Evidence map›Paper›PMID 34578893›Full record

ArticleNutrients2021

Biologic Treatment in Combination with Lifestyle Intervention in Moderate to Severe Plaque Psoriasis and Concomitant Metabolic Syndrome: Rationale and Methodology of the METABOLyx Randomized Controlled Clinical Trial.

Andreas Pinter, Peter Schwarz, Sascha Gerdes, Jan C Simon, Anja Saalbach, James Rush, Nima Melzer, Thomas Kramps, Benjamin Häberle, Maximilian Reinhardt

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Nutrients, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.2field-weighted citation impact, top 22% 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

15 citing papers in PubMed, 21 citations in OpenAlex.

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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

10 authors at 6 institutions in 2 countries.

Andreas PinterDepartment of Dermatology, Venereology and Allergology, Clinical Research Division University Hospital Frankfurt am Main, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany.ORCID 0000-0002-1330-1502
Peter SchwarzDepartment for Prevention and Care of Diabetes, Medical Faculty Carl Gustav Carus, Technical University of Dresden, 01062 Dresden, Germany.ORCID 0000-0001-6317-7880
Sascha GerdesPsoriasis-Center, Department of Dermatology, Campus Kiel, University Medical Center Schleswig-Holstein, 24105 Kiel, Germany.
Jan C SimonDepartment of Dermatology, Venerology and Allergology, Leipzig University Medical Center, 04103 Leipzig, Germany.
Anja SaalbachDepartment of Dermatology, Venerology and Allergology, Leipzig University Medical Center, 04103 Leipzig, Germany.ORCID 0000-0002-1084-3875
James RushNovartis Pharma AG, 4056 Basel, Switzerland.
Nima MelzerNovartis Pharma GmbH, 90429 Nuremberg, Germany.
Thomas KrampsNovartis Pharma GmbH, 90429 Nuremberg, Germany.
Benjamin HäberleNovartis Pharma GmbH, 90429 Nuremberg, Germany.
Maximilian ReinhardtNovartis Pharma AG, 4056 Basel, Switzerland.
Novartis (Germany) · DELeipzig University · DENovartis (Switzerland) · CHChristian-Albrechts-Universität zu Kiel · DEDeutsches Diabetes-Zentrum e.V. · DEGoethe University Frankfurt · DE

Funding

Novartis Pharma NA
6 · The paper itself

Abstract

Inflammatory diseases including psoriasis are associated with metabolic and cardiovascular comorbidities, including obesity and metabolic syndrome. Obesity is associated with greater psoriasis disease severity and reduced response to treatment. Therefore, targeting metabolic comorbidities could improve patients' health status and psoriasis-specific outcomes. METABOLyx is a randomized controlled trial evaluating the combination of a lifestyle intervention program with secukinumab treatment in psoriasis. Here, the rationale, methodology and baseline patient characteristics of METABOLyx are presented. A total of 768 patients with concomitant moderate to severe plaque psoriasis and metabolic syndrome were randomized to secukinumab 300 mg, or secukinumab 300 mg plus a tailored lifestyle intervention program, over 24 weeks. A substudy of immunologic and metabolic biomarkers is ongoing. The primary endpoint of METABOLyx is PASI90 response at week 24. Other endpoints include patient-reported outcomes and safety. METABOLyx represents the first large scale clinical trial of an immunomodulatory biologic in combination with a standardized lifestyle intervention.

Indexed as

Life StyleAntibodies, Monoclonal, HumanizedBiological ProductsFemaleHumansMaleMetabolic SyndromeMiddle AgedMulticenter Studies as TopicPsoriasisRandomized Controlled Trials as TopicSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedBiological Productssecukinumabinflammationmetabolic syndromeobesitypsoriasissecukinumab

Identifiers

PMID34578893
PMCPMC8471656
OpenAlexW3197321368

What OpenQuestion holds

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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.