Evidence map›Paper›PMID 41381211›Full record

Trial reportRMD open2025

Efficacy of ozoralizumab in rheumatoid arthritis patients with large joint involvement: a post hoc analysis of OHZORA and NATSUZORA trials.

Kosuke Ebina, Shunsuke Okamoto, Masanao Kyuuma, Nobuko Horiuchi, Rumiko Matsumoto, Yuki Etani, Takaaki Noguchi, Yoshiya Tanaka, Tsutomu Takeuchi

Abstract readRandomized Controlled Trial
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 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. Article
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

9 authors.

Kosuke EbinaDepartment of Orthopaedic Surgery, Osaka University Faculty of Medicine Graduate School of Medicine, Suita, Japan k-ebina@ort.med.osaka-u.ac.jp.ORCID 0000-0002-2426-1024
Shunsuke OkamotoTaisho Pharmaceutical Co., Ltd, Tokyo, Japan.
Masanao KyuumaTaisho Pharmaceutical Co., Ltd, Tokyo, Japan.
Nobuko HoriuchiTaisho Pharmaceutical Co., Ltd, Tokyo, Japan.
Rumiko MatsumotoTaisho Pharmaceutical Co., Ltd, Tokyo, Japan.
Yuki EtaniDepartment of Sports Medical Biomechanics, Osaka University Graduate School of Medicine, Suita, Japan.ORCID 0000-0001-5741-5969
Takaaki NoguchiDepartment of Orthopaedic Surgery, Osaka University Faculty of Medicine Graduate School of Medicine, Suita, Japan.ORCID 0000-0001-9938-6780
Yoshiya TanakaDepartment of Molecular Targeted Therapeutics, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.ORCID 0000-0002-0807-7139
Tsutomu TakeuchiKeio University School of Medicine, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo compare the efficacy of ozoralizumab in patients with rheumatoid arthritis (RA), with or without large joint involvement (LJI).

methodsA post hoc analysis was conducted for Japanese patients with RA who received ozoralizumab 30 mg every 4 weeks for 52 weeks in the previous OHZORA (with concomitant methotrexate) and NATSUZORA (without concomitant methotrexate) randomised trials. Patients were subgrouped by LJI, defined as the presence of swelling in the shoulder, elbow, knee or ankle. Disease activity, physical dysfunction, blood inflammatory marker levels and progression of joint destruction during treatment were examined.

resultsThe numbers of patients included were 152 for the OHZORA trial (111 with LJI, 41 without LJI) and 94 for the NATSUZORA trial (72 with LJI, 22 without LJI). The completion rates of both trials did not differ significantly between the patient groups. Baseline Clinical Disease Activity Index scores were significantly higher in patients with LJI than in those without LJI, but this difference was not present as early as day 3 of ozoralizumab treatment and at most subsequent assessments. A similar trend was observed for patient-reported/physician-reported outcomes and Health Assessment Questionnaire. Blood interleukin-6 and matrix metalloproteinase-3 levels in patients with LJI continuously decreased during treatment. Changes in modified Total Sharp Score at week 24 were similar between the groups in the OHZORA trial.

conclusionOzoralizumab has the potential to improve disease activity and physical dysfunction and prevent joint destruction in patients, regardless of the presence of LJI, and is a reasonable treatment option, even for patients with LJI. TRIAL REGISTRATION NUMBER: jRCT2080223971 and jRCT2080223973.

Indexed as

Antibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidJointsAdultAgedBiomarkersFemaleHumansMaleMatrix Metalloproteinase 3MethotrexateMiddle AgedSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsBiomarkersMatrix Metalloproteinase 3Methotrexatearthritis, rheumatoidbiological therapycytokinesinflammationtumor necrosis factor inhibitors

Identifiers

PMID41381211
PMCPMC12699771

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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.