FEIBA^®in treatment of acute bleeding episodes in patients with haemophilia A and factor VIII inhibitors: a retrospective survey in regional haemophilia centre

Abstract

FEIBA (factor eight inhibitor by-passing activity) is used to achieve haemostasis in haemophiliacs with inhibitor. The aim of this study was to evaluate efficacy and consumption of the product in treatment of haemorrhages in haemophiliacs with factor VIII inhibitor, and determine factors that can influence the results of treatment. We used data from our haemophilia centre from years 2000-2008. Six haemophiliacs with factor VIII inhibitor were treated on demand with FEIBA for 61 bleeding episodes (45 haemarthroses, six muscle bleeds, six other sites bleeds and four multiple sites bleeds). The median cumulative dose of FEIBA per bleeding episode was 205 U kg(-1). Bleeding was stopped in 96.7% (59 of 61) of events but re-bleeding occurred in 3 events (4.9%) within 48 h after cessation of bleeding. In home treatment (20 of 61) bleeding stopped in 90% (18 of 20) without recurrence and the median consumption per event was reduced to 153 U kg(-1). Without the use of home treatment the median consumption was 250 U kg(-1) per event and bleeding ceased definitely in 92.7% (38 of 41) of cases. The cumulative dose of FEIBA was lower for three episodes with re-bleeding: median 96 U kg(-1) but not in the two cases of ineffective treatment: 361 U kg(-1). FEIBA in management of bleeding episodes completely resolved the haemorrhage in 91.8% of events and in a further 4.9% if treatment was restarted. Using home treatment saved expenditure due to the lower cumulative dose needed for treatment of haemorrhage.

Evidence Supporting the Use of Recombinant Activated Factor VII in Congenital Bleeding Disorders

“…Definite cessation of bleeding was demonstrated in 93% of the patients receiving a cumulative median dose of 205 IU/kg per event. 34 The authors observed that FEIBA treatment stopped the hemorrhaging later than rFVIIa treatment but resulted in a lower number of rebleeding episodes. 34 …”

“…15 The considerable heterogeneity in the assessment of hemostatic efficacy and in sampling time points is in agreement with reports from nonrandomized studies. 10,[22][23][24][25][32][33][34][37][38][39] Obviously, this constitutes a significant problem for the interpretation and comparison of results from the studies of patients with hemophilia. Thus, data interpretation and the comparison of efficacy in the future studies on patients with hemophilia would be improved if efficacy parameters were standardized.…”

“…The hemostatic efficacy of FEIBA has previously been observed to vary from 80% to nearly 100% under different conditions, including at-home treatment of spontaneous or traumatic bleeds and major and minor surgery. [32][33][34] Possible explanations for the discrepancy in treatment efficacy observed between RCTs and observational studies may involve different study populations, as mentioned earlier. Differences in dose and dosing frequency, ancillary hemostatic therapy, efficacy criteria, and time points at which efficacy was evaluated may also contribute significantly to the observed discrepancies.…”

“…This is because the treatment efficacy depends on the administered dose of FEIBA. 34 This was illustrated in 6 hemophilic patients with coagulation-factor inhibitors who experienced 61 bleeds that were treated with FEIBA. Definite cessation of bleeding was demonstrated in 93% of the patients receiving a cumulative median dose of 205 IU/kg per event.…”

“…Differences in dose and dosing frequency, ancillary hemostatic therapy, efficacy criteria, and time points at which efficacy was evaluated may also contribute significantly to the observed discrepancies. 21,[32][33][34] Furthermore, it could be argued that because the standard recommended dose of FEIBA is 50-100 IU/kg every 4-6 hours, and the standard dose of rFVIIa is 90 µg/kg every 2-3 hours until hemostasis is achieved, the doses administered to the FEIBA and rFVIIa treatment groups were markedly unmatched. This is because the treatment efficacy depends on the administered dose of FEIBA.…”