Evidence map›Paper›PMID 32087715›Full record

ArticlePediatric rheumatology online journal2020

Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2-5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept.

Hermine I Brunner, Nikolay Tzaribachev, Gabriel Vega Cornejo, Rik Joos, Elisabeth Gervais, Rolando Cimaz, Inmaculada Calvo Penadés, Rubén Cuttica, Thomas Lutz, Pierre Quartier and 7 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pediatric rheumatology online journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01844518 (A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 11% 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.

NCT01844518 phase3completednot on this map

A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)

TypeinterventionalSponsorBristol-Myers SquibbRan2013 to 2023Enrolled219ConditionsActive Polyarticular Juvenile Idiopathic ArthritisArmsAbatacept
3 · Its place in the literature

Who cites it

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

  1. Pooled it
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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

17 authors at 11 institutions in 7 countries.

Hermine I BrunnerCincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. hermine.brunner@cchmc.org.ORCID http://orcid.org/0000-0001-9478-2987
Nikolay TzaribachevPediatric Rheumatology Research Institute, Bad Bramstedt, Germany.
Gabriel Vega CornejoCREA de Guadalajara, Guadalajara, Jalisco, Mexico.
Rik JoosUniversitair Ziekenhuis Ghent, Ghent, Belgium.
Elisabeth GervaisCHU de Poitiers, Rheumatology, Poitiers, France.
Rolando CimazDepartment of Clinical Sciences and Community Health, University of Milano, Milan, Italy.
Inmaculada Calvo PenadésHospital Universitario y Politécnico de La Fe, Valencia, Spain.
Rubén CutticaHospital General de Niños Pedro de Elizalde, Buenos Aires, Argentina.
Thomas LutzCenter for Pediatric and Adolescent Medicine/Pediatric Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.
Pierre QuartierParis University, IMAGINE Institute, RAISE reference centre, Necker-Enfants Malades Hospital, Assistance Publique-Hopitaux de Paris, Paris, France.
Yash GandhiBristol-Myers Squibb, Princeton, NJ, USA.
Marleen NysBristol-Myers Squibb, Braine-L'Alleud, Belgium.
Robert WongBristol-Myers Squibb, Princeton, NJ, USA.
Alberto MartiniIstituto Giannina Gaslini, Genoa, Italy.
Daniel J LovellCincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Nicolino RupertoIstituto Giannina Gaslini, Genoa, Italy.
Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation
Bristol-Myers Squibb (United States) · USCincinnati Children's Hospital Medical Center · USIstituto Giannina Gaslini · ITBristol-Myers Squibb (Belgium) · BECentre Hospitalier Universitaire de Poitiers · FRHeidelberg University · DEHNO Bad Bramstedt · DEHôpital Necker-Enfants Malades · FRHospital Pedro de Elizalde · ARHospital Universitari i Politècnic La Fe · ESUniversity of Milan · IT

Funding

Bristol-Myers Squibb N/A
6 · The paper itself

Abstract

backgroundPatients with polyarticular-course juvenile idiopathic arthritis (pJIA), receiving disease-modifying anti-rheumatic drugs with immunosuppressive effects, may be at increased risk of vaccine-preventable infections. This substudy assessed protective antibody responses to diphtheria and tetanus vaccination given prior to study enrolment in patients with pJIA.

findingsThis was a substudy of a 24-month, single-arm, open-label, multicenter, Phase III trial (NCT01844518) of subcutaneous abatacept in children with active pJIA (N = 219). Patients aged 2-5 years, with ≥2 continuous months of weekly weight-tiered (10-< 25 kg [50 mg], 25-< 50 kg [87.5 mg]) subcutaneous abatacept treatment (with/without methotrexate and/or low-dose corticosteroids), who received diphtheria/tetanus vaccine prior to enrolment, were eligible. Protective antibody levels to diphtheria/tetanus (> 0.1 IU/mL), and safety, were assessed. Overall, 29 patients were analyzed: 19 (65.5%), 1 (3.4%) and 9 (31.0%) patients had > 12, 6-12 and 2-< 6 months of abatacept exposure, respectively. All patients had protective antibody levels to tetanus and 26 (89.7%) patients had protective antibody levels to diphtheria. Of the 3 patients without protective antibody levels to diphtheria, each had an antibody level of 0.1 IU/mL, bordering the lower threshold of protection. Concomitant use of methotrexate and/or low-dose corticosteroids had no evident effect on antibody levels. No unexpected adverse events, including cases of diphtheria or tetanus, were reported during the 24-month period.

conclusionsPatients aged 2-5 years with pJIA who received 2-24 months of weekly subcutaneous abatacept, with or without concomitant methotrexate and/or low-dose corticosteroids, maintained effective diphtheria and tetanus vaccination protection without new safety signals.

trial registrationClinicalTrials.gov (NCT01844518); registered May 1, 2013; https://clinicaltrials.gov/ct2/show/NCT01844518?term=NCT01844518&rank=1.

Indexed as

AbataceptAntibodies, BacterialArthritis, JuvenileChild, PreschoolDiphtheriaDiphtheria-Tetanus VaccineFemaleHumansImmunosuppressive AgentsMaleTetanusTreatment OutcomeAbataceptAntibodies, BacterialDiphtheria-Tetanus VaccineImmunosuppressive AgentsAbataceptBiologic DMARDsJuvenile idiopathic arthritisVaccination

Identifiers

PMID32087715
PMCPMC7036185
OpenAlexW3011017077

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.