Cutaneous necrosis after injection of polyethylene glycol–modified interferon alfa

Dalmau, Joan; Pimentel, Carmen Lucía; Puig, L.; Peramiquel, Laura; Roé, Esther; Alomar, A.

doi:10.1016/j.jaad.2005.02.031

Cited by 24 publications

(10 citation statements)

References 9 publications

(5 reference statements)

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“…Vasculitis is mostly cutaneous but can be systemic if severe Porphyria cutanea tarda [3,6] Most common viral infection associated with PCT. Prevalence of HCV infection in PCT cases varies geographically Lichen planus [7] Strongly correlated with HCV infection in meta-analysis Localized reactions Erythematous or eczematous dermatitis and psoriasis [16,19] Localized alopecia associated with local cutaneous reactions to interferon [20] Skin ulceration and necrosis [21] Local infections and local allergic reactions to interferon injection [16] Generalized reactions Alopecia/hair growth anomalies [16] Skin xerosis, dermatitis and pruritus [16,22] skin, such as lichen planus or psoriasis, Chronic inflammatory diseases of the which may be induced or exacerbated by interferon [16,19] Autoimmune disorders and immune-mediated inflammatory disease (e.g. psoriasis and sarcoidosis) [23,24] 1.62, 95% CI 1.29-2.02), and rash (RR 1.74, 95%CI 1.17-2.61), as demonstrated in a recent Cochrane meta-analysis [25].…”

Section: Dermatological Adverse Events On Peginterferon/ribavirinbasementioning

confidence: 99%

Dermatological side effects of hepatitis C and its treatment: Patient management in the era of direct-acting antivirals

Cacoub¹,

Bourlière²,

Lübbe³

et al. 2012

Journal of Hepatology

133

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Dermatological adverse events (AEs) are an existing concern during hepatitis C virus (HCV) infection and peginterferon/ribavirin treatment. HCV infection leads to dermatological and muco-cutaneous manifestations including small-vessel vasculitis as part of the mixed cryoglobulinemic syndrome. Peginterferon/ribavirin treatment is associated with well-characterized dermatological AEs tending towards a uniform entity of dermatitis. New direct-acting antivirals have led to significant improvements in sustained virologic response rates, but several have led to an increase in dermatological AEs versus peginterferon/ribavirin alone. In telaprevir trials, approximately half of treated patients had rash. More than 90% of these events were Grade 1 or 2 (mild/moderate) and in the majority (92%) of cases, progression to a more severe grade did not occur. In a small number of cases (6%), rash led to telaprevir discontinuation, whereupon symptoms commonly resolved. Dermatological AEs with telaprevir-based triple therapy were generally similar to those observed with peginterferon/ribavirin (xerosis, pruritus, and eczema). A few cases were classified as severe cutaneous adverse reaction (SCAR), also referred to as serious skin reactions, a group of rare conditions that are potentially life-threatening. It is therefore important to distinguish between telaprevir-related dermatitis and SCAR. The telaprevir prescribing information does not require telaprevir discontinuation for Grade 1 or 2 (mild/moderate) rash, which can be treated using emollients/moisturizers and topical corticosteroids. For Grade 3 rash, the prescribing information mandates immediate telaprevir discontinuation, with ribavirin interruption (with or without peginterferon) within 7 days of stopping telaprevir if there is no improvement, or sooner if it worsens. In case of suspicion or confirmed diagnosis of SCAR, all study medication must be discontinued.

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Section: Dermatological Adverse Events On Peginterferon/ribavirinbasementioning

confidence: 99%

Dermatological side effects of hepatitis C and its treatment: Patient management in the era of direct-acting antivirals

Cacoub¹,

Bourlière²,

Lübbe³

et al. 2012

Journal of Hepatology

133

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“…There are some drugs which may lead to ISRs in human like HIV-1 fusion inhibitor enfuvirtide, interferons, anti-TNF drugs adalimumab and etanercept. [46][47][48][49] Most of these ISRs are mild as erythema and self-limited, whereas necrotic ulcerative lesions of skin are rare. There are human cases of cutaneous necrotic ulcers related with subcutaneous administration of polyethyleneglycol modified (pegylated) interferon-a-2b, 50,51 interferon beta-1b, 52 and enoxaparine sodium.…”

Section: Discussionmentioning

confidence: 99%

Subcutaneous Toxicity of Agmatine in Rats

Uzbay¹,

Yertutanol²,

Mıdı³

et al. 2017

tjps

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ÖZAmaç: Bu çalışmanın amacı sıçanlarda ilk kez tekrarlayan agmatin uygulamasının sensorimotor kapılama sistemi üzerine etkilerini incelemekti, ancak subkütan uygulamada karşımıza çıkan beklenmedik ülseratif nekrotik lezyonlar bu konuya odaklanmamıza neden oldu. Gereç ve Yöntemler: İlk grup deneylerde, erkek Wistar albino sıçanlara 14 gün süreyle subkütan yoldan agmatin (40, 80 ve 160 mg/kg) veya salin (kontrol grubu) enjeksiyonu yapıldı (n=8 her bir grup). Uygulamaların üçüncü gününden itibaren agmatin verilen gruplarda ülseratif nekrotik deri lezyonları gözlendi. Bu etkilerin dermal bir reaksiyona bağlı olup olmadığını anlamak için ayrı bir denek grubuna aynı protokolle agmatin (80 mg/kg) intraperitoneal yoldan verildi (n=8 her bir grup). Bulgular: Bulgularımız subkütan yoldan verilen agmatinin geç dönemde ortaya çıkan bir dermal reaksiyona neden olurken, intraperitoneal uygulamanın böyle bir etki oluşturmadığına işaret etti. Lezyon gözlenen deneklerden alınan deri örneklerinin histopatolojik incelemesinde, enjeksiyon yerindeki deride aseptik nekroz saptanırken, bu deneklerin kan testleri normal bulundu. Sonuç: Bu bulgu sıçanlarda uzun süreli subkütan agmatin uygulamasının denek refahı bakımından risk oluşturan toksik bir etkiye neden olduğuna işaret etmektedir. Bu bulgu insanlarda oral yoldan reçetesiz olarak alınabilen agmatinin bazı potansiyel riskleri olabileceği konusunda sorular ortaya çıkarmaktadır. Anahtar kelimeler: Agmatin, deri reaksiyonu, subkütan yol, toksisite, sıçan Objectives: The aim of this study was to investigate the effects of repetitive agmatine administration on sensorimotor gating in rats first but, as unexpected, ulcerative necrotic cutaneous lesions appeared, thus, the study was directed primarily to clarify these results. Materials and Methods:In the first set of experiments, we administered agmatine (40, 80 and 160 mg/kg) and saline (control group) subcutaneously to male Wistar albino rats (n=8 for each group) for 14 consecutive days. Ulcerative necrotic cutaneous lesions appeared following the third day of agmatine administration. We decided to explore the potential toxic dermal effects of agmatine and conducted second set of experiments with two groups (n=8) to compare the effects of subcutaneous vs. intraperitoneal agmatine (80 mg/kg) injection to understand if the injection route determines the toxicity. Results: Our results showed that prolonged subcutaneous but not intraperitoneal administration of agmatine leads to a delayed dermal reaction in rats. Histopathologic examination of skin samples revealed cutaneous aseptic necrosis at the injection site whereas blood tests were found to be normal. Conclusion: This finding is important to point out the risks of prolonged subcutaneous administration of agmatine to rats within the concept of animal welfare. In addition, the results raise questions about the possible risks of over-the-counter use of agmatine among humans although the agent is taken via oral route.

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“…At the site of injections a pruritic erythematous patch was seen in a few patients, in 2 of them as a vesicobullous eruption. Others reported more frequent localized reactions with various presentations [5,6,7]. These changes were managed by the use of emollients and topical corticosteroids.…”

Section: Discussionmentioning

confidence: 99%

Cutaneous Reactions in Patients with Chronic Hepatitis C Treated with Peginterferon and Ribavirin

Patrk¹,

Morović²,

Markulin³

et al. 2014

Dermatology

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Background/Objective: Peginterferon alfa and ribavirin could cause various cutaneous reactions. Treatment-related cutaneous reactions are common, and treatable complications can contribute to the treatment discontinuation. Methods: We performed a 6-year prospective study of cutaneous reactions in 271 patients with chronic hepatitis C treated with peginterferon and ribavirin. Results: Cutaneous reactions of mild to moderate degree were seen in 36 (13.3%) patients: localized cutaneous reactions in 7 (2.6%) patients, generalized reactions - pruritus, skin xerosis and eczematous changes - in 28 (10.3%) patients, alopecia in 11 (4.1%) patients; exacerbation of lichen planus was seen in 1 patient. Conclusion: The study showed a relatively low prevalence of cutaneous reactions without the need for discontinuation of any of the drugs used. These reactions correlated only with the age of the patients and treatment duration. This finding is of particular importance with regard to the recently introduced direct-acting antivirals in the treatment of hepatitis C virus infection, which can cause a very severe form of cutaneous reactions.

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Cutaneous necrosis after injection of polyethylene glycol–modified interferon alfa

Cited by 24 publications

References 9 publications

Dermatological side effects of hepatitis C and its treatment: Patient management in the era of direct-acting antivirals

Dermatological side effects of hepatitis C and its treatment: Patient management in the era of direct-acting antivirals

Subcutaneous Toxicity of Agmatine in Rats

Cutaneous Reactions in Patients with Chronic Hepatitis C Treated with Peginterferon and Ribavirin

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