An international randomized controlled study reports a higher incidence of inhibitors with recombinant factor VIII than plasma-derived factor VIII containing von Willebrand factor in previously untreated patients with hemophilia A

• The Angelo Bianchi Bonomi Foundation is pleased to announce that
  the SIPPET (Survey of Inhibitors in Plasma-Products Exposed Toddlers),
  the first randomized and controlled study on hemophilia and inhibitors
  designed to answer a key clinical question regarding the role that the
  product source plays in the development of inhibitors, has been
  completed.
• The results of the study were selected for presentation in the
  prestigious and highly selective Plenary Session at the congress of
  the American Society of Hematology and were presented in Orlando on
  December 6th, 2015 at 2 PM.
• The results may have implications in the choice of products for
  management in previously untreated patients (PUPs) with severe
  hemophilia A.
• SIPPET is an investigator-driven study sponsored by the Angelo
  Bianchi Bonomi Foundation that obtained financial support from the
  Italian Ministry of Health and unrestricted grants from Grifols,
  Kedrion and LFB.

MILAN–(BUSINESS WIRE)–SIPPET, a study involving 42 sites and 14 countries in 5 continents
began to definitely answer – for the first time through the scientific
and rigorous approach of a randomized clinical trial – whether the
source of factor VIII (FVIII) replacement (plasma derived, pd; or
recombinant, r) affects the rate of inhibitory antibodies in previous
untreated patients (PUPs) with severe hemophilia A.

According to the results from the SIPPET study led by the investigators
Flora Peyvandi and Pier M. Mannucci, from the Angelo Bianchi Bonomi
Hemophilia and Thrombosis Center of Milan (Italy), the treatment of
severe hemophilia A with recombinant factor VIII (rFVIII) is associated
with an 87% higher incidence of inhibitors than treatment with
plasma-derived factor VIII containing von Willebrand factor
(pdFVIII/VWF). The results were presented at the Annual Meeting of the
American Society of Hematology in Orlando, FL (United States) and
according to Prof. Peyvandi, “they may have implications for the choice
of products to treat PUPs, since the development of inhibitors remains
the major challenge in the management of hemophilia A.”

Hemophilia A is a coagulopathy characterized by the deficiency of
coagulation factor VIII. It can be treated by replacing factor VIII from
either a plasma-derived or recombinant source. SIPPET was designed to
establish whether or not the source of product affects the rate of
inhibitors in previously untreated patients (PUPs) with severe
hemophilia A. It is the first randomized controlled study on hemophilia
A and inhibitors and is reflective of clinical practice using current
treatments worldwide.

Investigators conducted the study between 2010 and 2015, and included
251 patients. 76 patients developed an inhibitor, of whom 50 presented
high titers. 90% of inhibitors developed in the first 20 days of
treatment.

SIPPET is an investigator-driven, international, multicenter,
prospective, randomized, open label, study, sponsored by the Angelo
Bianchi Bonomi Foundation. It obtained financial support from the
Italian Ministry of Health and unrestricted grants from Grifols, Kedrion
and LFB.

Further information:

SIPPET abstract: https://ash.confex.com/ash/2015/webprogram/Paper82866.html

SIPPET website: http://www.sippet.org

Contacts

Media Contact in the US:
Salamone Associates LLC
John
Salamone, 703-819-1919
John@SalamoneAssociatesllc.com
or
Media
contact for Angelo Bianchi Bonomi Foundation:
Siray
Silvio
Sircana, +39.335.6383265
silvio@sircana.it