| 論文種別 | 原著(症例報告除く) |
| 言語種別 | 英語 |
| 査読の有無 | 査読あり |
| 表題 | Association of physical activity with bleeding events and safety in patients with haemophilia A starting emicizumab prophylaxis: an interim analysis of the TSUBASA study. |
| 掲載誌名 | 正式名：International journal of hematology 略 称：Int J Hematol ISSNコード：18653774/09255710 |
| 掲載区分 | 国外 |
| 巻・号・頁 | 119(1),pp.14-23 |
| 著者・共著者 | Keiji Nogami, Teruhisa Fujii, Akihiro Sawada, Azusa Nagao, Chiai Nagae, Masanori Nojima, Nobuaki Suzuki, Daisuke Nosaka, Tomomi Shimura, Yoshimasa Sugao, Kagehiro Amano |
| 発行年月 | 2024/01 |
| 概要 | 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 | 10.1007/s12185-023-03679-8 |
| PMID | 38100026 |