Does Iatrogenic Scleroderma due to Injection-Site Reaction to Enfuvirtide Impair Absorption of the Drug?
Background: Chronic iatrogenic scleroderma is a possible obstacle to the absorption of subcutaneously administered drugs. This study correlated the clinical and histopathological pattern of injection-site reactions (ISRs) to the pharmacokinetics of enfuvirtide in patients with HIV . Methods: Fourtee...
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Veröffentlicht in: | Clinical drug investigation 2008-01, Vol.28 (5), p.305-311 |
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creator | Maggi, Paolo Filotico, Raffaele Bonora, Stefano Volpe, Anna Bellacosa, Chiara Cinori, Eliana de Requena, Daniel Gonzalez D’Avolio, Antonio Di Perri, Giovanni |
description | Background:
Chronic iatrogenic scleroderma is a possible obstacle to the absorption of subcutaneously administered drugs. This study correlated the clinical and histopathological pattern of injection-site reactions (ISRs) to the pharmacokinetics of enfuvirtide in patients with
HIV
.
Methods:
Fourteen patients treated with an enfuvirtide-based antiretroviral regimen for a median of 45 weeks were enrolled and their ISRs were evaluated. Twelve patients with evidence of ISRs underwent cutaneous biopsies using a 4-mm punch. The maximum plasma enfuvirtide concentration (Cmax) and the area under the enfuvirtide concentration-time curve (AUC) were assessed using blood sampling.
Results:
Four different macroscopic patterns of ISR were identified: A — no evidence of cutaneous lesions; B — transient infiltrative lesions that auto-resolved within 24 hours; C — transient nodular lesions that auto-resolved within 7–15 days; and D–stable lesions after more than 30 days. Histological examination showed three morphological patterns: (1) acute urticaria/vasculitis-like pattern, (2) subacute pattern and (3) chronic scleroderma-like pattern. No differences among patients with the various patterns of ISRs were observed, except for a higher C
max
and AUC in patients with pattern 1.
Conclusions:
These results confirm that although iatrogenic scleroderma is not related to impaired enfuvirtide absorption, higher C
max
and AUC values are observed in patients with urticaria/vasculitis-like patterns. |
doi_str_mv | 10.2165/00044011-200828050-00004 |
format | Article |
fullrecord | <record><control><sourceid>gale_cross</sourceid><recordid>TN_cdi_gale_infotracmisc_A199865780</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A199865780</galeid><sourcerecordid>A199865780</sourcerecordid><originalsourceid>FETCH-LOGICAL-c430t-ff90aa628bdfc991f76d22b8ceec8ab401657fc3fddf7c2596f1b97d538abdb3</originalsourceid><addsrcrecordid>eNqFkd1KJDEQhcOysv6-ggS8bq2kp9PJlQzqrgPCwup9SCeVMcN0Z0i6hX17MzO6iyBILpKqc76CyiGEMrjkTDRXADCbAWMVB5BcQgMVbHvfyBFjraqYYvL77l1XvBH1ITnOeQXABBP8BzlkcgZty8QReb6NmOnCjCkucQiWPto1pugw9Ya6CekY6WJYoR1DHKrHMCL9g2ZXbaW7wU8vIY3BIV30GxMSnXc5ps3OED0dn5Hepml5fUoOvFlnPHu7T8jTz7unm_vq4fevxc38obKzGsbKewXGCC47561SzLfCcd5Ji2il6crSomm9rb1zvrW8UcKzTrWuqYvquvqEXOzHLs0adRh8HJOxfchWz5lSstASiuvyE1c5Dvtg44A-lP4HQO4Bm2LOCb3epNCb9Fcz0NtI9Hsk-l8kehdJQc_36GbqenT_wbcMikHtDblIwxKTXsUpDeWTvh7-Cs61l9Y</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Does Iatrogenic Scleroderma due to Injection-Site Reaction to Enfuvirtide Impair Absorption of the Drug?</title><source>MEDLINE</source><source>SpringerNature Journals</source><creator>Maggi, Paolo ; Filotico, Raffaele ; Bonora, Stefano ; Volpe, Anna ; Bellacosa, Chiara ; Cinori, Eliana ; de Requena, Daniel Gonzalez ; D’Avolio, Antonio ; Di Perri, Giovanni</creator><creatorcontrib>Maggi, Paolo ; Filotico, Raffaele ; Bonora, Stefano ; Volpe, Anna ; Bellacosa, Chiara ; Cinori, Eliana ; de Requena, Daniel Gonzalez ; D’Avolio, Antonio ; Di Perri, Giovanni</creatorcontrib><description>Background:
Chronic iatrogenic scleroderma is a possible obstacle to the absorption of subcutaneously administered drugs. This study correlated the clinical and histopathological pattern of injection-site reactions (ISRs) to the pharmacokinetics of enfuvirtide in patients with
HIV
.
Methods:
Fourteen patients treated with an enfuvirtide-based antiretroviral regimen for a median of 45 weeks were enrolled and their ISRs were evaluated. Twelve patients with evidence of ISRs underwent cutaneous biopsies using a 4-mm punch. The maximum plasma enfuvirtide concentration (Cmax) and the area under the enfuvirtide concentration-time curve (AUC) were assessed using blood sampling.
Results:
Four different macroscopic patterns of ISR were identified: A — no evidence of cutaneous lesions; B — transient infiltrative lesions that auto-resolved within 24 hours; C — transient nodular lesions that auto-resolved within 7–15 days; and D–stable lesions after more than 30 days. Histological examination showed three morphological patterns: (1) acute urticaria/vasculitis-like pattern, (2) subacute pattern and (3) chronic scleroderma-like pattern. No differences among patients with the various patterns of ISRs were observed, except for a higher C
max
and AUC in patients with pattern 1.
Conclusions:
These results confirm that although iatrogenic scleroderma is not related to impaired enfuvirtide absorption, higher C
max
and AUC values are observed in patients with urticaria/vasculitis-like patterns.</description><identifier>ISSN: 1173-2563</identifier><identifier>EISSN: 1179-1918</identifier><identifier>DOI: 10.2165/00044011-200828050-00004</identifier><identifier>PMID: 18407716</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Adult ; Anti-HIV Agents - adverse effects ; Anti-HIV Agents - pharmacokinetics ; Area Under Curve ; Female ; HIV Envelope Protein gp41 - adverse effects ; HIV Envelope Protein gp41 - pharmacokinetics ; Humans ; Iatrogenic Disease ; Injections, Intravenous - adverse effects ; Internal Medicine ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Original Research Article ; Peptide Fragments - adverse effects ; Peptide Fragments - pharmacokinetics ; Pharmacology/Toxicology ; Pharmacotherapy ; Scleroderma, Localized - chemically induced ; Scleroderma, Localized - metabolism ; Skin - pathology ; Urticaria - pathology ; Vasculitis - pathology</subject><ispartof>Clinical drug investigation, 2008-01, Vol.28 (5), p.305-311</ispartof><rights>Adis Data Information BV 2008</rights><rights>COPYRIGHT 2008 Wolters Kluwer Health, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c430t-ff90aa628bdfc991f76d22b8ceec8ab401657fc3fddf7c2596f1b97d538abdb3</citedby><cites>FETCH-LOGICAL-c430t-ff90aa628bdfc991f76d22b8ceec8ab401657fc3fddf7c2596f1b97d538abdb3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.2165/00044011-200828050-00004$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.2165/00044011-200828050-00004$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>315,781,785,27929,27930,41493,42562,51324</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18407716$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Maggi, Paolo</creatorcontrib><creatorcontrib>Filotico, Raffaele</creatorcontrib><creatorcontrib>Bonora, Stefano</creatorcontrib><creatorcontrib>Volpe, Anna</creatorcontrib><creatorcontrib>Bellacosa, Chiara</creatorcontrib><creatorcontrib>Cinori, Eliana</creatorcontrib><creatorcontrib>de Requena, Daniel Gonzalez</creatorcontrib><creatorcontrib>D’Avolio, Antonio</creatorcontrib><creatorcontrib>Di Perri, Giovanni</creatorcontrib><title>Does Iatrogenic Scleroderma due to Injection-Site Reaction to Enfuvirtide Impair Absorption of the Drug?</title><title>Clinical drug investigation</title><addtitle>Clin. Drug Investig</addtitle><addtitle>Clin Drug Investig</addtitle><description>Background:
Chronic iatrogenic scleroderma is a possible obstacle to the absorption of subcutaneously administered drugs. This study correlated the clinical and histopathological pattern of injection-site reactions (ISRs) to the pharmacokinetics of enfuvirtide in patients with
HIV
.
Methods:
Fourteen patients treated with an enfuvirtide-based antiretroviral regimen for a median of 45 weeks were enrolled and their ISRs were evaluated. Twelve patients with evidence of ISRs underwent cutaneous biopsies using a 4-mm punch. The maximum plasma enfuvirtide concentration (Cmax) and the area under the enfuvirtide concentration-time curve (AUC) were assessed using blood sampling.
Results:
Four different macroscopic patterns of ISR were identified: A — no evidence of cutaneous lesions; B — transient infiltrative lesions that auto-resolved within 24 hours; C — transient nodular lesions that auto-resolved within 7–15 days; and D–stable lesions after more than 30 days. Histological examination showed three morphological patterns: (1) acute urticaria/vasculitis-like pattern, (2) subacute pattern and (3) chronic scleroderma-like pattern. No differences among patients with the various patterns of ISRs were observed, except for a higher C
max
and AUC in patients with pattern 1.
Conclusions:
These results confirm that although iatrogenic scleroderma is not related to impaired enfuvirtide absorption, higher C
max
and AUC values are observed in patients with urticaria/vasculitis-like patterns.</description><subject>Adult</subject><subject>Anti-HIV Agents - adverse effects</subject><subject>Anti-HIV Agents - pharmacokinetics</subject><subject>Area Under Curve</subject><subject>Female</subject><subject>HIV Envelope Protein gp41 - adverse effects</subject><subject>HIV Envelope Protein gp41 - pharmacokinetics</subject><subject>Humans</subject><subject>Iatrogenic Disease</subject><subject>Injections, Intravenous - adverse effects</subject><subject>Internal Medicine</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Original Research Article</subject><subject>Peptide Fragments - adverse effects</subject><subject>Peptide Fragments - pharmacokinetics</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacotherapy</subject><subject>Scleroderma, Localized - chemically induced</subject><subject>Scleroderma, Localized - metabolism</subject><subject>Skin - pathology</subject><subject>Urticaria - pathology</subject><subject>Vasculitis - pathology</subject><issn>1173-2563</issn><issn>1179-1918</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkd1KJDEQhcOysv6-ggS8bq2kp9PJlQzqrgPCwup9SCeVMcN0Z0i6hX17MzO6iyBILpKqc76CyiGEMrjkTDRXADCbAWMVB5BcQgMVbHvfyBFjraqYYvL77l1XvBH1ITnOeQXABBP8BzlkcgZty8QReb6NmOnCjCkucQiWPto1pugw9Ya6CekY6WJYoR1DHKrHMCL9g2ZXbaW7wU8vIY3BIV30GxMSnXc5ps3OED0dn5Hepml5fUoOvFlnPHu7T8jTz7unm_vq4fevxc38obKzGsbKewXGCC47561SzLfCcd5Ji2il6crSomm9rb1zvrW8UcKzTrWuqYvquvqEXOzHLs0adRh8HJOxfchWz5lSstASiuvyE1c5Dvtg44A-lP4HQO4Bm2LOCb3epNCb9Fcz0NtI9Hsk-l8kehdJQc_36GbqenT_wbcMikHtDblIwxKTXsUpDeWTvh7-Cs61l9Y</recordid><startdate>20080101</startdate><enddate>20080101</enddate><creator>Maggi, Paolo</creator><creator>Filotico, Raffaele</creator><creator>Bonora, Stefano</creator><creator>Volpe, Anna</creator><creator>Bellacosa, Chiara</creator><creator>Cinori, Eliana</creator><creator>de Requena, Daniel Gonzalez</creator><creator>D’Avolio, Antonio</creator><creator>Di Perri, Giovanni</creator><general>Springer International Publishing</general><general>Wolters Kluwer Health, Inc</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></search><sort><creationdate>20080101</creationdate><title>Does Iatrogenic Scleroderma due to Injection-Site Reaction to Enfuvirtide Impair Absorption of the Drug?</title><author>Maggi, Paolo ; Filotico, Raffaele ; Bonora, Stefano ; Volpe, Anna ; Bellacosa, Chiara ; Cinori, Eliana ; de Requena, Daniel Gonzalez ; D’Avolio, Antonio ; Di Perri, Giovanni</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c430t-ff90aa628bdfc991f76d22b8ceec8ab401657fc3fddf7c2596f1b97d538abdb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adult</topic><topic>Anti-HIV Agents - adverse effects</topic><topic>Anti-HIV Agents - pharmacokinetics</topic><topic>Area Under Curve</topic><topic>Female</topic><topic>HIV Envelope Protein gp41 - adverse effects</topic><topic>HIV Envelope Protein gp41 - pharmacokinetics</topic><topic>Humans</topic><topic>Iatrogenic Disease</topic><topic>Injections, Intravenous - adverse effects</topic><topic>Internal Medicine</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Original Research Article</topic><topic>Peptide Fragments - adverse effects</topic><topic>Peptide Fragments - pharmacokinetics</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacotherapy</topic><topic>Scleroderma, Localized - chemically induced</topic><topic>Scleroderma, Localized - metabolism</topic><topic>Skin - pathology</topic><topic>Urticaria - pathology</topic><topic>Vasculitis - pathology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Maggi, Paolo</creatorcontrib><creatorcontrib>Filotico, Raffaele</creatorcontrib><creatorcontrib>Bonora, Stefano</creatorcontrib><creatorcontrib>Volpe, Anna</creatorcontrib><creatorcontrib>Bellacosa, Chiara</creatorcontrib><creatorcontrib>Cinori, Eliana</creatorcontrib><creatorcontrib>de Requena, Daniel Gonzalez</creatorcontrib><creatorcontrib>D’Avolio, Antonio</creatorcontrib><creatorcontrib>Di Perri, Giovanni</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Clinical drug investigation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Maggi, Paolo</au><au>Filotico, Raffaele</au><au>Bonora, Stefano</au><au>Volpe, Anna</au><au>Bellacosa, Chiara</au><au>Cinori, Eliana</au><au>de Requena, Daniel Gonzalez</au><au>D’Avolio, Antonio</au><au>Di Perri, Giovanni</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Does Iatrogenic Scleroderma due to Injection-Site Reaction to Enfuvirtide Impair Absorption of the Drug?</atitle><jtitle>Clinical drug investigation</jtitle><stitle>Clin. Drug Investig</stitle><addtitle>Clin Drug Investig</addtitle><date>2008-01-01</date><risdate>2008</risdate><volume>28</volume><issue>5</issue><spage>305</spage><epage>311</epage><pages>305-311</pages><issn>1173-2563</issn><eissn>1179-1918</eissn><abstract>Background:
Chronic iatrogenic scleroderma is a possible obstacle to the absorption of subcutaneously administered drugs. This study correlated the clinical and histopathological pattern of injection-site reactions (ISRs) to the pharmacokinetics of enfuvirtide in patients with
HIV
.
Methods:
Fourteen patients treated with an enfuvirtide-based antiretroviral regimen for a median of 45 weeks were enrolled and their ISRs were evaluated. Twelve patients with evidence of ISRs underwent cutaneous biopsies using a 4-mm punch. The maximum plasma enfuvirtide concentration (Cmax) and the area under the enfuvirtide concentration-time curve (AUC) were assessed using blood sampling.
Results:
Four different macroscopic patterns of ISR were identified: A — no evidence of cutaneous lesions; B — transient infiltrative lesions that auto-resolved within 24 hours; C — transient nodular lesions that auto-resolved within 7–15 days; and D–stable lesions after more than 30 days. Histological examination showed three morphological patterns: (1) acute urticaria/vasculitis-like pattern, (2) subacute pattern and (3) chronic scleroderma-like pattern. No differences among patients with the various patterns of ISRs were observed, except for a higher C
max
and AUC in patients with pattern 1.
Conclusions:
These results confirm that although iatrogenic scleroderma is not related to impaired enfuvirtide absorption, higher C
max
and AUC values are observed in patients with urticaria/vasculitis-like patterns.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>18407716</pmid><doi>10.2165/00044011-200828050-00004</doi><tpages>7</tpages></addata></record> |
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source | MEDLINE; SpringerNature Journals |
subjects | Adult Anti-HIV Agents - adverse effects Anti-HIV Agents - pharmacokinetics Area Under Curve Female HIV Envelope Protein gp41 - adverse effects HIV Envelope Protein gp41 - pharmacokinetics Humans Iatrogenic Disease Injections, Intravenous - adverse effects Internal Medicine Male Medicine Medicine & Public Health Middle Aged Original Research Article Peptide Fragments - adverse effects Peptide Fragments - pharmacokinetics Pharmacology/Toxicology Pharmacotherapy Scleroderma, Localized - chemically induced Scleroderma, Localized - metabolism Skin - pathology Urticaria - pathology Vasculitis - pathology |
title | Does Iatrogenic Scleroderma due to Injection-Site Reaction to Enfuvirtide Impair Absorption of the Drug? |
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