Dimethyl fumarate is efficacious in severe plaque psoriasis : Post hoc analysis from the BRIDGE trial in Austria.

Abstract

Fumaric acid esters are recommended in European guidelines for induction and maintenance treatment of patients with moderate to severe plaque psoriasis. Asystemic medication with pure dimethyl fumarate without monoethyl fumarate salts was recently licensed in Europe. The efficacy and safety of pure dimethyl fumarate were assessed in patients with severe (physician global assessment) plaque psoriasis in Austria in the BRIDGE trial. In this double blind, randomized, placebo-controlled trial patients received 16-week treatment with pure dimethyl fumarate in ahead to head comparison with dimethyl fumarate with monoethyl fumarate salts, which is licensed in Germany. In this post hoc analysis the efficacy and safety were assessed in patients with severe psoriasis in Austria. Efficacy measures significantly improved in both active treatment arms compared to placebo in 65patients after 16weeks of treatment. Physician global assessment of clear/almost clear in the dimethyl fumarate group was non-inferior to the dimethyl fumarate with monoethyl fumarate salts group 2 months after end of treatment. No serious adverse reaction occurred in patients with dimethyl fumarate in contrast to the second active treatment. Efficacy outcome was paralleled by quality of life improvements. This is the first report of dimethyl fumarate in aseverely affected population with plaque psoriasis. Dimethyl fumarate is effective and safe in the systemic treatment of adults with severe psoriasis (physician global assessment).