Efficacy and safety of systemic treatments for moderate-to-severe atopic dermatitis: A systematic review

Roekevisch, Evelien; Spuls, Phyllis I.; Kuester, Denise; Limpens, Jacqueline; Schmitt, Jochen

doi:10.1016/j.jaci.2013.07.049

Cited by 300 publications

(303 citation statements)

References 47 publications

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“…Tedavi başlangıcında yapılması gereken testler; tam kan sayımı, karaciğer ve böbrek fonksiyon testleri, hepatit B ve C, Tbc testleri ve gerekli durumlarda HIV, gebelik ve pulmoner fonksiyon testleridir. İzleme ilk ay haftalık, sonraki ay iki haftada bir, daha sonra ayda bir kez yapılır, bu kontrollerde tam kan sayımı ve karaciğer fonksiyon testleri yeterlidir 124 . Gebelerde kategorisi X'dir ve kullanımı kesinlikle önerilmez.…”

Section: Metotreksatunclassified

The Turkish guideline for the diagnosis and management of atopic dermatitis-2018

Ertam¹,

Küçük²,

Alper³

et al. 2018

TURKDERM

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Section: Metotreksatunclassified

The Turkish guideline for the diagnosis and management of atopic dermatitis-2018

Ertam¹,

Küçük²,

Alper³

et al. 2018

TURKDERM

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“…At present, the main evidence to inform clinical practice around conventional systemic immuno-modulatory treatments is derived from a rather small body of randomised controlled trials (RCTs) (Roekevisch et al, 2014) as well as case series (i.a. (Garritsen et al, 2015;van der Schaft et al, 2015)).…”

Section: To the Editormentioning

confidence: 99%

The International TREatment of ATopic Eczema (TREAT) Registry Taskforce: An Initiative to Harmonize Data Collection across National Atopic Eczema Photo- and Systemic Therapy Registries

Spuls

Gerbens

Apfelbacher

et al. 2017

Journal of Investigative Dermatology

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“…A number of systemic treatment regimens have been tested in the management of moderate-to-severe forms of AD (10,12). These belong either to the class of immunosuppressive drugs such as CsA (13), AZA (14), MTX (14), or MMF (15).…”

Section: Off-label Use In Pediatric Populationmentioning

confidence: 99%

Off-label prescriptions for atopic dermatitis in Europe

Bieber

Straeter

2014

Allergy

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Moderate-to-severe forms of atopic dermatitis (AD) have a substantial impact on the quality of life of patients and their relatives, carrying a significant socioeconomic burden. They often require a systemic therapy, and ciclosporine A (CsA) is the only medicinal product approved for this indication in a limited number of European countries. However, due to the safety profile of CsA and its approval conditions, this treatment can only be prescribed for a limited period of time. Thus, moderate-to-severe forms of AD represent a significant unmet medical need and are subject to off-label prescriptions. Besides giving some insights into the approval procedures for medicinal products in the European Union, this short review is aimed to provide some relevant background information for off-label prescription in AD. It also provides a clinical algorithm for the off-label prescription of systemic immunosuppressants in AD, discusses the apparent dilemma between approval and guidelines, and finally suggests practical rules to be considered in the context of off-label prescription.Atopic dermatitis (AD) is usually seen as one of the most common chronic inflammatory skin diseases (1, 2). The pathophysiology (3) and clinical phenotype of AD are highly heterogeneous and vary not only from patient to patient but also within the natural history of the disease for one given patient (4, 5). It has been estimated that patients suffering from the mild form [tentatively scored below 18 according to the Scoring of Atopic dermatitis (SCORAD)] represent 70% of the overall AD population. In contrast, the moderate form represents 20% (tentatively scored between 18 and 40) and the more severe form (tentatively scored more than 40) represents 10% of all AD cases. The latter represents the AD population with the most significant unmet medical need, mainly due to high impact on the quality of life (6). Moderate-to-severe AD causes more than two billion euro lost in productivity in the European Union (EU) every year (7,8). Thus, AD represents a significant economic burden and a clear opportunity for new therapeutic approaches to moderate-to-severe forms. There is a significant gap in the availability of approved drugs for the management and efficacious control of moderate-to-severe and severe forms of AD. Ciclosporine A (CsA) is the only drug approved for AD in most European countries. However, it is not approved for this indication by the Food and Drug Agency (FDA) in the United States. The present review is aimed to give a short summary on the current approval procedures in the EU and on the definition of offlabel use. The management of moderate-to-severe and severe forms of AD will be taken as a case study for off-label prescription, and the dilemma with current therapeutic guidelines will be shortly discussed. Figure 1 shows in a schematic way how medicinal products (drugs) are currently approved in the EU. Briefly, there are three different ways to achieve marketing authorization for one given drug in the EU (9). Brief regulatory ...

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Efficacy and safety of systemic treatments for moderate-to-severe atopic dermatitis: A systematic review

Cited by 300 publications

References 47 publications

The Turkish guideline for the diagnosis and management of atopic dermatitis-2018

The Turkish guideline for the diagnosis and management of atopic dermatitis-2018

The International TREatment of ATopic Eczema (TREAT) Registry Taskforce: An Initiative to Harmonize Data Collection across National Atopic Eczema Photo- and Systemic Therapy Registries

Off-label prescriptions for atopic dermatitis in Europe

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