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The Goeckerman Regimen for the Treatment of Moderate to Severe Psoriasis
Published on: July 11, 2013
Off-Label Treatments for Pediatric Psoriasis: Lessons for the Clinic
Morten B Haulrig1, Claus Zachariae1,2, Lone Skov1,2
1Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, DK-2900, Denmark.
Insights
Pediatric psoriasis treatments often lack approval, with limited studies available. Off-label therapies like topical corticosteroids show promise, but more clinical trials are crucial for childhood psoriasis management.
Area of Science:
- Dermatology
- Pediatrics
- Pharmacology
Background:
- Psoriasis affects up to 1.2% of children and adolescents.
- Pediatric psoriasis treatments often mirror adult protocols.
- Few treatments are FDA-approved for childhood psoriasis, relying heavily on adult data.
Purpose of the Study:
- To review existing literature on off-label psoriasis treatments in pediatric populations.
- To assess the current evidence base for unapproved therapies in children and adolescents with psoriasis.
Main Methods:
- Conducted a literature search on PubMed, identifying 50 studies on off-label psoriasis treatments.
- Included 23 clinical trials, four of which were randomized controlled trials.
- Focused on studies involving children and adolescents with psoriasis.
Main Results:
- A limited number of studies exist for off-label pediatric psoriasis treatments.
- Many studies are retrospective with small participant numbers.
- Topical corticosteroids, vitamin D analogs, and methotrexate show promising effects despite limited data.
Conclusions:
- Despite data scarcity, off-label treatments are recommended based on clinical experience.
- Regular clinical trials are essential to establish safety and efficacy of unapproved treatments.
- European Union's Pediatric Investigation Plans may increase pediatric drug trial data, benefiting psoriasis research.
Abstract:
Psoriasis is a chronic inflammatory skin disease that affects up to 1.2% of children and adolescents. The treatment options for childhood psoriasis are often based on the same principles as in adults. However, most data on safety and efficacy derive from adult studies, and only a few of the frequently used treatments have achieved approval for use in children. The aim of this study was to review the current literature on off-label treatments for psoriasis in children and adolescents. We searched PubMed and identified 50 studies on off-label treatments. Of these, 23 studies were clinical trials (four randomized). There are only a small number of available studies on off-label treatments for children and adolescents with psoriasis, and many of these are retrospective reviews with few participants. Despite the current lack of studies, we still recommend the use of unapproved treatments since we have clinical experience with treatments such as topical corticosteroids, vitamin D analogs, and methotrexate that have shown promising effects. Regular clinical trials are needed to investigate the safety and efficacy of unapproved treatments. Due to The Pediatric Investigation Plans issued by The European Union, new drugs developed by pharmaceutical companies are required to undergo clinical trials in a pediatric population to get their application for marketing authorization processed. This will hopefully lead to much more data on the efficacy and safety of the new treatments, including treatments for children and adolescents with psoriasis.
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