Long-Term Treatment with Fumaric Acid Esters in an 11-Year-Old Male Child with Psoriasis

Gerdes, Sascha; Domm, Silja; Mrowietz, Ulrich

doi:10.1159/000327086

Cited by 18 publications

(32 citation statements)

References 13 publications

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“…The maximum daily FAE dose was up to four tablets (containing 120 mg dimethyl fumarate [DMF], 87 mg ethyl hydrogen fumarate [EHF] [calcium salt], 5 mg EHF [magnesium salt] and 3 mg EHF [zinc salt]). The case reports as well as unpublished expert experience thus suggest that FAEs may also be effective and well tolerated in children and adolescents. In 1994, FAEs (Fumaderm initial ® and Fumaderm ® ) were licensed for the treatment of severe psoriasis in adults; in 2008, this approval was extended to moderate psoriasis .…”

Section: Introductionmentioning

confidence: 84%

“…All other systemic antipsoriatic agents therefore have to be used off‐label in children and adolescents . Thus, the prescribing doctor is in a legal gray area, especially because there is only very limited safety data for long‐term treatment of psoriasis in this age group . With respect to children and adolescents, experience with conventional systemic therapeutic agents also used in the treatment of psoriasis comes from other approved indications such as juvenile arthritis and Crohn's disease, as well as following organ transplants .…”

Section: Introductionmentioning

confidence: 99%

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Retrospective data collection of psoriasis treatment with fumaric acid esters in children and adolescents in Germany (KIDS FUTURE study)

Reich

Hartl²,

Gambichler

et al. 2015

J Deutsche Derma Gesell

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SummaryBackground: Given that there is no standard systemic treatment for children and adolescents with plaque psoriasis, this non-interventional, multicenter, retrospective study collected data on the efficacy and safety of long-term treatment with fumaric acid esters (FAEs) in this particular patient group. Patients and methods: In patients younger than 18 years of age at the start of FAE treatment, data on efficacy and safety was retrospectively collected for at least 36 months. Results: Data from 127 patients (aged 6-17 years) was collected for treatment durations of up to 60 months. Physician's Global Assessment, Psoriasis Area and Severity Index, and Body Surface Area showed marked improvement in the first six months. After 36 months, these parameters had, on average, improved by up to two-thirds of baseline values. Thirty-seven patients experienced at least one adverse event (AE), which was FAE-related in 36 individuals. Three AEs (proteinuria (one case), flushing (two cases)) persisted during the observation period while on treatment. Fifteen AEs led to the discontinuation of therapy; nearly all of these cases were related to gastrointestinal disorders. Conclusions: The KIDS FUTURE study -for the first time -included a larger population of children and adolescents with psoriasis who were treated with FAEs. The data obtained suggests that long-term FAE therapy in this patient group may be effective and safe. The results are currently being verified in an ongoing clinical study.

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Section: Introductionmentioning

confidence: 84%

Section: Introductionmentioning

confidence: 99%

Retrospective data collection of psoriasis treatment with fumaric acid esters in children and adolescents in Germany (KIDS FUTURE study)

Reich

Hartl²,

Gambichler

et al. 2015

J Deutsche Derma Gesell

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“…The other patient (No. 3) was treated in our psoriasis centre [9,10]. Recently, in a Dutch retrospective registry study using three different local pharmacy-produced fumarate products (not specified in the paper), data on 14 paediatric patients was published [17].…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, FAE can also be considered as a promising therapeutic option for the long-term treatment in paediatric patients. Interestingly, until today only two case reports about the use of FAE in children have been published [9,10]. …”

Section: Introductionmentioning

confidence: 99%

Systemic Treatment with Fumaric Acid Esters in Six Paediatric Patients with Psoriasis in a Psoriasis Centre

et al. 2014

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Background: Psoriasis is one of the most common inflammatory skin disorders. There are only limited data on systemic treatment in children. Objective: To assess the safety and clinical efficacy of the treatment of six paediatric patients with fumaric acid esters (FAE, Fumaderm®) for psoriasis. Methods: Six patients aged 6-17 years were treated with FAE. Patients underwent regular assessment. Treatment efficacy was evaluated using the Psoriasis Area and Severity Index (PASI) and body surface area (BSA). Results: The mean duration of treatment was 17.8 months. PASI and BSA were determined after 12 weeks. All patients showed improvement in their skin condition, two achieving PASI75, one PASI90 and three PASI100 response. Proteinuria was encountered in one patient and two patients suffered from gastrointestinal discomfort. Treatment was discontinued due to remission in two patients. Conclusion: Treatment with FAE in paediatric patients is a valuable alternative option when systemic treatment is needed.

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“…Das allgemein empfohlene Dosierungsschema für Fumarsäurees-ter sollte an die individuelle Verträglich-keit angepasst werden. Daten zu Fumarsäureestern bei Kindern liegen nur sehr beschränkt vor [9,11]. Vor Einsatz von Etanercept müssen alle aus der Erwachsenentherapie bekannten Voruntersuchungen zum Ausschluss von Infektionen und schwerer Leber-, Nieren-und Herzfunktionsstörungen durchgeführt werden.…”

Section: » Etanercept Ist Das Ersteunclassified

Kinder und Jugendliche mit Psoriasis

Sticherling

2012

Hautarzt

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Juvenile psoriasis shows a cumulative incidence of 1.76% until the 18th year of life and thus is important for both pediatricians and dermatologists. In contrast to psoriasis in adults, the main trigger factors are infections, mechanical trauma and stress factors and to a much lesser extent medical and recreational drugs. Apart from the classical predilection sites, the diaper area, scalp and face are mainly involved. Guttate psoriasis following streptococcal infections is a specific clinical manifestation in childhood and adolescence. Psoriasis arthritis of childhood falls into the group of juvenile idiopathic arthritis and typically presents before or simultaneously with skin symptoms. All recommended childhood vaccinations should be administered, ideally when the disease is under remission. Therapy relies heavily on topical agents like dithranol, corticosteroids, and alternatively topical calcineurin inhibitors in addition to individually adapted skin moisturizing measures. In severe cases which do not adequately respond to topical therapy, systemic treatment with classical immunomodulatory agents like methotrexate, cyclosporin, retinoids and fumarates may be initiated but all usage is off-label. The only agent licensed for the treatment of psoriasis in patients above the age of 8 years is etanercept if classical treatment has failed. Rehabilitative measures in mountain and seaside areas are reasonable for maintaining improvement and helping patient learn to deal with disease.

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Long-Term Treatment with Fumaric Acid Esters in an 11-Year-Old Male Child with Psoriasis

Cited by 18 publications

References 13 publications

Retrospective data collection of psoriasis treatment with fumaric acid esters in children and adolescents in Germany (KIDS FUTURE study)

Retrospective data collection of psoriasis treatment with fumaric acid esters in children and adolescents in Germany (KIDS FUTURE study)

Systemic Treatment with Fumaric Acid Esters in Six Paediatric Patients with Psoriasis in a Psoriasis Centre

Kinder und Jugendliche mit Psoriasis

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