Evidence map›Paper›PMID 41235938›Full record

Trial reportArthritis care & research2026

Sarilumab in Polyarticular-Course Juvenile Idiopathic Arthritis: Dose-Finding and 1-Year Analysis of a Phase 2b, Open-Label, Multicenter Study.

Fabrizio De Benedetti, Inmaculada C Penadés, Irina Nikishina, Ivan Foeldvari, Alberto J Spindler, Anna Kozlova, Nadina Rubio-Pérez, Pierre Quartier, Zbigniew Żuber, Raul Barria and 10 more

Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Arthritis care & research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02776735 (An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT02776735 phase2completednot on this map

An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase

TypeinterventionalSponsorSanofiRan2016 to 2023Enrolled102ConditionsJuvenile Idiopathic ArthritisArmsSarilumab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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

20 authors.

Fabrizio De BenedettiOspedale Pediatrico Bambino Gesù IRCCS, ERN-RITA Center, Rome, Italy.ORCID 0000-0001-8749-8232
Inmaculada C PenadésHospital Universitario y Politécnico la Fe, Valencia, Spain.
Irina NikishinaV. A. Nasonova Research Institute of Rheumatology, Moscow, Russia.
Ivan FoeldvariAm Schoen Klinik Eilbek, Hamburg, Germany.ORCID 0000-0003-0659-5298
Alberto J SpindlerCentro Médico Privado de Reumatologia, Tucumán, Argentina.
Anna KozlovaCentre of Pediatric Hematology, Oncology and Immunology, Moscow, Russia.
Nadina Rubio-PérezHospital Universitario "Dr. J. E. González," Universidad Autónoma de Nuevo León, Monterrey, Mexico.
Pierre QuartierNecker-Enfants Malades Hospital, Assistance Publique-Hopitaux de Paris, Paris, France.
Zbigniew ŻuberAndrzej Frycz Modrzewski Krakow University, Krakow, Poland.
Raul BarriaBioreuma, Concepción, Chile.
Daniel ClementeHospital Infantil Universitario Niño Jesús, Madrid, Spain.
Gabriel V CornejoClinica de Reumatologia y Enfermedades Autoinmunes, Guadalajara, Jalisco, Mexico.
Katherine MarzanChildren's Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, California.
Nancy LiuSanofi, Morristown, New Jersey.
Christine XuSanofi, Morristown, New Jersey.
Stephen DiMartinoRegeneron Pharmaceuticals, Inc, Tarrytown, New York.ORCID 0009-0002-9165-9419
Angeliki GiannelouRegeneron Pharmaceuticals, Inc, Tarrytown, New York.
Fei Cao-GhoulSanofi, Paris, France.
Bolanle AkinladeRegeneron Pharmaceuticals, Inc, Tarrytown, New York.
Lydie Baret-CormelSanofi, Paris, France.

Funding

Regeneron PharmaceuticalsSanofi
6 · The paper itself

Abstract

objectiveThis study assessed sarilumab in treating patients with polyarticular-course juvenile idiopathic arthritis (pcJIA).

methodsThis phase 2b, open-label study (NCT02776735) consisted of three sequential parts (each with a core-treatment and extension phase). During part 1, three doses were assessed in two weight groups (group A/B: ≥30-60 kg/≥10 to <30 kg) to select the optimal dose with regard to pharmacokinetics, safety and efficacy were evaluated in latter parts. During the extension phase of part 1, patients initially assigned to the selected optimal dose continued on this dose; the remaining patients were switched to this selected dose. Patients in parts 2 and 3 received the selected dose from baseline. The primary endpoint was pharmacokinetic exposure (area under the serum concentration versus time curve during a dose interval Շ of 2 weeks [AUC

resultsThe mean age of treated patients (N = 101; 76.2% female) was 9.4 years. Of the evaluated doses in part 1, dose 2 (group A/B: 3.0/4.0 mg/kg every 2 weeks [q2w]) was selected. In patients receiving the selected dose from baseline (n = 73), C

conclusionIn patients with pcJIA receiving the selected dose from baseline, pharmacokinetic exposure was comparable to a dose of 200 mg q2w for adults with rheumatoid arthritis. Clinically relevant improvements were observed in disease activity, with safety being consistent with the known profile of sarilumab.

Indexed as

Antibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, JuvenileAdolescentChildChild, PreschoolDose-Response Relationship, DrugFemaleHumansMaleTime FactorsTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic Agentssarilumab

Identifiers

PMID41235938
PMCPMC13206441

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.