Recombinant human hyaluronidase PH20 (rHuPH20) facilitates subcutaneous infusions of large volumes of immunoglobulin in a swine model
Many patients with primary immunodeficiency disease (PIDD) require lifelong immunoglobulin (Ig) replacement therapy. Home-based subcutaneous (SC) infusion provides advantages to patients with PIDD compared to hospital-based intravenous infusion. One limitation of current practice with SCIg infusion...
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| Veröffentlicht in: | Drug delivery and translational research 2012-08, Vol.2 (4), p.254-264 |
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| creator | Kang, David W. Jadin, Laurence Nekoroski, Tara Drake, Fred H. Zepeda, Monica L. |
| description | Many patients with primary immunodeficiency disease (PIDD) require lifelong immunoglobulin (Ig) replacement therapy. Home-based subcutaneous (SC) infusion provides advantages to patients with PIDD compared to hospital-based intravenous infusion. One limitation of current practice with SCIg infusion is the need for small-volume infusions at multiple injection sites on a frequent basis. A method was developed for large-volume SC infusion that uses preinfusion of recombinant human hyaluronidase (rHuPH20) to facilitate fluid dispersion. Miniature swine was used as a preclinical model to assess the effects of rHuPH20-facilitated infusions, of a single monthly dose, on fluid dispersion, infusion-related pressure, swelling, induration, and tissue damage. Preinfusion of vehicle (control) or rHuPH20 (75 U/g Ig) was performed simultaneously on contralateral abdominal sites on each animal, followed by infusion of 300 mL 10 % Ig (30 g) at each site. Compared to control infusions, rHuPH20 significantly reduced infusion pressure and induration (
p
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| doi_str_mv | 10.1007/s13346-012-0065-3 |
| format | Article |
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p
< 0.05) and accelerated postinfusion Ig dispersion. Histological evaluation of infusion site tissue showed moderate to severe swelling for the control. Swelling after rHuPH20-facilitated infusion was mild on day 1 and had completely resolved shortly thereafter. Laser Doppler imaging of control infusion sites revealed local cutaneous hypoperfusion during Ig infusion, which was reduced almost 7-fold (
p
< 0.05) with the use of rHuPH20. These results demonstrate that rHuPH20-facilitated Ig infusion is associated with improved dispersion of Ig, resulting in reduced tissue pressure, induration, and reduced risk of tissue damage from mechanical trauma or local ischemia, thus enabling SC administration of large volumes of Ig at a single site.</description><identifier>ISSN: 2190-393X</identifier><identifier>EISSN: 2190-3948</identifier><identifier>DOI: 10.1007/s13346-012-0065-3</identifier><identifier>PMID: 25787031</identifier><language>eng</language><publisher>Boston: Springer US</publisher><subject>Biomedical and Life Sciences ; Biomedicine ; Pharmaceutical Sciences/Technology ; Research Article</subject><ispartof>Drug delivery and translational research, 2012-08, Vol.2 (4), p.254-264</ispartof><rights>Controlled Release Society 2012</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c344t-19acf66883b801759268316025bcffd960faaed4e28e6c490bf2f954738d63b93</citedby><cites>FETCH-LOGICAL-c344t-19acf66883b801759268316025bcffd960faaed4e28e6c490bf2f954738d63b93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s13346-012-0065-3$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s13346-012-0065-3$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25787031$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kang, David W.</creatorcontrib><creatorcontrib>Jadin, Laurence</creatorcontrib><creatorcontrib>Nekoroski, Tara</creatorcontrib><creatorcontrib>Drake, Fred H.</creatorcontrib><creatorcontrib>Zepeda, Monica L.</creatorcontrib><title>Recombinant human hyaluronidase PH20 (rHuPH20) facilitates subcutaneous infusions of large volumes of immunoglobulin in a swine model</title><title>Drug delivery and translational research</title><addtitle>Drug Deliv. and Transl. Res</addtitle><addtitle>Drug Deliv Transl Res</addtitle><description>Many patients with primary immunodeficiency disease (PIDD) require lifelong immunoglobulin (Ig) replacement therapy. Home-based subcutaneous (SC) infusion provides advantages to patients with PIDD compared to hospital-based intravenous infusion. One limitation of current practice with SCIg infusion is the need for small-volume infusions at multiple injection sites on a frequent basis. A method was developed for large-volume SC infusion that uses preinfusion of recombinant human hyaluronidase (rHuPH20) to facilitate fluid dispersion. Miniature swine was used as a preclinical model to assess the effects of rHuPH20-facilitated infusions, of a single monthly dose, on fluid dispersion, infusion-related pressure, swelling, induration, and tissue damage. Preinfusion of vehicle (control) or rHuPH20 (75 U/g Ig) was performed simultaneously on contralateral abdominal sites on each animal, followed by infusion of 300 mL 10 % Ig (30 g) at each site. Compared to control infusions, rHuPH20 significantly reduced infusion pressure and induration (
p
< 0.05) and accelerated postinfusion Ig dispersion. Histological evaluation of infusion site tissue showed moderate to severe swelling for the control. Swelling after rHuPH20-facilitated infusion was mild on day 1 and had completely resolved shortly thereafter. Laser Doppler imaging of control infusion sites revealed local cutaneous hypoperfusion during Ig infusion, which was reduced almost 7-fold (
p
< 0.05) with the use of rHuPH20. These results demonstrate that rHuPH20-facilitated Ig infusion is associated with improved dispersion of Ig, resulting in reduced tissue pressure, induration, and reduced risk of tissue damage from mechanical trauma or local ischemia, thus enabling SC administration of large volumes of Ig at a single site.</description><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Pharmaceutical Sciences/Technology</subject><subject>Research Article</subject><issn>2190-393X</issn><issn>2190-3948</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><recordid>eNp9kU1rFjEQx0NR2lL7AbxIjvWwmpfd7OYoRX2EgiIteAvZ7ORpSl5qsqn0A_i9zePWHp3LDDO_-cPMH6HXlLyjhIzvC-W8Fx2hrCNEDB0_QqeMStJx2U8vnmv-4wSdl3JHWvSCjnI8RidsGKeRcHqKfn8Hk8Lsoo4rvq1BR3z7qH3NKbpFF8Dfdozgi7yrh-Ittto471a9QsGlzqauOkKqBbtoa3EpFpws9jrvAT8kXwP8bbgQakx7n-bqXWww1rj8chFwSAv4V-il1b7A-VM-QzefPl5f7rqrr5-_XH646gzv-7WjUhsrxDTxeSJ0HCQTE6eCsGE21i5SEKs1LD2wCYTpJZkts3LoRz4tgs-Sn6GLTfc-p58VyqqCKwa8345QVIiBUtn-1FC6oSanUjJYdZ9d0PlRUaIOBqjNANUMUAcDFG87b57k6xxged749-4GsA0obRT3kNVdqjm2k_-j-gdlUJGh</recordid><startdate>20120801</startdate><enddate>20120801</enddate><creator>Kang, David W.</creator><creator>Jadin, Laurence</creator><creator>Nekoroski, Tara</creator><creator>Drake, Fred H.</creator><creator>Zepeda, Monica L.</creator><general>Springer US</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20120801</creationdate><title>Recombinant human hyaluronidase PH20 (rHuPH20) facilitates subcutaneous infusions of large volumes of immunoglobulin in a swine model</title><author>Kang, David W. ; Jadin, Laurence ; Nekoroski, Tara ; Drake, Fred H. ; Zepeda, Monica L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c344t-19acf66883b801759268316025bcffd960faaed4e28e6c490bf2f954738d63b93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Pharmaceutical Sciences/Technology</topic><topic>Research Article</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kang, David W.</creatorcontrib><creatorcontrib>Jadin, Laurence</creatorcontrib><creatorcontrib>Nekoroski, Tara</creatorcontrib><creatorcontrib>Drake, Fred H.</creatorcontrib><creatorcontrib>Zepeda, Monica L.</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Drug delivery and translational research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kang, David W.</au><au>Jadin, Laurence</au><au>Nekoroski, Tara</au><au>Drake, Fred H.</au><au>Zepeda, Monica L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Recombinant human hyaluronidase PH20 (rHuPH20) facilitates subcutaneous infusions of large volumes of immunoglobulin in a swine model</atitle><jtitle>Drug delivery and translational research</jtitle><stitle>Drug Deliv. and Transl. Res</stitle><addtitle>Drug Deliv Transl Res</addtitle><date>2012-08-01</date><risdate>2012</risdate><volume>2</volume><issue>4</issue><spage>254</spage><epage>264</epage><pages>254-264</pages><issn>2190-393X</issn><eissn>2190-3948</eissn><abstract>Many patients with primary immunodeficiency disease (PIDD) require lifelong immunoglobulin (Ig) replacement therapy. Home-based subcutaneous (SC) infusion provides advantages to patients with PIDD compared to hospital-based intravenous infusion. One limitation of current practice with SCIg infusion is the need for small-volume infusions at multiple injection sites on a frequent basis. A method was developed for large-volume SC infusion that uses preinfusion of recombinant human hyaluronidase (rHuPH20) to facilitate fluid dispersion. Miniature swine was used as a preclinical model to assess the effects of rHuPH20-facilitated infusions, of a single monthly dose, on fluid dispersion, infusion-related pressure, swelling, induration, and tissue damage. Preinfusion of vehicle (control) or rHuPH20 (75 U/g Ig) was performed simultaneously on contralateral abdominal sites on each animal, followed by infusion of 300 mL 10 % Ig (30 g) at each site. Compared to control infusions, rHuPH20 significantly reduced infusion pressure and induration (
p
< 0.05) and accelerated postinfusion Ig dispersion. Histological evaluation of infusion site tissue showed moderate to severe swelling for the control. Swelling after rHuPH20-facilitated infusion was mild on day 1 and had completely resolved shortly thereafter. Laser Doppler imaging of control infusion sites revealed local cutaneous hypoperfusion during Ig infusion, which was reduced almost 7-fold (
p
< 0.05) with the use of rHuPH20. These results demonstrate that rHuPH20-facilitated Ig infusion is associated with improved dispersion of Ig, resulting in reduced tissue pressure, induration, and reduced risk of tissue damage from mechanical trauma or local ischemia, thus enabling SC administration of large volumes of Ig at a single site.</abstract><cop>Boston</cop><pub>Springer US</pub><pmid>25787031</pmid><doi>10.1007/s13346-012-0065-3</doi><tpages>11</tpages></addata></record> |
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| title | Recombinant human hyaluronidase PH20 (rHuPH20) facilitates subcutaneous infusions of large volumes of immunoglobulin in a swine model |
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