Pharmacokinetics of plasma-derived C1-esterase inhibitor after subcutaneous versus intravenous administration in subjects with mild or moderate hereditary angioedema: the PASSION study
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作者:
Martinez-Saguer, Inmaculada
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Hemophilia Ctr Rhine Main GmbH, D-64546 Morfelden Walldorf, GermanyHemophilia Ctr Rhine Main GmbH, D-64546 Morfelden Walldorf, Germany
Martinez-Saguer, Inmaculada
[1
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Cicardi, Marco
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Univ Milan, Dept Clin Sci Luigi Sacco, Milan, ItalyHemophilia Ctr Rhine Main GmbH, D-64546 Morfelden Walldorf, Germany
Cicardi, Marco
[2
]
Suffritti, Chiara
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Univ Milan, Dept Clin Sci Luigi Sacco, Milan, ItalyHemophilia Ctr Rhine Main GmbH, D-64546 Morfelden Walldorf, Germany
Background Hereditary angioedema (HAE) is a rare disease caused by C1-esterase inhibitor (C1-INH) deficiency, characterized by periodic attacks of acute edema affecting subcutaneous (SC) tissues and mucous membranes. Human C1-INH concentrate given intravenously (IV) is effective and safe, but venous access may be difficult. We compared SC and IV administration of human pasteurized C1-INH concentrate with respect to pharmacokinetics, pharmacodynamics, and safety. Study Design and Methods This was a prospective, randomized, open-label, crossover study. Twenty-four subjects with mild or moderate HAE were randomly assigned during an attack-free interval to receive 1000 units of human pasteurized C1-INH concentrate IV or SC. Plasma levels of C1-INH activity and antigen, C4 antigen, cleaved high-molecular-weight kininogen (clHK), and C1-INH antibodies were measured. Results The mean relative bioavailability of functional C1-INH after SC administration was 39.7%. Maximum C1-INH activity after SC administration occurred within 48 hours and persisted longer than after IV administration. C4 antigen levels increased and clHK levels decreased after IV and SC administration, indicating the pharmacodynamic action of C1-INH. The mean half-life of functional C1-INH was 62 hours after IV administration and 120 hours after SC administration (p=0.0595). C1-INH concentrate was safe and well tolerated when administered via both routes. As expected, SC administration resulted in a higher incidence of injection site reactions, all of which were mild. Conclusion With a relative bioavailability of 39.7%, SC administration of human pasteurized C1-INH yields potentially clinically relevant and sustained plasma levels of C1-INH and is safe and well tolerated.
机构:
Barzilai Govt Hosp, Div Allergy Immunol & Angioedema, Ashqelon, IsraelBarzilai Govt Hosp, Div Allergy Immunol & Angioedema, Ashqelon, Israel
Reshef, Avner
Levy, Donald
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Univ Calif Irvine, Dept Med, Div Basic & Clin Immunol, Orange, CA 92668 USABarzilai Govt Hosp, Div Allergy Immunol & Angioedema, Ashqelon, Israel
Levy, Donald
Longhurst, Hilary
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Addenbrookes Hosp, Dept Immunol, Cambridge, England
UCLH, London, EnglandBarzilai Govt Hosp, Div Allergy Immunol & Angioedema, Ashqelon, Israel
Longhurst, Hilary
Cicardi, Marco
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UO Med Gen, Osped Luigi Sacco, Milan, ItalyBarzilai Govt Hosp, Div Allergy Immunol & Angioedema, Ashqelon, Israel
Cicardi, Marco
Craig, Timothy
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Penn State Univ, Dept Med & Pediat, Allergy Immunol & Resp Res, Hershey, PA USABarzilai Govt Hosp, Div Allergy Immunol & Angioedema, Ashqelon, Israel
Craig, Timothy
Keith, Paul K.
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McMaster Univ, Dept Med, Hamilton, ON, CanadaBarzilai Govt Hosp, Div Allergy Immunol & Angioedema, Ashqelon, Israel
Keith, Paul K.
Feussner, Annette
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CSL Behring GmbH, Marburg, GermanyBarzilai Govt Hosp, Div Allergy Immunol & Angioedema, Ashqelon, Israel
Feussner, Annette
Feuersenger, Henrike
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CSL Behring GmbH, Marburg, GermanyBarzilai Govt Hosp, Div Allergy Immunol & Angioedema, Ashqelon, Israel
Feuersenger, Henrike
Machnig, Thomas
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CSL Behring GmbH, Marburg, GermanyBarzilai Govt Hosp, Div Allergy Immunol & Angioedema, Ashqelon, Israel
Machnig, Thomas
Prusty, Subhransu
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CSL Behring GmbH, Marburg, GermanyBarzilai Govt Hosp, Div Allergy Immunol & Angioedema, Ashqelon, Israel
Prusty, Subhransu
Pragst, Ingo
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CSL Behring GmbH, Marburg, GermanyBarzilai Govt Hosp, Div Allergy Immunol & Angioedema, Ashqelon, Israel
机构:
Univ Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
Bernstein Clin Res Ctr, Cincinnati, OH USAUniv Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
Bernstein, Jonathan A.
Ritchie, Bruce
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Univ Alberta, Dept Med, Edmonton, AB, Canada
Univ Alberta, Dept Med Oncol, Edmonton, AB, CanadaUniv Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
Ritchie, Bruce
Levy, Robyn J.
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Family Allergy & Asthma Ctr, Atlanta, GA USAUniv Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
Levy, Robyn J.
Wasserman, Richard L.
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DallasAllergyImmunol, Dallas, TX USAUniv Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
Wasserman, Richard L.
Bewtra, Againdra K.
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Creighton Univ, Sch Med, Omaha, NE USAUniv Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
Bewtra, Againdra K.
Hurewitz, David S.
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Tulsa Inc, Allergy Clin, Tulsa, OK USAUniv Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
Hurewitz, David S.
Obtulowicz, Krystyna
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Jagiellonian Univ Hosp, Krakow, PolandUniv Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
Obtulowicz, Krystyna
Reshef, Avner
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Chaim Sheba Med Ctr, IL-52621 Tel Hashomer, IsraelUniv Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
Reshef, Avner
Moldovan, Dumitru
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Univ Med & Pharm, Dept Allergy, Mures Cty Hosp, Targu Mures, RomaniaUniv Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
Moldovan, Dumitru
Shirov, Todor
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Univ Hosp Queen Jovanna ISUL, ENT Clin, Sofia, BulgariaUniv Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
Shirov, Todor
Grivcheva-Panovska, Vesna
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PHI Univ Clin Ctr, Dept Dermatol Allergol & Clin Immunol, Skopje, MacedoniaUniv Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
Grivcheva-Panovska, Vesna
Kiessling, Peter C.
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CSL Behring GmbH, Marburg, GermanyUniv Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
Kiessling, Peter C.
Schindel, Fritz
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Accov GmbH, Marburg, GermanyUniv Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
Schindel, Fritz
Craig, Timothy J.
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Penn State Univ, Coll Med, Hershey, PA USAUniv Cincinnati, Div Allergy Immunol, Dept Internal Med, Med Ctr, Cincinnati, OH 45267 USA
机构:
Saitama Med Univ, Saitama Med Ctr, Dept Dermatol, Saitama, Japan
Saitama Med Univ, Saitama Med Ctr, Dept Dermatol, 1981 Kamoda, Kawagoe, Saitama 3508550, JapanSaitama Med Univ, Saitama Med Ctr, Dept Dermatol, Saitama, Japan
Fukuda, Tomoo
Yamagami, Keiko
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Osaka City Gen Hosp, Dept Internal Med, Osaka, JapanSaitama Med Univ, Saitama Med Ctr, Dept Dermatol, Saitama, Japan
Yamagami, Keiko
Kawahata, Kimito
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St Marianna Univ, Sch Med, Dept Internal Med, Div Rheumatol & Allergol, Kawasaki, Kanagawa, JapanSaitama Med Univ, Saitama Med Ctr, Dept Dermatol, Saitama, Japan
Kawahata, Kimito
Suzuki, Yuzo
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Clover Hosp, Dept Resp Med, Fujisawa, Kanagawa, JapanSaitama Med Univ, Saitama Med Ctr, Dept Dermatol, Saitama, Japan
Suzuki, Yuzo
Sasaki, Yoshihiro
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Natl Hosp Org Disaster Med Ctr, Dept Gastroenterol, Tokyo, JapanSaitama Med Univ, Saitama Med Ctr, Dept Dermatol, Saitama, Japan
Sasaki, Yoshihiro
Miyagi, Takashi
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Heart Life Hosp, Dept Hematol, Okinawa, JapanSaitama Med Univ, Saitama Med Ctr, Dept Dermatol, Saitama, Japan
Miyagi, Takashi
Jacobs, Iris
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CSL Behring, King Of Prussia, PA USASaitama Med Univ, Saitama Med Ctr, Dept Dermatol, Saitama, Japan
Jacobs, Iris
Lawo, John-Philip
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机构:
CSL Behring Innovat GmbH, Marburg, GermanySaitama Med Univ, Saitama Med Ctr, Dept Dermatol, Saitama, Japan
Lawo, John-Philip
Glassman, Fiona
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机构:
CSL Behring, King Of Prussia, PA USASaitama Med Univ, Saitama Med Ctr, Dept Dermatol, Saitama, Japan
Glassman, Fiona
Akama, Hideto
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CSL Behring Japan, Tokyo, JapanSaitama Med Univ, Saitama Med Ctr, Dept Dermatol, Saitama, Japan
Akama, Hideto
Hide, Michihiro
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Hiroshima Univ, Dept Dermatol, Hiroshima, Japan
Hiroshima Citizens Hosp, Dept Dermatol, Hiroshima, JapanSaitama Med Univ, Saitama Med Ctr, Dept Dermatol, Saitama, Japan
Hide, Michihiro
Ohsawa, Isao
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Saiyu Soka Hosp, Dept Nephrol, Saitama, JapanSaitama Med Univ, Saitama Med Ctr, Dept Dermatol, Saitama, Japan