Time to Elevate Protection in Haemophilia Care: New Data From Sobi
(4 months ago)
STOCKHOLM, Feb. 10: Swedish Orphan Biovitrum AB (publ) (Sobi) will present new evidence at the upcoming 11th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), in Madrid, Spain, 7-9 February 2018.
These data mark the company´s long-term commitment to elevate haemophilia management and expand the available clinical evidence for Elocta and Alprolix, demonstrating the need to rethink the current concept of protection, and advance the standard of haemophilia care for people with haemophilia A and B.
"Bleeding control and prevention remain the cornerstone of haemophilia care, however new findings advocate for a more holistic view on protection that can never compromise on safety. This is built on prevention and treatment of bleeds, joint health, freedom of pain, as well as patient´s preferences, physical activity and overall quality of life", said Philip Wood, Head of Haemophilia at Sobi. "This may encourage the haemophilia community to re-think the current definition of protection and evolve the standard of care".
Sobi is dedicating significant efforts to generating both clinical and real-world evidence and translate this holistic perspective on protection into reality for the haemophilia community; from safety and clinical outcomes, to quality of life and sustainable access, to more effective treatments for people with haemophilia A and B.
In line with this, one of the posters presented by Sobi includes the first real world comparison of prophylactic treatment in patients with haemophilia A, before and after switching from conventional rFVIII therapy, to Elocta (rFVIIIFc). The data, gathered from the UK National Haemophilia Database, demonstrates a significant reduction of injection frequency and clotting factor consumption and provides further evidence that extended half-life rFVIII products can reduce treatment burden.
Sobi will also present the results of pharmacokinetic simulations for different prophylactic treatments and dosing regimens for haemophilia A in Germany, and the economic impact thereof. The simulation suggests that by using rFVIIIFc instead of conventional rFVIII therapy it is possible to achieve better bleed protection and extend the dosing interval, lower factor consumption and reduce healthcare costs.
"Protection for people with haemophilia should always be made a priority without compromising on safety", said MD, PhD, Armin Reininger, Head of Medical and Scientific Affairs, at Sobi.
The development of inhibitors is one of the greatest challenges in haemophilia treatment and eradication of the inhibitor is considered the current standard of care. Sobi and its collaborator Bioverativ are committed to further investigate Elocta in the Immune Tolerance Induction (ITI) setting. The poor quality of life (QoL) of severe haemophilia patients with inhibitors and QoL improvement following eradication of inhibitors via ITI are well documented in the literature. The design of ReITIrate, the first prospective study of ITI with an extended half-life FVIII product in patients not responding to previous ITI attempts, and the study design for verITI-8, a global interventional study evaluating rFVIIIFc for initial ITI therapy, could further contribute to the growing evidence of the potential use of Elocta in this setting.
"We are committed to providing the haemophilia community with an increasing amount of scientific evidence that will help in advancing haemophilia care. This includes taking a more holistic approach, understanding how we can provide protection beyond bleeds", said MD, PhD, Armin Reininger, Head of Medical and Scientific Affairs, at Sobi. "We envision a world where people with haemophilia can live a normal life, without any constraints or compromises".
The posters which have been accepted for the 11th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) meeting 2018 include:
Sobi posters and presentation
•Poster P 073: Study design for ReITIrate - A prospective study of rescue ITI with recombinant factor VIII FC (rFVIIIFc) in patients who have failed previous ITI attempts
Konigs C, Meeks S, Jain N, Lethagen S
•Poster P195: Reduced ABR and injection frequency in haemophilia A subjects with short endogenous factor half-life on prophylaxis with rFVIIIFc: A long post hoc analysis
Winding B, Szamosi J, Lethagen S
•Poster P113: The effect of inhibitors and immune tolerance induction treatment on quality of life for adult patients with severe haemophilia; The CHESS study
Kritikou P, Noone D, Myren K-J, O' Hara
•Poster P052: Assessment of clotting activity of recombinant FIX fusion protein in European haemophilia treatment centres
Willemze A, Sadeghi-Khomami A, Sorskog L, Wiken M, Lethagen S
•Poster P131: Pharmacokinetics simulations of different treatment regimens with rFVIIIFc and rFVIII: Economic impact from a German perspective
Myren K-J, Gozzi P, Zucca F, Lethagen S
•Oral presentation OR02: Within-patient comparison of treatment patterns before and after switching to rFVIIIFc: A report from the UK National Haemophilia Database
Scott MJ, Xiang H, Collins PW, Hay CRM
•Poster: How our patients view EHL products in haemophilia expectations expressed before switching (the HOPE study) Khair K, O'Driscoll M, Pollard D, Harrison C, Hook S, Holland M, The HOPE study working group