Evidence map›Paper›PMID 30078086›Full record

Trial reportClinical rheumatology2018

Structural damage progression in patients with early rheumatoid arthritis treated with methotrexate, baricitinib, or baricitinib plus methotrexate based on clinical response in the phase 3 RA-BEGIN study.

Désirée van der Heijde, Patrick Durez, Georg Schett, Esperanza Naredo, Mikkel Østergaard, Gabriella Meszaros, Francesco De Leonardis, Inmaculada de la Torre, Pedro López-Romero, Douglas Schlichting and 2 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical rheumatology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Efficacy of methotrexate in reducing the risk of bone erosion in patients with rheumatoid arthritis: a systematic review of randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    Pooled it
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  12. JAK Inhibition as a New Treatment Strategy for Patients with COVID-19.International archives of allergy and immunology · 2020
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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

12 authors.

Désirée van der HeijdeLeiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands. mail@dvanderheijde.nl.
Patrick DurezPôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain and Service de Rhumatologie, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
Georg SchettFriedrich-Alexander University Erlangen-Nuremberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Esperanza NaredoHospital Universitario Fundación Jimenez Diaz, Madrid, Spain.
Mikkel ØstergaardCopenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Gabriella MeszarosEli Lilly & Company, Indianapolis, IN, USA.
Francesco De LeonardisEli Lilly & Company, Indianapolis, IN, USA.
Inmaculada de la TorreEli Lilly & Company, Indianapolis, IN, USA.
Pedro López-RomeroEli Lilly & Company, Indianapolis, IN, USA.
Douglas SchlichtingEli Lilly & Company, Indianapolis, IN, USA.
Eric NantzEli Lilly & Company, Indianapolis, IN, USA.
Roy FleischmannMetroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.

Funding

Eli Lilly and Company N/A
6 · The paper itself

Abstract

The objective of this study was to evaluate structural damage progression based on clinical response in rheumatoid arthritis patients with no or limited prior disease-modifying anti-rheumatic drug treatment receiving the Janus kinase (JAK)1/JAK2 inhibitor baricitinib 4 mg, methotrexate (MTX), or the combination. Data from the phase 3 RA-BEGIN study were analysed post hoc. Proportions of patients with structural damage progression (change from baseline greater than the smallest detectable change in modified total Sharp score) at week 52 were evaluated based on sustained Disease Activity Score for 28-joint count with serum high-sensitivity C-reactive protein (DAS28-hsCRP) ≤ 3.2 or Simplified Disease Activity Index (SDAI) score ≤ 11; no formal statistical comparisons between treatments were performed to test these proportions. Baseline factors associated with risk of structural damage progression, including Clinical Disease Activity Index (CDAI) score, were identified using multivariate analysis. Patients achieving versus not achieving sustained DAS28-hsCRP ≤ 3.2 or SDAI score ≤ 11 were less likely to experience structural damage progression at week 52. In patients achieving these responses, structural damage progression was less likely with baricitinib monotherapy or plus MTX than with MTX monotherapy. In patients not achieving these sustained clinical thresholds, structural damage progression was less likely with baricitinib plus MTX than with either monotherapy. Independent of treatment, baseline factors significantly associated with increased risk of structural damage progression included higher hsCRP and CDAI score, smoking, female sex, and lower body mass index. In conclusion, patients achieving versus not achieving sustained DAS28-hsCRP ≤ 3.2 or SDAI score ≤ 11 were less likely to show structural damage progression, irrespective of treatment.

Indexed as

Disease ProgressionAntirheumatic AgentsArthritis, RheumatoidAzetidinesC-Reactive ProteinDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedOdds RatioPurinesPyrazolesSulfonamidesAntirheumatic AgentsAzetidinesbaricitinibC-Reactive ProteinMethotrexatePurinesPyrazolesSulfonamidesBaricitinibJoint damageMethotrexateRA-BEGIN studyRheumatoid arthritisStructural progression

Identifiers

PMID30078086
PMCPMC6097080

What OpenQuestion holds

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Registered trials

None linked

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.