Paul Sator1, Robert Loewe2, Omid Zamani3, Gregor Holzer4, Peter Wolf5, Alexander Mlynek6, Thomas Berger7, Leo Richter8, Elisabeth Schuller9. 1. Department of Dermatology, Krankenhaus Hietzing, Vienna, Austria. 2. Division of Dermatology and Dermato-Oncology, Department of Dermatology, Medical University of Vienna, Vienna, Austria. 3. Klinisches Studienzentrum Wien, Quellenstraße 181, 1100, Vienna, Austria. 4. Sozialmedizinisches Zentrum Ost-Donauspital, Langobardenstraße 122, 1220, Vienna, Austria. 5. Department of Dermatology, Medical University of Graz, Graz, Austria. 6. Ordensklinikum Linz Elisabethinen, Fadingerstraße 1, 4020, Linz, Austria. 7. Abteilung Dermatologie, Klinikum Wels-Grieskirchen, Grieskirchner Straße 42, 4600, Wels, Austria. 8. Krankenanstalt Rudolfstiftung, Juchgasse 25, 1030, Vienna, Austria. 9. Almirall GmbH, Breitenfurterstraße 113, Vienna, Austria. elisabeth.schuller@almirall.com.
Abstract
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).
RCT Entities:
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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