Evidence map›Paper›PMID 40537275›Full record

Trial reportRMD open2025

Early effects of ozoralizumab 30 mg in patients with rheumatoid arthritis and inadequate response to methotrexate: a post hoc trajectory analysis of the phase II/III OHZORA trial.

Yusuke Miyazaki, Nobuko Horiuchi, Shunsuke Okamoto, Rumiko Matsumoto, Tsutomu Takeuchi, Yoshiya Tanaka

Abstract readClinical Trial, Phase IIRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in RMD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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.

Yusuke MiyazakiFirst Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.ORCID 0000-0001-5692-3881
Nobuko HoriuchiTaisho Pharmaceutical Co Ltd, Tokyo, Japan.
Shunsuke OkamotoTaisho Pharmaceutical Co Ltd, Tokyo, Japan.
Rumiko MatsumotoTaisho Pharmaceutical Co Ltd, Tokyo, Japan.
Tsutomu TakeuchiSaitama Medical University, Iruma, Japan.
Yoshiya TanakaFirst Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan tanaka@med.uoeh-u.ac.jp.ORCID 0000-0002-0807-7139

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study assessed the early effects of ozoralizumab (OZR) 30 mg in patients with rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX-IR), drawing on OHZORA trial data for efficacy and safety insights.

methodsThe study included 141 patients with RA from the OHZORA trial, initiated on OZR 30 mg. The primary measure was the rate of achieving low disease activity (LDA) by the Clinical Disease Activity Index (CDAI) 3 days post-OZR initiation. Growth mixture modelling (GMM) of CDAI trajectories was performed to enable a more detailed analysis of the impact of OZR on disease activity improvement.

resultsThe retention rate of OZR up to 52 weeks was 87.9% (n=124). The LDA achievement rate on the third day of OZR introduction was 12.8% (n=18), and by week 52, 70.9% (n=100) had improved to LDA. Three distinct groups were identified using GMM: one group (n=78) reached LDA within 4 weeks of OZR initiation and maintained LDA up to week 52. Multiple logistic regression analysis revealed that both low baseline C-reactive protein (CRP) and low CDAI were independently associated with group membership.

conclusionOZR 30 mg demonstrated both immediate and sustained efficacy in MTX-IR patients with RA. Multivariate analysis suggested that both baseline inflammation and disease activity-represented by CRP and CDAI-may independently influence treatment response. However, residual confounding due to baseline disease activity cannot be completely excluded, and this remains a limitation of the present study.

Indexed as

Antibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidMethotrexateAdultAgedFemaleHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsMethotrexateRheumatoid ArthritisTreatmentTumor Necrosis Factor Inhibitors

Identifiers

PMID40537275
PMCPMC12182106

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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.