Pro-FEIBA Study results

Significant reduction in bleeding events

26 subjects completed both of the prophylaxis and on-demand study periods.

These 26 subjects (the Pro-FEIBA Study cohort)1:

  • Experienced a mean of 2.2 bleeds per month
  • 18 patients (69%) had target joints (≥3 bleeds in a single joint in 6 months)
  • 7 high-frequency bleeder patients experienced >3 bleeding episodes per month

Significant reduction in bleeds with 3 treatments per week

Primary endpoint: Reduction of bleeding events1

  • Approximately 80% of total bleeding events were joint bleeds

The mean patient age of the Pro-FEIBA Study cohort was 28.7 years, with ages ranging from 2.8-62.8 years of age

  • 6 patients were below 12 years of age
  • 4 patients were between 12 and 21 years of age
  • 16 patients were older than 21 years of age

Reductions in bleeds in good responders*1

  • An 84% reduction in bleeding (P<0.001) was achieved during the FEIBA prophylaxis period in good responders1
  • 6 of 16 good responders experienced no bleeding events during prophylaxis1
  • Among patients with <50% reduction in bleeding episodes, 10 of 26 patients still had a reduction in bleeds of 28% (P<0.02). Only 2 subjects had an increase in bleeding events1
  • In the study cohort (N=26) bleeding episodes declined from 2.2 bleeds per month during the on-demand period to 0.8 per month during prophylaxis (P<0.001) for good responders1
  • Among good responders, high-frequency bleeders (>3 bleeding episodes per month) saw bleed rates drop from 3.8 to 1.1 per month (n=7)1

Notation

* The 16 patients showing ≥50% reduction in bleeding during prophylaxis.

Significant reduction in joint bleeding events with 3 treatments per week

Secondary endpoint: Reduction of joint bleeds1

  • A 61% reduction in joint bleeding events (P<0.001) was achieved during the FEIBA prophylaxis period1

Secondary endpoint: Reduction of target joint bleeds1

  • A target joint was defined as ≥3 bleeds in a single joint in a 6-month period1
  • Nearly 70% of Pro-FEIBA Study patients were already experiencing target joint bleeds before the study began1
  • A 72% reduction in target joint bleeding (P<0.001) was achieved during the FEIBA prophylaxis period1

Adverse events

  • There was one serious adverse event, an episode of allergic reaction to the study drug.1
  • Three subjects had multiple bleeding events related to central venous access devices, including infection, bleeding, and line placement. No thromboembolic event occurred1
  • There were no thrombotic events in the Pro-FEIBA Study1
Learn about the Quality of Life results of the Pro-FEIBA Study >>

References

  1. 1 Leissinger C, Gringeri A, Antmen B, et al. Anti-inhibitor coagulant complex prophylaxis in hemophilia with inhibitors. N Engl J Med. 2011;365:1684-1692.

The results are in

In the Pro-FEIBA study (n=26), FEIBA prophylaxis showed a significant reduction in the frequency of bleeding events in severe haemophilia A patients with FVIII inhibitors Read more

Publications

Visit Haemophilia to read the PROOF Study and access to more articles related to managing haemophilia patients with inhibitors. Read more

Sustained activity

FEIBA offers a long dosing interval. Read more

Demonstrated efficacy in prophylaxis

Learn how FEIBA prophylaxis can reduce bleed frequency and preserve joints. Read more

Dosing FEIBA

Learn how to dose FEIBA. Read more