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Summary  Factor replacement therapy for the treatment of moderate to severe haemophilia A and B can be complicated by the production of inhibitory alloantibodies to factor VIII (FVIII) or factor IX. Treatment with the nanofiltered anti‐inhibitor coagulant complex, Factor Eight Inhibitor Bypassing Activity (FEIBA NF), is a key therapeutic option for controlling acute haemorrhages in patients with high‐titre inhibitors or low‐titre inhibitors refractory to replacement therapy. Given the high risk for morbidity and mortality in haemophilia patients with inhibitors to FVIII or FIX, we conducted this Phase 3 prospective study to evaluate whether prophylaxis with FEIBA NF is a safe and effective treatment option. Over a 1‐year period, 17 subjects were treated prophylactically (85 ± 15 U kg −1  every other day) while 19 subjects were treated on demand. The median (IQR) annualized bleeding rate (ABR) during prophylaxis was 7.9 (8.1), compared to 28.7 (32.3) during on‐demand treatment, which amounts to a 72.5% reduction and a statistically significant difference in ABRs between arms ( P  = 0.0003). Three (17.6%) subjects (ITT) on prophylaxis experienced no bleeding episodes, whereas none treated on demand were bleeding episode‐free. Total utilization of FEIBA NF for the treatment of bleeding episodes was significantly higher during on‐demand therapy than prophylaxis ( P  = 0.0067). There were no differences in the rates of related adverse events between arms. This study demonstrates that FEIBA prophylaxis significantly reduces all types of bleeding compared with on‐demand treatment, and the safety of prophylaxis is comparable to that of on‐demand treatment.

Randomized comparison of prophylaxis and on‐demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors