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
Hauptverfasser: Maggi, Paolo, Filotico, Raffaele, Bonora, Stefano, Volpe, Anna, Bellacosa, Chiara, Cinori, Eliana, de Requena, Daniel Gonzalez, D’Avolio, Antonio, Di Perri, Giovanni
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container_end_page 311
container_issue 5
container_start_page 305
container_title Clinical drug investigation
container_volume 28
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
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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 &amp; 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. 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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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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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