Efficacy and safety of fumaric acid esters in young patients aged 10–17 years with moderate‐to‐severe plaque psoriasis: a randomized, double‐blinded, placebo‐controlled trial*

Background Apart from biologics, no systemic drugs are approved in Europe for children with moderate-to-severe psoriasis. Retrospective observational studies have shown promising results fumaric acid esters (FAE) this setting. Objectives To show superiority of FAE over placebo terms treatment response after 20 weeks and adolescents aged 10–17 years. Methods In a multicentre, randomized, double-blind, placebo-controlled phase IIIb study, patients years plaque psoriasis requiring therapy were randomized 2 : 1 to receive (n = 91) or 43) weeks, followed by an open-label phase. The coprimary endpoints ≥ 75% improvement Psoriasis Area Severity Index (PASI 75) Physician’s Global Assessment (PGA) score 0 (clear almost clear) at week 20. study was registered EudraCT number 2012-000035-82. Results At 20, 55% [95% confidence interval (CI) 0·44–0·65] FAE-treated achieved PASI 75 vs. 19% (95% CI 0·08–0·33) the group (absolute difference 36%, 95% 0·20–0·53; P < 0·001). total, 42% 0·32–0·53) 7% 0·01–0·19) PGA 35%, 0·21–0·49; During double-blind period, drug-related adverse events occurred more frequently receiving compared (76% 47%). Gastrointestinal disorders most common events. Conclusions administered period demonstrated better than placebo; statistically significant clinically meaningful. Application up 40 generally well tolerated. However, further required.