Evidence map›Paper›PMID 42367664›Full record

ArticleEULAR rheumatology open2025

Individualised treatment effect prediction: the benefit of initial biological treatment in early rheumatoid arthritis.

Sina Fadaei, Julia Spierings, Jacob M van Laar, Johannes W J Bijlsma, Johannes W G Jacobs, Paco M J Welsing

Registry-linked trialAbstract read
In one paragraph

Article in EULAR rheumatology open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01007435 (A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab), 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.

NCT01007435 phase3completednot on this map

A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis

TypeinterventionalSponsorHoffmann-La RocheRan2009 to 2014Enrolled1,162ConditionsRheumatoid ArthritisArmsTocilizumab, Placebo to tocilizumab, Methotrexate, Placebo to methotrexate
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

6 authors.

Sina FadaeiUniversity Medical Center Utrecht, Department of Rheumatology & Clinical Immunology, Utrecht, The Netherlands.
Julia SpieringsUniversity Medical Center Utrecht, Department of Rheumatology & Clinical Immunology, Utrecht, The Netherlands.
Jacob M van LaarUniversity Medical Center Utrecht, Department of Rheumatology & Clinical Immunology, Utrecht, The Netherlands.
Johannes W J BijlsmaUniversity Medical Center Utrecht, Department of Rheumatology & Clinical Immunology, Utrecht, The Netherlands.
Johannes W G JacobsUniversity Medical Center Utrecht, Department of Rheumatology & Clinical Immunology, Utrecht, The Netherlands.
Paco M J WelsingUniversity Medical Center Utrecht, Department of Rheumatology & Clinical Immunology, Utrecht, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: Initiating biologics upfront in early disease-modifying antirheumatic drugs (DMARDs)-naïve rheumatoid arthritis (RA) may benefit selected patients more than starting with methotrexate (MTX) monotherapy. Current guidelines recommend using prognostic markers to define high-risk groups for early biological treatment. Predictive models combining these markers could better identify individuals likely to benefit. This study aimed to develop and validate models predicting the benefit of starting tocilizumab (TCZ) plus MTX over MTX alone in early DMARD-naïve RA. Methods: We used data from the FUNCTION trial (NCT01007435, Results: Both models aligned with observed outcomes. In U-Act-Early, patients selected by the models for TCZ + MTX had an average CDAI reduction compared with MTX alone of 7 points, compared with 3 points in those not selected. The number needed to treat (NNT) to achieve an average CDAI ≤22 (below high disease activity) over 6 months was 12 for the full trial population and 5 in model-selected patients. Conclusions: Our prediction models identified early patients with RA more likely to benefit from initiating TCZ + MTX over MTX monotherapy, reducing the NNT to a clinically acceptable threshold of 5.

Identifiers

PMID42367664
PMCPMC13292418

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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.