Efficacy and safety of OBI-1, an antihaemophilic factor VIII (recombinant), porcine sequence, in subjects with acquired haemophilia A
Summary Acquired haemophilia A (AHA) is a rare bleeding disorder caused by autoantibodies against human factor VIII (hFVIII). OBI‐1 is an investigational, B‐domain deleted, recombinant FVIII, porcine sequence, with low cross‐reactivity to anti‐hFVIII antibodies. Efficacy can be monitored with FVIII...
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| Published in | Haemophilia : the official journal of the World Federation of Hemophilia Vol. 21; no. 2; pp. 162 - 170 |
|---|---|
| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Blackwell Publishing Ltd
01.03.2015
Wiley Subscription Services, Inc |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Summary
Acquired haemophilia A (AHA) is a rare bleeding disorder caused by autoantibodies against human factor VIII (hFVIII). OBI‐1 is an investigational, B‐domain deleted, recombinant FVIII, porcine sequence, with low cross‐reactivity to anti‐hFVIII antibodies. Efficacy can be monitored with FVIII activity levels in addition to clinical assessments. This prospective, open label, phase 2/3 study was designed to evaluate the efficacy of OBI‐1 treatment for bleeding episodes in subjects with AHA. After an initial dose of 200 U kg−1, OBI‐1 was titrated to maintain target FVIII activity levels, in correlation with clinical assessments, throughout the treatment phase. All 28 subjects with AHA had a positive response to OBI‐1 treatment 24 h after initiation despite inhibition of FVIII activity levels immediately after infusion in 10 subjects with baseline anti‐porcine FVIII inhibitors. Control of the qualifying bleed was ultimately achieved in 24 of 28 subjects. No related serious adverse events, thrombotic events, allergic reactions or thrombocytopaenia occurred. The results of this study indicate that OBI‐1 is safe and effective in treating bleeding episodes in subjects with AHA. The ability to safely and effectively titrate dosing based on FVIII activity levels in this study demonstrates that OBI‐1 fulfils the unmet medical need to monitor the key coagulation parameter in AHA patients. |
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| AbstractList | Summary
Acquired haemophilia A (AHA) is a rare bleeding disorder caused by autoantibodies against human factor VIII (hFVIII). OBI‐1 is an investigational, B‐domain deleted, recombinant FVIII, porcine sequence, with low cross‐reactivity to anti‐hFVIII antibodies. Efficacy can be monitored with FVIII activity levels in addition to clinical assessments. This prospective, open label, phase 2/3 study was designed to evaluate the efficacy of OBI‐1 treatment for bleeding episodes in subjects with AHA. After an initial dose of 200 U kg−1, OBI‐1 was titrated to maintain target FVIII activity levels, in correlation with clinical assessments, throughout the treatment phase. All 28 subjects with AHA had a positive response to OBI‐1 treatment 24 h after initiation despite inhibition of FVIII activity levels immediately after infusion in 10 subjects with baseline anti‐porcine FVIII inhibitors. Control of the qualifying bleed was ultimately achieved in 24 of 28 subjects. No related serious adverse events, thrombotic events, allergic reactions or thrombocytopaenia occurred. The results of this study indicate that OBI‐1 is safe and effective in treating bleeding episodes in subjects with AHA. The ability to safely and effectively titrate dosing based on FVIII activity levels in this study demonstrates that OBI‐1 fulfils the unmet medical need to monitor the key coagulation parameter in AHA patients. Acquired haemophilia A (AHA) is a rare bleeding disorder caused by autoantibodies against human factor VIII (hFVIII). OBI-1 is an investigational, B-domain deleted, recombinant FVIII, porcine sequence, with low cross-reactivity to anti-hFVIII antibodies. Efficacy can be monitored with FVIII activity levels in addition to clinical assessments. This prospective, open label, phase 2/3 study was designed to evaluate the efficacy of OBI-1 treatment for bleeding episodes in subjects with AHA. After an initial dose of 200 U kg(-1) , OBI-1 was titrated to maintain target FVIII activity levels, in correlation with clinical assessments, throughout the treatment phase. All 28 subjects with AHA had a positive response to OBI-1 treatment 24 h after initiation despite inhibition of FVIII activity levels immediately after infusion in 10 subjects with baseline anti-porcine FVIII inhibitors. Control of the qualifying bleed was ultimately achieved in 24 of 28 subjects. No related serious adverse events, thrombotic events, allergic reactions or thrombocytopaenia occurred. The results of this study indicate that OBI-1 is safe and effective in treating bleeding episodes in subjects with AHA. The ability to safely and effectively titrate dosing based on FVIII activity levels in this study demonstrates that OBI-1 fulfils the unmet medical need to monitor the key coagulation parameter in AHA patients. Acquired haemophilia A ( AHA ) is a rare bleeding disorder caused by autoantibodies against human factor VIII ( hFVIII ). OBI ‐1 is an investigational, B‐domain deleted, recombinant FVIII , porcine sequence, with low cross‐reactivity to anti‐ hFVIII antibodies. Efficacy can be monitored with FVIII activity levels in addition to clinical assessments. This prospective, open label, phase 2/3 study was designed to evaluate the efficacy of OBI ‐1 treatment for bleeding episodes in subjects with AHA . After an initial dose of 200 U kg −1 , OBI ‐1 was titrated to maintain target FVIII activity levels, in correlation with clinical assessments, throughout the treatment phase. All 28 subjects with AHA had a positive response to OBI ‐1 treatment 24 h after initiation despite inhibition of FVIII activity levels immediately after infusion in 10 subjects with baseline anti‐porcine FVIII inhibitors. Control of the qualifying bleed was ultimately achieved in 24 of 28 subjects. No related serious adverse events, thrombotic events, allergic reactions or thrombocytopaenia occurred. The results of this study indicate that OBI ‐1 is safe and effective in treating bleeding episodes in subjects with AHA . The ability to safely and effectively titrate dosing based on FVIII activity levels in this study demonstrates that OBI ‐1 fulfils the unmet medical need to monitor the key coagulation parameter in AHA patients. Acquired haemophilia A (AHA) is a rare bleeding disorder caused by autoantibodies against human factor VIII (hFVIII). OBI‐1 is an investigational, B‐domain deleted, recombinant FVIII, porcine sequence, with low cross‐reactivity to anti‐hFVIII antibodies. Efficacy can be monitored with FVIII activity levels in addition to clinical assessments. This prospective, open label, phase 2/3 study was designed to evaluate the efficacy of OBI‐1 treatment for bleeding episodes in subjects with AHA. After an initial dose of 200 U kg−1, OBI‐1 was titrated to maintain target FVIII activity levels, in correlation with clinical assessments, throughout the treatment phase. All 28 subjects with AHA had a positive response to OBI‐1 treatment 24 h after initiation despite inhibition of FVIII activity levels immediately after infusion in 10 subjects with baseline anti‐porcine FVIII inhibitors. Control of the qualifying bleed was ultimately achieved in 24 of 28 subjects. No related serious adverse events, thrombotic events, allergic reactions or thrombocytopaenia occurred. The results of this study indicate that OBI‐1 is safe and effective in treating bleeding episodes in subjects with AHA. The ability to safely and effectively titrate dosing based on FVIII activity levels in this study demonstrates that OBI‐1 fulfils the unmet medical need to monitor the key coagulation parameter in AHA patients. Acquired haemophilia A (AHA) is a rare bleeding disorder caused by autoantibodies against human factor VIII (hFVIII). OBI-1 is an investigational, B-domain deleted, recombinant FVIII, porcine sequence, with low cross-reactivity to anti-hFVIII antibodies. Efficacy can be monitored with FVIII activity levels in addition to clinical assessments. This prospective, open label, phase 2/3 study was designed to evaluate the efficacy of OBI-1 treatment for bleeding episodes in subjects with AHA. After an initial dose of 200 U kg(-1) , OBI-1 was titrated to maintain target FVIII activity levels, in correlation with clinical assessments, throughout the treatment phase. All 28 subjects with AHA had a positive response to OBI-1 treatment 24 h after initiation despite inhibition of FVIII activity levels immediately after infusion in 10 subjects with baseline anti-porcine FVIII inhibitors. Control of the qualifying bleed was ultimately achieved in 24 of 28 subjects. No related serious adverse events, thrombotic events, allergic reactions or thrombocytopaenia occurred. The results of this study indicate that OBI-1 is safe and effective in treating bleeding episodes in subjects with AHA. The ability to safely and effectively titrate dosing based on FVIII activity levels in this study demonstrates that OBI-1 fulfils the unmet medical need to monitor the key coagulation parameter in AHA patients.Acquired haemophilia A (AHA) is a rare bleeding disorder caused by autoantibodies against human factor VIII (hFVIII). OBI-1 is an investigational, B-domain deleted, recombinant FVIII, porcine sequence, with low cross-reactivity to anti-hFVIII antibodies. Efficacy can be monitored with FVIII activity levels in addition to clinical assessments. This prospective, open label, phase 2/3 study was designed to evaluate the efficacy of OBI-1 treatment for bleeding episodes in subjects with AHA. After an initial dose of 200 U kg(-1) , OBI-1 was titrated to maintain target FVIII activity levels, in correlation with clinical assessments, throughout the treatment phase. All 28 subjects with AHA had a positive response to OBI-1 treatment 24 h after initiation despite inhibition of FVIII activity levels immediately after infusion in 10 subjects with baseline anti-porcine FVIII inhibitors. Control of the qualifying bleed was ultimately achieved in 24 of 28 subjects. No related serious adverse events, thrombotic events, allergic reactions or thrombocytopaenia occurred. The results of this study indicate that OBI-1 is safe and effective in treating bleeding episodes in subjects with AHA. The ability to safely and effectively titrate dosing based on FVIII activity levels in this study demonstrates that OBI-1 fulfils the unmet medical need to monitor the key coagulation parameter in AHA patients. |
| Author | Greist, A. Bourgeois, C. Mo, M. Smith, H. Chowdary, P. Gomperts, E. Farin, H. Kruse-Jarres, R. St-Louis, J. Drebes, A. Novack, A. Shapiro, A. Ewenstein, B. |
| Author_xml | – sequence: 1 givenname: R. surname: Kruse-Jarres fullname: Kruse-Jarres, R. organization: Section of Hematology/Oncology, Tulane University, LA, New Orleans, USA – sequence: 2 givenname: J. surname: St-Louis fullname: St-Louis, J. organization: Division of Hematology, Hôpital Maisonneuve-Rosemont, University of Montreal, QC, Montreal, Canada – sequence: 3 givenname: A. surname: Greist fullname: Greist, A. organization: Indiana Hemophilia and Thrombosis Center, IN, Indianapolis, USA – sequence: 4 givenname: A. surname: Shapiro fullname: Shapiro, A. organization: Indiana Hemophilia and Thrombosis Center, IN, Indianapolis, USA – sequence: 5 givenname: H. surname: Smith fullname: Smith, H. organization: Division of Hematology/Oncology, Tufts New England Medical Center, MA, Boston, USA – sequence: 6 givenname: P. surname: Chowdary fullname: Chowdary, P. organization: Katharine Dormandy Haemophilia Centre and Thrombosis Unit, Royal Free Hospital, London, UK – sequence: 7 givenname: A. surname: Drebes fullname: Drebes, A. organization: Katharine Dormandy Haemophilia Centre and Thrombosis Unit, Royal Free Hospital, London, UK – sequence: 8 givenname: E. surname: Gomperts fullname: Gomperts, E. organization: Division of Hematology/Oncology, Children's Hospital of Los Angeles, CA, Los Angeles, USA – sequence: 9 givenname: C. surname: Bourgeois fullname: Bourgeois, C. organization: Baxter BioScience, Vienna, Austria – sequence: 10 givenname: M. surname: Mo fullname: Mo, M. organization: Baxter Healthcare, CA, Westlake Village, USA – sequence: 11 givenname: A. surname: Novack fullname: Novack, A. organization: Baxter Healthcare, CA, Westlake Village, USA – sequence: 12 givenname: H. surname: Farin fullname: Farin, H. email: heinrich_farin@baxter.com organization: Baxter Healthcare, CA, Westlake Village, USA – sequence: 13 givenname: B. surname: Ewenstein fullname: Ewenstein, B. organization: Baxter Healthcare, CA, Westlake Village, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/25623166$$D View this record in MEDLINE/PubMed |
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| Keywords | acquired haemophilia A bleeding episodes recombinant FVIII porcine sequence replacement therapy |
| Language | English |
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| Notes | Table S1. Efficacy assessment criteria. Table S2. Investigator assessment of control of bleeding by body system of anticipated sites of bleeding. Table S3. Exposure per subject within the first 24 hours (n = 28). Table S4. Dose reduction from initial dose and from the first 24- hour period to treat primary serious bleed in AHA patients. Table S5. Subject deaths. Figure S1. Subject enrolment and disposition ark:/67375/WNG-H855BS56-R istex:582818C41A8692C9109C9774F329CA65D3A7FCCC ArticleID:HAE12627 Baxter ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Article-2 ObjectType-Feature-1 content type line 23 |
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| PublicationTitle | Haemophilia : the official journal of the World Federation of Hemophilia |
| PublicationTitleAlternate | Haemophilia |
| PublicationYear | 2015 |
| Publisher | Blackwell Publishing Ltd Wiley Subscription Services, Inc |
| Publisher_xml | – name: Blackwell Publishing Ltd – name: Wiley Subscription Services, Inc |
| References | 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. 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. 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. 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. 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. Cugno M, Gualtierotti R, Tedeschi A, Meroni PL. Autoantibodies to coagulation factors: from pathophysiology to diagnosis and therapy. Autoimmun Rev 2014; 13: 40-8. 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. Cohen AJ, Kessler CM. Acquired inhibitors. Baillieres Clin Haematol 1996; 9: 331-54. Hay CRM. Porcine factor VIII: current status and future developments. Haemophilia 2002; 8(Suppl 1): 24-7. Morrison AE, Ludlam CA, Kessler C. Use of porcine factor VIII in the treatment of patients with acquired hemophilia. Blood 1993; 81: 1513-20. 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. Healey JF, Lubin IM, Lollar P. The cDNA and derived amino acid sequence of porcine factor VIII. Blood 1996; 88: 4209-14. Giangrande PLF. Porcine factor VIII. Haemophilia 2012; 18: 305-9. Hoffman M, Dargaud Y. Mechanisms and monitoring of bypassing agent therapy. J Thromb Haemost 2012; 10: 1478-85. 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. 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. 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. Green D, Lechner K. A survey of 215 non-hemophilic patients with inhibitors to Factor VIII. Thromb Haemost 1981; 45: 200-3. Astermark J, Santagostino E, Hoots WK. Clinical issues in inhibitors. Haemophilia 2010; 16(Suppl 5): 54-60. 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. 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. Koshihara K, Qian J, Lollar P, Hoyer LW. Immunoblot cross-reactivity of factor VIII inhibitors with porcine factor VIII. Blood 1995; 86: 2183-90. 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. Franchini M, Mannucci PM. Acquired haemophilia A: a 2013 update. Thromb Haemost 2013; 110: 1114-20. Ma AD, Carrizosa D. Acquired factor VIII inhibitors: pathophysiology and treatment. Hematology Am Soc Hematol Educ Program 2006; 432-7. 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. Gringeri A, Santagostino E, Tradati F, Giangrande PL, Mannucci PM. Adverse effects of treatment with porcine factor VIII. Thromb Haemost 1991; 65: 245-7. 2010; 12 1995; 73 2012; 120 2010; 16 1993; 81 2002; 8 2002; 277 2008; 14 2006 1997; 27 2012; 18 2013; 162 2007; 109 2012; 10 1981; 45 2014; 20 1995; 86 1989; 149 2013; 14 1986; 63 2009; 94 1991; 65 2014; 13 2013; 110 1996; 9 1996; 88 e_1_2_9_11_1 e_1_2_9_10_1 e_1_2_9_13_1 e_1_2_9_12_1 e_1_2_9_15_1 e_1_2_9_14_1 e_1_2_9_17_1 e_1_2_9_16_1 Mahlangu J (e_1_2_9_18_1) 2008; 14 e_1_2_9_20_1 e_1_2_9_22_1 e_1_2_9_21_1 e_1_2_9_24_1 e_1_2_9_23_1 e_1_2_9_8_1 e_1_2_9_7_1 e_1_2_9_6_1 e_1_2_9_5_1 e_1_2_9_4_1 e_1_2_9_3_1 e_1_2_9_2_1 Toschi V (e_1_2_9_19_1) 2010; 12 e_1_2_9_9_1 e_1_2_9_26_1 e_1_2_9_25_1 e_1_2_9_28_1 e_1_2_9_27_1 |
| References_xml | – reference: Morrison AE, Ludlam CA, Kessler C. Use of porcine factor VIII in the treatment of patients with acquired hemophilia. Blood 1993; 81: 1513-20. – reference: 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. – reference: Franchini M, Mannucci PM. Acquired haemophilia A: a 2013 update. Thromb Haemost 2013; 110: 1114-20. – reference: Green D, Lechner K. A survey of 215 non-hemophilic patients with inhibitors to Factor VIII. Thromb Haemost 1981; 45: 200-3. – reference: 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. – reference: 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. – reference: 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. – reference: 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. – reference: Hay CRM. Porcine factor VIII: current status and future developments. Haemophilia 2002; 8(Suppl 1): 24-7. – reference: Healey JF, Lubin IM, Lollar P. The cDNA and derived amino acid sequence of porcine factor VIII. Blood 1996; 88: 4209-14. – reference: 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. – reference: 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. – reference: 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. – reference: Cohen AJ, Kessler CM. Acquired inhibitors. Baillieres Clin Haematol 1996; 9: 331-54. – reference: Astermark J, Santagostino E, Hoots WK. Clinical issues in inhibitors. Haemophilia 2010; 16(Suppl 5): 54-60. – reference: Koshihara K, Qian J, Lollar P, Hoyer LW. Immunoblot cross-reactivity of factor VIII inhibitors with porcine factor VIII. Blood 1995; 86: 2183-90. – reference: Giangrande PLF. Porcine factor VIII. Haemophilia 2012; 18: 305-9. – reference: 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. – reference: Ma AD, Carrizosa D. Acquired factor VIII inhibitors: pathophysiology and treatment. Hematology Am Soc Hematol Educ Program 2006; 432-7. – reference: Gringeri A, Santagostino E, Tradati F, Giangrande PL, Mannucci PM. Adverse effects of treatment with porcine factor VIII. Thromb Haemost 1991; 65: 245-7. – reference: Cugno M, Gualtierotti R, Tedeschi A, Meroni PL. Autoantibodies to coagulation factors: from pathophysiology to diagnosis and therapy. Autoimmun Rev 2014; 13: 40-8. – reference: 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. – reference: 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. – reference: 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. – reference: 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. – reference: 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. – reference: Hoffman M, Dargaud Y. Mechanisms and monitoring of bypassing agent therapy. J Thromb Haemost 2012; 10: 1478-85. – volume: 277 start-page: 38345 year: 2002 end-page: 9 article-title: High level expression of recombinant porcine coagulation factor VIII publication-title: J Biol Chem – volume: 12 start-page: 617 year: 2010 end-page: 25 article-title: OBI‐1, porcine recombinant Factor VIII for the potential treatment of patients with congenital hemophilia A and alloantibodies against human Factor VIII publication-title: Curr Opin Mol Ther – volume: 45 start-page: 200 year: 1981 end-page: 3 article-title: A survey of 215 non‐hemophilic patients with inhibitors to Factor VIII publication-title: Thromb Haemost – start-page: 432 year: 2006 end-page: 7 article-title: Acquired factor VIII inhibitors: pathophysiology and treatment publication-title: Hematology Am Soc Hematol Educ Program – volume: 120 start-page: 39 year: 2012 end-page: 46 article-title: Management of bleeding in acquired hemophilia A (AHA): results from the European Acquired Hemophilia (EACH2) Registry publication-title: Blood – volume: 14 start-page: 15 issue: Suppl 2 year: 2008 end-page: 6 article-title: 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 publication-title: Haemophilia – volume: 81 start-page: 1513 year: 1993 end-page: 20 article-title: Use of porcine factor VIII in the treatment of patients with acquired hemophilia publication-title: Blood – volume: 110 start-page: 1114 year: 2013 end-page: 20 article-title: Acquired haemophilia A: a 2013 update publication-title: Thromb Haemost – volume: 88 start-page: 4209 year: 1996 end-page: 14 article-title: The cDNA and derived amino acid sequence of porcine factor VIII publication-title: Blood – volume: 65 start-page: 245 year: 1991 end-page: 7 article-title: Adverse effects of treatment with porcine factor VIII publication-title: Thromb Haemost – volume: 109 start-page: 1870 year: 2007 end-page: 7 article-title: Acquired hemophilia A in the United Kingdom: a 2‐year national surveillance study by the United Kingdom Haemophilia Centre Doctors’ Organisation publication-title: Blood – volume: 149 start-page: 1381 year: 1989 end-page: 5 article-title: The use of porcine factor VIII concentrate (Hyate:C) in the treatment of patients with inhibitor antibodies to factor VIII. A multicenter US experience publication-title: Arch Intern Med – volume: 13 start-page: 40 year: 2014 end-page: 8 article-title: Autoantibodies to coagulation factors: from pathophysiology to diagnosis and therapy publication-title: Autoimmun Rev – volume: 18 start-page: 305 year: 2012 end-page: 9 article-title: Porcine factor VIII publication-title: Haemophilia – volume: 18 start-page: 798 year: 2012 end-page: 804 article-title: Pharmacokinetics and safety of OBI‐1, a recombinant B domain‐deleted porcine factor VIII, in subjects with haemophilia A publication-title: Haemophilia – volume: 63 start-page: 703 year: 1986 end-page: 11 article-title: von Willebrand factor contaminating porcine factor VIII concentrate (Hyate:C) causes platelet aggregation publication-title: Br J Haematol – volume: 73 start-page: 247 year: 1995 end-page: 51 article-title: The Nijmegen modification of the bethesda assay for factor VIII: C inhibitors: improved specificity and reliability publication-title: Thromb Haemost – volume: 9 start-page: 331 year: 1996 end-page: 54 article-title: Acquired inhibitors publication-title: Baillieres Clin Haematol – volume: 8 start-page: 24 issue: Suppl 1 year: 2002 end-page: 7 article-title: Porcine factor VIII: current status and future developments publication-title: Haemophilia – volume: 20 start-page: e185 year: 2014 end-page: 8 article-title: 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 publication-title: Haemophilia – volume: 16 start-page: 54 issue: Suppl 5 year: 2010 end-page: 60 article-title: Clinical issues in inhibitors publication-title: Haemophilia – volume: 14 start-page: 223 year: 2013 end-page: 8 article-title: Long term outcome of patients with acquired haemophilia – a monocentre interim analysis of 82 patients publication-title: Atheroscler Suppl – volume: 162 start-page: 758 year: 2013 end-page: 73 article-title: Diagnosis and management of acquired coagulation inhibitors: a guideline from UKHCDO publication-title: Br J Haematol – volume: 27 start-page: 658 year: 1997 end-page: 64 article-title: Cross‐reactivity to porcine factor VIII of factor VIII inhibitors in patients with haemophilia in Australia and New Zealand publication-title: Aust N Z J Med – volume: 10 start-page: 1478 year: 2012 end-page: 85 article-title: Mechanisms and monitoring of bypassing agent therapy publication-title: J Thromb Haemost – volume: 86 start-page: 2183 year: 1995 end-page: 90 article-title: Immunoblot cross‐reactivity of factor VIII inhibitors with porcine factor VIII publication-title: Blood – volume: 94 start-page: 566 year: 2009 end-page: 75 article-title: International recommendations on the diagnosis and treatment of patients with acquired hemophilia A publication-title: Haematologica – ident: e_1_2_9_11_1 doi: 10.1111/j.1365-2516.2010.02294.x – ident: e_1_2_9_12_1 doi: 10.1182/blood.V88.11.4209.bloodjournal88114209 – ident: e_1_2_9_15_1 doi: 10.1055/s-0038-1647658 – ident: e_1_2_9_7_1 doi: 10.3324/haematol.2008.001743 – ident: e_1_2_9_27_1 doi: 10.1016/S0950-3536(96)80067-9 – ident: e_1_2_9_25_1 doi: 10.1182/blood.V86.6.2183.bloodjournal8662183 – ident: e_1_2_9_21_1 doi: 10.1074/jbc.M206959200 – ident: e_1_2_9_23_1 doi: 10.1111/j.1538-7836.2012.04793.x – volume: 14 start-page: 15 issue: 2 year: 2008 ident: e_1_2_9_18_1 article-title: 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 publication-title: Haemophilia – ident: e_1_2_9_13_1 doi: 10.1111/j.1365-2516.2012.02803.x – ident: e_1_2_9_26_1 doi: 10.1111/j.1445-5994.1997.tb00994.x – ident: e_1_2_9_9_1 doi: 10.1111/bjh.12463 – ident: e_1_2_9_22_1 doi: 10.1055/s-0038-1653759 – ident: e_1_2_9_17_1 doi: 10.1111/j.1365-2516.2012.02789.x – ident: e_1_2_9_16_1 doi: 10.1111/j.1365-2141.1986.tb07554.x – ident: e_1_2_9_6_1 doi: 10.1055/s-0038-1650169 – ident: e_1_2_9_28_1 doi: 10.1001/archinte.1989.00390060103022 – ident: e_1_2_9_2_1 doi: 10.1160/TH13-05-0363 – ident: e_1_2_9_5_1 doi: 10.1016/j.atherosclerosissup.2012.10.033 – ident: e_1_2_9_8_1 doi: 10.1182/blood-2012-02-408930 – ident: e_1_2_9_20_1 doi: 10.1111/hae.12372 – ident: e_1_2_9_4_1 doi: 10.1182/blood-2006-06-029850 – ident: e_1_2_9_24_1 doi: 10.1182/blood.V81.6.1513.1513 – ident: e_1_2_9_3_1 doi: 10.1016/j.autrev.2013.08.001 – ident: e_1_2_9_10_1 doi: 10.1182/asheducation-2006.1.432 – ident: e_1_2_9_14_1 doi: 10.1046/j.1365-2516.2002.00125.x – volume: 12 start-page: 617 year: 2010 ident: e_1_2_9_19_1 article-title: OBI‐1, porcine recombinant Factor VIII for the potential treatment of patients with congenital hemophilia A and alloantibodies against human Factor VIII publication-title: Curr Opin Mol Ther |
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Acquired haemophilia A (AHA) is a rare bleeding disorder caused by autoantibodies against human factor VIII (hFVIII). OBI‐1 is an investigational,... Acquired haemophilia A ( AHA ) is a rare bleeding disorder caused by autoantibodies against human factor VIII ( hFVIII ). OBI ‐1 is an investigational,... Acquired haemophilia A (AHA) is a rare bleeding disorder caused by autoantibodies against human factor VIII (hFVIII). OBI-1 is an investigational, B-domain... Acquired haemophilia A (AHA) is a rare bleeding disorder caused by autoantibodies against human factor VIII (hFVIII). OBI‐1 is an investigational, B‐domain... |
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| SubjectTerms | acquired haemophilia A Adult Aged Aged, 80 and over Animals Antibodies, Neutralizing Autoantibodies Autoantibodies - immunology Bleeding bleeding episodes Coagulation factors Cross Reactions - immunology Dosage Factor VIII - administration & dosage Factor VIII - adverse effects Factor VIII - immunology Factor VIII - therapeutic use Female Hemophilia Hemophilia A - drug therapy Hemophilia A - immunology Humans Hypersensitivity Male Middle Aged recombinant FVIII porcine sequence Recombinant Proteins - administration & dosage Recombinant Proteins - adverse effects Recombinant Proteins - immunology Recombinant Proteins - therapeutic use replacement therapy Swine Thrombocytopenia Time Factors Treatment Outcome |
| Title | Efficacy and safety of OBI-1, an antihaemophilic factor VIII (recombinant), porcine sequence, in subjects with acquired haemophilia A |
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