PROOF Study Clinical Results

FEIBA was efficacious in controlling acute bleeding episodes in both prophylaxis and on-demand treatment arms.1

In addition, prophylaxis with FEIBA reduced ABR for all bleeds, compared to on-demand therapy.1

The PROOF Study: primary endpoints1

  • Significant reduction (72.5%) in the median annual bleed rate (ABR) for all bleeds was achieved with prophylactic use of FEIBA compared with on-demand therapy.1

Statistically significant reduction in median ABR in new target joint

  • The median ABR in new target joints was higher in the on-demand arm (5.9 [12.9]) than in the prophylaxis arm (0 [4.1]).1
  • Occurrence of new target joints was lower in the prophylaxis arm (7 in 5/17 subjects) compared with the on-demand arm (23 in 11/19 subjects) but was not statistically significant.1

Adverse events

  • Of the 104 adverse events (AEs) reported, 30 in 13 subjects were serious and 74 in 17 subjects were non-serious. Twenty-eight (27%) AEs in 9 (22.2%) subjects were deemed related to FEIBA; of these, 4 were serious. Thirteen of the 36 subjects treated with FEIBA did not report any AEs.1

Notations

*Not significant
†1 patient was in the study for 2.5 weeks

References

  1. 1 Antunes SV, Tangada S, Stasyshyn O, et al. Randomized comparison of prophylaxis and on-demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors [published online ahead of print August 1, 2013]. Haemophilia. 2014;20(1):65-72. DOI:10.1111/hae.12246.

The results are in

In the Pro-FEIBA study (n=26), FEIBA prophylaxis showed a significant reduction in the frequency of bleeding events in severe haemophilia A patients with FVIII inhibitors Read more

Publications

Visit Haemophilia to read the PROOF Study and access to more articles related to managing haemophilia patients with inhibitors. Read more

Sustained activity

FEIBA offers a long dosing interval. Read more

Demonstrated efficacy in prophylaxis

Learn how FEIBA prophylaxis can reduce bleed frequency and preserve joints. Read more

Dosing FEIBA

Learn how to dose FEIBA. Read more