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
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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
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References
- 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.
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