Hematologic safety of caplacizumab in immune-mediated thrombotic thrombocytopenic purpura: insights from platelet-related signal detection in the FAERS database

In FAERS post-marketing data, caplacizumab-associated adverse events were mainly bleeding-related, generally predictable, and tended to occur early during therapy. Close clinical and laboratory monitoring-particularly of hematologic parameters-during the initial treatment period is warranted to balance bleeding vigilance with therapeutic efficacy. These findings provide real-world evidence to inform hematologists about the safety profile of caplacizumab in iTTP management.