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  • 1
    Electronic Resource
    Electronic Resource
    Efficacy of a sucrose-formulated recombinant factor VIII used for 22 surgical procedures in patients with severe haemophilia A (2000)
    Oxford UK : Blackwell Science Ltd
    Haemophilia 6 (2000), S. 0 
    Details
    ISSN: 1365-2516
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: A sucrose-formulated recombinant FVIII (rFVIII-SF) was investigated under clinical trial conditions during surgical procedures in previously treated patients (PTPs). Fifteen PTPs with severe haemophilia A (FVIII ≤ 1%) underwent 22 surgical procedures. The procedures performed cover a spectrum from minor to major surgery. Haemostatic outcome was assessed by the investigators to be excellent in 16 procedures and good in the remaining six procedures. It is concluded that rFVIII-SF is efficacious and safe in severe haemophilia A patients undergoing minor or major surgery.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1365-2516.2000.00432.x
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    Paper (German National Licenses)
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  • 2
    Electronic Resource
    Electronic Resource
    Experience with KOGENATE® Bayer in surgical procedures (2002)
    Oxford, UK : Blackwell Science, Ltd
    Haemophilia 8 (2002), S. 0 
    Details
    ISSN: 1365-2516
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Summary.   The study objectives were to assess the efficacy of KOGENATE® Bayer (Kogenate® FS) in achieving haemostasis during surgical procedures in patients with severe haemophilia A and to evaluate its safety when given in the doses needed for this purpose. Dosing for surgical procedures was in accordance with clinical practice in the management of haemophilia A patients during and after surgery. Efficacy was evaluated by estimated blood loss and assessment of haemostasis as determined by the attending physician. Safety was assessed by the incidence of adverse events related to study drug and the incidence of viral seroconversions. In total, 15 previously treated patients (PTPs) and seven previously untreated patients (PUPs)/minimally treated patients (MTPs) underwent 30 surgical procedures ranging from minor (port placement/tooth extraction) to major (orthopaedic endoprosthesis/brain tumour excision) surgery. The efficacy profile was good to excellent as assessed by the attending physician, and recorded blood loss was minimal to none. No adverse events were recorded that were related to study drug. No viral seroconversions were observed. In conclusion, KOGENATE® Bayer was shown to be safe and efficacious in patients with severe haemophilia A during surgical procedures.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1351-8216.2001.00132.x
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    Paper (German National Licenses)
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  • 3
    Electronic Resource
    Electronic Resource
    Reported inhibitor incidence in FVIII PUP studies: comparing apples with oranges? (2004)
    Oxford, UK : Blackwell Science Ltd
    Haemophilia 10 (2004), S. 0 
    Details
    ISSN: 1365-2516
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1365-2516.2004.00887.x
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    Paper (German National Licenses)
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  • 4
    Electronic Resource
    Electronic Resource
    A high-purity double virus inactivated FVIII/vWF concentrate (Immunate) in the successful treatment of patients with von Willebrand disease (2002)
    Oxford, UK : Blackwell Science Ltd
    Haemophilia 8 (2002), S. 0 
    Details
    ISSN: 1365-2516
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Patients with severe forms of von Willebrand disease (vWD) most frequently require substitution of both factor VIII and von Willebrand factor (vWF). Immunate is a high-purity, double-virus inactivated FVIII/vWF concentrate derived from human plasma. The clinical efficacy of Immunate concerning the management of acute bleeding episodes and surgical prophylaxis in patients with von Willebrand disease (vWD) is being investigated and documented in a prospective, phase III, open-label, single-armed multicenter trial. Data on its pharmacokinetics are collected, and the product's safety with respect to adverse experiences is monitored.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1365-2516.2002.d01-2_3.x
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  • 5
    Electronic Resource
    Electronic Resource
    Lack of evidence for increased inhibitor incidence in patients switched from plasma-derived to recombinant factor VIII (2001)
    Oxford UK : Blackwell Science Ltd
    Haemophilia 7 (2001), S. 0 
    Details
    ISSN: 1365-2516
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: De novo inhibitor development is a rare event in PTPs switched from pdFVIII to rFVIII. Based on previously published data of clinical studies a change in FVIII product is unlikely to provoke inhibitor formation.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1365-2516.2001.00515.x
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  • 6
    Electronic Resource
    Electronic Resource
    European data of a clinical trial with a sucrose formulated recombinant factor VIII in previously treated haemophilia A patients (2002)
    Oxford, UK : Blackwell Science, Ltd
    Haemophilia 8 (2002), S. 0 
    Details
    ISSN: 1365-2516
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Summary.  To increase the safety of antihaemophilic treatment, the production process of full-length recombinant factor VIII (FVIII) KOGENATE® Bayer (Kogenate®FS)has been modified. Human albumin is no longer added as stabilizer during purification and in final formulation. Instead, the new KOGENATE® Bayer production process uses sucrose as a stabilizer in the formulation and adds solvent/detergent virus inactivation step. An European clinical trial was carried out in Germany and France in previously treated patients with severe haemophilia A who had more than 100 exposure days to exogenous FVIII. Pharmacokinetic data was analysed according to one-stage and chromogenic assays. Efficacy and safety during home therapy and in surgical procedures were evaluated; inhibitor formation was carefully monitored. Safety and efficacy were evaluated in 33 European patients for 24 months. Patients received more than 13 million IU KOGENATE® Bayer. Over 75% of patients accrued more than 100 exposure days with the new product. Of 875 bleeding episodes, 90.7% were treated with 1 or 2 infusions and 75.8% of responses to treatment were rated as ‘excellent’ or ‘good’. Prophylactic treatment was the most common mode of therapy (60.7% of infusions). The product was well-tolerated and FVIII recovery studies were consistent throughout the study period. Only 0.26% of adverse events were reported to be drug related. No evidence of de novo inhibitor formation was observed. Overall, KOGENATE® Bayer was efficacious, safe and well-tolerated for the treatment of haemophilia A in multitransfused patients.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1351-8216.2001.00131.x
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    Paper (German National Licenses)
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  • 7
    Electronic Resource
    Electronic Resource
    Management of haemophilic patients with inhibitors in major orthopaedic surgery by immunadsorption, substitution of factor VIII and recombinant factor VIIa (NovoSeven®): a single centre experience (2004)
    Oxford, UK : Blackwell Science Ltd
    Haemophilia 10 (2004), S. 0 
    Details
    ISSN: 1365-2516
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Summary.  Inhibitors of factor VIII or FIX in haemophilic patients are a common and serious complication associated with an increased risk of life-threatening bleeding during elective surgery. Substitution therapy fails to be effective, therefore an alternative treatment is needed. We have performed six major elective orthopaedic interventions in four patients with haemophilia A and inhibitors. A preoperative immunadsorbant therapy with TherasorbTM to eliminate inhibitors was successful in four cases, but during FVIII substitution inhibitors increased on day 4 to day 6 after surgery, leading to decreasing FVIII levels. Therefore, therapy was changed to recombinant FVIIa (rFVIIa; NovoSeven®). Two interventions had to be covered with sole rFVIIa therapy as immunadsorbant therapy failed to be effective in one case and the need for acute intervention did not allow pretreatment in the other. We did not see increased bleeding during or after surgery when compared to our experience with non-inhibitor haemophilic patients. In conclusion, a preoperative decrease of inhibitors from immunadsorbant therapy, perioperative substitution of FVIII and changing treatment to rFVIIa when inhibitors are increased, is a safe and economic therapy for guaranteeing haemostasis in major elective orthopaedic surgery. On the contrary, sole therapy with rFVIIa allows immediate surgical intervention without a long hospital stay prior to surgery and a need for laboratory monitoring of inhibitor titres and FVIII levels. Our findings support data previously published.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1365-2516.2004.01037.x
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    Paper (German National Licenses)
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  • 8
    Electronic Resource
    Electronic Resource
    Treatment patterns and cost-of-illness of severe haemophilia in patients with inhibitors in Germany (2004)
    Oxford, UK : Blackwell Science Ltd
    Haemophilia 10 (2004), S. 0 
    Details
    ISSN: 1365-2516
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Summary.  To evaluate current treatment patterns and resource utilization as well as related cost in the management of severe haemophilia patients with inhibitors in Germany, a cost-of-illness study was conducted. Generally, data were generated by structured literature search. Missing data were collected by expert interviews. All data were validated by a panel of German experts in haemophilia care. In Germany, immune tolerance therapy (ITT) is first-line therapy in inhibitor management for children in the initial year after inhibitor development, particularly for high responders (HR). In adult HR patients ITT is applied but to a remarkably lower extent than in children. To treat bleeding episodes, factor VIII (FVIII) is first-line therapy in low responders (LR). For paediatric HR patients, bleeds are mainly treated with recombinant FVIIa (rFVIIa). In adult HR patients, activated prothrombin complex concentrate (aPCC) and rFVIIa are more equally distributed as treatment options. Treatment costs were calculated for paediatric patients (15 kg) and adult patients (75 kg) from third party payers’ perspective. Cost for ITT ranges from €70 290 (2 months; LR) to €3 812 400 (24 months; with aPCC; HR) in a paediatric patient. For an adult patient ITT cost ranges from €287 500 (6 months; LR) to €17 253 000 (36 months; HR). For on average 12.5 acute bleeds, average annual treatment costs amount to €77 000 for a child and €354 000 for an adult. Assessing the results it has been taken into consideration that ITT can last longer and annual number of bleeds can be extremely higher than on average 12.5 episodes. This indicates more health care resource consumption in some patients.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1365-2516.2004.00950.x
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  • 9
    Electronic Resource
    Electronic Resource
    Erworbene Hemmkörperhämophilie (2000)
    Springer
    Der Anaesthesist 49 (2000), S. 34-42 
    Details
    ISSN: 1432-055X
    Keywords: Schlüsselwörter ; Erworbene Hemmkörperhämophilie ; spontane Faktor-VIII-Inhibitoren ; spontane Faktor-IX-Inhibitoren ; Diagnose ; Therapie ; Key words ; Acquired haemophilia ; Spontaneous factor VIII inhibitors ; Spontaneous factor IX inhibitors ; Diagnosis ; Therapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Abstract Although autoantibodies against factor VIII or factor IX are a rare phenomenon, they are associated with a high risk of bleeding and high mortality. The condition, termed ac- quired haemophilia, occurs equally in both sexes and is most frequent in higher age groups. Patients typically present with severe bleedings in muscles and skin. In contrast to patients with congenital haemophilia and inhibitors, joint bleedings are very rare. In approximately half of all cases an associated disease state can be identified as the cause of autoantibody formation. An immediate and comprehensive diagnosis is essential for a rapid initiation of therapy. Equally important are a careful diagnostic differentiation between congenital and acquired factor deficiencies and the exclusion of non-specific inhibitors, which increase the occurrence of thrombolic events. The inhibitor titre, quantified using the Bethesda assay, is an important criterion for selecting the appropriate therapy. A wide range of treatment options is now available for the management of bleedings in patients with acquired haemophilia, namely porcine factor VIII, recombinant factor VIIa, prothrombin complex concentrates, and immunoadsorptions. In addition, immunosuppressive therapies are used to achieve permanent reduction or elimination of inhibitors.
    Notes: Zusammenfassung Autoantikörper gegen Faktor VIII oder Faktor IX sind ein zwar seltenes, aber mit hohem Blutungsrisiko und hoher Letalität verbundenes Phänomen. Diese als erworbene Hemmkörperhämophilie bezeichnete Erkrankung kommt bei beiden Geschlechtern gleich häufig vor und tritt gehäuft im hohen Lebensalter auf. Die Patienten fallen klinisch v. a. durch schwere Blutungen in Muskeln und Haut auf, wogegen Gelenkeinblutungen – im Gegensatz zur angeborenen Hämophilie mit Hemmkörpern – sehr selten auftreten. In etwa der Hälfte der Fälle kann eine assoziierte Grunderkrankung als Auslöser der Autoantikörperbildung identifiziert werden. Eine rasche und umfassende Diagnostik ist entscheidend für einen schnellen Therapiebeginn. Ebenso bedeutend ist eine sorgfältige differentialdiagnostische Abgrenzung gegen einen angeborenen oder erworbenen Faktorenmangel sowie der Ausschluß unspezifischer Inhibitoren, die vermehrt zu Thrombosen führen können. Wichtig für die Auswahl der geeigneten Therapieform ist der Inhibitortiter, gemessen im Bethesda-Assay. Für die Blutstillungstherapie steht heute mit porcinem Faktor VIII, rekombinantem Faktor VIIa, Prothrombinkomplexpräparaten und Immunadsorptionen ein breites Spektrum an Möglichkeiten zur Verfügung. Für eine dauerhafte Reduktion bzw. Elimination der Autoantikörper finden immunsuppressive Therapien Anwendung.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s001010050007
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