Fumaric acid esters in recalcitrant pediatric psoriasis: A prospective, daily clinical practice case series.

BACKGROUND: Evidence on fumaric acid esters (FAE) in the treatment of pediatric psoriasis is scarce. OBJECTIVE: Describe the effectiveness, influence on the quality of life (QoL) and safety of FAE in children with recalcitrant psoriasis in daily clinical practice. METHODS: A prospective case series. RESULTS: Fourteen patients with recalcitrant plaque-type psoriasis were described (mean age 13.7, range 8-17 years). Mean treatment duration was 48.6 weeks (range 12-124). Maximum daily dose varied between 180 and 1200 mg with a mean of 564 mg per day. Mean Psoriasis Area and Severity Index (PASI) (±SEM) at baseline was 10.5 (1.0) compared to 8.6 (1.1), 6.2 (1.6) and 4.9 (1.5) at week 12, 24 and 36, respectively. An improvement in PASI was observed in nine patients (64.3%). Mean CDLQI (±SEM) at week 0, 12, 24 and 36 was 8.9 (1.4), 6.8 (1.2), 3.7 (1.4) and 3.1 (2.0), respectively. Most common adverse events (AEs) were gastrointestinal complaints (n = 13, 92.9%) and flushes (n = 10, 71.4%). Lymphocytopenia (n = 5, 45.5%) and eosinophilia (n = 4, 36.4%) were frequently observed laboratory abnormalities. AEs were usually mild and transient. One serious adverse event, unrelated to FAE, was reported. CONCLUSIONS: FAE showed improvement of disease severity and QoL in the majority of children. Side-effects occurred frequently, but were usually mild and transient. FAE may be an alternative systemic treatment option for pediatric psoriasis, provided that also the long-term safety data are closely monitored, in particular lymphocytopenia.

Methotrexate in pediatric plaque-type psoriasis: Long-term daily clinical practice results from the Child-CAPTURE registry.

BACKGROUND: Evidence on effectiveness and safety of methotrexate (MTX) in pediatric psoriasis is scarce. OBJECTIVES: To study the effectiveness and safety of MTX in pediatric plaque-type psoriasis and its influence on quality of life (Qol) in daily clinical practice. METHODS: Subset analysis of prospectively collected data extracted from the Child-CAPTURE registry, a single center, longitudinal, long-term, observational daily practice cohort of pediatric psoriasis patients. A maximum dose between 0.14 and 0.63 mg/kg once weekly was prescribed in 25 children. Primary endpoints were percentages of patients with ≥ 75% improvement in the Psoriasis Area and Severity Index (PASI) at week 12 and 24. RESULTS: PASI75 was achieved in 4.3% and 33.3% of patients at week 12 and 24, whereas 40% and 28.6% reached PASI 75 at week 36 and 48. Median PASI and body surface area decreased from 10.0 (range 3.8-42.4) and 11.0 (range 3.5-72.0) at baseline to 4.3 (range 0-19.8) and 2.6 (range 0.0-39.6) at week 24, respectively. Physician Global Assessment improved significantly from 3.0 to 1.2 at week 24. A significant decrease in Children's Dermatology Life Quality Index from 9.0 to 3.8 at week 24 was found. Most reported adverse events were severe nausea (n = 5), infections requiring antibiotics (n = 5) and tiredness (n = 4). CONCLUSIONS: MTX shows a positive effect on PASI scores, improves Qol and has a reasonable safety profile.