Wolfgang Miesbach: Predicting Breakthrough Bleeding in Emicizumab-Treated Acquired Haemophilia A
Wolfgang Miesbach, Professor of Medicine at Frankfurt University Hospital, shared on LinkedIn:
“Predicting Breakthrough Bleeding in Emicizumab-Treated Acquired Haemophilia A. Excellent work presented at ASH2025 by Fabius Pelzer addressing one of the most pressing challenges in acquired haemophilia A:
Despite emicizumab’s remarkable efficacy in preventing bleeds, up to 30% of patients still experience breakthrough bleeding—and we currently lack reliable predictive tools to identify who’s at risk.
This changes today.
Using FXIa-triggered thrombin generation (FXIa-TGA) as a surrogate biomarker, Pelzer and colleagues developed an innovative nomogram to assess individual bleeding risk based on:
- Peak thrombin generation potential
- Emicizumab levels
- Residual Factor VIII activity
Main findings:
- FXIa-TGA peak thrombin is more sensitive than conventional TGA to low factor levels and emicizumab concentrations
- Both emicizumab and residual Factor VIII significantly influence peak thrombin generation in the multivariable model
- Higher peak thrombin values correlated with lower bleeding rates (IRR 0.40 [0.17-0.84])
This is precision haemostasis and enables patient-specific risk stratification in real time. Moving beyond one-size-fits-all dosing to truly personalized management of AHA.
Having a functional biomarker that predicts individual risk opens pathways for:
- Optimized prophylactic dosing strategies
- Early detection of patients requiring intervention
- Better understanding of emicizumab mechanism in real-world AHA
Congratulations to Fabius, Andreas Tiede and the entire GTH study team on this rigorous work that has now been published in Haematologica Journal.”
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