Evidence map›Paper›PMID 38243722›Full record

Observational studyRheumatology (Oxford, England)2024

Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry.

Daniel J Lovell, Nikolay Tzaribachev, Michael Henrickson, Gabriele Simonini, Thomas A Griffin, Ekaterina Alexeeva, John F Bohnsack, Andrew Zeft, Gerd Horneff, Richard K Vehe and 16 more

Registry-linked trialOpen access · hybridAbstract readObservational StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Rheumatology (Oxford, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01357668 (An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
6.4field-weighted citation impact, top 3% 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.

NCT01357668 active not recruitingnot on this map

An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

TypeobservationalSponsorBristol-Myers SquibbRan2013 to 2029Enrolled800ConditionsJuvenile Idiopathic Arthritis
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
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  5. Neuromuscular complications associated with cancer immunotherapy.Journal of the National Cancer Center · 2025
    Review
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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

26 authors at 20 institutions in 8 countries.

Daniel J LovellDivision of Rheumatology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.ORCID 0000-0003-1604-0130
Nikolay TzaribachevPRI Research, Bad Bramstedt, Germany.
Michael HenricksonDivision of Rheumatology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.
Gabriele SimoniniIRCCS Meyer Children's Hospital, Rheumatology Unit, ERN-ReCONNECT Center, Florence, Italy.
Thomas A GriffinAtrium Health, Levine Children's Hospital, Charlotte, NC, USA.
Ekaterina AlexeevaDepartment of Rheumatology, National Medical Research Center of Children's Health, Moscow, Russia.
John F BohnsackDivision of Allergy, Immunology and Pediatric Rheumatology, University of Utah, Salt Lake City, UT, USA.
Andrew ZeftCenter for Pediatric Rheumatology and Immunology, Cleveland Clinic, Cleveland, OH, USA.
Gerd HorneffAsklepios Clinic Sankt Augustin, Sankt Augustin, Germany.ORCID 0000-0001-5491-7832
Richard K VeheDepartment of Pediatrics, Division of Pediatric Rheumatology, University of Minnesota, Minneapolis, MN, USA.
Valda StaņēvičaRiga Stradins University, Riga, Latvia.
Stacey TarvinRiley Hospital for Children at Indiana University, Indianapolis, IN, USA.
Maria TrachanaAristotle University of Thessaloniki, Thessaloníki, Greece.
Ana Quintero Del RíoUniversity of Oklahoma Health Science Center, Oklahoma City, OK, USA.
Adam M HuberIWK Health Centre and Dalhousie University, Halifax, NS, Canada.ORCID 0000-0002-6616-1689
Daniel KietzChildren's Hospital of Pittsburgh, Pittsburgh, PA, USA.
Ilonka OrbánNational Institute of Locomotor Diseases and Disabilities, Budapest, Hungary.
Jason DareUniversity of Arkansas for Medical Sciences, Little Rock, AR, USA.
Ivan FoeldvariHamburg Centre for Pediatric and Adolescent Rheumatology, Hamburg, Germany.
Pierre QuartierNecker-Enfants Malades University Hospital, Assistance Publique-Hopitaux de Paris, Paris, France.
Alyssa DominiqueBristol Myers Squibb, Princeton, NJ, USA.
Teresa A SimonBristol Myers Squibb, Princeton, NJ, USA.
Alberto MartiniDipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI), Università degli Studi di Genova, Genova, Italy.
Hermine I BrunnerDivision of Rheumatology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.ORCID 0000-0001-9478-2987
Nicolino RupertoIRCCS Istituto Giannina Gaslini, UOSID Centro Trial-PRINTO, Genova, Italy.ORCID 0000-0001-8407-7782
for PRINTO and the Pediatric Rheumatology Collaborative Study Group (PRCSG)§
Cincinnati Children's Hospital Medical Center · USIstituto Giannina Gaslini · ITLevine Children's Hospital · USChildren's Hospital of Pittsburgh · USSechenov University · RUAristotle University of Thessaloniki · GRAsklepios Klinik Sankt Augustin · DEDalhousie University · CAHNO Bad Bramstedt · DEHôpital Necker-Enfants Malades · FRRiley Hospital for Children · USUniversity of Arkansas for Medical Sciences · USUniversity of Minnesota · USUniversity of Oklahoma Health Sciences Center · USUniversity of Utah · USBristol-Myers Squibb (United States) · USCleveland Clinic · USMeyer Children's Hospital · ITRiga Stradiņš University · LVUniversity of Genoa · IT

Funding

Bristol Myers Squibb
6 · The paper itself

Abstract

objectiveThe aim of this study was to report the interim 5-year safety and effectiveness of abatacept in patients with JIA in the PRINTO/PRCSG registry.

methodsThe Abatacept JIA Registry (NCT01357668) is an ongoing observational study of children with JIA receiving abatacept; enrolment started in January 2013. Clinical sites enrolled patients with JIA starting or currently receiving abatacept. Eligible patients were assessed for safety (primary end point) and effectiveness over 10 years. Effectiveness was measured by clinical 10-joint Juvenile Arthritis Disease Activity Score (cJADAS10) in patients with JIA over 5 years. As-observed analysis is presented according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.

resultsAs of 31 March 2020, 587 patients were enrolled; 569 are included in this analysis (including 134 new users) with 1214.6 patient-years of safety data available. Over 5 years, the incidence rate (IR) per 100 patient-years of follow-up of serious adverse events was 5.52 (95% CI: 4.27, 7.01) and of events of special interest was 3.62 (95% CI: 2.63, 4.86), with 18 serious infections [IR 1.48 (95% CI: 0.88, 2.34)]. As early as month 3, 55.9% of patients achieved cJADAS10 low disease activity and inactive disease (20.3%, 72/354 and 35.6%, 126/354, respectively), sustained over 5 years. Disease activity measures improvement over 5 years across JIA categories.

conclusionAbatacept was well tolerated in patients with JIA, with no new safety signals identified and with well-controlled disease activity, including some patients achieving inactive disease or remission.

trial registrationClinicaltrials.gov, NCT01357668.

Indexed as

AbataceptAntirheumatic AgentsArthritis, JuvenileRegistriesAdolescentChildChild, PreschoolFemaleHumansMaleTreatment OutcomeAbataceptAntirheumatic Agentsadolescent rheumatologybiologic therapiesDMARDsjuvenile idiopathic arthritispaediatric/juvenile rheumatology

Identifiers

PMID38243722
PMCPMC11381685
OpenAlexW4391052066

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.