Real-world data on bleeding patterns of hemophilia a patients treated with emicizumab

Sarina Levy-Mendelovich, Tami Brutman-Barazani, Ivan Budnik, Einat Avishai, Assaf A. Barg, Tamara Levy, Mudi Misgav, Tami Livnat, Gili Kenet

Research output: Contribution to journalArticlepeer-review

18 Scopus citations


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.

Original languageEnglish
Article number4303
JournalJournal of Clinical Medicine
Issue number19
StatePublished - 22 Sep 2021
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.


Conflicts of Interest: All authors have no competing interests except GiliKenet—receives grant and research support from Alnylam, Bayer, BPL, Opko Biologics, Pfizer, Shire and honoraria for consultancy/lectures from Alnylam, Bayer, CSL, Opko Biologics, Pfizer, Takeda, and ROCHE.Assaf A. Barg and MudiMisgav receive honoraria for lectures from ROCHE.

FundersFunder number
Commonwealth Serum Laboratories


    • Bleeding
    • Emicizumab
    • Hemarthrosis
    • Hemophilia
    • Monitoring


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