Measurement of Pre-Existing IgG and IgM Antibodies against Polyethylene Glycol in Healthy Individuals
Polyethylene glycol (PEG) is a biocompatible polymer that is often attached to therapeutic molecules to improve bioavailability and therapeutic efficacy. Although antibodies with specificity for PEG may compromise the safety and effectiveness of PEGylated medicines, the prevalence of pre-existing an...
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| Veröffentlicht in: | Analytical chemistry (Washington) 2016-11, Vol.88 (21), p.10661-10666 |
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| creator | Chen, Bing-Mae Su, Yu-Cheng Chang, Chia-Jung Burnouf, Pierre-Alain Chuang, Kuo-Hsiang Chen, Chien-Hsiun Cheng, Tian-Lu Chen, Yuan-Tsong Wu, Jer-Yuarn Roffler, Steve R |
| description | Polyethylene glycol (PEG) is a biocompatible polymer that is often attached to therapeutic molecules to improve bioavailability and therapeutic efficacy. Although antibodies with specificity for PEG may compromise the safety and effectiveness of PEGylated medicines, the prevalence of pre-existing anti-PEG antibodies in healthy individuals is unclear. Chimeric human anti-PEG antibody standards were created to accurately measure anti-PEG IgM and IgG antibodies by direct ELISA with confirmation by a competition assay in the plasma of 1504 healthy Han Chinese donors residing in Taiwan. Anti-PEG antibodies were detected in 44.3% of healthy donors with a high prevalence of both anti-PEG IgM (27.1%) and anti-PEG IgG (25.7%). Anti-PEG IgM and IgG antibodies were significantly more common in females as compared to males (32.0% vs 22.2% for IgM, p < 0.0001 and 28.3% vs 23.0% for IgG, p = 0.018). The prevalence of anti-PEG IgG antibodies was higher in younger (up to 60% for 20 year olds) as opposed to older (20% for >50 years) male and female donors. Anti-PEG IgG concentrations were negatively associated with donor age in both females (p = 0.0073) and males (p = 0.026). Both anti-PEG IgM and IgG strongly bound PEGylated medicines. The described assay can assist in the elucidation of the impact of anti-PEG antibodies on the safety and therapeutic efficacy of PEGylated medicines. |
| doi_str_mv | 10.1021/acs.analchem.6b03109 |
| format | Article |
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Although antibodies with specificity for PEG may compromise the safety and effectiveness of PEGylated medicines, the prevalence of pre-existing anti-PEG antibodies in healthy individuals is unclear. Chimeric human anti-PEG antibody standards were created to accurately measure anti-PEG IgM and IgG antibodies by direct ELISA with confirmation by a competition assay in the plasma of 1504 healthy Han Chinese donors residing in Taiwan. Anti-PEG antibodies were detected in 44.3% of healthy donors with a high prevalence of both anti-PEG IgM (27.1%) and anti-PEG IgG (25.7%). Anti-PEG IgM and IgG antibodies were significantly more common in females as compared to males (32.0% vs 22.2% for IgM, p < 0.0001 and 28.3% vs 23.0% for IgG, p = 0.018). The prevalence of anti-PEG IgG antibodies was higher in younger (up to 60% for 20 year olds) as opposed to older (20% for >50 years) male and female donors. Anti-PEG IgG concentrations were negatively associated with donor age in both females (p = 0.0073) and males (p = 0.026). Both anti-PEG IgM and IgG strongly bound PEGylated medicines. The described assay can assist in the elucidation of the impact of anti-PEG antibodies on the safety and therapeutic efficacy of PEGylated medicines.</description><identifier>ISSN: 0003-2700</identifier><identifier>EISSN: 1520-6882</identifier><identifier>DOI: 10.1021/acs.analchem.6b03109</identifier><identifier>PMID: 27726379</identifier><identifier>CODEN: ANCHAM</identifier><language>eng</language><publisher>United States: American Chemical Society</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Animals ; Antibodies ; Asian Continental Ancestry Group ; Biocompatibility ; Biopolymers ; Doxorubicin - analogs & derivatives ; Doxorubicin - immunology ; Effectiveness ; Enzyme-Linked Immunosorbent Assay - methods ; Female ; Females ; Humans ; IgG antibody ; Immunoassay ; Immunoglobulin G - blood ; Immunoglobulin G - immunology ; Immunoglobulin M - blood ; Immunoglobulin M - immunology ; Immunoglobulins ; Interferon-alpha - immunology ; Male ; Males ; Measurement ; Medicine ; Mice ; Middle Aged ; Polyethylene glycol ; Polyethylene Glycols - metabolism ; Recombinant Fusion Proteins - immunology ; Recombinant Proteins - immunology ; Safety ; Young Adult</subject><ispartof>Analytical chemistry (Washington), 2016-11, Vol.88 (21), p.10661-10666</ispartof><rights>Copyright © 2016 American Chemical Society</rights><rights>Copyright American Chemical Society Nov 1, 2016</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a545t-e6718466fbb5a62f201fa01dd3eb8e03ef2db8c654ae64ecc1d1f84bb02b41c43</citedby><cites>FETCH-LOGICAL-a545t-e6718466fbb5a62f201fa01dd3eb8e03ef2db8c654ae64ecc1d1f84bb02b41c43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://pubs.acs.org/doi/pdf/10.1021/acs.analchem.6b03109$$EPDF$$P50$$Gacs$$H</linktopdf><linktohtml>$$Uhttps://pubs.acs.org/doi/10.1021/acs.analchem.6b03109$$EHTML$$P50$$Gacs$$H</linktohtml><link.rule.ids>314,776,780,2752,27053,27901,27902,56713,56763</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27726379$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chen, Bing-Mae</creatorcontrib><creatorcontrib>Su, Yu-Cheng</creatorcontrib><creatorcontrib>Chang, Chia-Jung</creatorcontrib><creatorcontrib>Burnouf, Pierre-Alain</creatorcontrib><creatorcontrib>Chuang, Kuo-Hsiang</creatorcontrib><creatorcontrib>Chen, Chien-Hsiun</creatorcontrib><creatorcontrib>Cheng, Tian-Lu</creatorcontrib><creatorcontrib>Chen, Yuan-Tsong</creatorcontrib><creatorcontrib>Wu, Jer-Yuarn</creatorcontrib><creatorcontrib>Roffler, Steve R</creatorcontrib><title>Measurement of Pre-Existing IgG and IgM Antibodies against Polyethylene Glycol in Healthy Individuals</title><title>Analytical chemistry (Washington)</title><addtitle>Anal. Chem</addtitle><description>Polyethylene glycol (PEG) is a biocompatible polymer that is often attached to therapeutic molecules to improve bioavailability and therapeutic efficacy. Although antibodies with specificity for PEG may compromise the safety and effectiveness of PEGylated medicines, the prevalence of pre-existing anti-PEG antibodies in healthy individuals is unclear. Chimeric human anti-PEG antibody standards were created to accurately measure anti-PEG IgM and IgG antibodies by direct ELISA with confirmation by a competition assay in the plasma of 1504 healthy Han Chinese donors residing in Taiwan. Anti-PEG antibodies were detected in 44.3% of healthy donors with a high prevalence of both anti-PEG IgM (27.1%) and anti-PEG IgG (25.7%). Anti-PEG IgM and IgG antibodies were significantly more common in females as compared to males (32.0% vs 22.2% for IgM, p < 0.0001 and 28.3% vs 23.0% for IgG, p = 0.018). The prevalence of anti-PEG IgG antibodies was higher in younger (up to 60% for 20 year olds) as opposed to older (20% for >50 years) male and female donors. Anti-PEG IgG concentrations were negatively associated with donor age in both females (p = 0.0073) and males (p = 0.026). Both anti-PEG IgM and IgG strongly bound PEGylated medicines. The described assay can assist in the elucidation of the impact of anti-PEG antibodies on the safety and therapeutic efficacy of PEGylated medicines.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Animals</subject><subject>Antibodies</subject><subject>Asian Continental Ancestry Group</subject><subject>Biocompatibility</subject><subject>Biopolymers</subject><subject>Doxorubicin - analogs & derivatives</subject><subject>Doxorubicin - immunology</subject><subject>Effectiveness</subject><subject>Enzyme-Linked Immunosorbent Assay - methods</subject><subject>Female</subject><subject>Females</subject><subject>Humans</subject><subject>IgG antibody</subject><subject>Immunoassay</subject><subject>Immunoglobulin G - blood</subject><subject>Immunoglobulin G - immunology</subject><subject>Immunoglobulin M - blood</subject><subject>Immunoglobulin M - immunology</subject><subject>Immunoglobulins</subject><subject>Interferon-alpha - immunology</subject><subject>Male</subject><subject>Males</subject><subject>Measurement</subject><subject>Medicine</subject><subject>Mice</subject><subject>Middle Aged</subject><subject>Polyethylene glycol</subject><subject>Polyethylene Glycols - metabolism</subject><subject>Recombinant Fusion Proteins - immunology</subject><subject>Recombinant Proteins - immunology</subject><subject>Safety</subject><subject>Young Adult</subject><issn>0003-2700</issn><issn>1520-6882</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkUtr3DAUhUVpaaZp_0Epgm6y8fTqYVlehjCdDCQ0i3Zt9LieKMhyatkh8-_ryUwa6CJ0deDynSPQR8hnBksGnH0zLi9NMtHdYrdUFgSD-g1ZsJJDobTmb8kCAETBK4AT8iHnOwDGgKn35IRXFVeiqhcEr9HkacAO00j7lt4MWKweQx5D2tLNdk1N8nNe0_M0Btv7gJmarQkpj_Smjzscb3cRE9J13Lk-0pDoJZo4X-km-fAQ_GRi_kjetXPgp2Oekl_fVz8vLourH-vNxflVYUpZjgWqimmpVGttaRRvObDWAPNeoNUIAlvurXaqlAaVROeYZ62W1gK3kjkpTsnZYfd-6H9PmMemC9lhjCZhP-WGaSVLLaSu_gMVsq6FUHv06z_oXT8N89c_UarUUItypuSBckOf84Btcz-Ezgy7hkGzN9bMxppnY83R2Fz7chyfbIf-b-lZ0QzAAdjXXx5-bfMPiFOlJw</recordid><startdate>20161101</startdate><enddate>20161101</enddate><creator>Chen, Bing-Mae</creator><creator>Su, Yu-Cheng</creator><creator>Chang, Chia-Jung</creator><creator>Burnouf, Pierre-Alain</creator><creator>Chuang, Kuo-Hsiang</creator><creator>Chen, Chien-Hsiun</creator><creator>Cheng, Tian-Lu</creator><creator>Chen, Yuan-Tsong</creator><creator>Wu, Jer-Yuarn</creator><creator>Roffler, Steve R</creator><general>American Chemical Society</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QF</scope><scope>7QO</scope><scope>7QQ</scope><scope>7SC</scope><scope>7SE</scope><scope>7SP</scope><scope>7SR</scope><scope>7TA</scope><scope>7TB</scope><scope>7TM</scope><scope>7U5</scope><scope>7U7</scope><scope>7U9</scope><scope>8BQ</scope><scope>8FD</scope><scope>C1K</scope><scope>F28</scope><scope>FR3</scope><scope>H8D</scope><scope>H8G</scope><scope>H94</scope><scope>JG9</scope><scope>JQ2</scope><scope>KR7</scope><scope>L7M</scope><scope>L~C</scope><scope>L~D</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20161101</creationdate><title>Measurement of Pre-Existing IgG and IgM Antibodies against Polyethylene Glycol in Healthy Individuals</title><author>Chen, Bing-Mae ; 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Chem</addtitle><date>2016-11-01</date><risdate>2016</risdate><volume>88</volume><issue>21</issue><spage>10661</spage><epage>10666</epage><pages>10661-10666</pages><issn>0003-2700</issn><eissn>1520-6882</eissn><coden>ANCHAM</coden><abstract>Polyethylene glycol (PEG) is a biocompatible polymer that is often attached to therapeutic molecules to improve bioavailability and therapeutic efficacy. Although antibodies with specificity for PEG may compromise the safety and effectiveness of PEGylated medicines, the prevalence of pre-existing anti-PEG antibodies in healthy individuals is unclear. Chimeric human anti-PEG antibody standards were created to accurately measure anti-PEG IgM and IgG antibodies by direct ELISA with confirmation by a competition assay in the plasma of 1504 healthy Han Chinese donors residing in Taiwan. Anti-PEG antibodies were detected in 44.3% of healthy donors with a high prevalence of both anti-PEG IgM (27.1%) and anti-PEG IgG (25.7%). Anti-PEG IgM and IgG antibodies were significantly more common in females as compared to males (32.0% vs 22.2% for IgM, p < 0.0001 and 28.3% vs 23.0% for IgG, p = 0.018). The prevalence of anti-PEG IgG antibodies was higher in younger (up to 60% for 20 year olds) as opposed to older (20% for >50 years) male and female donors. Anti-PEG IgG concentrations were negatively associated with donor age in both females (p = 0.0073) and males (p = 0.026). Both anti-PEG IgM and IgG strongly bound PEGylated medicines. The described assay can assist in the elucidation of the impact of anti-PEG antibodies on the safety and therapeutic efficacy of PEGylated medicines.</abstract><cop>United States</cop><pub>American Chemical Society</pub><pmid>27726379</pmid><doi>10.1021/acs.analchem.6b03109</doi><tpages>6</tpages></addata></record> |
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| subjects | Adult Aged Aged, 80 and over Animals Antibodies Asian Continental Ancestry Group Biocompatibility Biopolymers Doxorubicin - analogs & derivatives Doxorubicin - immunology Effectiveness Enzyme-Linked Immunosorbent Assay - methods Female Females Humans IgG antibody Immunoassay Immunoglobulin G - blood Immunoglobulin G - immunology Immunoglobulin M - blood Immunoglobulin M - immunology Immunoglobulins Interferon-alpha - immunology Male Males Measurement Medicine Mice Middle Aged Polyethylene glycol Polyethylene Glycols - metabolism Recombinant Fusion Proteins - immunology Recombinant Proteins - immunology Safety Young Adult |
| title | Measurement of Pre-Existing IgG and IgM Antibodies against Polyethylene Glycol in Healthy Individuals |
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