Evidence map›Paper›PMID 31591676›Full record

Trial reportWiener klinische Wochenschrift2019

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

Paul Sator, Robert Loewe, Omid Zamani, Gregor Holzer, Peter Wolf, Alexander Mlynek, Thomas Berger, Leo Richter, Elisabeth Schuller

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Wiener klinische Wochenschrift, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Article
  3. Current Landscape of NRF2 Biomarkers in Clinical Trials.Antioxidants (Basel, Switzerland) · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 8 institutions in 2 countries.

Paul SatorDepartment of Dermatology, Krankenhaus Hietzing, Vienna, Austria.
Robert LoeweDivision of Dermatology and Dermato-Oncology, Department of Dermatology, Medical University of Vienna, Vienna, Austria.
Omid ZamaniKlinisches Studienzentrum Wien, Quellenstraße 181, 1100, Vienna, Austria.
Gregor HolzerSozialmedizinisches Zentrum Ost-Donauspital, Langobardenstraße 122, 1220, Vienna, Austria.
Peter WolfDepartment of Dermatology, Medical University of Graz, Graz, Austria.
Alexander MlynekOrdensklinikum Linz Elisabethinen, Fadingerstraße 1, 4020, Linz, Austria.
Thomas BergerAbteilung Dermatologie, Klinikum Wels-Grieskirchen, Grieskirchner Straße 42, 4600, Wels, Austria.
Leo RichterKrankenanstalt Rudolfstiftung, Juchgasse 25, 1030, Vienna, Austria.
Elisabeth SchullerAlmirall GmbH, Breitenfurterstraße 113, Vienna, Austria. elisabeth.schuller@almirall.com.ORCID http://orcid.org/0000-0003-4979-2945
Almirall (Germany) · DEDonauspital · ATKlinik Hietzing · ATKlinikum Wels-Grieskirchen · ATKrankenanstalt Rudolfstiftung der Stadt Wien · ATKrankenhaus der Elisabethinen · ATMedical University of Graz · ATMedical University of Vienna · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFumaric 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.

objectiveThe efficacy and safety of pure dimethyl fumarate were assessed in patients with severe (physician global assessment) plaque psoriasis in Austria in the BRIDGE trial.

methodsIn 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.

resultsEfficacy 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.

conclusionThis 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).

Indexed as

Dimethyl FumaratePsoriasisAdultAgedAustriaDouble-Blind MethodEuropeFemaleGermanyHumansMaleMiddle AgedQuality of LifeSeverity of Illness IndexTreatment OutcomeYoung AdultDimethyl FumarateDimethyl fumaratePsoriasisSystemic treatment

Identifiers

PMID31591676
OpenAlexW2978542469

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.