Efficacy and safety of OBI-1, an antihaemophilic factor VIII (recombinant), porcine sequence, in subjects with acquired haemophilia A

Haemophilia

Volumn 21, Issue 2, 2015, Pages 162-170

  Kruse Jarres, R ^a   St Louis, J ^b   Greist, A ^c   Shapiro, A ^c   Smith, H ^d   Chowdary, P ^e   Drebes, A ^e   Gomperts, E ^f   Bourgeois, C ^g   Mo, M ^h   Novack, A ^h   Farin, H ^h   Ewenstein, B ^h  

^a TULANE UNIVERSITY   (United States)

^b MAISONNEUVE ROSEMONT HOSPITAL   (Canada)

^c INDIANA HEMOPHILIA AND THROMBOSIS CENTER   (United States)

^d TUFTS MEDICAL CENTER   (United States)

^e ROYAL FREE HOSPITAL   (United Kingdom)

^f CHILDREN S HOSPITAL LOS ANGELES   (United States)

^g BAXTER BIOSCIENCE   (Austria)

^h BAXTER HEALTHCARE CORPORATION   (United States)

Author keywords

Acquired haemophilia A; Bleeding episodes; Recombinant FVIII porcine sequence; Replacement therapy

Indexed keywords

AUTOANTIBODY; B DOMAIN DELETED RECOMBINANT PORCINE BLOOD CLOTTING FACTOR VIII; BLOOD CLOTTING FACTOR 8; RECOMBINANT BLOOD CLOTTING FACTOR 8; UNCLASSIFIED DRUG; NEUTRALIZING ANTIBODY; RECOMBINANT PROTEIN;

ADULT; AGED; ARTICLE; BLEEDING; BLOOD CLOTTING; CLINICAL ARTICLE; CLINICAL ASSESSMENT; CROSS REACTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG INFUSION; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HEMOPHILIA A; HUMAN; MALE; MIDDLE AGED; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; THROMBOCYTOPENIA; THROMBOSIS; TREATMENT RESPONSE; VERY ELDERLY; ANIMAL; CLINICAL TRIAL; IMMUNOLOGY; PIG; TIME; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; ANIMALS; ANTIBODIES, NEUTRALIZING; AUTOANTIBODIES; CROSS REACTIONS; FACTOR VIII; FEMALE; HEMOPHILIA A; HUMANS; MALE; MIDDLE AGED; RECOMBINANT PROTEINS; SWINE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84923093912     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/hae.12627     Document Type: Article

References (27)

1. Franchini M, Mannucci PM. Acquired haemophilia A: a 2013 update. Thromb Haemost 2013; 110: 1114-20.
2. Cugno M, Gualtierotti R, Tedeschi A, Meroni PL. Autoantibodies to coagulation factors: from pathophysiology to diagnosis and therapy. Autoimmun Rev 2014; 13: 40-8.
3. Collins PW, Hirsch S, Baglin TP et al. Acquired hemophilia A in the United Kingdom: a 2-year national surveillance study by the United Kingdom Haemophilia Centre Doctors' Organisation. Blood 2007; 109: 1870-7.
4. Zeitler H, Goldmann G, Marquardt N, Ulrich-Merzenich G. Long term outcome of patients with acquired haemophilia - a monocentre interim analysis of 82 patients. Atheroscler Suppl 2013; 14: 223-8.
5. Green D, Lechner K. A survey of 215 non-hemophilic patients with inhibitors to Factor VIII. Thromb Haemost 1981; 45: 200-3.
6. Huth-Kühne A, Baudo F, Collins P et al. International recommendations on the diagnosis and treatment of patients with acquired hemophilia A. Haematologica 2009; 94: 566-75.
7. Baudo F, Collins P, Huth-Kuehne A et al. Management of bleeding in acquired hemophilia A (AHA): results from the European Acquired Hemophilia (EACH2) Registry. Blood 2012; 120: 39-46.
8. Collins PW, Chalmers E, Hart D et al. Diagnosis and management of acquired coagulation inhibitors: a guideline from UKHCDO. Br J Haematol 2013; 162: 758-73.
9. Ma AD, Carrizosa D. Acquired factor VIII inhibitors: pathophysiology and treatment. Hematology Am Soc Hematol Educ Program 2006; 432-7.
10. Astermark J, Santagostino E, Hoots WK. Clinical issues in inhibitors. Haemophilia 2010; 16(Suppl 5): 54-60.
11. Healey JF, Lubin IM, Lollar P. The cDNA and derived amino acid sequence of porcine factor VIII. Blood 1996; 88: 4209-14.
12. Giangrande PLF. Porcine factor VIII. Haemophilia 2012; 18: 305-9.
13. Hay CRM. Porcine factor VIII: current status and future developments. Haemophilia 2002; 8(Suppl 1): 24-7.
14. Gringeri A, Santagostino E, Tradati F, Giangrande PL, Mannucci PM. Adverse effects of treatment with porcine factor VIII. Thromb Haemost 1991; 65: 245-7.
15. Altieri D, Capitanio AM, Mannucci PM. von Willebrand factor contaminating porcine factor VIII concentrate (Hyate:C) causes platelet aggregation. Br J Haematol 1986; 63: 703-11.
16. Kempton CL, Abshire TC, Deveras RA et al. Pharmacokinetics and safety of OBI-1, a recombinant B domain-deleted porcine factor VIII, in subjects with haemophilia A. Haemophilia 2012; 18: 798-804.
17. Mahlangu J, Andreeva T, Macfarlane D et al. A phase II open-label study evaluating the hemostatic activity, pharmacokinetics and safety of recombinant porcine factor VIII (OBI-1) in hemophilia A patients with inhibitors directed against human FVIII. Haemophilia 2008; 14(Suppl 2): 15-6.
18. Toschi V. OBI-1, porcine recombinant Factor VIII for the potential treatment of patients with congenital hemophilia A and alloantibodies against human Factor VIII. Curr Opin Mol Ther 2010; 12: 617-25.
19. Lozier JN, Nghiem K, Lee M et al. Acquired haemophilia A after stem cell transplant for sickle cell disease: treatment with recombinant porcine factor VIII (OBI-1) and tolerance induction with rituximab/prednisone. Haemophilia 2014; 20: e185-8.
20. Doering CB, Healey JF, Parker ET, Barrow RT, Lollar P. High level expression of recombinant porcine coagulation factor VIII. J Biol Chem 2002; 277: 38345-9.
21. Verbruggen B, Novakova I, Wessels H, Boezeman J, van den Berg M, Mauser-Bunschoten E. The Nijmegen modification of the bethesda assay for factor VIII: C inhibitors: improved specificity and reliability. Thromb Haemost 1995; 73: 247-51.
22. Hoffman M, Dargaud Y. Mechanisms and monitoring of bypassing agent therapy. J Thromb Haemost 2012; 10: 1478-85.
23. Morrison AE, Ludlam CA, Kessler C. Use of porcine factor VIII in the treatment of patients with acquired hemophilia. Blood 1993; 81: 1513-20.
24. Koshihara K, Qian J, Lollar P, Hoyer LW. Immunoblot cross-reactivity of factor VIII inhibitors with porcine factor VIII. Blood 1995; 86: 2183-90.
25. Lloyd JV, Street AM, Berry E et al. Cross-reactivity to porcine factor VIII of factor VIII inhibitors in patients with haemophilia in Australia and New Zealand. Aust N Z J Med 1997; 27: 658-64.
26. Cohen AJ, Kessler CM. Acquired inhibitors. Baillieres Clin Haematol 1996; 9: 331-54.
27. Brettler DB, Forsberg AD, Levine PH et al. The use of porcine factor VIII concentrate (Hyate:C) in the treatment of patients with inhibitor antibodies to factor VIII. A multicenter US experience. Arch Intern Med 1989; 149: 1381-5.