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Real-World Data on Bleeding Patterns of Hemophilia A Patients Treated with Emicizumab
Emicizumab (Hemlibra™) is approved for prophylaxis of hemophilia A (HA) patients. The HAVEN studies addressed bleeding reduction in emicizumab-treated patients, but real-world data on bleeding patterns during emicizumab therapy are lacking. We aimed to compare the occurrence of breakthrough bleeding...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8509656/ https://www.ncbi.nlm.nih.gov/pubmed/34640320 http://dx.doi.org/10.3390/jcm10194303 |
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author | Levy-Mendelovich, Sarina Brutman-Barazani, Tami Budnik, Ivan Avishai, Einat Barg, Assaf A. Levy, Tamara Misgav, Mudi Livnat, Tami Kenet, Gili |
author_facet | Levy-Mendelovich, Sarina Brutman-Barazani, Tami Budnik, Ivan Avishai, Einat Barg, Assaf A. Levy, Tamara Misgav, Mudi Livnat, Tami Kenet, Gili |
author_sort | Levy-Mendelovich, Sarina |
collection | PubMed |
description | Emicizumab (Hemlibra™) is approved for prophylaxis of hemophilia A (HA) patients. The HAVEN studies addressed bleeding reduction in emicizumab-treated patients, but real-world data on bleeding patterns during emicizumab therapy are lacking. We aimed to compare the occurrence of breakthrough bleeding at different time points, starting from emicizumab initiation. This longitudinal prospective observational cohort study included HA patients (n = 70, aged 1 month to 74.9 years) that completed at least 18 months of follow-up in our center. We analyzed the number of spontaneous and traumatic bleeds during selected time points of the study (“bleeding periods”). The percentage of traumatic and spontaneous bleeding episodes was not significantly different among “bleeding periods” (P = 0.053 and P = 0.092, respectively). Most trauma-related treated bleeds resulted from either hemarthrosis (53%) or head trauma (33%). Spontaneous bleeding episodes were mostly hemarthroses (80%). Potential associations of the patients’ age, annualized bleeding rate before emicizumab treatment, and the presence of inhibitors with spontaneous bleed occurrence were analyzed with binomial logistic regression. The odds of bleeding while on emicizumab increased by a factor of 1.029 (P = 0.034) for every one year of age. Conclusions: Our real-world data revealed that the risk of bleeding persists, especially in older patients, despite therapy with emicizumab. These data may help clinicians in counselling their patients and in planning their management. |
format | Online Article Text |
id | pubmed-8509656 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-85096562021-10-13 Real-World Data on Bleeding Patterns of Hemophilia A Patients Treated with Emicizumab Levy-Mendelovich, Sarina Brutman-Barazani, Tami Budnik, Ivan Avishai, Einat Barg, Assaf A. Levy, Tamara Misgav, Mudi Livnat, Tami Kenet, Gili J Clin Med Article Emicizumab (Hemlibra™) is approved for prophylaxis of hemophilia A (HA) patients. The HAVEN studies addressed bleeding reduction in emicizumab-treated patients, but real-world data on bleeding patterns during emicizumab therapy are lacking. We aimed to compare the occurrence of breakthrough bleeding at different time points, starting from emicizumab initiation. This longitudinal prospective observational cohort study included HA patients (n = 70, aged 1 month to 74.9 years) that completed at least 18 months of follow-up in our center. We analyzed the number of spontaneous and traumatic bleeds during selected time points of the study (“bleeding periods”). The percentage of traumatic and spontaneous bleeding episodes was not significantly different among “bleeding periods” (P = 0.053 and P = 0.092, respectively). Most trauma-related treated bleeds resulted from either hemarthrosis (53%) or head trauma (33%). Spontaneous bleeding episodes were mostly hemarthroses (80%). Potential associations of the patients’ age, annualized bleeding rate before emicizumab treatment, and the presence of inhibitors with spontaneous bleed occurrence were analyzed with binomial logistic regression. The odds of bleeding while on emicizumab increased by a factor of 1.029 (P = 0.034) for every one year of age. Conclusions: Our real-world data revealed that the risk of bleeding persists, especially in older patients, despite therapy with emicizumab. These data may help clinicians in counselling their patients and in planning their management. MDPI 2021-09-22 /pmc/articles/PMC8509656/ /pubmed/34640320 http://dx.doi.org/10.3390/jcm10194303 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Levy-Mendelovich, Sarina Brutman-Barazani, Tami Budnik, Ivan Avishai, Einat Barg, Assaf A. Levy, Tamara Misgav, Mudi Livnat, Tami Kenet, Gili Real-World Data on Bleeding Patterns of Hemophilia A Patients Treated with Emicizumab |
title | Real-World Data on Bleeding Patterns of Hemophilia A Patients Treated with Emicizumab |
title_full | Real-World Data on Bleeding Patterns of Hemophilia A Patients Treated with Emicizumab |
title_fullStr | Real-World Data on Bleeding Patterns of Hemophilia A Patients Treated with Emicizumab |
title_full_unstemmed | Real-World Data on Bleeding Patterns of Hemophilia A Patients Treated with Emicizumab |
title_short | Real-World Data on Bleeding Patterns of Hemophilia A Patients Treated with Emicizumab |
title_sort | real-world data on bleeding patterns of hemophilia a patients treated with emicizumab |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8509656/ https://www.ncbi.nlm.nih.gov/pubmed/34640320 http://dx.doi.org/10.3390/jcm10194303 |
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