Real Efficacy

Demonstrated efficacy as episodic (on-demand) treatment

In clinical trials, 79.7% of bleeds in PTPs were successfully treated with 1 infusion; 13% were successfully treated with 2 infusions¹

In clinical trials, 73.1% of bleeds in PUPs and MTPs were successfully treated with 1 infusion; 15% were successfully treated with 2 infusions ¹

In children (0-16 years) with hemophilia A with no preexisting joint damage

Real joint protection…

No joint damage seen in 9 out of 10 children on routine prophylaxis^1,2

In the first study of its kind, 93% (25 of 27) of children with no preexisting joint damage who were treated with Kogenate^® or Kogenate^® FS for routine prophylaxis up to 5.5 years had no joint damage as measured by magnetic resonance imaging (MRI), compared with 55% (16 of 29) of children given enhanced episodic (on-demand) treatment with Kogenate or Kogenate FS^1,2

• The difference between the 2 groups was significant when using MRI but not when using x-ray alone¹

Percentage of children with no joint damage (knees, ankles, elbows) as measured by MRI²

Study Description: A total of 65 boys <30 months of age with severe hemophilia A (FVIII level ≤2 IU/dL) and with ≤2 bleeds into each index joint and normal baseline joint imaging were observed for up to 5.5 years in a multicenter, open-label, prospective, randomized, controlled clinical study. Patients received either 25 IU/kg every other day (primary prophylaxis; n=32) or at least 3 doses totaling a minimum of 80 IU/kg at the time of a bleeding episode (enhanced episodic; n=33). Joint damage was evaluated by MRI or radiography, and the frequency of bleeding episodes was assessed.^1,2

Please consult with your healthcare provider to determine if Kogenate^® FS is appropriate for you.

means real assurance…

• Reduced the frequency of all types of bleeds, including bleeds that lead to joint damage²

Real safety in routine prophylaxis

• Overall, 8 of 64 study patients developed any level of inhibitors over the 5.5-year study¹
  • Two patients developed high-titer inhibitors and were withdrawn from the study^1,2
• There were no life-threatening bleeds in the routine prophylaxis group (0 of 32 patients), compared with approximately 10% (3 of 33) in the episodic group^1,2
• Most adverse events were associated with central venous access, and there were no differences between the 2 study groups^1,2

 

References

1. Kogenate FS with Bio-Set [package insert]. Tarrytown, NY: Bayer HealthCare LLC; 2009.
2. Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357(6):535-544.