Evidence map›Paper›PMID 41407433›Full record

Observational studyRMD open2025

Comparison of long-term efficacy, tolerability and drug survival rates of baricitinib as monotherapy or combination therapy in RA patients: data from a real-world prospective cohort study.

Alp Temiz, Koray Tascilar, Arnd Kleyer, Axel J Hueber, Fabian Hartmann, Georg Schett, Sara Bayat

Abstract readObservational StudyComparative Study
In one paragraph

Observational study in RMD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

1 citing paper in PubMed.

  1. Observational
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

7 authors.

Alp TemizDepartment of Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.ORCID 0000-0003-0804-3198
Koray TascilarDepartment of Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.ORCID 0000-0002-8109-826X
Arnd KleyerDepartment of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Axel J HueberDivision of Rheumatology, Klinikum Nürnberg, Paracelsus Medical University, Nürnberg, Germany.
Fabian HartmannDepartment of Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Georg SchettDepartment of Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Sara BayatDepartment of Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany Sara.Bayat@uk-erlangen.de.ORCID 0000-0002-2799-184X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundJanus kinase inhibitors (JAKi), like baricitinib, are used as monotherapy (MONO) and in combination with methotrexate (MTX) in rheumatoid arthritis (RA) patients. This study aimed to evaluate the long-term efficacy, drug survival and safety of baricitinib MONO versus combination therapy (COMBO) in a prospective cohort of patients with RA.

methodsWe analysed data from 219 RA patients initiating baricitinib in a single-centre, prospective observational cohort between 2017 and 2023. Clinical data, patient-reported outcomes and safety events were collected every 3 months. Drug survival was analysed using the Kaplan-Meier method, and longitudinal outcomes were assessed using linear mixed-effects models.

resultsThe cohort included 219 patients (165 MONO, 54 COMBO) with high baseline disease activity (mean DAS28-ESR 4.0). Both groups showed rapid and sustained clinical improvement, with disease activity stabilising in the low range by 6 months of treatment. One third of the patients (n=72, 33%) achieved Boolean remission, with no significant difference between groups (p=0.35). Median drug survival was 36 months and was similar for both regimens (log-rank p=0.82). Discontinuation due to adverse events occurred in 10.9% of patients. Four thrombotic events were noted, all in patients with pre-existing cardiovascular risk factors, with no new safety signals emerging.

conclusionsIn this real-world cohort, baricitinib demonstrated sustained long-term effectiveness, drug survival and an acceptable safety profile. The similar outcomes observed for MONO and COMBO indicate that baricitinib may be used effectively as MONO in patients with RA for whom MTX is not suitable or tolerated.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAzetidinesPyrazolesSulfonamidesAdultAgedDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedProspective StudiesPurinesTreatment OutcomeAntirheumatic AgentsAzetidinesbaricitinibMethotrexatePurinesPyrazolesSulfonamidesArthritis, RheumatoidDMARDEpidemiology

Identifiers

PMID41407433
PMCPMC12716592

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Registered trials

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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.