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

Abstract

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.

Efficacy, effectiveness and safety of fumaric acid esters in the treatment of psoriasis: a systematic review of randomized and observational studies

“…In some studies a small number of patients with subtypes other than plaque psoriasis, such as guttate or palmoplantar pustular psoriasis, were included. Almost all studies involved adult patients, except for two studies that included paediatric patients with psoriasis . Sample sizes ranged from six to 984 patients.…”

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

“…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 The case reports as well as unpublished expert experience thus suggest that FAEs may also be effective and well tolerated in children and adolescents.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 .…”

“…Given that only isolated case reports have been published to date and that the prescription of FAEs in children and adolescents currently constitutes off‐label use due to lack of official approval (etanercept is the only approved [since 2008] systemic second‐line drug for children ≥ 6 years with severe psoriasis), there is great demand for more information about the efficacy and safety of systemic long‐term therapy with FAEs in this patient group. This multicenter, retrospective study has – for the first time – collected data on the use of FAEs (as Fumaderm initial ® : 30 mg DMF, 67 mg EHF [calcium salt], 5 mg EHF [magnesium salt] and 3 mg EHF [zinc salt] and Fumaderm ® : 120 mg DMF, 87 mg EHF [calcium salt], 5 mg EHF [magnesium salt] und 3 mg EHF [zinc salt]) in children and adolescents with respect to long‐term efficacy and safety.…”

“…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 .…”

Retrospektive Datenerhebung der Psoriasis‐Behandlung mit Fumarsäureestern bei Kindern und Jugendlichen in Deutschland (KIDS FUTURE‐Studie)

“…Alle weiteren systemischen Antipsoriatika müssen daher bei Kindern und Jugendlichen im Off‐Label‐Use eingesetzt werden . Rechtlich bewegt sich der verordnende Arzt damit in einer Grauzone, zumal nur sehr begrenzte Sicherheitsdaten für die Langzeitbehandlung der Psoriasis vulgaris in dieser Altersgruppe vorliegen . Erfahrungen mit konventionellen Systemtherapeutika, die auch zur Therapie der Psoriasis vulgaris verwendet werden, liegen bei Kindern und Jugendlichen in anderen zugelassenen Indikationen wie juveniler Arthritis, Morbus Crohn bzw.…”