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Abstract

Apart from three biologics, no systemic drugs are approved in Europe for children with moderate-to-severe psoriasis, due to a relative lack of evidence. In this multicentre randomized controlled trial, 134 patients aged 10–17 years with moderate-to-severe psoriasis requiring systemic therapy were randomized 2 : 1 to receive fumaric acid esters (FAE) or placebo for 20 weeks, followed by an open-label FAE phase. Coprimary endpoints were ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) and Physician’s Global Assessment (PGA) score of 0 or 1 (clear or almost clear) at week 20. PASI 75 was achieved by 55% on FAE compared with 19% on placebo (absolute difference 36%, 95% confidence interval 20–53), and PGA 0 or 1 was attained by 42% on FAE compared with 7% on placebo (absolute difference 35%, 95% confidence interval 21–49). During the randomized phase, adverse events leading to permanent study discontinuation occurred in six and three patients in the FAE and placebo groups, respectively. There was one case of severe reversible drug-induced liver injury and one case of proteinuria associated with FAE treatment.