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07.10.2019 | original article | Ausgabe 19-20/2019

Wiener klinische Wochenschrift 19-20/2019

Dimethyl fumarate is efficacious in severe plaque psoriasis

Post hoc analysis from the BRIDGE trial in Austria

Zeitschrift:
Wiener klinische Wochenschrift > Ausgabe 19-20/2019
Autoren:
Paul Sator, Robert Loewe, Omid Zamani, Gregor Holzer, Peter Wolf, Alexander Mlynek, Thomas Berger, Leo Richter, Elisabeth Schuller
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s00508-019-01551-6) contains supplementary material, which is available to authorized users.

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Summary

Background

Fumaric acid esters are recommended in European guidelines for induction and maintenance treatment of patients with moderate to severe plaque psoriasis. A systemic medication with pure dimethyl fumarate without monoethyl fumarate salts was recently licensed in Europe.

Objective

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.

Methods

In this double blind, randomized, placebo-controlled trial patients received 16-week treatment with pure dimethyl fumarate in a head 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.

Results

Efficacy measures significantly improved in both active treatment arms compared to placebo in 65 patients after 16 weeks 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.

Conclusion

This is the first report of dimethyl fumarate in a severely affected population with plaque psoriasis. Dimethyl fumarate is effective and safe in the systemic treatment of adults with severe psoriasis (physician global assessment).

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Zusatzmaterial
Flowchart with study design and medication schedule
508_2019_1551_MOESM1_ESM.docx
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