Emicizumab is a novel, subcutaneously (SC) administered, recombinant, humanized, bispecific monoclonal antibody approved for the prevention of bleeds in persons with hemophilia A (PwHA). Emicizumab restores the function of activated coagulation FVIII, which is deficient in PwHA, by bridging activated FIX and FX to enable effective hemostasis. Due to its mechanism of action, emicizumab is not expected to induce or be affected by inhibitors. Once-weekly emicizumab prophylaxis was shown to substantially reduce bleed rates by 87% in PwHA with inhibitors compared with no prophylaxis in the Phase 3 HAVEN 1 study. The HAVEN 2 study showed that once-weekly emicizumab also prevented or reduced bleeds in pediatric PwHA with inhibitors (<12 years of age). The HAVEN 3 study assessed emicizumab prophylaxis in PwHA without inhibitors. The Phase 3 HAVEN 4 study assessed emicizumab administered every 4 weeks (Q4W) PwHA with and without inhibitors. Dr. Elena Santagostino and colleagues aimed to report their experience of patients using this prophylaxis who underwent surgical procedures by extracting pooled data from the four phase III HAVEN studies.
As Santagostino stated, “Across the HAVEN studies, 215 minor and 18 major surgeries were performed in 115 and 18 participants, respectively. The majority of minor surgeries were dental and central venous access device (CVAD) procedures, which were primarily managed without use of prophylactic coagulation factor replacement, with ~90% not resulting in treated post-operative bleeds. Of the 34% procedures managed with prophylactic coagulation factor, ~88% did not result in treated post-operative bleeds.”
Of the 19 major surgeries, ~83% were managed with prophylactic coagulation factor; only one of which resulted in a treated post-operative bleed. Of the three major surgeries managed without prophylactic coagulation factor, no post-operative bleeding occurred. “Importantly, no procedure resulted in death, thrombosis, FVIII inhibition, or unexpected bleed,” Santagostino emphasized.
She concluded that all surgeries were performed safely and emicizumab alone provides “good hemostatic coverage for patients undergoing certain types of minor surgeries, such as those involving central venous access devices. The majority of minor procedures were performed without prophylactic coagulation factor, and of these, >90% did not result in a treated post-operative bleed.”