Dimethyl Fumarate is Efficacious in Severe Plaque Psoriasis : Post Hoc Analysis from the BRIDGE Trial in Austria

Overview

Journal Wien Klin Wochenschr

Publisher Springer

Specialty General Medicine

Date 2019 Oct 9

PMID 31591676

Citations 3

Authors

Paul Sator

Robert Loewe

Omid Zamani

Gregor Holzer

Peter Wolf

Alexander Mlynek

Thomas Berger

Leo Richter

Elisabeth Schuller

Affiliations

Soon will be listed here.

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).

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References

Phillips J, Erwin A, Agrella S, Kremenchutzky M, Kramer J, Darkes M . Consensus Management of Gastrointestinal Events Associated with Delayed-Release Dimethyl Fumarate: A Delphi Study. Neurol Ther. 2015; 4(2):137-46. PMC: 4685868. DOI: 10.1007/s40120-015-0037-x. View

Nast A, Gisondi P, Ormerod A, Saiag P, Smith C, Spuls P . European S3-Guidelines on the systemic treatment of psoriasis vulgaris--Update 2015--Short version--EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015; 29(12):2277-94. DOI: 10.1111/jdv.13354. View

Inzinger M, Weger W, Heschl B, Salmhofer W, Quehenberger F, Wolf P . Methotrexate vs. fumaric acid esters in moderate-to-severe chronic plaque psoriasis: data registry report on the efficacy under daily life conditions. J Eur Acad Dermatol Venereol. 2012; 27(7):861-6. DOI: 10.1111/j.1468-3083.2012.04596.x. View

Tahvili S, Zandieh B, Amirghofran Z . The effect of dimethyl fumarate on gene expression and the level of cytokines related to different T helper cell subsets in peripheral blood mononuclear cells of patients with psoriasis. Int J Dermatol. 2015; 54(7):e254-60. DOI: 10.1111/ijd.12834. View

Ronholt K, Iversen L . Old and New Biological Therapies for Psoriasis. Int J Mol Sci. 2017; 18(11). PMC: 5713267. DOI: 10.3390/ijms18112297. View

Atwan A, Ingram J, Abbott R, Kelson M, Pickles T, Bauer A . Oral fumaric acid esters for psoriasis: abridged Cochrane systematic review including GRADE assessments. Br J Dermatol. 2016; 175(5):873-881. PMC: 5095877. DOI: 10.1111/bjd.14676. View

Michalek I, Loring B, John S . A systematic review of worldwide epidemiology of psoriasis. J Eur Acad Dermatol Venereol. 2016; 31(2):205-212. DOI: 10.1111/jdv.13854. View

Papp K, Tyring S, Lahfa M, Prinz J, Griffiths C, Nakanishi A . A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005; 152(6):1304-12. DOI: 10.1111/j.1365-2133.2005.06688.x. View

Reich K, Thaci D, Mrowietz U, Kamps A, Neureither M, Luger T . Efficacy and safety of fumaric acid esters in the long-term treatment of psoriasis--a retrospective study (FUTURE). J Dtsch Dermatol Ges. 2009; 7(7):603-11. DOI: 10.1111/j.1610-0387.2009.07120.x. View

10.

Mrowietz U, Altmeyer P, Bieber T, Rocken M, Schopf R, Sterry W . Treatment of psoriasis with fumaric acid esters (Fumaderm). J Dtsch Dermatol Ges. 2007; 5(8):716-7. DOI: 10.1111/j.1610-0387.2007.06346.x. View

11.

Werdenberg D, Joshi R, Wolffram S, Merkle H, Langguth P . Presystemic metabolism and intestinal absorption of antipsoriatic fumaric acid esters. Biopharm Drug Dispos. 2003; 24(6):259-73. DOI: 10.1002/bdd.364. View

12.

Fiedler S, Kerns A, Tsang C, Tsang V, Bourdette D, Salinthone S . Dimethyl fumarate activates the prostaglandin EP2 receptor and stimulates cAMP signaling in human peripheral blood mononuclear cells. Biochem Biophys Res Commun. 2016; 475(1):19-24. DOI: 10.1016/j.bbrc.2016.05.021. View

13.

Puig L, Carrascosa J, Dauden E, Sanchez-Carazo J, Ferrandiz C, Sanchez-Regana M . [Spanish evidence-based guidelines on the treatment of moderate-to-severe psoriasis with biologic agents]. Actas Dermosifiliogr. 2009; 100(5):386-413. View

14.

Carboni I, de Felice C, De Simoni I, Soda R, Chimenti S . Fumaric acid esters in the treatment of psoriasis: an Italian experience. J Dermatolog Treat. 2004; 15(1):23-6. DOI: 10.1080/09546630310019346. View

15.

Heelan K, Markham T . Fumaric acid esters as a suitable first-line treatment for severe psoriasis: an Irish experience. Clin Exp Dermatol. 2012; 37(7):793-5. DOI: 10.1111/j.1365-2230.2012.04351.x. View

16.

Ovejero-Benito M, Munoz-Aceituno E, Reolid A, Saiz-Rodriguez M, Abad-Santos F, Dauden E . Pharmacogenetics and Pharmacogenomics in Moderate-to-Severe Psoriasis. Am J Clin Dermatol. 2017; 19(2):209-222. DOI: 10.1007/s40257-017-0322-9. View

17.

Mrowietz U, Christophers E, Altmeyer P . Treatment of psoriasis with fumaric acid esters: results of a prospective multicentre study. German Multicentre Study. Br J Dermatol. 1998; 138(3):456-60. DOI: 10.1046/j.1365-2133.1998.02124.x. View

18.

Nieboer C, de Hoop D, Langendijk P, van Loenen A, Gubbels J . Fumaric acid therapy in psoriasis: a double-blind comparison between fumaric acid compound therapy and monotherapy with dimethylfumaric acid ester. Dermatologica. 1990; 181(1):33-7. DOI: 10.1159/000247856. View

19.

Augustin M, Langenbruch A, Gutknecht M, Reich K, Korber A, Maassen D . Definition of psoriasis severity in routine clinical care: current guidelines fail to capture the complexity of long-term psoriasis management. Br J Dermatol. 2018; 179(6):1385-1391. DOI: 10.1111/bjd.17128. View

20.

Rostami Yazdi M, Mrowietz U . Fumaric acid esters. Clin Dermatol. 2008; 26(5):522-6. DOI: 10.1016/j.clindermatol.2008.07.001. View