Evidence map›Paper›PMID 31118099›Full record

Trial reportPediatric rheumatology online journal2019

The PRINTO evidence-based proposal for glucocorticoids tapering/discontinuation in new onset juvenile dermatomyositis patients.

Gabriella Giancane, Claudio Lavarello, Angela Pistorio, Sheila K Oliveira, Francesco Zulian, Ruben Cuttica, Michel Fischbach, Bo Magnusson, Serena Pastore, Roberto Marini and 12 more

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pediatric rheumatology online journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 13% 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.

NCT00323960 phase3completednot on this map

Five-year Single-blind, Phase III Effectiveness Randomised Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis: Prednisone Versus Prednisone Plus Cyclosporine a Versus Prednisone Plus Methotrexate

TypeinterventionalSponsorIstituto Giannina GasliniRan2006 to 2015Enrolled139ConditionsJuvenile DermatomyositisArms3 MPDN pulse + PDN, 3 MPDN pulse + PDN + CSA, 3 MPDN pulse + PDN + MTX
NCT05524311 phase2completednot on this mapstarted 2022, after this paper: background citation

Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2022 to 2026Enrolled16ConditionsJuvenile DermatomyositisArmsBaricitinib, pharmacokinetics study, dosage of cytokines, transcriptomic analysis, Parent version of the Child Health Questionnaire (CHQ)
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

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  14. Juvenile Dermatomyositis: New Clues to Diagnosis and Therapy.Current treatment options in rheumatology · 2021
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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

22 authors at 15 institutions in 9 countries.

Gabriella GiancaneIRCCS Istituto Giannina Gaslini, Clinica Pediatrica - Reumatologia, PRINTO, Genoa, Italy.
Claudio LavarelloIRCCS Istituto Giannina Gaslini, Clinica Pediatrica - Reumatologia, PRINTO, Genoa, Italy.
Angela PistorioIRCCS Istituto Giannina Gaslini, Servizio di Epidemiologia e Biostatistica, Genoa, Italy.
Sheila K OliveiraInstituto de Puericultura e Pediatria Martagão Gesteira (IPPMG), Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
Francesco ZulianDepartment of Woman and Child Health, University of Padua, Padua, Italy.
Ruben CutticaHospital General de Niños Pedro de Elizalde, Unidad de Reumatología, Buenos Aires, Argentina.
Michel FischbachHôpital Universitaire Hautepierre, Pédiatrie I, Strasbourg, France.
Bo MagnussonPediatric Rheumatology Unit, Karolinska University Hospital, Stockholm, Sweden.
Serena PastoreIRCCS Burlo Garofolo, Institute for Maternal and Child Health, Trieste, Italy.
Roberto MariniDepartamento de Pediatria, Faculdade de Ciências Médicas, Universidade Estadual de Campinas, Campinas, Brazil.
Silvana MartinoClinica Pediatrica, Università degli Studi di Torino, Torino, Italy.
Anne PagnierMédecine Infantile, Centre Hospitalier Universitaire Grenoble-Alpes (CHU de Grenoble), Grenoble, France.
Christine SolerService de Pédiatrie, Hôpital de l'Archet, Nice, France.
Valda StaņēvichaDepartment of Pediatrics, Bērnu Klīniskā Universitātes Slimnīca, Riga, Latvia.
Rebecca Ten CateAfdelingkindergeneeskunde, Academisch Ziekenhuis Leiden, Leiden, Netherlands.
Yosef UzielMeir Medical Centre, Pediatric Rheumatology Unit, Department of Pediatrics, Kfar Saba and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Jelena VojinovicDepartment of Pediatric Immunology and Rheumatology, Faculty of Medicine, University of Nis, Nis, Serbia.
Elena FueriIRCCS Istituto Giannina Gaslini, Clinica Pediatrica - Reumatologia, PRINTO, Genoa, Italy.
Angelo RavelliIRCCS Istituto Giannina Gaslini, Clinica Pediatrica - Reumatologia, Genoa, Italy.
Alberto MartiniIRCCS Istituto Giannina Gaslini, Clinica Pediatrica - Reumatologia, Genoa, Italy.
Nicolino RupertoIRCCS Istituto Giannina Gaslini, Clinica Pediatrica - Reumatologia, PRINTO, Genoa, Italy. nicolaruperto@gaslini.org.ORCID http://orcid.org/0000-0001-8407-7782
Paediatric Rheumatology International Trials Organisation (PRINTO)
Istituto Giannina Gaslini · ITCentre Hospitalier Universitaire de Grenoble · FRChildren's Clinical University Hospital · LVHôpital d'Hautepierre · FRHôpital l'Archet · FRHospital Pedro de Elizalde · ARIRCCS Materno Infantile Burlo Garofolo · ITKarolinska University Hospital · SENederlandse Vereniging voor Kindergeneeskunde · NLTel Aviv University · ILUniversidade Estadual de Campinas (UNICAMP) · BRUniversidade Federal do Rio de Janeiro · BRUniversity of Nis · RSUniversity of Padua · ITUniversity of Turin · IT

Funding

IRCCS Istituto Giannina Gaslini n.a.Italian Agency of Drug Evaluation (AIFA) FARM52EBT5Myositis Association n.a.
6 · The paper itself

Abstract

backgroundPrednisone (PDN) in juvenile dermatomyositis (JDM), alone or in association with other immunosuppressive drugs, namely methotrexate (MTX) and cyclosporine (CSA), represents the first-line treatment option for new onset JDM patients. No clear evidence based guidelines are actually available to standardize the tapering and discontinuation of glucocorticoids (GC) in JDM. Aim of our study was to provide an evidence-based proposal for GC tapering/discontinuation in new onset juvenile dermatomyositis (JDM), and to identify predictors of clinical remission and GC discontinuation.

methodsNew onset JDM children were randomized to receive either PDN alone or in combination with methotrexate (MTX) or cyclosporine (CSA). In order to derive steroid tapering indications, PRINTO/ACR/EULAR JDM core set measures (CSM) and their median absolute and relative percent changes over time were compared in 3 groups. Group 1 included those in clinical remission who discontinued PDN, with no major therapeutic changes (MTC) (reference group) and was compared with those who did not achieve clinical remission, without or with MTC (Group 2 and 3, respectively). A logistic regression model identified predictors of clinical remission with PDN discontinuation.

resultsBased on the median change in the CSM of 30/139 children in Group 1, after 3 pulses of methyl-prednisolone, GC could be tapered from 2 to 1 mg/kg/day in the first two months from onset if any of the CSM decreased by 50-94%, and from 1 to 0.2 mg/kg/day in the following 4 months if any CSM further decreased by 8-68%, followed by discontinuation in the ensuing 18 months. The achievement of PRINTO JDM 50-70-90 response after 2 months of treatment (ORs range 4.5-6.9), an age at onset > 9 years (OR 4.6) and the combination therapy PDN + MTX (OR 3.6) increase the probability of achieving clinical remission (p < 0.05).

conclusionsThis is the first evidence-based proposal for glucocorticoid tapering/discontinuation based on the change in JDM CSM of disease activity.

trial registrationTrial full title: Five-Year Single-Blind, Phase III Effectiveness Randomized Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis: Prednisone versus Prednisone plus Cyclosporine A versus Prednisone plus Methotrexate. EUDRACT registration number: 2005-003956-37 . CLINICAL TRIAL: gov is NCT00323960 . Registered on 17 August 2005.

Indexed as

Analysis of VarianceAnti-Inflammatory AgentsChildChild, PreschoolCyclosporineDermatologic AgentsDermatomyositisDrug SubstitutionDrug Therapy, CombinationHumansMethotrexatePrednisoneSingle-Blind MethodAnti-Inflammatory AgentsCyclosporineDermatologic AgentsMethotrexatePrednisoneCore set measuresDisease activityGlucorticoidsJuvenile dermatomyositisPrednisone tapering

Identifiers

PMID31118099
PMCPMC6530070
OpenAlexW2947528424

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.