SAFETY AND EFFICACY OF B-DOMAIN DELETED 3RD GENERATION RECOMBINANT FACTOR VIII (GREENGENE FTM) IN KOREAN PATIENTS WITH HAEMOPHILIA A: DATA FROM A POST-MARKETING SURVEILLANCE STUDY
(Abstract release date: 05/19/16)
EHA Library. Kim S. 06/09/16; 132551; E1002
Disclosure(s): The authors stated that they had no interests which might be perceived as posing a conflict or bias.
Prof. Dr. Soon Ki Kim
Contributions
Contributions
Abstract
Abstract: E1002
Type: Eposter Presentation
Background
New B-domain deleted 3rd generation recombinant factor VIII (GreenGene FTM, beroctocog alfa) was launched in 2010.
Aims
This clinical trial evaluated the safety and efficacy of GreenGene FTM in patients with haemophilia A over a period of 12 months.
Methods
From July 2010 to July 2014, a total 136 hemophilia A patients were enrolled in the post marketing surveillance (PMS) study and were analyzed for safety of the drug. Among them, 114 patients were analyzed for efficacy. Subjects with differing haemophilia A severities and medical histories were monitored during 12 months of prophylactic and/or on-demand therapy. Efficacy was rated by their doctors with 4 scales as excellent, good, moderate, or no effect.
Results
Among 135 evaluable subjects, 85 (63.0%) had severe haemophilia, 35 (25.9%) had moderate haemophilia and 15 (11.1%) had mild haemophilia. Excellent/good efficacy rate was 91.3% for hemostasis and 89.4% for hemorrhage prevention. Twelve subjects reported 13 adverse drug reactions (ADRs), which were recovered without sequelae. The frequent ADRs were gastrointestinal disorders, nervous system, vascular disorders and general disorders. In 113 previously treated patients (PTP), two patients (1.8%) developed inhibitors after intensive FVIII treatment for surgery and hematuria, respectively.
Conclusion
The results of this PMS study support that GreenGene FTM is safe and efficacious in the treatment and prevention of patients with hemophilia A. The results of this study are consistent with the previously published GreenGene FTM studies.
Session topic: E-poster
Keyword(s): Hemophilia A, Recombinant factor
Type: Eposter Presentation
Background
New B-domain deleted 3rd generation recombinant factor VIII (GreenGene FTM, beroctocog alfa) was launched in 2010.
Aims
This clinical trial evaluated the safety and efficacy of GreenGene FTM in patients with haemophilia A over a period of 12 months.
Methods
From July 2010 to July 2014, a total 136 hemophilia A patients were enrolled in the post marketing surveillance (PMS) study and were analyzed for safety of the drug. Among them, 114 patients were analyzed for efficacy. Subjects with differing haemophilia A severities and medical histories were monitored during 12 months of prophylactic and/or on-demand therapy. Efficacy was rated by their doctors with 4 scales as excellent, good, moderate, or no effect.
Results
Among 135 evaluable subjects, 85 (63.0%) had severe haemophilia, 35 (25.9%) had moderate haemophilia and 15 (11.1%) had mild haemophilia. Excellent/good efficacy rate was 91.3% for hemostasis and 89.4% for hemorrhage prevention. Twelve subjects reported 13 adverse drug reactions (ADRs), which were recovered without sequelae. The frequent ADRs were gastrointestinal disorders, nervous system, vascular disorders and general disorders. In 113 previously treated patients (PTP), two patients (1.8%) developed inhibitors after intensive FVIII treatment for surgery and hematuria, respectively.
Conclusion
The results of this PMS study support that GreenGene FTM is safe and efficacious in the treatment and prevention of patients with hemophilia A. The results of this study are consistent with the previously published GreenGene FTM studies.
Session topic: E-poster
Keyword(s): Hemophilia A, Recombinant factor
Abstract: E1002
Type: Eposter Presentation
Background
New B-domain deleted 3rd generation recombinant factor VIII (GreenGene FTM, beroctocog alfa) was launched in 2010.
Aims
This clinical trial evaluated the safety and efficacy of GreenGene FTM in patients with haemophilia A over a period of 12 months.
Methods
From July 2010 to July 2014, a total 136 hemophilia A patients were enrolled in the post marketing surveillance (PMS) study and were analyzed for safety of the drug. Among them, 114 patients were analyzed for efficacy. Subjects with differing haemophilia A severities and medical histories were monitored during 12 months of prophylactic and/or on-demand therapy. Efficacy was rated by their doctors with 4 scales as excellent, good, moderate, or no effect.
Results
Among 135 evaluable subjects, 85 (63.0%) had severe haemophilia, 35 (25.9%) had moderate haemophilia and 15 (11.1%) had mild haemophilia. Excellent/good efficacy rate was 91.3% for hemostasis and 89.4% for hemorrhage prevention. Twelve subjects reported 13 adverse drug reactions (ADRs), which were recovered without sequelae. The frequent ADRs were gastrointestinal disorders, nervous system, vascular disorders and general disorders. In 113 previously treated patients (PTP), two patients (1.8%) developed inhibitors after intensive FVIII treatment for surgery and hematuria, respectively.
Conclusion
The results of this PMS study support that GreenGene FTM is safe and efficacious in the treatment and prevention of patients with hemophilia A. The results of this study are consistent with the previously published GreenGene FTM studies.
Session topic: E-poster
Keyword(s): Hemophilia A, Recombinant factor
Type: Eposter Presentation
Background
New B-domain deleted 3rd generation recombinant factor VIII (GreenGene FTM, beroctocog alfa) was launched in 2010.
Aims
This clinical trial evaluated the safety and efficacy of GreenGene FTM in patients with haemophilia A over a period of 12 months.
Methods
From July 2010 to July 2014, a total 136 hemophilia A patients were enrolled in the post marketing surveillance (PMS) study and were analyzed for safety of the drug. Among them, 114 patients were analyzed for efficacy. Subjects with differing haemophilia A severities and medical histories were monitored during 12 months of prophylactic and/or on-demand therapy. Efficacy was rated by their doctors with 4 scales as excellent, good, moderate, or no effect.
Results
Among 135 evaluable subjects, 85 (63.0%) had severe haemophilia, 35 (25.9%) had moderate haemophilia and 15 (11.1%) had mild haemophilia. Excellent/good efficacy rate was 91.3% for hemostasis and 89.4% for hemorrhage prevention. Twelve subjects reported 13 adverse drug reactions (ADRs), which were recovered without sequelae. The frequent ADRs were gastrointestinal disorders, nervous system, vascular disorders and general disorders. In 113 previously treated patients (PTP), two patients (1.8%) developed inhibitors after intensive FVIII treatment for surgery and hematuria, respectively.
Conclusion
The results of this PMS study support that GreenGene FTM is safe and efficacious in the treatment and prevention of patients with hemophilia A. The results of this study are consistent with the previously published GreenGene FTM studies.
Session topic: E-poster
Keyword(s): Hemophilia A, Recombinant factor
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