Off-Label Use of Biologic Agents in the Treatment of Dermatosis, Part 1: Infliximab and Adalimumab

Díaz-Ley, B.; Guhl, Guillermo; Fernández‐Herrera, Jesús

doi:10.1016/s1578-2190(07)70539-5

Cited by 5 publications

(7 citation statements)

References 231 publications

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“…Respondents reported the off‐label use of infliximab for colitis ulcerosa and for refractory graft versus host disease. The literature also discusses the off‐label use of this antibody for Kawasaki's disease, psoriasis and Sjogren's syndrome, but these conditions were not identified by our respondents [17] …”

Section: Discussionmentioning

confidence: 99%

“…The literature also discusses the off-label use of this antibody for Kawasaki's disease, psoriasis and Sjogren's syndrome, but these conditions were not identified by our respondents. [17] Patients suffering from systemic autoimmune disorders such as rheumatoid arthritis, Crohn's disease and colitis ulcerosa do not always respond to traditional treatments with, for example, disease-modifying anti-rheumatic drugs. If a patient in Belgium fails treatment with at least two disease-modifying anti-rheumatic drugs, reimbursement is granted to treatment with one of three monoclonal antibodies (i.e.…”

Section: Discussionmentioning

confidence: 99%

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Monoclonal antibodies: indications, budget impact and use

Simoens

Rijdt²,

Declerck

2010

Journal of Pharmaceutical Health Services Research

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Objectives This study aims to compile a list of monoclonal antibodies and their indications in the European Union, and to examine the budget impact and use of monoclonal antibodies in a Belgian university hospital. Methods Information about monoclonal antibodies was extracted from the European Public Assessment Reports published by the European Medicines Agency. The Belgian Centre for Pharmacotherapeutic Information was accessed to explore which monoclonal antibodies were marketed in Belgium. Annual data about the budget impact and the number of patients using monoclonal antibodies in University Hospitals Leuven were extracted from pharmacy databases from 2004 to 2008. A qualitative questionnaire was sent to hospital physicians to elicit approved and off‐label use of monoclonal antibodies. Key findings In March 2010, 39 monoclonal antibodies (17 of which are orphan drugs) were registered in the European Union. Around 40% of these were marketed in Belgium. Six monoclonal antibodies were revoked for commercial reasons. The proportion of the hospital drug budget spent on monoclonal antibodies has more than doubled from 8% in 2004 to 17% in 2008. The monoclonal antibody budget was made up of infliximab (41% of budget), trastuzumab (20%), rituximab (10%), cetuximab (9%), ranibizumab (9%) and others (11%) in 2008. Although monoclonal antibodies tend to be used in their registered indications in University Hospitals Leuven, a number of cases of off‐label use were documented. Conclusions The monoclonal antibody market is expected to continue to evolve with the registration of new antibodies, expansion of indications and increased utilisation.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Monoclonal antibodies: indications, budget impact and use

Simoens

Rijdt²,

Declerck

2010

Journal of Pharmaceutical Health Services Research

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“…Os fármacos anti-TNF-α têm sido utilizados com bons resultados no tratamento de várias dermatoses granulomatosas, dados apoiados por modelos experimentais que verificaram que o TNF-α é a citocina central na formação dos granulomas [3][4][5] .…”

Section: Etanerceptunclassified

“…No entanto, ao longo dos últimos anos tem-se acumulado alguma experiência no uso destes fármacos no tratamento de determinadas dermatoses, nas quais não estando aprovados, a fisiopatologia sugere poderem ser eficazes. Apesar desta crescente utilização, o ainda limitado número de casos descritos, por vezes relacionado com a raridade de algumas doenças, não permite a aprovação pelas entidades reguladoras, sendo o uso nestas situações feito em modalidade offlabel [3][4][5] .…”

Section: Introductionunclassified

Utilização Off-Label De Terapêutica Biológica Em Dermatologia – Experiência Clínica De 5 Anos

Diamantino

Lestre

Ponte

et al. 2016

SPDV

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Introdução: Nos últimos anos, a terapêutica biológica expandiu de forma expressiva as opções terapêuticas disponíveis em Dermatologia. Ainda que o seu uso esteja apenas aprovado no tratamento da psoríase e psoríase atropática, a utilização off-label em diversas dermatoses inflamatórias tem sido descrita de forma crescente na literatura.Métodos: Efectuou-se um estudo retrospectivo dos doentes com dermatoses (que não a psoríase) tratados com terapêutica biológica entre Janeiro de 2005 e Dezembro de 2009, no nosso Serviço. Foram analisados os dados clínicos, as terapêuticas efectuadas, a eficácia e o perfil de segurança.Resultados: Foram incluídos 15 doentes e tratadas 7 diferentes patologias dermatológicas resistentes às terapêuticas convencionais. O etanercept foi utilizado em 4 casos: 3 doentes com Esclerodermia sistémica (2 doentes interromperam a terapêutica antes das 12 semanas por efeitos adversos graves; no 3º doente verificaram-se bons resultados) e um doente com granuloma elastolítico, no qual se registou uma boa resposta clínica. O infliximab foi utilizado com sucesso em 4 doentes (3 casos de doença de Behçet e 1 de pitiríase rubra pilar). O adalimumab foi utilizado num caso de dermatose pustulosa subcórnea com excelentes resultados. O efalizumab foi ineficaz em 2 casos de dermite atópica. O rituximab foi utilizado em 5 doentes: 3 casos de pênfigo (com excelentes resultados terapêuticos) e 2 casos de dermite atópica (numa doente houve uma boa resposta, mas interrompeu a terapêutica após 1 semana de tratamento por gravidez e na 2ª doente não se observou qualquer melhoria significativa).Conclusão: A terapêutica biológica tem demonstrado eficácia no tratamento de várias dermatoses; no entanto a maioria da informação disponível na literatura é referente a casos isolados ou a pequenas séries de casos. Apesar da nossa experiência ser limitada, estes resultados parecem-nos promissores na terapêutica de determinadas dermatoses inflamatórias refractárias aos tratamentos convencionais.

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“…[41] Infliximab is a chimeric monoclonal antibody composed of human constant regions of IgG1k with murine variable regions, which exerts anti-TNFa activities through various mechanisms including inhibition of binding of soluble TNFa to TNFa receptors, neutralization of soluble and membrane-bound TNFa, and potential dissociation of soluble TNFa-receptor complexes; and which, like etanercept, is also used for treatment of rheumatoid arthritis, ankylosing spondilitis, or psoriatic arthritis, but also for the treatment of inflammatory bowel diseases such as Crohn disease or ulcerative colitis. [91,92] In a mouse model of ovalbumin-induced asthma, infliximab given both prior to allergen priming and when subsequently challenged, demonstrated anti-inflammatory effects on cellular and cytokine markers of inflammation in BAL fluid, reducing eosinophils and neutrophils and also IL-4, IL-6, and TNFa levels. [93] Clinical efficacy of infliximab was assessed in patients with milder asthma uncontrolled by inhaled corticosteroids, and improvements in asthma symptoms, reduced lung function variability, sputum levels of TNFa, IL-6, IL-8, and the exacerbation rate were reported over an 8-week period.…”

Section: Anti-tnfa Therapiesmentioning

confidence: 99%

Cytokine Antagonists for the Treatment of Asthma

Antoniu

2009

BioDrugs

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Asthma is a disease of the airways in which several cytokines such as interleukin (IL)-4, IL-5, IL-13 and tumor necrosis factor-alpha (TNFalpha) play a major role in the development and progression of inflammation, airway hyperresponsiveness, mucus production, and airway remodeling. The conventional anti-inflammatory therapies, represented by inhaled corticosteroids and antileukotrienes, are not always able to provide optimal disease control and it is therefore hoped that cytokine antagonists could achieve this goal in such situations. Anticytokine therapies have been tested in preclinical studies and some have entered clinical trials. Anti-IL-4 therapies have been tested in animal models of allergy-related asthma, but because of unclear efficacy their development was discontinued. However, IL-4/IL-13 dual antagonists and IL-13-specific blocking agents are more promising, as they exhibit more sustained anti-inflammatory effects. IL-5 antagonists have been found to be of limited efficacy in clinical studies but might be useful in conditions characterized by severe hypereosinophilia, and in which asthma is one of the disease manifestations. Unlike other chronic inflammatory conditions, such as rheumatoid arthritis, the use of anti-TNFalpha therapies in asthma might be limited by the unfavorable risk/benefit ratio associated with long-term use. The identification of so-called asthma TNFalpha phenotypes and perhaps the use of a less aggressive treatment regimen might address this important aspect. Other cytokine antagonists (for example for IL-9 or IL-25) are currently being evaluated in the asthma setting, and could open new therapeutic perspectives based on their efficacy and safety.

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Off-Label Use of Biologic Agents in the Treatment of Dermatosis, Part 1: Infliximab and Adalimumab

Cited by 5 publications

References 231 publications

Monoclonal antibodies: indications, budget impact and use

Monoclonal antibodies: indications, budget impact and use

Utilização Off-Label De Terapêutica Biológica Em Dermatologia – Experiência Clínica De 5 Anos

Cytokine Antagonists for the Treatment of Asthma

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