Evidence map›Paper›PMID 30587248›Full record

Observational studyArthritis research & therapy2018

Pharmacovigilance in juvenile idiopathic arthritis patients treated with biologic or synthetic drugs: combined data of more than 15,000 patients from Pharmachild and national registries.

Joost Swart, Gabriella Giancane, Gerd Horneff, Bo Magnusson, Michael Hofer, Еkaterina Alexeeva, Violeta Panaviene, Brigitte Bader-Meunier, Jordi Anton, Susan Nielsen and 20 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Arthritis research & therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01399281 (Pharmacovigilance in Juvenile Idiopathic Arthritis Patients), which is not on this map. Cited by 51 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 2 pooled it
8.5field-weighted citation impact, top 2% 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.

NCT01399281 unknown statusnot on this map

Pharmacovigilance in Juvenile Idiopathic Arthritis Patients (Pharmachild) Treated With Biologic Agents and/or Methotrexate. A PRINTO/PRES Registry

TypeobservationalSponsorIstituto Giannina GasliniRan2011 to 2021Enrolled9,000ConditionsJuvenile Idiopathic Arthritis
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 2 syntheses or guidelines pooled it, 106 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

30 authors at 18 institutions in 13 countries.

Joost SwartDepartment of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, Lundlaan, 6 PO box 85090, Utrecht, The Netherlands.
Gabriella GiancaneIRCCS Istituto Giannina Gaslini, Clinica Pediatrica e Reumatologia, PRINTO, Via Gaslini, 5, 16147, Genoa, Italy.
Gerd HorneffAsklepios Clinic Sankt Augustin, Arnold-Janssen strasse 29, Sankt Augustin, Germany.
Bo MagnussonKarolinska University Hospital, Pediatric Rheumatology Unit, Stockholm, Sweden.
Michael HoferUnité Romande d'Immuno-Rhumatologie Pediatrique/Centre Hospitalier Universitaire Vaudois (CHUV), Pediatrie, University of Lausanne, Av Bugnon 46, Lausanne, Switzerland.
Еkaterina AlexeevaFederal State Autonomous Institution "National Medical Research Center of Children's Health" of the Ministry of Health of the Russian Federation, LOMONOSOVSKIJ PR-T,2/62, Moscow, Russia.
Violeta PanavieneVilnius University, Clinic of Children's Diseases, Vilnius, Lithuania and Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos, Santariskiu, 4, Vilnius, Lithuania.
Brigitte Bader-MeunierUniversité Paris-Descartes, Institut IMAGINE, Centre de référence national pour les Rhumatismes inflammatoires et les maladies Auto-Immunes Systémiques rares de l'Enfant (RAISE), Unité d'Immunologie, Hématologie et Rhumatologie Pediatrique, Hôpital Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris, 149 Rue De Sevres, Paris, France.
Jordi AntonHospital Sant Joan de Déu, Universitat de Barcelona, Unidad de Reumatología Pediátrica, Esplugues de Llobregat, Passeig Sant Joan de Deu 2, Barcelona, Spain.
Susan NielsenJuliane Marie Centret, Rigshospitalet, Paediatric Rheumatology Unit, Blegdamsvej 9, Copenhagen, Denmark.
Fabrizio De BenedettiDivision of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Piazza S. Onofrio, 4, Rome, Italy.
Sylvia KamphuisSophia Children's Hospital, Department of Paediatric Rheumatology, Erasmus University Medical Centre, Dr Molewaterplein 60, Rotterdam, The Netherlands.
Valda StaņēvičaRiga Stradins University, Department of Pediatrics, Children University Hospital, Vienibas gatve 45, Riga, LV, Latvia.
Maria TracahanaHippokration General Hospital, First Department of pediatrics, Thessaloniki University School of Medicine, Konstantinoupoleos 49, Thessaloniki, Greece.
Laura Marinela AilioaieAlexandru Ioan Cuza University of Iasi, V. Lupu str.nr. 62, Iasi, Romania.
Elena TsitsamiAghia Sophia Childrens Hospital, First Department of Pediatrics, University of Athens Medical School, Thivon 1, Athens, Greece.
Ariane KleinAsklepios Clinic Sankt Augustin, Arnold-Janssen strasse 29, Sankt Augustin, Germany.
Kirsten MindenGerman Rheumatism Research Centre, Berlin, Germany.
Ivan FoeldvariHamburg Centre for Pediatric and Adolescent Rheumatology, Dehnhaide 120, Hamburg, Germany.
Johannes Peter HaasGerman Center for Pediatric and Adolescent Rheumatology, Deutsches Zentrum für Kinder- und Jugendrheumatologie, Zentrum für Schmerztherapie junger Menschen, Gehfeldstrasse 24, Garmisch-Partenkirchen, Germany.
Jens KlotscheGerman Rheumatism Research Centre, Berlin, Germany.
Anna Carin HorneKarolinska University Hospital, Pediatric Rheumatology Unit, Stockholm, Sweden.
Alessandro ConsolaroIRCCS Istituto Giannina Gaslini, Clinica Pediatrica e Reumatologia, via Gaslini 5, Genoa, Italy.
Francesca BovisIRCCS Istituto Giannina Gaslini, Clinica Pediatrica e Reumatologia, PRINTO, Via Gaslini, 5, 16147, Genoa, Italy.
Francesca BagnascoIRCCS Istituto Giannina Gaslini, Clinica Pediatrica e Reumatologia, PRINTO, Via Gaslini, 5, 16147, Genoa, Italy.
Angela PistorioIRCCS Istituto Giannina Gaslini, Servizio di Epidemiologia e Biostatistica, via Gaslini 5, Genoa, Italy.
Alberto MartiniIRCCS Istituto Giannina Gaslini, Direzione Scientifica, via Gaslini 5, Genoa, Italy.
Nico WulffraatDepartment of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, Lundlaan, 6 PO box 85090, Utrecht, The Netherlands.
Nicolino RupertoIRCCS Istituto Giannina Gaslini, Clinica Pediatrica e Reumatologia, PRINTO, Via Gaslini, 5, 16147, Genoa, Italy. nicolaruperto@gaslini.org.ORCID 0000-0001-8407-7782
Paediatric Rheumatology International Trials Organisation (PRINTO), BiKeR and the board of the Swedish Registry
Istituto Giannina Gaslini · ITAsklepios Klinik Sankt Augustin · DEGerman Rheumatism Research Centre · DEKarolinska University Hospital · SEWilhelmina Children's Hospital · NLAlexandru Ioan Cuza University · ROBambino Gesù Children's Hospital · ITErasmus MC - Sophia Children’s Hospital · NLGerman Center for Pediatric and Adolescent Rheumatology · DEHôpital Necker-Enfants Malades · FRHospital Sant Joan de Déu Barcelona · ESIppokrateio General Hospital of Thessaloniki · GRNational and Kapodistrian University of Athens · GRRiga Stradiņš University · LVRigshospitalet · DKSechenov University · RUUniversity Hospital of Lausanne · CHVilnius University Hospital Santariskiu Klinikos · LT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe availability of methotrexate and the introduction of multiple biological agents have revolutionized the treatment of juvenile idiopathic arthritis (JIA). Several international and national drug registries have been implemented to accurately monitor the long-term safety/efficacy of these agents. This report aims to present the combined data coming from Pharmachild/PRINTO registry and the national registries from Germany (BiKeR) and Sweden.

methodsDescriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESIs). For the Swedish register, AE data were not available.

resultsData from a total of 15,284 patients were reported: 8274 (54%) from the Pharmachild registry and 3990 (26%) and 3020 (20%) from the German and the Swedish registries, respectively. Pharmachild children showed a younger age (median of 5.4 versus 7.6 years) at JIA onset and shorter disease duration at last available visit (5.3 versus 6.1-6.8) when compared with the other registries. The most frequent JIA category was the rheumatoid factor-negative polyarthritis (range of 24.6-29.9%). Methotrexate (61-84%) and etanercept (24%-61.8%) were the most frequently used synthetic and biologic disease-modifying anti-rheumatic drugs (DMARDs), respectively. There was a wide variability in glucocorticoid use (16.7-42.1%). Serious AEs were present in 572 (6.9%) patients in Pharmachild versus 297 (7.4%) in BiKeR. Infection and infestations were the most frequent AEs (29.4-30.1%) followed by gastrointestinal disorders (11.5-19.6%). The most frequent ESIs were infections (75.3-89%).

conclusionsThis article is the first attempt to present a very large sample of data on JIA patients from different national and international registries and represents the first proposal for data merging as the most powerful tool for future analysis of safety and effectiveness of immunosuppressive therapies in JIA. REGISTRY REGISTRATION: The Pharmachild registry is registered at ClinicalTrials.gov ( NCT01399281 ) and at the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) ( http://www.encepp.eu/encepp/viewResource.htm?id=19362 ). The BiKeR registry is registered at ENCePP ( http://www.encepp.eu/encepp/viewResource.htm?id=20591 ).

Indexed as

PharmacovigilanceAdolescentAntirheumatic AgentsArthritis, JuvenileBiological ProductsChildChild, PreschoolDrug MonitoringEtanerceptFemaleHumansMaleMethotrexateProspective StudiesRegistriesRetrospective StudiesAntirheumatic AgentsBiological ProductsEtanerceptMethotrexateSynthetic DrugsAdverse eventsBiologicsJuvenile idiopathic arthritisMethotrexateRegistrySafety

Identifiers

PMID30587248
PMCPMC6307151
OpenAlexW2905915579

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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.