Evolving the standard of care for patients with FVIII inhibitors

Factor prophylaxis is the standard of care for haemophilia patients without inhibitors, helping prevent bleeds that can lead to long-term joint damage.1,2

"The primary aim of care is to prevent and treat bleeding with the deficient clotting factor."1

— Guidelines for the Management of Hemophilia, Second Edition, 2012 World Federation of Hemophilia (WFH)

The evidence adds up

Now there are two recent clinical studies — the PROOF Study and the Pro-FEIBA Study — to support prophylaxis treatment for patients with inhibitors.
The authors of these studies conclude that FEIBA prophylaxis delivers significant reductions in annual bleed rates (ABRs) compared with on-demand therapy.2,4

The data from these two studies add up to provide compelling clinical evidence. FEIBA prophylactic therapy has been shown to demonstrate a significant reduction in bleeds compared with on-demand treatment.2-4

FEIBA is an efficacious prophylaxis therapy. It can lower annual bleed rates (ABRs) and may provide your patients corresponding quality-of-life (QoL) benefits.

About the PROOF Study2

PROOF was a phase 3, prospective, randomised, open-label, parallel study conducted at 17 centres globally. Patients were 7 to 56 years of age, with haemophilia A or B and a history of high-titre inhibitor (> 5 BU) or refractory to increased dosing of either FVIII or FIX for ≥ 12 months with low-titre inhibitor (≤ 5 BU).

17 patients received FEIBA prophylaxis treatment at a dose of 85 ± 15 U/kg every other day; and 19 patients received FEIBA on-demand treatment at dosages determined by their treating physicians.

Learn more about the PROOF Study Clinical Results >>

About the Pro-FEIBA Study4

The Pro-FEIBA Study was an investigator-initiated prospective, multicentre, randomised, crossover arm trial conducted at 16 haemophilia treatment centres in Europe and the United States.

It compared 6 months of FEIBA prophylaxis with 6 months of on-demand therapy in 34 patients. Patients were ≥ 2 years of age with haemophilia A and a history of high-titre FVIII inhibitors, and with ≥ 6 bleeding episodes requiring bypassing therapy in the 6 months prior to enrolment.

At the conclusion of the study, 26 patients were evaluable per protocol.

Learn more about the Pro-FEIBA Study Clinical Results >>

Clinical evidence from two trials

The number of bleeding events was significantly reduced in both of these trials, and in the PROOF Study, there was a trend toward a reduction† in new target joints with FEIBA prophylaxis, compared to on-demand therapy.2,4

FEIBA prophylaxis may be of value to haemophilia A and B patients with inhibitors at high risk for2,5:

  • Failure of current treatment5
  • Spontaneous bleeding
  • Trauma
  • Haemarthrosis2


ns=not significant
*Traumatic non-joint bleeds were not significant
†Not significant


  1. 1. Srivastava A, Brewer AK, Mauser-Bunschoten EP, et al; Treatment Guidelines Working Group on Behalf of the World Federation of Hemophilia. Guidelines for the management of hemophilia. Haemophilia. 2013;19:e1-47.
  2. 2. Antunes SV, Tangada S, Stasyshyn O, et al. Randomized comparison of prophylaxis and on-demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors [published online ahead of print August 1, 2013]. Haemophilia. 2014;20(1):65-72. DOI:10.1111/hae.12246.
  3. 3. Hilgartner MW, Knatterud GL. The use of factor eight inhibitor by-passing activity (FEIBA Immuno) product for treatment of bleeding episodes in hemophiliacs with inhibitors. Blood. 1983;61:36-40.
  4. 4. 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.

Sustained activity

FEIBA offers a long dosing interval. Read more

Prophylaxis in clinical practice

Learn why prophylaxis with bypassing therapy is increasingly used for haemophilia patients with inhibitors. Read more

Prophylaxis case studies

Learn how FEIBA prophylaxis reduced bleeding episodes in multiple patients. Read more


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