilia A starting emicizumab prophylaxis: an interim analysis of the TSUBASA study</atitle><jtitle>International journal of hematology</jtitle><stitle>Int J Hematol</stitle><addtitle>Int J Hematol</addtitle><date>2024-01-01</date><risdate>2024</risdate><volume>119</volume><issue>1</issue><spage>14</spage><epage>23</epage><pages>14-23</pages><issn>0925-5710</issn><eissn>1865-3774</eissn><abstract>Introduction
Little information exists on the relationship between bleeding outcomes and physical activity in patients with haemophilia A (PwHA).
Aim
This interim analysis of the TSUBASA study (UMIN-CTR ID: UMIN000037448) evaluated the association of physical activity with bleeding and safety in PwHA starting emicizumab.
Methods
PwHA without factor VIII inhibitors were recruited. Physical activity and bleed data were obtained using an electronic patient-reported outcome application and wearable activity tracker. Adverse events (AEs) were documented.
Results
At data cut-off (31-May-2021), 107 PwHA were enrolled, with a median (range) age of 35 (0–73) years. Physical activity data were obtained for 74 participants. Of these, 47 (63.5%) recorded a total of 396 exercise events. The most common exercise events were walking (32.4%), cycling (14.9%), and football (5.4%). Two (0.5%) exercise events in the same individual were associated with bleeding (running, weight training).
The safety analysis population consisted of 106 participants treated with emicizumab (median observation period: 241.5 days). Twenty-one (19.8%) participants experienced a total of 39 AEs. Five (4.7%) experienced a serious AE, none of which was emicizumab-related, and three (2.8%) experienced an adverse drug reaction.
Conclusions
PwHA receiving emicizumab in the TSUBASA study experienced minimal bleeding associated with physical activity.
Trial registration
Trial registration: UMIN-CTR ID: UMIN000037448.</abstract><cop>Singapore</cop><pub>Springer Nature Singapore</pub><pmid>38100026</pmid><doi>10.1007/s12185-023-03679-8</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-2415-2194</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0925-5710 |
| ispartof | International journal of hematology, 2024-01, Vol.119 (1), p.14-23 |
| issn | 0925-5710 1865-3774 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10769904 |
| source | SpringerLink Journals - AutoHoldings |
| subjects | Bleeding Coagulation factors Exercise Hematology Hemophilia Medicine Medicine & Public Health Monoclonal antibodies Oncology Original Original Article Physical activity Physical fitness Physical training Prophylaxis Safety Tracking devices Weightlifting |
| title | Association of physical activity with bleeding events and safety in patients with haemophilia A starting emicizumab prophylaxis: an interim analysis of the TSUBASA study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-08T16%3A06%3A46IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Association%20of%20physical%20activity%20with%20bleeding%20events%20and%20safety%20in%20patients%20with%20haemophilia%20A%20starting%20emicizumab%20prophylaxis:%20an%20interim%20analysis%20of%20the%20TSUBASA%20study&rft.jtitle=International%20journal%20of%20hematology&rft.au=Nogami,%20Keiji&rft.date=2024-01-01&rft.volume=119&rft.issue=1&rft.spage=14&rft.epage=23&rft.pages=14-23&rft.issn=0925-5710&rft.eissn=1865-3774&rft_id=info:doi/10.1007/s12185-023-03679-8&rft_dat=%3Cproquest_pubme%3E2902971749%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2910730308&rft_id=info:pmid/38100026&rfr_iscdi=true |