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Volumn 112, Issue 2, 2014, Pages

Recombinant human C1-esterase inhibitor relieves symptoms of hereditary angioedema attacks: Phase 3, randomized, placebo-controlled trial

(13)  Riedl, Marc A a   Bernstein, Jonathan A b   Li, Henry c   Reshef, Avner d   Lumry, William e   Moldovan, Dumitru f   Farkas, Henriette g   Levy, Robyn h   Baker, James i   Hardiman, Yun j   Totoritis, Mark C j   Relan, Anurag k   Cicardi, Marco l  


Author keywords

[No Author keywords available]

Indexed keywords

COMPLEMENT COMPONENT C1S INHIBITOR; D DIMER; PLACEBO;

EID: 84893684243     PISSN: 10811206     EISSN: 15344436     Source Type: Journal    
DOI: 10.1016/j.anai.2013.12.004     Document Type: Article
Times cited : (73)

References (29)
  • 1
    • 50949089029 scopus 로고    scopus 로고
    • Clinical practice. Hereditary angioedema
    • B.L. Zuraw Clinical practice. Hereditary angioedema N Engl J Med 359 2008 1027 1036
    • (2008) N Engl J Med , vol.359 , pp. 1027-1036
    • Zuraw, B.L.1
  • 2
    • 84893698005 scopus 로고    scopus 로고
    • Cinryze (C1 esterase inhibitor [human]). Package insert. Accessed June 4, 2013
    • Cinryze (C1 esterase inhibitor [human]). Package insert. Available at: http://www.viropharma.com/products/cinryze/cinryze%20pi.aspx. Accessed June 4, 2013.
  • 3
    • 84893713079 scopus 로고    scopus 로고
    • Berinert (C1 esterase inhibitor [human]). Package insert. Accessed June 4, 2013
    • Berinert (C1 esterase inhibitor [human]). Package insert. Available at: http://druginserts.com/lib/other/meds/berinert. Accessed June 4, 2013.
  • 4
    • 84867289618 scopus 로고    scopus 로고
    • Thrombotic events associated with C1 esterase inhibitor products in patients with hereditary angioedema: Investigation from the United States Food and Drug Administration adverse event reporting system database
    • P.K. Gandhi, W.M. Gentry, and M.B. Bottorff Thrombotic events associated with C1 esterase inhibitor products in patients with hereditary angioedema: investigation from the United States Food and Drug Administration adverse event reporting system database Pharmacotherapy 32 2012 902 909
    • (2012) Pharmacotherapy , vol.32 , pp. 902-909
    • Gandhi, P.K.1    Gentry, W.M.2    Bottorff, M.B.3
  • 5
    • 84893637646 scopus 로고    scopus 로고
    • Viropharma, Inc. United States Securities and Exchange Commission Form 10-Q Quarterly report pursuant to sections 13 or 15(d) of the Securities and Exchange Act of 1934; filed on 10/28/2009; filed period 9/30/2009. Accessed June 4, 2013
    • Viropharma, Inc. United States Securities and Exchange Commission Form 10-Q Quarterly report pursuant to sections 13 or 15(d) of the Securities and Exchange Act of 1934; filed on 10/28/2009; filed period 9/30/2009. Available at: http://apps.shareholder.com/sec/viewerContent.aspx?companyid=ABEA- 4ZUL1I&docid=6574386. Accessed June 4, 2013.
  • 6
    • 0036972268 scopus 로고    scopus 로고
    • Responding to the immunoglobulin shortage: A case study
    • A. Boulis, S. Goold, and P.A. Ubel Responding to the immunoglobulin shortage: a case study J Health Polit Policy Law 27 2002 977 999
    • (2002) J Health Polit Policy Law , vol.27 , pp. 977-999
    • Boulis, A.1    Goold, S.2    Ubel, P.A.3
  • 7
    • 84868463742 scopus 로고    scopus 로고
    • Characterization of recombinant human C1 inhibitor secreted in milk of transgenic rabbits
    • H.A. Van Veen, J. Koiter, and C.J. Vogelezang et al. Characterization of recombinant human C1 inhibitor secreted in milk of transgenic rabbits J Biotechnol 162 2012 319 326
    • (2012) J Biotechnol , vol.162 , pp. 319-326
    • Van Veen, H.A.1    Koiter, J.2    Vogelezang, C.J.3
  • 8
    • 77957792655 scopus 로고    scopus 로고
    • Recombinant human C1-inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema
    • B. Zuraw, M. Cicardi, and R.J. Levy et al. Recombinant human C1-inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema J Allergy Clin Immunol 126 2010 821 827.e14
    • (2010) J Allergy Clin Immunol , vol.126
    • Zuraw, B.1    Cicardi, M.2    Levy, R.J.3
  • 9
    • 84865173076 scopus 로고    scopus 로고
    • Efficacy and safety of recombinant human C1-inhibitor for the treatment of attacks of hereditary angioedema: European open-label extension study
    • D. Moldovan, A. Reshef, and J. Fabiani et al. Efficacy and safety of recombinant human C1-inhibitor for the treatment of attacks of hereditary angioedema: European open-label extension study Clin Exp Allergy 42 2012 929 935
    • (2012) Clin Exp Allergy , vol.42 , pp. 929-935
    • Moldovan, D.1    Reshef, A.2    Fabiani, J.3
  • 10
    • 84875436177 scopus 로고    scopus 로고
    • Efficacy and safety of recombinant C1 inhibitor for the treatment of hereditary angioedema attacks: A North American open-label study
    • M.A. Riedl, R.J. Levy, and D. Suez et al. Efficacy and safety of recombinant C1 inhibitor for the treatment of hereditary angioedema attacks: a North American open-label study Ann Allergy Asthma Immunol 110 2013 295 299
    • (2013) Ann Allergy Asthma Immunol , vol.110 , pp. 295-299
    • Riedl, M.A.1    Levy, R.J.2    Suez, D.3
  • 11
    • 84886728753 scopus 로고    scopus 로고
    • Population pharmacokinetics of recombinant human C1-inhibitor in patients with hereditary angioedema
    • C. Farell, S. Hayes, A. Relan, E.S. van Amersfoort, R. Pijpstra, and C.E. Hack Population pharmacokinetics of recombinant human C1-inhibitor in patients with hereditary angioedema Br J Clin Pharmacol 76 2013 897 907
    • (2013) Br J Clin Pharmacol , vol.76 , pp. 897-907
    • Farell, C.1    Hayes, S.2    Relan, A.3    Van Amersfoort, E.S.4    Pijpstra, R.5    Hack, C.E.6
  • 12
    • 84870589984 scopus 로고    scopus 로고
    • Recombinant human C1 inhibitor for the prophylaxis of hereditary angioedema attacks: A pilot study
    • A. Reshef, D. Moldovan, and K. Obtulowicz et al. Recombinant human C1 inhibitor for the prophylaxis of hereditary angioedema attacks: a pilot study Allergy 68 2013 118 124
    • (2013) Allergy , vol.68 , pp. 118-124
    • Reshef, A.1    Moldovan, D.2    Obtulowicz, K.3
  • 14
    • 0025322263 scopus 로고
    • Plasma levels of C1-inhibitor complexes and cleaved C1-inhibitor in patients with hereditary angioneurotic edema
    • M. Cugno, J.H. Nuijens, and C.E. Hack et al. Plasma levels of C1-inhibitor complexes and cleaved C1-inhibitor in patients with hereditary angioneurotic edema J Clin Invest 85 1990 1215 1220
    • (1990) J Clin Invest , vol.85 , pp. 1215-1220
    • Cugno, M.1    Nuijens, J.H.2    Hack, C.E.3
  • 15
    • 83555161732 scopus 로고    scopus 로고
    • Target levels of functional C1-inhibitor in hereditary angioedema
    • C.E. Hack, A. Relan, E.S. van Amersfoort, and M. Cicardi Target levels of functional C1-inhibitor in hereditary angioedema Allergy 67 2012 123 130
    • (2012) Allergy , vol.67 , pp. 123-130
    • Hack, C.E.1    Relan, A.2    Van Amersfoort, E.S.3    Cicardi, M.4
  • 16
    • 70449727672 scopus 로고    scopus 로고
    • Efficacy of human C1 esterase inhibitor concentrate compared with placebo in acute hereditary angioedema attacks
    • T.J. Craig, R.J. Levy, and R.L. Wasserman et al. Efficacy of human C1 esterase inhibitor concentrate compared with placebo in acute hereditary angioedema attacks J Allergy Clin Immunol 124 2009 801 808
    • (2009) J Allergy Clin Immunol , vol.124 , pp. 801-808
    • Craig, T.J.1    Levy, R.J.2    Wasserman, R.L.3
  • 17
    • 77955299623 scopus 로고    scopus 로고
    • Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema
    • B.L. Zuraw, P. Busse, and M. White et al. Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema N Engl J Med 363 2010 513 522
    • (2010) N Engl J Med , vol.363 , pp. 513-522
    • Zuraw, B.L.1    Busse, P.2    White, M.3
  • 18
    • 0031820676 scopus 로고    scopus 로고
    • A randomized, controlled trial to study the efficacy and safety of C1 inhibitor concentrate in treating hereditary angioedema
    • M. Kunschak, W. Engl, and F. Maritsch et al. A randomized, controlled trial to study the efficacy and safety of C1 inhibitor concentrate in treating hereditary angioedema Transfusion 38 1998 540 549
    • (1998) Transfusion , vol.38 , pp. 540-549
    • Kunschak, M.1    Engl, W.2    Maritsch, F.3
  • 19
    • 84860198173 scopus 로고    scopus 로고
    • Content validity of visual analog scales to assess symptom severity of acute angioedema attacks in adults with hereditary angioedema: An interview study
    • C.V. McMillan, J. Speight, A. Relan, L. Bellizzi, G. Haase, and M. Cicardi Content validity of visual analog scales to assess symptom severity of acute angioedema attacks in adults with hereditary angioedema: an interview study Patient 5 2012 113 126
    • (2012) Patient , vol.5 , pp. 113-126
    • McMillan, C.V.1    Speight, J.2    Relan, A.3    Bellizzi, L.4    Haase, G.5    Cicardi, M.6
  • 20
    • 58649108068 scopus 로고    scopus 로고
    • Plasma biomarkers of acute attacks in patients with angioedema due to C1-inhibitor deficiency
    • M. Cugno, A. Zanichelli, A.G. Bellatorre, S. Griffini, and M. Cicardi Plasma biomarkers of acute attacks in patients with angioedema due to C1-inhibitor deficiency Allergy 64 2009 254 257
    • (2009) Allergy , vol.64 , pp. 254-257
    • Cugno, M.1    Zanichelli, A.2    Bellatorre, A.G.3    Griffini, S.4    Cicardi, M.5
  • 21
    • 78650897413 scopus 로고    scopus 로고
    • 2010 International consensus algorithm for the diagnosis, therapy, and management of hereditary angioedema
    • T. Bowen, M. Cicardi, and H. Farkas et al. 2010 International consensus algorithm for the diagnosis, therapy, and management of hereditary angioedema Allergy Asthma Clin Immunol 6 2010 24 36
    • (2010) Allergy Asthma Clin Immunol , vol.6 , pp. 24-36
    • Bowen, T.1    Cicardi, M.2    Farkas, H.3
  • 22
    • 84872302853 scopus 로고    scopus 로고
    • WAO guideline for the management of hereditary angioedema
    • T. Craig, E. Aygören-Pürsün, and K. Bork et al. WAO guideline for the management of hereditary angioedema World Allergy Organ J 5 2012 182 199
    • (2012) World Allergy Organ J , vol.5 , pp. 182-199
    • Craig, T.1    Aygören-Pürsün, E.2    Bork, K.3
  • 23
    • 84855779242 scopus 로고    scopus 로고
    • Evidence-based recommendations for the therapeutic management of angioedema owing to hereditary C1 inhibitor deficiency: Consensus report of an international working group
    • M. Cicardi, K. Bork, and T. Caballero et al. Evidence-based recommendations for the therapeutic management of angioedema owing to hereditary C1 inhibitor deficiency: consensus report of an international working group Allergy 67 2012 147 157
    • (2012) Allergy , vol.67 , pp. 147-157
    • Cicardi, M.1    Bork, K.2    Caballero, T.3
  • 24
    • 84874310709 scopus 로고    scopus 로고
    • A study of the self-administration of icatibant for acute attacks of hereditary angioedema (HAE)
    • W. Aberer, T.K. Hoffmann, and M. Wiednig et al. A study of the self-administration of icatibant for acute attacks of hereditary angioedema (HAE) Ann Allergy Asthma Immunol 105 2010 A92
    • (2010) Ann Allergy Asthma Immunol , vol.105 , pp. 92
    • Aberer, W.1    Hoffmann, T.K.2    Wiednig, M.3
  • 25
    • 82955233701 scopus 로고    scopus 로고
    • Randomized placebo-controlled trial of the bradykinin B2 receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: The FAST-3 trial
    • W.R. Lumry, H.H. Li, and R.J. Levy et al. Randomized placebo-controlled trial of the bradykinin B2 receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial Ann Allergy Asthma Immunol 107 2011 529 537
    • (2011) Ann Allergy Asthma Immunol , vol.107 , pp. 529-537
    • Lumry, W.R.1    Li, H.H.2    Levy, R.J.3
  • 26
    • 77955295556 scopus 로고    scopus 로고
    • Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema
    • M. Cicardi, A. Banerji, and F. Bracho et al. Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema N Engl J Med 363 2010 532 541
    • (2010) N Engl J Med , vol.363 , pp. 532-541
    • Cicardi, M.1    Banerji, A.2    Bracho, F.3
  • 27
    • 84893712581 scopus 로고    scopus 로고
    • Kalbitor (ecallantide) clinical briefing document. Accessed June 4, 2013
    • Kalbitor (ecallantide) clinical briefing document. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM193572.pdf. Accessed June 4, 2013.
  • 28
    • 84893645775 scopus 로고    scopus 로고
    • Firazyr (icatibant) clinical briefing document. Accessed June 4, 2013
    • Firazyr (icatibant) clinical briefing document. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM260020.pdf. Accessed June 4, 2013.
  • 29
    • 84866100966 scopus 로고    scopus 로고
    • Immunogenicity assessment of recombinant human C1-inhibitor: An integrated analysis of clinical studies
    • C.E. Hack, M. Mannesse, A. Baboeram, B. Oortwijn, and A. Relan Immunogenicity assessment of recombinant human C1-inhibitor: an integrated analysis of clinical studies Biodrugs 26 2012 303 313
    • (2012) Biodrugs , vol.26 , pp. 303-313
    • Hack, C.E.1    Mannesse, M.2    Baboeram, A.3    Oortwijn, B.4    Relan, A.5


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