Evidence map›Paper›PMID 40139716›Full record

Trial reportRheumatology (Oxford, England)2025

Ozoralizumab shows effectiveness regardless of baseline RF and ACPA titres in patients with RA: a post hoc analysis of the OHZORA trial.

Ryu Watanabe, Yoshiya Tanaka, Tsutomu Takeuchi, Shunsuke Okamoto, Masanao Kyuuma, Rumiko Matsumoto, Yoichi Nakayama, Masao Katsushima, Motomu Hashimoto

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIClinical Trial, Phase II
In one paragraph

Trial report in Rheumatology (Oxford, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Ozoralizumab, a trivalent anti-TNFα NANOBODYFrontiers in immunology · 2026
    Article
  3. 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

9 authors.

Ryu WatanabeDepartment of Clinical Immunology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan.
Yoshiya TanakaThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.ORCID 0000-0002-0807-7139
Tsutomu TakeuchiKeio University School of Medicine, Tokyo, Japan.
Shunsuke OkamotoTaisho Pharmaceutical Co, Ltd, Tokyo, Japan.
Masanao KyuumaTaisho Pharmaceutical Co, Ltd, Tokyo, Japan.
Rumiko MatsumotoTaisho Pharmaceutical Co, Ltd, Tokyo, Japan.
Yoichi NakayamaDepartment of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID 0000-0002-8130-4350
Masao KatsushimaDepartment of Clinical Immunology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan.
Motomu HashimotoDepartment of Clinical Immunology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan.ORCID 0000-0002-9241-060X

Funding

AbbVieAstraZenecaTaisho Pharmaceutical Co.
6 · The paper itself

Abstract

objectivesOzoralizumab (OZR) is a next-generation anti-TNF NANOBODY® compound. The primary objective was to evaluate the efficacy of OZR in patients with RA in varying RF and anti-citrullinated peptide antibody (ACPA) titres. The secondary objective was to evaluate the changes in RF and ACPA titres following OZR treatment.

methodsA post hoc analysis was conducted on data from the Phase II/III OHZORA trial, which included 381 Japanese patients with RA who were treated with either 30 or 80 mg OZR over 52 weeks after demonstrating an inadequate response to MTX. Patients were classified into four groups based on the baseline RF or ACPA titre quartiles. The disease activity scores, RF and ACPA titres, plasma OZR concentrations and OZR-neutralizing antibody levels were evaluated. Statistical analyses included the Kruskal-Wallis test, two-way ANOVA and correlation analysis.

resultsTreatment with OZR 30 mg significantly reduced disease activity in all the groups (P < 0.001), and the reduction in disease activity scores was comparable among the groups. Treatment with OZR 30 mg decreased the mean RF and ACPA titres from 149.5 to 71.1 IU/ml (P < 0.001) and 299.6 to 237.6 U/ml (P < 0.001), respectively. Effective trough concentrations of OZR were maintained for up to 52 weeks in all the groups, and baseline RF and ACPA titres were not associated with the generation of OZR-neutralizing antibodies.

conclusionOZR is an effective anti-TNF treatment for RA, regardless of RF and ACPA titres, and exhibits promise as a novel therapeutic option.

Indexed as

Antibodies, Monoclonal, HumanizedAnti-Citrullinated Protein AntibodiesAntirheumatic AgentsArthritis, RheumatoidRheumatoid FactorAdultAgedFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedAnti-Citrullinated Protein AntibodiesAntirheumatic AgentsRheumatoid FactorinhibitorNANOBODY®ozoralizumabRARFtumour necrosis factor-αVHH antibody

Identifiers

PMID40139716
PMCPMC12212905

What OpenQuestion holds

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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.