EndocrinologyAnalysis Of Four Large Post-Marketing Surveillance Studies Describe Clinical Effects Of Sucrose-Formulated Recombinant Factor VIII
New data pooled from four large, "real world" post-marketing surveillance studies showed that sucrose-formulated recombinant factor VIII (rFVIII-FS) reduced bleeding and provided data regarding adverse events in more than 950 patients with mild-to-severe hemophilia A. Additionally, rates of inhibitor formation were reported in both previously treated and previously untreated patients. The data were presented at the XXII Congress of the International Society on Thrombosis and Haemostasis (ISTH).(1)(2)
In this analysis, the investigators judged rFVIII-FS hemostasis to be "good" or "very good" in 98.9 percent of patients. Serious adverse drug reactions were seen in 1.1 percent of patients and new (de novo) inhibitors were observed in 0.8 percent of patients.
"In a "real world" setting, these data reflect some of the extensive global clinical experience with rFVIII-FS," said Georg Lemm, M.D., Ph.D., vice president, Global Clinical Development, and head, Hematology Group, Bayer Schering Pharma. "It is particularly noteworthy that a low rate of inhibitor formation was observed in this analysis of data pooled from post-marketing surveillance studies. Inhibitor formation is a significant challenge for both clinicians and their patients, and its treatment is costly and requires significant time to overcome."
Open label study investigating the efficacy of prophylactic versus on-demand rFVIII-FS treatment
In another presentation, (3) data from an open label clinical study that enrolled 20 adult men with severe hemophilia A (with and without target joints) demonstrated that patients who were changed from on-demand to prophylactic (preventive) infusions of rFVIII-FS had significantly reduced median joint bleeds per 6-month treatment period (zero events versus 15.0 events, respectively; PAbout Hemophilia A
Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is largely an inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. Hemophilia A is the most common type of hemophilia and is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. Approximately 400,000 people around the world have hemophilia A.
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Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a subsidiary of Bayer Corporation. One of the world"s leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units: Diagnostic Imaging, General Medicine, Specialty Medicine and Women"s Healthcare. The company"s aim is to provide products that will improve human health worldwide by diagnosing, preventing and treating diseases.
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References
(1) Fukutake K, et al. Post-marketing experience with sucrose-formulated recombinant factor VIII in patients with hemophilia A. Poster no. PP-MO-577; XXII Congress of the International Society on Thrombosis and Haemostasis.
(2) Fukutake K, et al. Inhibitor formation with sucrose-formulated recombinant factor VIII in patients with hemophilia A: Results from post-marketing surveillance studies. Poster no. PP-WE-579; XXII Congress of the International Society on Thrombosis and Haemostasis.
(3) Collins P, et al. Efficacy of secondary prophylactic versus on-demand sucrose-formulated recombinant factor VIII treatment in adults with severe hemophilia A with and without target joints. Poster no. PP-TH-584; XXII Congress of the International Society on Thrombosis and Haemostasis.
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