Publications related to managing haemophilia patients with inhibitors

Articles on inhibitor management

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. Haemophilia. DOI:10.1111/hae12246.
PROOF was a phase 3, prospective, randomised, open-label, parallel study conducted at 17 centres globally designed to determine the efficacy, safety, and health-related quality of life benefits with FEIBA prophylactic treatment as compared with on-demand treatment.

Gringeri A, Leissinger C, Cortesi PA, et al.
Health-related quality of life in patients with haemophilia and inhibitors on prophylaxis with anti-inhibitor complex concentrate: results from the Pro-FEIBA Study. Haemophilia. 2013;19:736-743.
To determine the impact of prophylaxis with FEIBA (Factor VIII Inhibitor Bypassing Activity), health-related quality of life (HRQoL) was assessed using the Short-Form (SF)-36 Health Survey and the EQ-5D questionnaire in subjects aged ≥ 14 years in a prospective, randomised, crossover arm study comparing 6 months of prophylaxis with 6 months of on-demand therapy. 18 of 19 patients completed the SF-36 survey and 16/19 completed the EQ-5D questionnaire before and after the on-demand therapy and prophylaxis periods.

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 Prophylaxis with Factor Eight Inhibitor Bypassing Activity (Pro-FEIBA) Study is the first trial designed to compare the efficacy and safety of AICC prophylaxis with on-demand therapy in this patient population. The Pro-FEIBA study was a prospective, randomized, crossover study and the primary outcome was comparison of bleeding during each 6-month treatment period.

Astermark J, Donfield SM, DiMichele DM, et al.
A randomized comparison of bypassing agents in haemophilia complicated by an inhibitor: the FEIBA NovoSeven Comparative (FENOC) Study.
Blood. 2007; 109(2): 546-551
The FENOC study employed a prospective, open-label, randomised, multicenter, crossover equivalency design to evaluate and compare the efficacy of FEIBA and rFVIIa in joint bleeds.

Perry D, Berntorp E, Tait C, et al.
FEIBA prophylaxis in haemophilia patients: a clinical update and treatment recommendations
Haemophilia. 2010; 16(1):80-89.
Guidance developed by a group of haematologists for clinicians considering initiating and maintaining patients on FEIBA prophylaxis with specific focus on practical aspects of patient selection, dosing, monitoring, and stop criteria.

Ettingshausen CE, Kreuz W.
Early long-term FEIBA prophylaxis in haemophilia A patients with inhibitor after failing immune tolerance induction: A prospective clinical case series
Haemophilia. 2010; 16(1): 90-100
This study was performed to assess the effectiveness and safety of early prophylaxis with FEIBA in preventing bleeding and joint damage after failed ITI in patients from 1.5 to 11.8 years of age.

Valentino LA.
Assessing the benefits of FEIBA prophylaxis in haemophilia patients with inhibitors
Haemophilia. 2010; 16(2): 263-271
A meta-analysis of six studies assessing the efficacy and safety of prophylaxis with FEIBA.

Berntorp E.
Differential response to bypassing agents complicates treatment in patients with haemophilia and inhibitors
Haemophilia. 2009; 15(1): 3-10
A review article that discusses the evidence of a differential haemostatic response to bypassing agents and the potential roles of mode of action and patient-specific factors in contributing to the differences in response.

Huth-Kühne A, Baudo F, Collins P, Ingerslev J, Kessler C, Lévesque H, et. al.
International recommendations on the diagnosis and treatment of patients with acquired hemophilia A.
Haematologica. 2009: 94 (4):566-575
These recommendations provide a set of practice guidelines for the diagnosis and treatment of patients with acquired haemophilia A.

Iorio A, Matino D, DAmico R, et al.
Recombinant Factor VIIa concentrate versus plasma derived concentrates for the treatment of acute bleeding episodes in people with haemophilia and inhibitors.
Cochrane Database Systematic Reviews. 2010 Aug 4;8:CD004449: 1-20
An independent review article to determine the clinical effectiveness of rFVIIa in comparison to FEIBA for the treatment of acute bleeding episodes in haemophilia patients with inhibitors.

Inhibitor guidelines from the World Federation of Hemophilia

World Federation of Hemophilia
Suggestions for the Management of Factor VIII Inhibitors, July 2000
Recommendations on practical approaches to patients with factor VIII inhibitors.

Proven efficacy

Discover the efficacy of FEIBA in both on-demand and prophylaxis treatment. Read more


Learn how FEIBA prophylaxis may help protect your patients against bleeds. Read more

Integral to inhibitor management

Learn how FEIBA is integral to the management of patients with inhibitors. Read more