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

摘要

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.