A single recombinant anti-RhD IgG prevents RhD immunization: association of RhD-positive red blood cell clearance rate with polymorphisms in the FcgammaRIIA and FcgammaIIIA genes
A single recombinant immunoglobulin G1 (IgG1) anti-RhD antibody (MonoRho) was compared with a currently used polyclonal anti-RhD product (Rhophylac) in a phase 1 study for safety, efficacy of Rhesus D (RhD)-positive red blood cell (RBC) clearance, and prevention of RhD immunization in RhD-negative m...
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| Veröffentlicht in: | Blood 2004-06, Vol.103 (11), p.4028 |
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| creator | Miescher, Sylvia Spycher, Martin O Amstutz, Hanspeter De Haas, Masja Kleijer, Marion Kalus, Ulrich J Radtke, Hartmut Hubsch, Alphonse Andresen, Irmgard Martin, Roland M Bichler, Johann |
| description | A single recombinant immunoglobulin G1 (IgG1) anti-RhD antibody (MonoRho) was compared with a currently used polyclonal anti-RhD product (Rhophylac) in a phase 1 study for safety, efficacy of Rhesus D (RhD)-positive red blood cell (RBC) clearance, and prevention of RhD immunization in RhD-negative men challenged with 15 mL RhD-positive RBCs. Both the polyclonal product and recombinant anti-RhD effectively cleared RhD-positive RBCs after intravenous and intramuscular injection. The recombinant anti-RhD demonstrated a slower clearance rate compared with the polyclonal anti-RhD. There was no dose response, and there was considerable variation among subjects who received the same dose of recombinant anti-RhD. Interestingly, RhD-positive RBC clearance rates were strongly associated with Fcgamma receptor IIA (FcgammaRIIA) and FcgammaIIIA but not with FcgammaIIIB polymorphisms. Subjects homozygous for FcgammaRIIA-131H or FcgammaRIIIA-158V allotypes showed a faster clearance rate compared with both the heterozygote and the corresponding alternative homozygote allotypes. A similar but less marked trend was seen for the polyclonal anti-RhD. Despite the variation in clearance rates there was no evidence of anti-RhD alloantibodies in any of the subjects at +6 months after the RBC challenge. |
| format | Article |
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Both the polyclonal product and recombinant anti-RhD effectively cleared RhD-positive RBCs after intravenous and intramuscular injection. The recombinant anti-RhD demonstrated a slower clearance rate compared with the polyclonal anti-RhD. There was no dose response, and there was considerable variation among subjects who received the same dose of recombinant anti-RhD. Interestingly, RhD-positive RBC clearance rates were strongly associated with Fcgamma receptor IIA (FcgammaRIIA) and FcgammaIIIA but not with FcgammaIIIB polymorphisms. Subjects homozygous for FcgammaRIIA-131H or FcgammaRIIIA-158V allotypes showed a faster clearance rate compared with both the heterozygote and the corresponding alternative homozygote allotypes. A similar but less marked trend was seen for the polyclonal anti-RhD. Despite the variation in clearance rates there was no evidence of anti-RhD alloantibodies in any of the subjects at +6 months after the RBC challenge.</description><identifier>ISSN: 0006-4971</identifier><identifier>PMID: 14976055</identifier><language>eng</language><publisher>United States</publisher><subject>Adolescent ; Adult ; Antibodies, Monoclonal - administration & dosage ; Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal - blood ; Antigens, CD - genetics ; Erythrocytes - immunology ; Follow-Up Studies ; Humans ; Immunization ; Immunoglobulin G - administration & dosage ; Immunoglobulin G - adverse effects ; Immunoglobulin G - blood ; Male ; Middle Aged ; Polymorphism, Genetic ; Protein Binding - immunology ; Receptors, IgG - genetics ; Recombinant Proteins - administration & dosage ; Recombinant Proteins - adverse effects ; Recombinant Proteins - blood ; Rh-Hr Blood-Group System - immunology</subject><ispartof>Blood, 2004-06, Vol.103 (11), p.4028</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/14976055$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Miescher, Sylvia</creatorcontrib><creatorcontrib>Spycher, Martin O</creatorcontrib><creatorcontrib>Amstutz, Hanspeter</creatorcontrib><creatorcontrib>De Haas, Masja</creatorcontrib><creatorcontrib>Kleijer, Marion</creatorcontrib><creatorcontrib>Kalus, Ulrich J</creatorcontrib><creatorcontrib>Radtke, Hartmut</creatorcontrib><creatorcontrib>Hubsch, Alphonse</creatorcontrib><creatorcontrib>Andresen, Irmgard</creatorcontrib><creatorcontrib>Martin, Roland M</creatorcontrib><creatorcontrib>Bichler, Johann</creatorcontrib><title>A single recombinant anti-RhD IgG prevents RhD immunization: association of RhD-positive red blood cell clearance rate with polymorphisms in the FcgammaRIIA and FcgammaIIIA genes</title><title>Blood</title><addtitle>Blood</addtitle><description>A single recombinant immunoglobulin G1 (IgG1) anti-RhD antibody (MonoRho) was compared with a currently used polyclonal anti-RhD product (Rhophylac) in a phase 1 study for safety, efficacy of Rhesus D (RhD)-positive red blood cell (RBC) clearance, and prevention of RhD immunization in RhD-negative men challenged with 15 mL RhD-positive RBCs. Both the polyclonal product and recombinant anti-RhD effectively cleared RhD-positive RBCs after intravenous and intramuscular injection. The recombinant anti-RhD demonstrated a slower clearance rate compared with the polyclonal anti-RhD. There was no dose response, and there was considerable variation among subjects who received the same dose of recombinant anti-RhD. Interestingly, RhD-positive RBC clearance rates were strongly associated with Fcgamma receptor IIA (FcgammaRIIA) and FcgammaIIIA but not with FcgammaIIIB polymorphisms. Subjects homozygous for FcgammaRIIA-131H or FcgammaRIIIA-158V allotypes showed a faster clearance rate compared with both the heterozygote and the corresponding alternative homozygote allotypes. A similar but less marked trend was seen for the polyclonal anti-RhD. Despite the variation in clearance rates there was no evidence of anti-RhD alloantibodies in any of the subjects at +6 months after the RBC challenge.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Antibodies, Monoclonal - administration & dosage</subject><subject>Antibodies, Monoclonal - adverse effects</subject><subject>Antibodies, Monoclonal - blood</subject><subject>Antigens, CD - genetics</subject><subject>Erythrocytes - immunology</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Immunization</subject><subject>Immunoglobulin G - administration & dosage</subject><subject>Immunoglobulin G - adverse effects</subject><subject>Immunoglobulin G - blood</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Polymorphism, Genetic</subject><subject>Protein Binding - immunology</subject><subject>Receptors, IgG - genetics</subject><subject>Recombinant Proteins - administration & dosage</subject><subject>Recombinant Proteins - adverse effects</subject><subject>Recombinant Proteins - blood</subject><subject>Rh-Hr Blood-Group System - immunology</subject><issn>0006-4971</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1kN1Kw0AQhXOh2Fp9BZkXCGx-tk29K9XWQEEovS-zu5NkJftDNq3Ux_IJTdReDMN3znA4zE00ZYzN43y5SCbRfQgfjCV5lvK7aJIM4pxxPo2-VxC0rVuCjqQzQlu0PQyj433zAmW9Bd_RmWwfYBS0MServ7DXzj4DhuCk_gVw1XgQexd0r89jngLROqdAUtuCbAk7tHIwsCf41H0D3rUX4zrf6GACaAt9Q7CRNRqD-7JcDT3UlcuRa7IUHqLbCttAj_97Fh02r4f1W7x735br1S72POdxTqmUi5RhxXApCuQZsUKxgi8kJXxwBVdZKkmoKlWqYIpVKIXiJGUiEkyyWfT0F-tPwpA6-k4b7C7H6--yH_ZFbiE</recordid><startdate>20040601</startdate><enddate>20040601</enddate><creator>Miescher, Sylvia</creator><creator>Spycher, Martin O</creator><creator>Amstutz, Hanspeter</creator><creator>De Haas, Masja</creator><creator>Kleijer, Marion</creator><creator>Kalus, Ulrich J</creator><creator>Radtke, Hartmut</creator><creator>Hubsch, Alphonse</creator><creator>Andresen, Irmgard</creator><creator>Martin, Roland M</creator><creator>Bichler, Johann</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope></search><sort><creationdate>20040601</creationdate><title>A single recombinant anti-RhD IgG prevents RhD immunization: association of RhD-positive red blood cell clearance rate with polymorphisms in the FcgammaRIIA and FcgammaIIIA genes</title><author>Miescher, Sylvia ; Spycher, Martin O ; Amstutz, Hanspeter ; De Haas, Masja ; Kleijer, Marion ; Kalus, Ulrich J ; Radtke, Hartmut ; Hubsch, Alphonse ; Andresen, Irmgard ; Martin, Roland M ; Bichler, Johann</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p545-4e2cc720af0a9b8a53e08d0857ce154e2b5d32cebdf2dd80d0facbd5ecc1b1a13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Antibodies, Monoclonal - administration & dosage</topic><topic>Antibodies, Monoclonal - adverse effects</topic><topic>Antibodies, Monoclonal - blood</topic><topic>Antigens, CD - genetics</topic><topic>Erythrocytes - immunology</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Immunization</topic><topic>Immunoglobulin G - administration & dosage</topic><topic>Immunoglobulin G - adverse effects</topic><topic>Immunoglobulin G - blood</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Polymorphism, Genetic</topic><topic>Protein Binding - immunology</topic><topic>Receptors, IgG - genetics</topic><topic>Recombinant Proteins - administration & dosage</topic><topic>Recombinant Proteins - adverse effects</topic><topic>Recombinant Proteins - blood</topic><topic>Rh-Hr Blood-Group System - immunology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Miescher, Sylvia</creatorcontrib><creatorcontrib>Spycher, Martin O</creatorcontrib><creatorcontrib>Amstutz, Hanspeter</creatorcontrib><creatorcontrib>De Haas, Masja</creatorcontrib><creatorcontrib>Kleijer, Marion</creatorcontrib><creatorcontrib>Kalus, Ulrich J</creatorcontrib><creatorcontrib>Radtke, Hartmut</creatorcontrib><creatorcontrib>Hubsch, Alphonse</creatorcontrib><creatorcontrib>Andresen, Irmgard</creatorcontrib><creatorcontrib>Martin, Roland M</creatorcontrib><creatorcontrib>Bichler, Johann</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>Blood</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Miescher, Sylvia</au><au>Spycher, Martin O</au><au>Amstutz, Hanspeter</au><au>De Haas, Masja</au><au>Kleijer, Marion</au><au>Kalus, Ulrich J</au><au>Radtke, Hartmut</au><au>Hubsch, Alphonse</au><au>Andresen, Irmgard</au><au>Martin, Roland M</au><au>Bichler, Johann</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A single recombinant anti-RhD IgG prevents RhD immunization: association of RhD-positive red blood cell clearance rate with polymorphisms in the FcgammaRIIA and FcgammaIIIA genes</atitle><jtitle>Blood</jtitle><addtitle>Blood</addtitle><date>2004-06-01</date><risdate>2004</risdate><volume>103</volume><issue>11</issue><spage>4028</spage><pages>4028-</pages><issn>0006-4971</issn><abstract>A single recombinant immunoglobulin G1 (IgG1) anti-RhD antibody (MonoRho) was compared with a currently used polyclonal anti-RhD product (Rhophylac) in a phase 1 study for safety, efficacy of Rhesus D (RhD)-positive red blood cell (RBC) clearance, and prevention of RhD immunization in RhD-negative men challenged with 15 mL RhD-positive RBCs. Both the polyclonal product and recombinant anti-RhD effectively cleared RhD-positive RBCs after intravenous and intramuscular injection. The recombinant anti-RhD demonstrated a slower clearance rate compared with the polyclonal anti-RhD. There was no dose response, and there was considerable variation among subjects who received the same dose of recombinant anti-RhD. Interestingly, RhD-positive RBC clearance rates were strongly associated with Fcgamma receptor IIA (FcgammaRIIA) and FcgammaIIIA but not with FcgammaIIIB polymorphisms. Subjects homozygous for FcgammaRIIA-131H or FcgammaRIIIA-158V allotypes showed a faster clearance rate compared with both the heterozygote and the corresponding alternative homozygote allotypes. A similar but less marked trend was seen for the polyclonal anti-RhD. Despite the variation in clearance rates there was no evidence of anti-RhD alloantibodies in any of the subjects at +6 months after the RBC challenge.</abstract><cop>United States</cop><pmid>14976055</pmid></addata></record> |
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| subjects | Adolescent Adult Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - blood Antigens, CD - genetics Erythrocytes - immunology Follow-Up Studies Humans Immunization Immunoglobulin G - administration & dosage Immunoglobulin G - adverse effects Immunoglobulin G - blood Male Middle Aged Polymorphism, Genetic Protein Binding - immunology Receptors, IgG - genetics Recombinant Proteins - administration & dosage Recombinant Proteins - adverse effects Recombinant Proteins - blood Rh-Hr Blood-Group System - immunology |
| title | A single recombinant anti-RhD IgG prevents RhD immunization: association of RhD-positive red blood cell clearance rate with polymorphisms in the FcgammaRIIA and FcgammaIIIA genes |
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