***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    Input: Patients with haemophilia who develop inhibitors have unique treatment needs ; bypassing agents such as Factor Eight Inhibitor Bypassing Activity , Anti-Inhibitor Coagulant Complex ( FEIBA ; Baxter AG , Vienna , Austria ) are part of this therapeutic armamentarium . This study sought to increase comprehension of the full therapeutic profile of FEIBA by evaluating its safety and efficacy in the setting s of acute bleeding , surgery , and prophylaxis . Information was collected through a postmarketing surveillance study ; question naire booklets were distributed to 72 treatment centers in the United States and Europe . The booklets contained questions related to patient demographics , inhibitor titre determinations , and FEIBA treatment . Information comprising 200 FEIBA treatment periods and representing > 4500 infusions was available for 63 patients with inhibitors ( n = 60 , haemophilia A ; n = 3 , haemophilia B ) . Twelve patients were in more than one treatment group .  Efficacy was determined by a subjective global evaluation and was good or excellent in 82 % of all acute , and 91 % of all surgical , treatments . Additionally , prophylactic treatment result ed in improved or stabilised clinical orthopaedic status in 11 of 13 patients ( 85 % ) . Based on available data , FEIBA was judged safe in all treatment situations by the small number of adverse events ( < 0.04 % ) . No thrombotic complications occurred during any treatment episode . Results indicated that FEIBA was safe and effective in acute , surgical , and prophylactic treatment setting s , supporting the utility of FEIBA as a treatment option for patients with inhibitors . However , prospect i ve studies are advised FEIBA ( factor eight inhibitor by-passing activity ) Immuno was used to achieve hemostasis in 46 patients with factor VIII inhibitors with titers greater than 4 Bethesda units , and 3 patients with factor IX inhibitors . One-hundred and sixty-five bleeding episodes were treated with 50 - 70 U/kg ; 102 of these episodes occurred in joints . 20 in mucous membranes , 33 muscle and soft tissue , and 10 were emergency episodes including 3 central nervous system and 4 surgical procedures . Ninety-three percent of the bleeding episodes were controlled , while 7 % were not controlled : 36 % were controlled by one infusion in 12 hr , another 42 % with 1 or more infusions in 36 hrs and an additional 14 % were controlled in more than 36 hr . There were no serious side effects , and while the inhibitor titer rose in 10 of the patients , the product continued to be efficacious Factor VIII or factor IX replacement is frequently impossible in inhibitor-developing hemophiliacs , because of the level of the inhibitor titer . Activated prothrombin complex concentrates are one of the available options to treat the bleeding episodes in such patients . However , the efficacy of these products and the associated thrombogenic risk , particularly in prolonged administration such as employed during surgeries , are important concerns for hemophilia care providers . We performed a multicenter retrospective study to evaluate the use of  FEIBA ( Factor Eight Bypassing Activity ) in France , and data is presented on 433 bleeding episodes , including surgical procedures , concerning 60 patients from 15 hemophilia centers . The efficacy was judged as good or excellent in 352 episodes ( 81.3 % ) , poor in 73 episodes ( 16.9 % ) and non-existent in 8 episodes ( 1.8 % ) . Minor and major surgical procedures were successfully performed using FEIBA as a second-line therapy after human or porcine factor VIII , and in some occasions FEIBA was utilized as the only substitution product . The tolerance was assessed as good in 428 episodes ( 98.8 % ) , but in 5 cases adverse effects were reported . Only 3 patients out of 52 regularly evaluated ( 5.8 % ) were HIV-seropositive , and for two of them the seroconversion occurred prior to the first use of FEIBA . In contrast , 80.4 % of the patients were HCV-seropositive . An anamnestic response after the administration of FEIBA was noted in 31.5 % of cases . This study points out the main features of the use of FEIBA in France , and particularly the low HIV seroprevalence in the patients treated . The good efficacy and the excellent tolerance still confer to this product a place to consider in the therapeutic options for the treatment of inhibitor-developing hemophiliacs or in acquired hemophilia We design ed a double-blind trial to study the effect of an " activated " prothrombin-complex concentrate ( FEIBA ) on joint and muscle bleeding in hemophiliacs with antibodies to factor VIII . Fifteen patients received either FEIBA or the control preparation ( a nonactivated prothrombin-complex concentrate )  for a total of 150 bleeding episodes ( four mucocutaneous bleeding , 117 joint bleeding , and 29 muscle bleeding ) . In 64 per cent of the episodes , FEIBA was judged by the physician to be effective ; the control preparation was perceived as effective in 52 per cent of the episodes in which it was used . Pairwise comparison of FEIBA and the control preparation for bleeding in the same joint or muscle showed a significantly better result with FEIBA ( P = 0.0085 ) . Joint mobility after the use of FEIBA was significantly improved ( P = 0.006 ) . There was a high incidence of hepatitis ( three of the 15 patients ) and of transient disturbances of liver function ( nine of 15 ) during the 15-month observation period The aim was to evaluate the efficacy and safety of two recombinant factor VIIa ( rFVIIa ) dose regimens for treating haemarthroses in patients with congenital haemophilia A or B and inhibitors . This was a multicentre , r and omised , cross-over , double-blind trial . Patients were r and omly allocated to treat a first joint bleeding episode with one 270 microg/kg rFVIIa dose followed by two doses of placebo at 3-hour intervals and a second joint bleed with three single doses of 90 microg/kg rFVIIa at 3-hour intervals , or vice versa . Efficacy was evaluated using a novel and robust treatment response-rating scale based on patient- assessment of pain and joint mobility . Outcome was rated at different timepoints , and an effective or ineffective treatment response was determined . Treatment " preference " was defined as effective treatment with one regimen and ineffective with the other . Patients with equally effective or ineffective treatments had no " preference " . Treatment was rated as effective for 65 % of patients using the 270 microg/kg dose versus 70 % for the 90 microg/kg x 3 regimen . An equal " preference " was noted for the two regimens ( 21 % for each ; p = 0.637 ) ; most patients ( 58 % ) had no " preference " . 37/42 bleeding episodes ( 88 % ) were successfully treated with rFVIIa ; additional haemostatic medications were administered for five episodes . No safety issues were identified . Administration of rFVIIa as a single 270 microg/kg dose to treat haemarthroses in patients with haemophilia and inhibitors was at least as efficacious and safe as the 90 microg/kg x 3 regimen The efficacy of recombinant activated factor VII ( rFVIIa , NovoSeven ) in five Haemophiliacs ( four Haemophilia A , one Haemophilia B ) , with high inhibitors ranging from 70 to 1900 Bethesda units , was evaluated . The treatment regimen was divided into two groups : group I , continuous infusion of 16.5 microg h-1 kg-1 body weight ( bw ) after the initial bolus of 90 microg kg-1 bw in three episodes of severe bleeding and group II , bolus injection 80 - 150 microg kg-1 bw every 3 hours for a maximum of four doses in six haemarthroses . The bleeding was effectively controlled within 1 to 48 h in five of nine bleeding episodes . One patient in group I , who had active arterial bleeding requiring sutures , had an ineffective response and three patients in group II had partially effective responses because the rFVIIa was given after the onset of bleeding at 36 , 44 and 72 h , respectively . The prothrombin time was shortened and the FVII : C levels were successfully achieved at approximately 10 U mL-1 . The continuous infusion reduced the total dose of rFVIIa by 50 % . Recurrent bleeding episodes were found in three patients ; two occurred at the same site after ceasing rFVIIa for 51 h and while receiving rFVIIa at 144 h and one occurred at a new site after ceasing rFVIIa for 12 h. Our experience would suggest that rFVIIa is effective in controlling acute bleeding episodes in Haemophiliacs with high inhibitors either by continuous infusion or bolus injection OBJECTIVE To assess the safety and efficacy of a fixed dose of recombinant activated factor VII ( rFVIIa ; NovoSeven ) in the home setting for mild to moderately severe joint , muscle ; and mucocutaneous bleeding episodes in patients with haemophilia A or B with inhibitors . DESIGN Multicentre , open-label , single arm , phase III study of one year duration . METHODS ; Patients or their caregivers administered up to three doses of rFVIIa ( 90 microg/kg i.v . ) at 3 h intervals within 8 h of the onset of a mild to moderate bleeding episode . Once the subject considered that rFVIIa had been " effective " with regard to haemostasis ( after 1 - 3 injections ) , one further ( maintenance ) dose of rFVIIa was administered . RESULTS Of 60 patients enrolled , 56 experienced at least one bleed , and 46 completed the one year study . 614 of 877 bleeds ( 70 % ) were evaluable according to protocol definitions . Haemostasis was rated as " effective " in 92 % ( 566/614 ) of evaluable bleeds after a mean of 2.2 injections . For successfully treated episodes , the time from onset of bleeding until administration of the first injection was 1.1+/-2.0 h ( mean+/-SD ) . Twenty-four hours after initial successful response , haemostasis was reported as having been maintained in 95 % of cases . Efficacy was comparable for muscle , joint and target joint , and mucocutaneous bleeding episodes . In an intent-to-treat analysis of all 877 bleeding events , efficacy outcomes were equivalent to the evaluable bleeds , with an effective response in 88 % of treated episodes . Treatment-related adverse events occurred in 32 ( 3 % of all ) bleeding episodes and consisted of re-bleeds/new bleeds in more than 50 % ( 18/32 ) of these events . A single episode of superficial thrombophlebitis was the only thrombotic complication encountered , and there were no patient withdrawals due to adverse events . Development of FVII(a ) antibodies could not be detected , and hypersensitivity reactions to rFVIIa were not reported . CONCLUSION rFVIIa is effective and well tolerated when used in the home setting to treat mild to moderate bleeding episodes in patients with haemophilia A or B with inhibitors To evaluate the feasibility , efficacy and safety of home treatment with recombinant activated factor VII ( rFVIIa ) , 10 inhibitor patients ( all haemophiliacs except one acquired post‐partum ) self‐administered up to four doses of 90 μg/kg rFVIIa every 3 ± 1 h. The response was rated by the patient as effective ( haemorrhage stopped or decreased substantially ) , partially effective ( reduced ) or ineffective ( unchanged or worsened ) . 45 haemarthroses and eight haematomas  were treated within a median time of 1.0 h ( range 0.3–11.9 ) from the onset of bleeding , with a median of two rFVIIa doses per course ( range 1–4 ) . rFVIIa was effective in 42 episodes ( 79 % ) , partially effective in six ( 11 % ) and failed in five ( 10 % ) . Compared with partially effective and ineffective treatments , effective treatments started earlier ( median time : 0.6 v 2.7 h , P = 0.02 ) and required a smaller number of doses ( median : 1.5 v 3 , P = 0.007 ) . The risk of a partially effective or ineffective treatment was smaller for treatments started within 6 h from the onset of bleeding than for those which started later ( OR 0.24 , 95 % CI 0.09–0.63 ) . Mild side‐effects were reported only after 3/113 self‐infusions ( 2.6 % ) . Early home treatment  with rFVIIa is safe , feasible and effective , inducing and maintaining haemostasis with a small number of doses The development of factor VIII : C inhibitors remains one of the most serious complications of repeated transfusion in patients with haemophilia A. The proportion of patients affected has been reported to range from 3.6 % to 25 % , but these figures have been derived mainly from retrospective data and from total numbers of known haemophiliacs instead of number at true risk . The assessment here is based on a prospect i ve study , started in 1976 , on the incidence of inhibitor development in haemophiliacs born after 1970 whose FVIII or FIX activity was 5 % or less , and who 
    Output:
    
No significant differences were found between the pooled efficacy rates  with aPCC and rFVIIa overall or at any of the time points evaluated .
Positive associations were found between reported efficacy and duration of follow-up and the number of bleeds evaluated .
Given the paucity of high- quality studies , the findings from the present review and meta- analysis suggest no conclusive evidence that aPCC or rFVIIa is significantly more efficacious than the other in the treatment of joint bleeding episodes in hemophiliac patients with inhibitors