Evidence map›Paper›PMID 38849152›Full record

ArticleAnnals of the rheumatic diseases2024

Safety and efficacy of tofacitinib for the treatment of patients with juvenile idiopathic arthritis: preliminary results of an open-label, long-term extension study.

Hermine I Brunner, Jonathan D Akikusa, Eslam Al-Abadi, John F Bohnsack, Alina Lucica Boteanu, Gaelle Chedeville, Ruben Cuttica, Wendy De La Pena, Lawrence Jung, Ozgur Kasapcopur and 19 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Annals of the rheumatic diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01500551 (A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–field-weighted citation impact
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.

NCT01500551 phase2 / phase3completednot on this map

A long-term, open-label follow-up study of tofacitinib for treatment of juvenile idiopathic arthritis (jia)

TypeinterventionalSponsorPfizerRan2013 to 2025Enrolled302ConditionsJuvenile Idiopathic ArthritisArmsTofacitinib
3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

  1. Trial
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  4. JAK Inhibition inJIMD reports · 2026
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  5. Review
  6. Comparative efficacy and safety of tofacitinib versus adalimumab in patients with Behçet's uveitis: a real-world retrospective study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
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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

29 authors.

Hermine I BrunnerDivision of Rheumatology and Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio, USA Hermine.brunner@cchmc.org.ORCID http://orcid.org/0000-0001-9478-2987
Jonathan D AkikusaPaediatric Rheumatology Service, The Royal Children's Hospital, Parkville, Victoria, Australia.
Eslam Al-AbadiPaediatric and Adolescent Rheumatology Service, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK.ORCID http://orcid.org/0000-0002-1999-6341
John F BohnsackDivision of Allergy and Immunology, Primary Children's Hospital, Salt Lake City, Utah, USA.
Alina Lucica BoteanuRheumatology Service, Hospital Universitario Ramon y Cajal, Madrid, Spain.
Gaelle ChedevilleDepartment of Pediatrics, Division of Rheumatology, McGill University Health Centre, Glen Site, Montreal, Quebec, Canada.
Ruben CutticaPaediatric Rheumatology, Hospital Britanico de Buenos Aires, Buenos Aires, Argentina.
Wendy De La PenaPediatric Rheumatology, Loma Linda University Children's Hospital, Loma Linda, California, USA.
Lawrence JungDepartment of Pediatrics, School of Medicine, George Washington University, Washington, District of Columbia, USA.
Ozgur KasapcopurDepartment of Paediatric Rheumatology, Cerrahpasa Medical Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey.
Katarzyna KobusinskaDepartment of Paediatrics, Haematology, Oncology and Rheumatology, Wojewodzki Szpital Dzieciecy im J Brudzinskiego, Bydgoszcz, Poland.
Grant S SchulertDivision of Rheumatology and Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.ORCID http://orcid.org/0000-0001-5923-7051
Claudia NeivaPaediatric Rheumatology Network, Santa Casa de Misericórdia de Belo Horizonte, Minas Gerais, Brazil.
Rafael Rivas-ChaconDivision of Rheumatology, Nicklaus Children's Hospital, Miami, Florida, USA.
Juan Cruz Rizo RodriguezCentro de Alta Especialidad en Reumatología e Investigación del Potosí, SC, San Luis Potosí, Mexico.
Monica Vazquez-Del MercadoClínica de Investigacion en Reumatologia y Obesidad, SC, Guadalajara, Mexico.ORCID http://orcid.org/0000-0002-3823-4676
Linda Wagner-WeinerPediatric Rheumatology, University of Chicago Medical Center, Chicago, Illinois, USA.
Jennifer E WeissPediatric Rheumatology, Hackensack University Medical Center, Hackensack, New Jersey, USA.
Carine WoutersPaediatric Rheumatology, Department of Paediatrics, UZ Leuven-Gasthuisberg, Leuven, Belgium.
Holly PosnerPfizer, New York, New York, USA.
Ann WoutersPfizer, New York, New York, USA.
Cheng ChangPfizer, Groton, Connecticut, USA.
Claire WhitePfizer, Walton Oaks, UK.
Keith KanikPfizer, Groton, Connecticut, USA.
Shixue LiuPfizer, Shanghai, China.
Alberto MartiniPaediatric Rheumatology, Department of Paediatrics, University of Genova, Genova, Italy.
Daniel J LovellDivision of Rheumatology and Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.ORCID http://orcid.org/0000-0003-1604-0130
Nicolino RupertoPediatric and Rheumatology Clinic, IRCCS Istituto Giannina Gaslini, Genova, Italy.ORCID http://orcid.org/0000-0001-8407-7782
Paediatric Rheumatology International Trials Organisation (PRINTO) and Pediatric Rheumatology Collaborative Study Group (PRCSG)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesWe report the safety, tolerability and efficacy of tofacitinib in patients with juvenile idiopathic arthritis (JIA) in an ongoing long-term extension (LTE) study.

methodsPatients (2-<18 years) with JIA who completed phase 1/3 index studies or discontinued for reasons excluding treatment-related serious adverse events (AEs) entered the LTE study and received tofacitinib 5 mg two times per day or equivalent weight-based doses. Safety outcomes included AEs, serious AEs and AEs of special interest. Efficacy outcomes included improvement since tofacitinib initiation per the JIA-American College of Rheumatology (ACR)70/90 criteria, JIA flare rate and disease activity measured by Juvenile Arthritis Disease Activity Score (JADAS)27, with inactive disease corresponding to JADAS ≤1.0.

resultsOf 225 patients with JIA (median (range) duration of treatment, 41.6 (1-103) months), 201 (89.3%) had AEs; 34 (15.1%) had serious AEs. 10 patients developed serious infections; three had herpes zoster. Two patients newly developed uveitis. Among patients with polyarticular course JIA, JIA-ACR70/90 response rates were 60.0% (78 of 130) and 33.6% (47 of 140), respectively, at month 1, and generally improved over time. JIA flare events generally occurred in <5% of patients through to month 48. Observed mean (SE) JADAS27 was 22.0 (0.6) at baseline, 6.2 (0.7) at month 1 and 2.8 (0.5) at month 48, with inactive disease in 28.8% (36 of 125) of patients at month 1 and 46.8% (29 of 82) at month 48.

conclusionsIn this interim analysis of LTE study data in patients with JIA, safety findings were consistent with the known profile of tofacitinib, and efficacy was maintained up to month 48. TRIAL REGISTRATION NUMBER: NCT01500551.

Indexed as

Arthritis, JuvenilePiperidinesPyrimidinesPyrrolesAdolescentAntirheumatic AgentsChildChild, PreschoolFemaleHerpes ZosterHumansMaleProtein Kinase InhibitorsSeverity of Illness IndexTreatment OutcomeAntirheumatic AgentsPiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolestofacitinibAntirheumatic AgentsArthritis, JuvenileTherapeutics

Identifiers

PMID38849152
PMCPMC11503147

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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.