Dimethyl fumarate is efficacious in severe plaque psoriasis
Autor: | Paul Sator, Peter Wolf, Gregor Holzer, Alexander Mlynek, Elisabeth Schuller, Omid Zamani, Leo Richter, Robert Loewe, Thomas Berger |
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Rok vydání: | 2019 |
Předmět: |
Adult
Male medicine.medical_specialty Dimethyl Fumarate Population 030204 cardiovascular system & hematology Placebo Severity of Illness Index Young Adult 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Double-Blind Method Germany Internal medicine Psoriasis Post-hoc analysis Humans Medicine In patient 030212 general & internal medicine Adverse effect education Aged Plaque psoriasis education.field_of_study Dimethyl fumarate business.industry General Medicine Middle Aged medicine.disease Europe Treatment Outcome chemistry Austria Quality of Life Female business |
Zdroj: | Wiener klinische Wochenschrift. 131:485-492 |
ISSN: | 1613-7671 0043-5325 |
Popis: | 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. 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 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. 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. 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). |
Databáze: | OpenAIRE |
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