메뉴 건너뛰기




Volumn 20, Issue 6, 2014, Pages 777-783

Patient data meta-analysis of Post-Authorization Safety Surveillance (PASS) studies of haemophilia A patients treated with rAHF-PFM

Author keywords

Bleeding rate; Factor VIII; Factor VIII inhibitors; Hemophilia A; Post marketing; Surveillance

Indexed keywords

BLOOD CLOTTING FACTOR 8 INHIBITOR; RECOMBINANT BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING INHIBITOR; RECOMBINANT PROTEIN;

EID: 84932088974     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/hae.12480     Document Type: Article
Times cited : (16)

References (33)
  • 1
    • 34249690732 scopus 로고    scopus 로고
    • Treatment-related risk factors of inhibitor development in previously untreated patients with hemophilia A: the CANAL cohort study
    • Gouw SC, van der Bom JG, Marijke van den Berg H. Marijke van den Berg H. Treatment-related risk factors of inhibitor development in previously untreated patients with hemophilia A: the CANAL cohort study. Blood 2007; 109: 4648-54.
    • (2007) Blood , vol.109 , pp. 4648-4654
    • Gouw, S.C.1    van der Bom, J.G.2    Marijke van den Berg, H.3    Marijke van den Berg, H.4
  • 2
    • 0038383605 scopus 로고    scopus 로고
    • The epidemiology of inhibitors in haemophilia A: a systematic review
    • Wight J, Paisley S. The epidemiology of inhibitors in haemophilia A: a systematic review. Haemophilia 2003; 9: 418-35.
    • (2003) Haemophilia , vol.9 , pp. 418-435
    • Wight, J.1    Paisley, S.2
  • 3
    • 77954506432 scopus 로고    scopus 로고
    • Rate of inhibitor development in previously untreated hemophilia A patients treated with plasma-derived or recombinant factor VIII concentrates: a systematic review
    • Iorio A, Halimeh S, Holzhauer S et al. Rate of inhibitor development in previously untreated hemophilia A patients treated with plasma-derived or recombinant factor VIII concentrates: a systematic review. J Thromb Haemost 2010; 8: 1256-65.
    • (2010) J Thromb Haemost , vol.8 , pp. 1256-1265
    • Iorio, A.1    Halimeh, S.2    Holzhauer, S.3
  • 4
    • 84883747381 scopus 로고    scopus 로고
    • Inhibitor development in previously treated hemophilia A patients: a systematic review, meta-analysis, and meta-regression
    • Xi M, Makris M, Marcucci M, Santagostino E, Mannucci PM, Iorio A. Inhibitor development in previously treated hemophilia A patients: a systematic review, meta-analysis, and meta-regression. J Thromb Haemost 2013; 11: 1655-62.
    • (2013) J Thromb Haemost , vol.11 , pp. 1655-1662
    • Xi, M.1    Makris, M.2    Marcucci, M.3    Santagostino, E.4    Mannucci, P.M.5    Iorio, A.6
  • 5
    • 0027392864 scopus 로고
    • A higher than expected incidence of factor VIII inhibitors in multitransfused haemophilia A patients treated with an intermediate purity pasteurized factor VIII concentrate
    • Peerlinck K, Arnout J, Gilles JG, Saint-Remy JM, Vermylen J. A higher than expected incidence of factor VIII inhibitors in multitransfused haemophilia A patients treated with an intermediate purity pasteurized factor VIII concentrate. Thromb Haemost 1993; 69: 115-8.
    • (1993) Thromb Haemost , vol.69 , pp. 115-118
    • Peerlinck, K.1    Arnout, J.2    Gilles, J.G.3    Saint-Remy, J.M.4    Vermylen, J.5
  • 6
    • 30344434999 scopus 로고    scopus 로고
    • Influence of the type of factor VIII concentrate on the incidence of factor VIII inhibitors in previously untreated patients with severe hemophilia A
    • Goudemand J, Rothschild C, Demiguel V et al. FVIII-LFB and Recombinant FVIII study groups. Influence of the type of factor VIII concentrate on the incidence of factor VIII inhibitors in previously untreated patients with severe hemophilia A. Blood 2006; 107: 46-51.
    • (2006) Blood , vol.107 , pp. 46-51
    • Goudemand, J.1    Rothschild, C.2    Demiguel, V.3
  • 7
    • 80055114308 scopus 로고    scopus 로고
    • Can B-domain deletion alter the immunogenicity of recombinant factor VIII?. A meta-analysis of prospective clinical studies
    • Aledort LM, Navickis RJ, Wilkes MM. Can B-domain deletion alter the immunogenicity of recombinant factor VIII? A meta-analysis of prospective clinical studies. J Thromb Haemost 2011; 9: 2180-92.
    • (2011) J Thromb Haemost , vol.9 , pp. 2180-2192
    • Aledort, L.M.1    Navickis, R.J.2    Wilkes, M.M.3
  • 8
    • 84872450786 scopus 로고    scopus 로고
    • Factor VIII products and inhibitor development in severe hemophilia A
    • Gouw SC, van der Bom JG, Ljung R et al. Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9.
    • (2013) N Engl J Med , vol.368 , pp. 231-239
    • Gouw, S.C.1    van der Bom, J.G.2    Ljung, R.3
  • 11
    • 79952066899 scopus 로고    scopus 로고
    • Harmonization of clinical trial guidelines for assessing the risk of inhibitor development in hemophilia A treatment
    • Aledort LM. Harmonization of clinical trial guidelines for assessing the risk of inhibitor development in hemophilia A treatment. J Thromb Haemost 2011; 9: 423-7.
    • (2011) J Thromb Haemost , vol.9 , pp. 423-427
    • Aledort, L.M.1
  • 12
    • 80055116249 scopus 로고    scopus 로고
    • Concentrate-related inhibitor risk: is a difference always real?
    • Iorio A, Marcucci M, Makris M. Concentrate-related inhibitor risk: is a difference always real? J Thromb Haemost 2011; 9: 2176-9.
    • (2011) J Thromb Haemost , vol.9 , pp. 2176-2179
    • Iorio, A.1    Marcucci, M.2    Makris, M.3
  • 13
    • 77955036315 scopus 로고    scopus 로고
    • Biovigilance and pharmacovigilance for haemophilia
    • Weinstein M, Makris M, Ludlam CA. Biovigilance and pharmacovigilance for haemophilia. Haemophilia 2010; 16(Suppl 5): 17-21.
    • (2010) Haemophilia , vol.16 , pp. 17-21
    • Weinstein, M.1    Makris, M.2    Ludlam, C.A.3
  • 14
    • 0032973849 scopus 로고    scopus 로고
    • Recommendation of the Scientific Subcommittee on Factor VIII and Factor IX of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis
    • White GC, DiMichele D, Mertens K et al. Utilization of previously treated patients (PTPs), noninfected patients (NIPs), and previously untreated patients (PUPs) in the evaluation of new factor VIII and factor IX concentrates. Recommendation of the Scientific Subcommittee on Factor VIII and Factor IX of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Thromb Haemost 1999; 81: 462.
    • (1999) Thromb Haemost , vol.81 , pp. 462
    • White, G.C.1    DiMichele, D.2    Mertens, K.3
  • 15
    • 78650784094 scopus 로고    scopus 로고
    • EUHASS: the European Haemophilia Safety Surveillance system
    • Makris M, Calizzani G, Fischer K et al. EUHASS: the European Haemophilia Safety Surveillance system. Thromb Res 2011; 127(Suppl 2): S22-5.
    • (2011) Thromb Res , vol.127 , pp. S22-S25
    • Makris, M.1    Calizzani, G.2    Fischer, K.3
  • 16
    • 4844225137 scopus 로고    scopus 로고
    • Inhibitor development in patients receiving recombinant factor VIII (Recombinate rAHF/Bioclate): a prospective pharmacovigilance study
    • Ewenstein BM, Gomperts ED, Pearson S, O'Banion ME. Inhibitor development in patients receiving recombinant factor VIII (Recombinate rAHF/Bioclate): a prospective pharmacovigilance study. Haemophilia 2004; 10: 491-8.
    • (2004) Haemophilia , vol.10 , pp. 491-498
    • Ewenstein, B.M.1    Gomperts, E.D.2    Pearson, S.3    O'Banion, M.E.4
  • 17
    • 33846916506 scopus 로고    scopus 로고
    • Efficacy, safety and tolerability of recombinant factor VIII (REFACTO) in patients with haemophilia A: interim data from a postmarketing surveillance study in Germany and Austria
    • Pollmann H, Externest D, Ganser A et al. Efficacy, safety and tolerability of recombinant factor VIII (REFACTO) in patients with haemophilia A: interim data from a postmarketing surveillance study in Germany and Austria. Haemophilia 2007; 13: 131-43.
    • (2007) Haemophilia , vol.13 , pp. 131-143
    • Pollmann, H.1    Externest, D.2    Ganser, A.3
  • 18
    • 38349109840 scopus 로고    scopus 로고
    • Safety and efficacy of sucrose-formulated full-length recombinant factor VIII: experience in the standard clinical setting
    • Musso R, Santagostino E, Faradji A et al. KOGENATE Bayer European PMS Study Group. Safety and efficacy of sucrose-formulated full-length recombinant factor VIII: experience in the standard clinical setting. Thromb Haemost 2008; 99: 52-8.
    • (2008) Thromb Haemost , vol.99 , pp. 52-58
    • Musso, R.1    Santagostino, E.2    Faradji, A.3
  • 19
    • 84942545559 scopus 로고    scopus 로고
    • ClinicalTrials.govIdentifier NCT00214734
    • ClinicalTrials.govIdentifier NCT00214734
  • 20
    • 4944263724 scopus 로고    scopus 로고
    • Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/albumin-free method: pharmokinetics, efficacy, and safety in previously treated patients with haemophilia A
    • Tarantino MD, Collins PW, Hay CRM et al. Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/albumin-free method: pharmokinetics, efficacy, and safety in previously treated patients with haemophilia A. Haemophilia 2004; 10: 428-37.
    • (2004) Haemophilia , vol.10 , pp. 428-437
    • Tarantino, M.D.1    Collins, P.W.2    Hay, C.R.M.3
  • 21
    • 47649131839 scopus 로고    scopus 로고
    • Plasma and albumin-free recombinant factor VIII: pharmacokinetics, efficacy and safety in previously treated pediatric patients
    • Blanchette VS, Shapiro AD, Liesner RJ et al. Plasma and albumin-free recombinant factor VIII: pharmacokinetics, efficacy and safety in previously treated pediatric patients. J Thromb Haemost 2008; 6: 1319-26.
    • (2008) J Thromb Haemost , vol.6 , pp. 1319-1326
    • Blanchette, V.S.1    Shapiro, A.D.2    Liesner, R.J.3
  • 22
    • 48949092183 scopus 로고    scopus 로고
    • Surgical evaluation of a recombinant factor VIII prepared using a plasma/albumin-free method: efficacy and safety of ADVATE in previously treated patients
    • Négrier C, Shapiro A, Berntorp E et al. Surgical evaluation of a recombinant factor VIII prepared using a plasma/albumin-free method: efficacy and safety of ADVATE in previously treated patients. Thromb Haemost 2008; 100: 217-23.
    • (2008) Thromb Haemost , vol.100 , pp. 217-223
    • Négrier, C.1    Shapiro, A.2    Berntorp, E.3
  • 23
    • 79955163296 scopus 로고    scopus 로고
    • Low risk of inhibitor formation in haemophilia A patients following en masse switch in treatment to a third generation full length plasma and albumin-free recombinant factor VIII product (ADVATE®)
    • Bacon CL, Singleton E, Brady B et al. Low risk of inhibitor formation in haemophilia A patients following en masse switch in treatment to a third generation full length plasma and albumin-free recombinant factor VIII product (ADVATE®). Haemophilia 2011; 17: 407-11.
    • (2011) Haemophilia , vol.17 , pp. 407-411
    • Bacon, C.L.1    Singleton, E.2    Brady, B.3
  • 24
    • 84857572936 scopus 로고    scopus 로고
    • A randomized comparison of two prophylaxis regimens and a paired comparison of on-demand and prophylaxis treatments in hemophilia A management
    • Valentino LA, Mamonov V, Hellmann A et al. Prophylaxis Study Group. A randomized comparison of two prophylaxis regimens and a paired comparison of on-demand and prophylaxis treatments in hemophilia A management. J Thromb Haemost 2012; 10: 359-67.
    • (2012) J Thromb Haemost , vol.10 , pp. 359-367
    • Valentino, L.A.1    Mamonov, V.2    Hellmann, A.3
  • 25
    • 84861735411 scopus 로고    scopus 로고
    • Experience of ADVATE rAHF-PFM in previously untreated patients and minimally treated patients with haemophilia A
    • Auerswald G, Thompson AA, Recht M et al. Experience of ADVATE rAHF-PFM in previously untreated patients and minimally treated patients with haemophilia A. Thromb Haemost 2012; 107: 1072-82.
    • (2012) Thromb Haemost , vol.107 , pp. 1072-1082
    • Auerswald, G.1    Thompson, A.A.2    Recht, M.3
  • 26
    • 84942522771 scopus 로고    scopus 로고
    • Integrated Analysis of Safety Data from 12 clinical interventional studies of a Plasma-and Albumin-free Recombinant Factor VIII (rAHF-PFM) in Persons with Hemophilia A (HemoA)
    • Abstracts of the XXIV Congress of the International Society on Thrombosis and Haemostasis. June 29-July 4, 2013. Amsterdam, The Netherlands
    • Shapiro A, Romanov V, Silvati-Fidell L, Wong WY, Schoenig-Diesing C. Integrated Analysis of Safety Data from 12 clinical interventional studies of a Plasma-and Albumin-free Recombinant Factor VIII (rAHF-PFM) in Persons with Hemophilia A (HemoA). Abstracts of the XXIV Congress of the International Society on Thrombosis and Haemostasis. June 29-July 4, 2013. Amsterdam, The Netherlands. J Thromb Haemost 2013; 11(Suppl 2): 1-1322.
    • (2013) J Thromb Haemost , vol.11 , pp. 1-1322
    • Shapiro, A.1    Romanov, V.2    Silvati-Fidell, L.3    Wong, W.Y.4    Schoenig-Diesing, C.5
  • 27
    • 78049307974 scopus 로고    scopus 로고
    • Postauthorization safety surveillance of ADVATE [antihaemophilic factor (recombinant), plasma/albumin-free method] demonstrates efficacy, safety and low-risk for immunogenicity in routine clinical practice
    • Oldenburg J, Goudemand J, Valentino L et al. Postauthorization safety surveillance of ADVATE [antihaemophilic factor (recombinant), plasma/albumin-free method] demonstrates efficacy, safety and low-risk for immunogenicity in routine clinical practice. Haemophilia 2010; 16: 866-77.
    • (2010) Haemophilia , vol.16 , pp. 866-877
    • Oldenburg, J.1    Goudemand, J.2    Valentino, L.3
  • 28
    • 80055106281 scopus 로고    scopus 로고
    • Postauthorization safety surveillance (PASS) program of antihemophilic factor (recombinant), plasma/albumin-free method (rAHFPFM) for Japanese hemophilia A patien
    • Abstracts of the XXII Congress of the International Society of Thrombosis and Haemostasis. Boston, Massachusetts, USA. July 11-16, 2009
    • Taki M, Fukutake K, Hanabusa H, Takamatsu J, Shima M, Shirahata A. Postauthorization safety surveillance (PASS) program of antihemophilic factor (recombinant), plasma/albumin-free method (rAHFPFM) for Japanese hemophilia A patients. Abstracts of the XXII Congress of the International Society of Thrombosis and Haemostasis. Boston, Massachusetts, USA. July 11-16, 2009. J Thromb Haemost 2009; 7(Suppl 2): 1-1204.
    • (2009) J Thromb Haemost , vol.7 , pp. 1-1204
    • Taki, M.1    Fukutake, K.2    Hanabusa, H.3    Takamatsu, J.4    Shima, M.5    Shirahata, A.6
  • 29
    • 84942515297 scopus 로고    scopus 로고
    • The post-authorization safety surveillance (pass) program confirmed actual clinical safety and efficacy of recombinant plasma/albumin-free method factor VIII in Ja
    • Abstracts of the XXIII Congress of the International Society on Thrombosis and Haemostasis with the 57th Annual SSC (Scientific and Standardization Committee) Meeting. July 23-28 2011. Kyoto, Japan
    • Fukutake K, Hanabusa H, Taki M et al. The post-authorization safety surveillance (pass) program confirmed actual clinical safety and efficacy of recombinant plasma/albumin-free method factor VIII in Japan. Abstracts of the XXIII Congress of the International Society on Thrombosis and Haemostasis with the 57th Annual SSC (Scientific and Standardization Committee) Meeting. July 23-28 2011. Kyoto, Japan. J Thromb Haemost 2011; 9(Suppl 2): 1-1055.
    • (2011) J Thromb Haemost , vol.9 , pp. 1-1055
    • Fukutake, K.1    Hanabusa, H.2    Taki, M.3
  • 30
    • 84942519405 scopus 로고    scopus 로고
    • A prospective post-authorization safety surveillance study in 384 hemophilia A patients with antihemophilic factor (recombinant) plasma/albumin free method demonstrates safety and efficacy in Ja
    • Abstracts of the XXIV Congress of the International Society on Thrombosis and Haemostasis. June 29-July 4, 2013. Amsterdam, The Netherlands
    • Fukutake K, Hanabusa H, Taki M et al. A prospective post-authorization safety surveillance study in 384 hemophilia A patients with antihemophilic factor (recombinant) plasma/albumin free method demonstrates safety and efficacy in Japan. Abstracts of the XXIV Congress of the International Society on Thrombosis and Haemostasis. June 29-July 4, 2013. Amsterdam, The Netherlands. J Thromb Haemost 2013; 11(Suppl 2): 1-1322.
    • (2013) J Thromb Haemost , vol.11 , pp. 1-1322
    • Fukutake, K.1    Hanabusa, H.2    Taki, M.3
  • 31
    • 84942515173 scopus 로고    scopus 로고
    • P.I.S.A. Safety, immunogenicity and efficacy of a full length DNA rAHF-PMF in patients with hemophilia A in the Italian post-marketing surveillance study. Abstracts of the XXIV Congress of the International Society on Thrombosis and Haemostasis. June 29-July 4, 2013. Amsterdam, The Netherlands
    • Schino M, Rocino A, Santagostino E, Mazzucconi MG. P.I.S.A.-safety, immunogenicity and efficacy of a full length DNA rAHF-PMF in patients with hemophilia A in the Italian post-marketing surveillance study. Abstracts of the XXIV Congress of the International Society on Thrombosis and Haemostasis. June 29-July 4, 2013. Amsterdam, The Netherlands. J Thromb Haemost 2013; 11(Suppl 2): 1-1322.
    • (2013) J Thromb Haemost , vol.11 , pp. 1-1322
    • Schino, M.1    Rocino, A.2    Santagostino, E.3    Mazzucconi, M.G.4
  • 32
    • 84942521024 scopus 로고    scopus 로고
    • The safety and efficacy surveillance study of full-length plasma and albumin-free recombinant factor VIII for previously treated patients with hemophilia A in Taiw
    • Abstracts of the XXX International Congress of the World Federation of Hemophilia. July 8-12, 2012. Paris, France
    • Chen Y, Cheng S, Chang P. The safety and efficacy surveillance study of full-length plasma and albumin-free recombinant factor VIII for previously treated patients with hemophilia A in Taiwan. Abstracts of the XXX International Congress of the World Federation of Hemophilia. July 8-12, 2012. Paris, France. Haemophilia 2012; 18(Suppl 3): 1-226.
    • (2012) Haemophilia , vol.18 , pp. 1-226
    • Chen, Y.1    Cheng, S.2    Chang, P.3
  • 33
    • 18344405441 scopus 로고    scopus 로고
    • A detailed comparison of the performance of the standard versus the Nijmegen modification of the Bethesda assay in detecting factor VIII: C inhibitors in the haemophilia A population of Canada
    • Association of Hemophilia Centre Directors of Canada. Factor VIII/IX Subcommittee of Scientific and Standardization Committee of International Society on Thrombosis and Haemostasis
    • Giles AR, Verbruggen B, Rivard GE, Teitel J, Walker I. A detailed comparison of the performance of the standard versus the Nijmegen modification of the Bethesda assay in detecting factor VIII: C inhibitors in the haemophilia A population of Canada. Association of Hemophilia Centre Directors of Canada. Factor VIII/IX Subcommittee of Scientific and Standardization Committee of International Society on Thrombosis and Haemostasis. Thromb Haemost 1998; 79: 872-5.
    • (1998) Thromb Haemost , vol.79 , pp. 872-875
    • Giles, A.R.1    Verbruggen, B.2    Rivard, G.E.3    Teitel, J.4    Walker, I.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.