Evidence map›Paper›PMID 32264969›Full record

Observational studyArthritis research & therapy2020

Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee.

Gabriella Giancane, Joost F Swart, Elio Castagnola, Andreas H Groll, Gerd Horneff, Hans-Iko Huppertz, Daniel J Lovell, Tom Wolfs, Troels Herlin, Pavla Dolezalova and 17 more

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

Observational study in Arthritis research & therapy, 2020. 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 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 6% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

  1. Pooled it
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  5. Article
  6. Review
  7. Observational
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  14. Juvenile idiopathic arthritis.Nature reviews. Disease primers · 2022
    Review
  15. Article
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  17. Article
  18. Article
  19. SARS-CoV-2 infections in children and young people.Clinical immunology (Orlando, Fla.) · 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

27 authors at 20 institutions in 12 countries.

Gabriella GiancaneIRCCS Istituto Giannina Gaslini, Clinica Pediatrica e Reumatologia, PRINTO, Genoa, Italy.
Joost F SwartDepartment of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, University Utrecht, European Reference Network-RITA, Utrecht, The Netherlands.
Elio CastagnolaDepartment of Infectious Diseases, IRCCS Istituto Giannina Gaslini, Genoa, Italy.
Andreas H GrollInfectious Disease Research Program, Department of Pediatric Hematology and Oncology, University Children's Hospital, Münster, Germany.
Gerd HorneffAsklepios Clinic Sankt Augustin, Department of General Paediatrics, Sankt Augustin, Germany.
Hans-Iko HuppertzClinic Bremen-Mitte, Prof.-Hesse Children's Hospital and Pediatric Intensive Care Medicine, Bremen, Germany.
Daniel J LovellDivision of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Tom WolfsDepartment of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, University Utrecht, European Reference Network-RITA, Utrecht, The Netherlands.
Troels HerlinPediatric Rheumatology Unit, Aarhus University Hospital, Aarhus, Denmark.
Pavla Dolezalova1st Faculty of Medicine, Department of Pediatrics and Adolescent Medicine, Charles University in Prague and General University Hospital, Praha, Czech Republic.
Helga SannerDepartment of Rheumatology, Oslo University Hospital, Oslo, Norway.
Gordana SusicInstitute of Rheumatology of Belgrade, Division of Pediatric Rheumatology, Belgrade, Serbia.
Flavio SztajnbokHospital Universitario Pedro Ernesto, Nucleo de Estudos da Saúde do Adolescente, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.
Despoina Maritsi2nd Department of Pediatrics Athens Medical School, National and Kapodistrian University of Athens (NKUA), Athens, Greece.
Tamas ConstantinUnit of Pediatric Rheumatology-Immunology, Second Department of Pediatrics, Semmelweis University, Budapest, Hungary.
Veronika VargovaFaculty of Medicine, Department of Paediatrics and Adolescent Medicine, Pavol Jozef Šafárik University in Košice, Kosice, Slovakia.
Sujata SawhneySir Ganga Ram Hospital Marg, Centre for Child Health, Sir Ganga Ram Hospital, New Delhi, India.
Marite RyggDepartment of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU - Norwegian University of Science and Technology, Trondheim, Norway.
Sheila K OliveiraInstituto de Puericultura e Pediatria Martagao Gesteira (IPPMG), Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
Marco CattaliniClinica Pediatrica dell'Università di Brescia, Spedali Civili, Unità di Immunologia e Reumatologia Pediatrica, Brescia, Italy.
Francesca BovisIRCCS Istituto Giannina Gaslini, Clinica Pediatrica e Reumatologia, PRINTO, Genoa, Italy.
Francesca BagnascoIRCCS Istituto Giannina Gaslini, Clinica Pediatrica e Reumatologia, PRINTO, Genoa, Italy.
Angela PistorioIRCCS Istituto Giannina Gaslini, Servizio di Epidemiologia e Biostatistica, Genoa, Italy.
Alberto MartiniDipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI), Università degli Studi di Genova, Genoa, Italy.
Nico WulffraatDepartment of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, University Utrecht, European Reference Network-RITA, Utrecht, The Netherlands.
Nicolino RupertoIRCCS Istituto Giannina Gaslini, Clinica Pediatrica e Reumatologia, PRINTO, Genoa, Italy. nicolaruperto@gaslini.org.
Paediatric Rheumatology International Trials Organisation (PRINTO)
Istituti di Ricovero e Cura a Carattere Scientifico · ITIstituto Giannina Gaslini · ITUtrecht University · NLAarhus University Hospital · DKAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITCharles University · CZCincinnati Children's Hospital Medical Center · USHospital Universitário Pedro Ernesto · BRKlinikum Bremen-Mitte · DENational and Kapodistrian University of Athens · GRNorwegian Centre for Violence and Traumatic Stress Studies · NONorwegian University of Science and Technology · NOSemmelweis University · HUSir Ganga Ram Hospital · INUniversidade Federal do Rio de Janeiro · BRUniversity Hospital Cologne · DEUniversity Hospital Münster · DEUniversity Medical Center Utrecht · NLUniversity of Genoa · ITUniversity of Pavol Jozef Šafárik · SK

Funding

Seventh Framework Programme 260353
6 · The paper itself

Abstract

backgroundTo derive a list of opportunistic infections (OI) through the analysis of the juvenile idiopathic arthritis (JIA) patients in the Pharmachild registry by an independent Safety Adjudication Committee (SAC).

methodsThe SAC (3 pediatric rheumatologists and 2 pediatric infectious disease specialists) elaborated and approved by consensus a provisional list of OI for use in JIA. Through a 5 step-procedure, all the severe and serious infections, classified as per MedDRA dictionary and retrieved in the Pharmachild registry, were evaluated by the SAC by answering six questions and adjudicated with the agreement of 3/5 specialists. A final evidence-based list of OI resulted by matching the adjudicated infections with the provisional list of OI.

resultsA total of 772 infectious events in 572 eligible patients, of which 335 serious/severe/very severe non-OI and 437 OI (any intensity/severity), according to the provisional list, were retrieved. Six hundred eighty-two of 772 (88.3%) were adjudicated as infections, of them 603/682 (88.4%) as common and 119/682 (17.4%) as OI by the SAC. Matching these 119 opportunistic events with the provisional list, 106 were confirmed by the SAC as OI, and among them infections by herpes viruses were the most frequent (68%), followed by tuberculosis (27.4%). The remaining events were divided in the groups of non-OI and possible/patient and/or pathogen-related OI.

conclusionsWe found a significant number of OI in JIA patients on immunosuppressive therapy. The proposed list of OI, created by consensus and validated in the Pharmachild cohort, could facilitate comparison among future pharmacovigilance studies.

trial registrationClinicaltrials.gov NCT01399281; ENCePP seal: awarded on 25 November 2011.

Indexed as

Immunocompromised HostAntirheumatic AgentsArthritis, JuvenileChildChild, PreschoolCohort StudiesFemaleHerpes ZosterHumansMaleOpportunistic InfectionsPharmacovigilanceRegistriesSeverity of Illness IndexTuberculosisAntirheumatic AgentsBiologicsImmunosuppressive therapyInfectionsJuvenile idiopathic arthritisOpportunistic

Identifiers

PMID32264969
PMCPMC7136994
OpenAlexW3014190322

What OpenQuestion holds

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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.