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

Abstract

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.